1
1 MOST PRESCRIBED, BRANDED BOWEL PREP KIT1 #
WINTER 2017 ISSUE GASTRO MAGAZINE
2
FIVE-STAR EFF1CACY ® WITH SUPREP Distinctive results in all colon segments >90% no residual stool in all colon segments compared to Standard 4-Liter Prep2*†‡ • These results were statistically significant in the cecum (P=.010)2*§ • Significantly more patients in the SUPREP group had no residual fluid in 4 out of 5 colon segments2*‡ Help meet the Gastroenterology Quality Improvement Consortium (GIQuIC) benchmark for 85% quality cleansing3 with the split-dose efficacy of SUPREP Bowel Prep Kit.4 *This clinical trial was not included in the product labeling. †Standard 4-Liter Prep [sulfate-free polyethylene glycol (PEG) electrolyte lavage solution]. ‡Based on investigator grading. §Statistically significant difference. References: 1. IMS Health, NPA Weekly, July 2016. 2. Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reducedvolume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010;72(2):328-336. 3. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53. 4. SUPREP Bowel Prep Kit [package insert]. Braintree, MA: Braintree Laboratories, Inc; 2012.
©2016 Braintree Laboratories, Inc. All rights reserved.
16-00927A
August 2016
IMPORTANT SAFETY INFORMATION SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance.
BRIEF SUMMARY: Before prescribing, please see full Prescribing Information and Medication Guide for SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution. INDICATIONS AND USAGE: An osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. WARNINGS AND PRECAUTIONS: SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Pre-dose and post-colonoscopy ECG’s should be considered in patients at increased risk of serious cardiac arrhythmias. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance. Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether this product can cause fetal harm or can affect reproductive capacity. Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Geriatric Use: Of the 375 patients who took SUPREP Bowel Prep Kit in clinical trials, 94 (25%) were 65 years of age or older, while 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of SUPREP Bowel Prep Kit administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients. DRUG INTERACTIONS: Oral medication administered within one hour of the start of administration of SUPREP may not be absorbed completely. ADVERSE REACTIONS: Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. Oral Administration: Split-Dose (Two-Day) Regimen: Early in the evening prior to the colonoscopy: Pour the contents of one bottle of SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Consume only a light breakfast or have only clear liquids on the day before colonoscopy. Day of Colonoscopy (10 to 12 hours after the evening dose): Pour the contents of the second SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Complete all SUPREP Bowel Prep Kit and required water at least two hours prior to colonoscopy. Consume only clear liquids until after the colonoscopy. STORAGE: Store at 20°-25°C (68°-77°F). Excursions permitted between 15°-30°C (59°-86°F). Rx only. Distributed by Braintree Laboratories, Inc. Braintree, MA 02185.
For additional information, please call 1-800-874-6756 or visit www.suprepkit.com
©2016 Braintree Laboratories, Inc. All rights reserved.
16-00927A
August 2016
3
Gastro Health Welcomes You
WINTER 2017 ISSUE GASTRO MAGAZINE
Happy New Year from Gastro Health! It is with much pleasure and anticipation that we present the 2017 winter issue of the Gastro Health Magazine, dedicated to Colon Cancer awareness. This issue features Terrence Howard, known to many as Lucious Lyon, the lead character in the television series Empire. Mr. Howard joined the Colon Cancer Alliance to share his personal story. In the article, he shares the importance of colon cancer screening starting at age 50 and sooner if you have a family history of colon cancer. Being the third leading cause of cancer deaths in the U.S.A., in both men and women, early detection makes all the difference in the fight to prevent colon cancer. In addition to colon cancer prevention, this issue features articles on the use of anesthesia during procedures, esophageal reflux also known as GERD, and the introduction of Balloongi, a new non-surgical weight-loss endoscopic procedure combined with a diet and exercise plan. If weight-loss is one of your new year’s resolution, you should participate in our monthly educational seminars to learn more about the program. For more information visit www.Balloongi.com. The physicians and staff of Gastro Health wish you and your family health and hapiness in 2017. Alejandro Fernandez MBA, CMPE Chief Executive Officer
Index
Pages
HOW TO STICK TO YOUR NEW YEAR’S RESOLUTIONS?
6
TERRENCE HOWARD
8
ORBERA: THE WEIGHT LOSS SOLUTION WITHOUT SURGERY
10
SURGICAL APPROACH TO COLON CANCER
12
MICROSCOPIC COLITIS
14
ALTERNATIVE METHODS FOR COLON CANCER SCREENING
20
GASTROESOPHAGEAL REFLUX DISEASE
22
COMFORT AND CARE FOR ENDOSCOPIC PROCEDURES
27
DO I NEED TO STOP MY HEARTBURN MEDICATION?
30
Designed and Published by:
9500 South Dadeland Boulevard Suite 200, Miami, FL 33156 T. 305.468.4180
www.gastrohealth.com
Copyright © 2015 Gastro Health, P.L. All rights reserved. This publication is published by Gastro Health, P.L., which is solely responsible for its contents. This information presented is intended only for residents of the United States. The material presented is intended only as informational, or as an educational aid, and it is not intended to be taken as medical advice. The ultimate responsibility for patient care resides with a healthcare professional.
12000 Biscayne Boulevard Suite 703, Miami, FL 33181 T. 305.820.0690 info@creativemindworks.com
All rights reserved. Cover Photo Credit: Getty Images
Caring for you and those you love.
MISSION
To provide outstanding medical care and an exceptional healthcare experience.
GUIDING PRINCIPLE
We will treat each patient as a valued member of our immediate family.
CORE VALUES Care and Compassion Provide competent, individualized care in a professional, respectful and caring way. Teamwork Recognize each other as valuable members of our healthcare team by treating one another with loyalty, respect and dignity. Responsibility Provide excellent and efficient administrative, accounting, personnel and business management services. Value and Excellence Develop valuable ancillary services that improve our patients’ quality of care and customer experience.
Honesty and Integrity Communicate openly and honestly, build trust and conduct ourselves according to the highest ethical standards. Stewardship Attract and retain great talent and the finest gastroenterologists by actively promoting a professionally satisfying work environment. Accountability Maintain mutually beneficial relationships with top referring physicians, payers, employers and health systems using performance, outcome, as well as satisfaction measurements to demonstrate accountability and improvement in our care delivery.
5
BY Jessica Tejera Health & Weight Loss Coach
WINTER 2017 ISSUE GASTRO MAGAZINE
How to Stick to your New Year’s Resolutions?
F
or many of us, the beginning of the year starts with a New Year’s Resolution. However, it can be quite challenging to stay on track. Statistically only about 8% of people can achieve their resolutions. How can you beat those odds? I have included some helpful tips to accomplish your New Year’s Resolutions. Setting realistic goals for long-term results Choosing a realistic goal is essential to ensuring you are successful. If you break your resolution into small parts it will seem much easier to succeed. For instance, your goal is to lose 25 pounds in 4 months. Start with one month at a time, and focus on making healthy changes. Make goals for each month, perhaps 7-8 pounds for the first month, and 5-6 pounds for the following three months. To help with the process, you may want to incorporate 30 minutes of exercise a day. If you typically don’t walk on a regular basis, then you may want to start with 15 minutes a day for two weeks and increase 5 minutes to your walk each week.
Focus on how, not when If you stick to resolutions that you have control over, you will have a better chance of success. Want to lose 25 pounds? Incorporating a healthy diet and exercise regimen is more important than the numbers on that scale. If you maintain a healthy lifestyle, the weight will come off. Focus on goals such as adding 3-5 servings of vegetables and drinking 64 ounces of water daily. These are things you have control over. Set time aside for your resolution It can be difficult to set aside time for things we like to do, let alone for resolutions that are challenging. Try to schedule your workout sessions into your calendar like you would for an event. Setting an alert on your phone would provide you with that extra motivation to go to the gym. Have coping strategies Things don’t always go as planned, so how do we cope? You planned to eat a healthy lunch today, but you were invited out for a friend’s birthday and ate too much. Don’t
fret, look for the healthiest options available such as grilled, oven-baked or steamed. As for the side items, you can never go wrong with steamed vegetables or a salad. Always ask for the dressing on the side, so you can control how much you add. Making this minor adjustment can save you over 100 calories. Another great coping strategy is having a buddy system. A friend or family member can lend a sense of support. They can keep you on track and challenge you to stick to your goals. It is important to remember there may be a slip up while working towards your goals. Don’t throw in the towel or be too hard on yourself. Move forward, tomorrow is a new day and you will be one step closer to success. Using these techniques will help you stick with your goals and to be proud of all your accomplishments. References: http://www.apa.org/helpcenter/resolution.aspx http://www.webmd.com/balance/features/newyears-resolutions-in-one-year-out-other
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© Janssen Biotech, Inc. 2015 12/15 043635-151119
7
WINTER 2017 ISSUE GASTRO MAGAZINE
Actor I Producer I Singer I Song Writer By Owen Johnston
B
orn on March 11, 1969 in Chicago, Terrence Howard wanted to be an actor from an early age. At sixteen, he moved to New York City to attend college and to pursue his dream of landing on the silver screen.
Terrence attended Pratt University and started acting in a series of small TV roles. In 1995, he began landing major roles in Dead Presidents and Mr. Holland’s Opus. Terrence’s star continued to rise, and in 2005 he received nominations from The Screen Actors Guild and The Golden Globes for his role in Hustle and Flow. Today, he is a household name known especially for his role as “Lucious Lyon” on HBO’s hit show Empire. Nowadays, Terrence is also known for his fight against colon cancer. His mother died tragically of the disease at the young age of 56, in 2008. Terrence attributes his success in acting to the determination she taught him, and he reports that her death has left a void in his life. “I miss her voice and her gentle kindness”.
“I miss her voice and her gentle kindness”
Terrence admits that had her cancer been detected earlier, she might be alive today. By the time she was diagnosed at age 50, the cancer was already at stage 3. She then battled the disease for six years until her untimely death at age 56. Terrence stresses that with proper screening, her death could have been prevented. That’s why he works so hard to advocate for regular colon cancer screening, especially for high risk groups such as African-Americans or those with a family history of the disease. Today, Terrence honors his mother’s death by helping to fight this disease in her name. He knows she would be proud of his efforts to save the lives of others. By volunteering with The Colon Cancer Alliance, he is spreading the critical message that screening and early detection can defeat colon cancer. Colon cancer claims the lives of over 50,000 American men and women each year. It is most often found in those over 50, but many groups are at an even higher risk. However, routine screening can prevent this terrible disease. Call your doctor today to ask if you should be screened for colon cancer. It could be the most important phone call of your life.
9
BY Roberto Gonzales, MD Gastroenterologist
WINTER 2017 ISSUE GASTRO MAGAZINE
BALLOONGI: The weight loss solution without surgery
O
besity has become one of this
weight maintenance in patients with obesity.
the balloon, several consultations with
country’s fastest growing medical epidemics,
ORBERA is a safe and effective non-surgical
a
affecting over 78 million people. In fact, 1
weight loss program with 20 years of global
counseling from a registered dietician for
in every 3 Americans are now considered
experience and real world results.
one year.
obese. It is estimated that by 2030, 50% of
more than 220,000 ORBERA balloons have
all Americans will be obese. It is a major risk
been used in over 80 countries. Gastro Health
Gastro Health is pleased to offer this new,
factor for developing high blood pressure,
will be one of the first in the United States to
non-invasive treatment that can help
diabetes, heart disease, heart attacks and
offer this new tool to help patients achieve
patients with obesity to treat their illness
stroke.
their weight loss goals.
now, before disease progression causes
Obesity is measured using the Body Mass
The Balloongi Weight Loss Program is a
Index (BMI) which is a calculation of body fat
comprehensive,
loss
To learn more about BALLOONGI and
based on height and weight. A person with a
program that includes the Orbera gastric
ORBERA, we invite you to one of our free
BMI between 30 and 40 is considered obese.
balloon placed in the patient’s stomach to
informative sessions or visit:
A BMI above 40 indicates morbid obesity.
reinforce proper portion control.
www.balloongi.com today.
Patients in this category have had success
ORBERA collected in a U.S. clinical trial has
with surgical procedures for weight loss, but
shown that the average person lost 3.1 times
what about those people with a BMI between
the weight as compared with diet and exercise
30 and 40 who do not want to undergo
alone over a six-month period.
So far,
Gastroenterologist,
and
nutritional
the need for more invasive procedures. non-surgical
weight
Data on
invasive surgery? The balloon is inserted into the patient’s Gastro Health introduces Balloongi, a new
stomach during an upper endoscopy and left
weight loss program designed to get your
in place for 6 months. It produces a feeling of
New Year’s resolution off to a positive start.
fullness which helps the patient to consume
The U.S. Food and Drug Administration has
smaller portions. The integrative one-year
approved ORBERA® for weight loss and
plan includes placement and removal of
11
BY Rodolfo Pigalarga, MD Colorectal Surgeon
Surgical approach to colon cancer
C
most
surgical resection, unless it has spread to distal
commonly diagnosed cancer in the US in
organs. In that case, the cancer is defined as
both men and women, and it’s also the third
metastatic and is incurable even though
leading cause of cancer deaths, overall.
chemotherapy protocols have made great
Recent estimates from the American Cancer
advances in prolonging the survival of these
Society indicated that approximately 140,000
patients.
olon
cancer
is
the
third
patients were diagnosed with colon cancer in 2011 and approximately 49,000 died from the
Surgery consists of removing the segment of
disease.
the colon containing the cancer along with the
WINTER 2017 ISSUE GASTRO MAGAZINE
lymph nodes related to that specific segment. The majority of these cancer diagnosis and
The two most important prognostic factors of
deaths can be prevented by early screening
a good operation are the presence of clean
tests such as Fecal Occult Blood Test, Stool
surgical margins of resection, indicating that
DNA Test and Colonoscopy. This approach
the cancer has been completely removed,
has been successful, because most of these
and negative lymph nodes, which indicates
cancers develop from colon polyps, which
that cancer cells have not started to spread
are benign growths of the inner lining of the
outside of the mass and into the blood stream.
colonic mucosa. Even though most polyps will
When tumor cells are noted at the surgical
not become cancer, detecting and removing
margins during pathologic analysis, prognosis
them can prevent cancer from occurring.
becomes very poor and even chemotherapy might not be effective enough to prevent local
increased
recurrence and progression of the cancer. On
adoption of these tests over the past years,
the other hand, if the margins are clear but
an unprecedented decrease in colon cancer
the lymph nodes appear affected by cancer,
incidence and death rates has been reported.
chemotherapy can significantly increase the
Unfortunately, only about half of people
chances of survival.
Thanks
to
the
significantly
techniques can significantly
aged 50 or older still have been following
expedite the
been
patient’s recovery from surgery because of
developed over the past several years. The
reduced postoperative pain, faster recovery
Overall prognosis and risk of recurrence
traditional “open” surgery consists of exposing
of bowel function, decreased hospital stay and
depends on the stage of the cancer, which
the abdominal cavity through a large midline
decreased risk of postoperative wound issues
indicates how deep into the colon wall the
incision, while the more recent minimally
such as wound infection and hernias.
cancer extends and whether cancer cells have
invasive procedures (such as laparoscopic,
spread to nearby lymph nodes or to distant
laparoscopic
robotic
The less invasive procedures are slightly
organs, most commonly the liver or lungs. The
surgery) adopt the use of small incisions to
shorter in duration and lower in cost as these
more advanced and the more aggressive the
insert a camera and small instruments into
patients are usually discharged from the
tumor, the higher the chances of recurrence
a CO2-filled abdominal cavity in order to
hospital much earlier than those that have
and death. In those cases, chemotherapy can
perform the resection.
undergone open procedures.
The results and the effectiveness of these
The feasibility of minimally invasive surgery
two approaches are similar as long as the
depends on whether the patient is a good
of
margins of resection and the obtained lymph
candidate for the procedure and whether that
chemotherapy protocols, the most effective
nodes are negative. It has been proven,
particular surgeon is experienced in minimally
approach to colon cancer treatment remains
time and time again, that minimally invasive
invasive surgery.
Multiple
recommended screening guidelines.
surgical
techniques
hand-assisted
have
and
significantly decrease mortality rates and increase survival rates. Despite
the
increased
effectiveness
13
BY Francisco J Baigorri, MD Gastroenterologist
Microscopic Colitis
C
olitis is an inflammation of the lining
of the colon (large intestine) that can cause chronic diarrhea. There is a myriad of reasons
WINTER 2017 ISSUE GASTRO MAGAZINE
why colitis may occur, including infection with bacteria, viruses, parasites, Crohn’s
anti-inflammatory drugs (NSAIDS: ibuprofen,
the treatment of microscopic colitis. In more
Disease and ulcerative colitis. Among the
naprosyn), SSRI type antidepressants, and
severe cases of diarrhea, corticosteroids can
variations of colitis, microscopic colitis is
antacids such as the PPI’s (omeprazole,
be used as treatment. Corticosteroids are
unique. A routine colonoscopy may reveal a
lansoprazole, pantoprazole, etc.) may trigger
medications that decrease inflammation and
normal looking lining of the colon, yet under
or
reduce the activity of the immune system.
the light of a microscope, the biopsies will
predisposition also has been implicated as
However,
show inflammation. Similarly, Irritable Bowel
the cause of microscopic colitis. There may
many side effects. Budesonide, is a type of
Syndrome can cause chronic diarrhea and
also be an increased incidence of microscopic
corticosteroid that is considered to be safer
a colonoscopy will reveal a normal looking
colitis in patients with celiac disease. The
with fewer side effects, than others such as
lining of the colon, and the biopsies of the
typical case of microscopic colitis is a middle
prednisone. Therefore, this is the treatment
colon will be normal. For these reasons, IBS is
aged woman with gradual onset of chronic,
of choice.
not considered a type of colitis.
non-bloody, watery diarrhea that persists
over months to years. It may worsen with
So, if you or someone you know suffers from
There are two types of microscopic colitis.
the
happens
diarrhea that has lasted for weeks, please
One is collagenous colitis in which there is
during menopause. The chances of getting
contact your gastroenterologist for further
an abnormal layer of protein (collagen). The
microscopic colitis increase if the patient is
evaluation and management. Microscopic
other is lymphocytic colitis where instead
female, older than 50 years, smoking (past
colitis is a chronic condition with symptoms
of the collagen layer, you find white blood
or present), on medications that have been
that may come and go intermittently and
cells (lymphocytes) underneath the lining
linked to the disease and is suffering from
cannot be diagnosed with blood tests
of the colon. They both have very similar
an autoimmune disease (type 1 diabetes,
or stool studies. In order to diagnose
presentations, symptoms and treatments.
autoimmune thyroiditis).
microscopic colitis, a physician must obtain
The best test to diagnose microscopic colitis
be easily treated and symptoms managed so
is a colonoscopy with biopsies of the right and
There is no evidence that microscopic colitis
patients can function normally.
left colon. There are two types of procedures
leads to an increase risk of colon cancer, as
by which the colon is evaluated: a colonoscopy
with ulcerative colitis. The clinical course
and a sigmoidoscopy. A colonoscopy is the
of microscopic colitis is not as aggressive
complete evaluation of the entire colon, while
as Crohn’s Disease and ulcerative colitis.
a sigmoidoscopy is a simpler procedure that
Management of microscopic colitis includes
only looks at the last 1/3 of the colon. The
lifestyle changes aimed at reducing the
physician is more likely to find abnormalities
diarrhea and discontinuing drugs like Nsaids
through a colonoscopy than through a
and PPi’s. Dietary recommendations include
sigmoidoscopy. Thus, a colonoscopy is the
reducing the amount of caffeine, lactose
preferred diagnostic procedure.
and fat in the diet. In many cases, treatment
with antidiarrheal medications is necessary.
worsen
microscopic
hormonal
imbalance
colitis. Genetic
that
these
medications
can
have
a biopsy from the colon. In most cases, it can
It’s not clear exactly why microscopic colitis
Loperamide, Bismuth (Pepto Bismol), bulking
develops, but there’s very likely more than one
agents like psyllium, or bile acid binding resins
reason. Certain drugs such as nonsteroidal
like cholestyramine are commonly used in
References: 1.Incidence, Prevalence, and Temporal Trends of Microscopic Colitis: A Systematic Review and Meta-Analysis. Tong J, Zheng Q, et al: Am J Gastroenterol; 2015;110 (February): 265-276. 2.Nguyen GC, Smalley WE, Vege SS, CarrascoLabra A, Clinical Guidelines Committee. American Gastroenterological Association Institute guideline on the medical management of microscopic colitis. Gastroenterology. 2016 Jan;150(1):242-6.
TOGETHER WE CAN BEAT CROHN’S The right support makes a difference. That’s why for over a decade, at UCB, Inc. we have been supporting the Crohn’s community online at CrohnsandMe.com. You can find tips, recipes, stories from others in the community, and educational info about the disease. Visit CrohnsandMe.com or our Crohn’s and Me Facebook page to learn more!
15
Francisco J. Baigorri, MD * Gastroenterologist
Simon Behar, MD * Gastroenterologist
Barry E. Brand, MD Gastroenterologist
Gustavo Calleja, MD * Gastroenterologist
Marc S. Carp, MD Gastroenterologist
CC1
CC3
CC2
CC1
CC6
Lewis R. Felder, MD Gastroenterologist
Edward Feller, MD Gastroenterologist
Jose P. Ferrer Jr., MD * Gastroenterologist
Jose P. Ferrer Sr., MD * Gastroenterologist
CC7
C C15
CC3
CC3
WINTER 2017 ISSUE GASTRO MAGAZINE
Steven Christie, MD Radiologist, Imaging Center
Amy Fisch, DO Anesthesiologist
Harris I. Goldberg, MD Gastroenterologist CC1
Paul G. Fishbein, MD Gastroenterologist
Nelson Garcia Jr., MD * Gastroenterologist
Pamela L. Garjian, MD* Gastroenterologist
Daniel Gelrud, MD * Gastroenterologist
C C18
CC3
C C16
CC1
Pedro J. Greer Jr., MD * Gastroenterologist
Mitchell Gregg, MD Radiologist, Imaging Center
Guillermo Gubbins, MD * Gastroenterologist
Roberto Gonzalez, MD * Gastroenterologist CC1
C C11
CC10
Alfredo J. Hernandez, MD * Gastroenterologist
Eugenio J. Hernandez, MD * Gastroenterologist
Moises E. Hernandez, MD * Gastroenterologist
Richard E. Hernandez, MD * Gastroenterologist
Enrique Hernandez-Sanchez, MD*
CC11
CC3
CC3
CC5
C C14
Pediatric Gastroenterologist
Eduardo Krajewski, MD * Colorectal Surgeon
Vicente Lago, MD * Gastroenterologist
Robert C. Lanoff, MD * Gastroenterologist
Jose A. Lavergne, MD * Gastroenterologist
James S. Leavitt, MD Gastroenterologist
CC9
C C19
CC2
CC7
CC1
Marc Lederhandler, MD Gastroenterologist
Irit Ludin-Ullman, MD* Anesthesiologist
CC1
Jerry Martel, MD, MPH * Gastroenterologist
Curtis L. McCarty III, MD Pathology Director
CC8
Flavia Mendes, MD * Gastroenterologist CC1
Pedro Morales, MD * Gastroenterologist
Brett R. Neustater, MD Gastroenterologist
Khristian Noto, MD * Colorectal Surgeon
Javier L. Parra, MD * Gastroenterologist
Leslie Perla MD, MPH Gastroenterologist
CC8
CC7
CC9
CC1
CC20
Rodolfo Pigalarga, MD* Colorectal Surgeon
Alfredo Rabassa, MD * Gastroenterologist
Gabriel Rodriguez, MD * Anesthesiologist
CC9
CC1
Andres I. Roig, MD * Gastroenterologist
Ricardo J. Roman, MD * Gastroenterologist
CC3
CC7
Jorge A. Rosario-Mulinelli, MD*
Pediatric Gastroenterologist
Seth D. Rosen, MD Gastroenterologist
Neil E. Rosenkranz, MD Gastroenterologist
S. Lawrence Rothman, MD Gastroenterologist
Eduardo Ruan, MD * Gastroenterologist
C C14
CC2
CC2
CC1
CC1
Andrew I. Sable, MD Gastroenterologist
George A. Sanchez, MD * Gastroenterologist
Howard I. Schwartz, MD Gastroenterologist
Somal S. Shah, MD * Gastroenterologist
Jason Slate, MD * Gastroenterologist
CC2
CC1
CC1
C C11
C C11
Arie Slomianski, MD * Gastroenterologist
Marcos Szomstein, MD * Colorectal Surgeon
Stefania L. Vernace, MD Gastroenterologist
CC1
CC9
CC1
* Habla EspaĂąol
17
Allied Healthcare Staff
Ellen Matas-Sosa, PA-C Care Center 1
Darlene Boytell-Perez, ARNP* Care Center 1
Carol Hernandez, PA-C Care Center 1
Jessica Jairala, PA-C * Care Center 1
Sabrina Kaplan, PA-C * Care Center 1
Rebecca Karousatos,MS,RD,LDN Care Center 1 & 2
Jose A. Miguel, PA-C * Care Center 1
Ronal R. Ricano, PA-C * Care Center 11
Yetzabel Rizo, ARNP * Care Center 1
Noe Tacoronte, PA-C * Care Center 1
Kayce Tugg, MSN, RN Infusion Center
Katiuska Iglesias, Pharm D * Specialty Pharmacy
* Habla Español
WINTER 2017 ISSUE GASTRO MAGAZINE
Care Centers
Insurances
Care Center 1 Main Office 7500 SW 87 Avenue, Suite 200 Miami, FL 33173 305-913-0666
Care Center 8 8200 SW 117 Avenue, Suite 110 Miami, FL 33183 305-274-5500
Care Center 19 351 NW 42nd Avenue, Suite 305 Miami, FL 33126 305-541-1041
Care Center 2 9555 N. Kendall Drive, Suite 100 Miami, FL 33176 305-273-7319
Care Center 9 7765 SW 87 Avenue, Suite 212 Miami, FL 33173 305-596-3080
Care Center 20 1157 S State Road 7 Wellington, FL 33414 561-214-6695
Care Center 3 8950 N. Kendall Drive, Suite 306-W Miami, FL 33176 305-596-9966
Care Center 10 475 Biltmore Way, Suite 207-A Coral Gables, FL 33134 305-662-6170
Imaging Center 7500 SW 87 Avenue, Suite 202 Miami, FL 33173 305-468-4190
Care Center 4 15955 SW 96 Street, Suite 307 Miami, FL 33196 305-468-4191
Care Center 11 3661 S. Miami Avenue, Suite 805 Miami, FL 33133 305-856-7333
Pathology Laboratory 12485 SW 137 Avenue, Suite 103 Miami, FL 33186 305-468-4194
Care Center 5 7765 SW 87 Avenue, Suite 105 Miami, FL 33173 305-274-0808
Care Center 13 9260 SW 72 Street, Suite 217 Miami, FL 33173 305-271-7330
Specialty Pharmacy 7500 SW 87 Avenue, Suite 202 Miami, FL 33173 305-468-4199
Care Center 6 1400 NE Miami Gardens Drive, Suite 221 North Miami Beach, FL 33179 305-949-2020
Care Center 14 9980 Central Park Blvd N., Suite 316 Boca Raton, FL 33428 561-206-6064
Care Center 7 Main Office 16855 NE 2nd Avenue, Suite 202 North Miami Beach, FL 33162 305-770-0062
Care Center 15 8353 SW 124 Street, Suite 203 Miami, FL 33156 305-259-8720
Care Center 7 Satellite Office #1 5803 NW 151 Street, Suite 105 Miami Lakes, FL 33014 305-770-0062
Care Center 16 8353 SW 124 Street, Suite 108 Miami, FL 33156 305-669-1115
Care Center 7 Satellite Office #2 21110 Biscayne Blvd, Suite 206 Aventura, FL 33180 305-770-0062
Care Center 18 8950 N. Kendall Drive, Suite 506W Miami, FL 33176 305-595-2710
AARP Medicare Complete Aetna American Heritage Life Insurance American Medical Security AvMed Baptist Executive Health Baptist International Beech street BHQN Blue Cross Blue Shield Care Plus (Colorectal only) Cigna Coventry Health Care Dimensions Health First Health Network Healthease of Florida HealthSun Health Plans Humana Humana Champus Tricare Leon Medical Center (Colorectal only) Magellan Healthcare Mail Handlers Benefit Plans Medica Health Plan Medicare Part B Molina Healthcare MultiPlan Neighborhood Health Plan Preferred Care Partners Prestige Health Choice Simply Healthcare Sunshine Health United Healthcare Wellcare / Staywell Only accepted at our Pediatric Care Centers
SIDE EFFECTS INCLUDE Increased Sales Brand Awareness Happy Customers
Convenient and Compassionate
305.820.0690 WWW.CREATIVEMINDWORKS.COM
Baptist Health Endoscopy Centers are accredited facilities offering diagnostic and therapeutic gastrointestinal procedures in a comfortable and convenient outpatient setting. Our compassionate, bilingual staff provides top-quality care while assisting our experienced and highly skilled doctors. Best of all, because of advances in medical technology, endoscopic procedures can be safely performed outside the hospital, so you can return to the comfort of your home the same day as your procedure. You have a choice in healthcare. Isn’t it time you got treated better?
Baptist Health Endoscopy Centers 7500 SW 87 Ave., Suite 101, Miami 305-595-9511 7600 SW 87 Ave., Suite 100, Miami 786-235-3750
BaptistHealth.net/Endoscopy
PREPOPIK® is a registered trademark of Ferring B.V. © 2016 Ferring B.V. All rights reserved. PK/3037/2016/US
19 Prepopik 3.5 x 5" Generic Ad_R2.indd 1
12/13/16 9:54 AM
BY Nelson Garcia, Jr., M.D., A.G.A.F. Gastroenterologist
WINTER 2017 ISSUE GASTRO MAGAZINE
Alternative Methods for Colon Cancer Screening
C
olon cancer remains the third most
Colonoscopy
is
presently
the
gold
restrictions, it has been replaced by Fecal
common cancer in both men and women
standard by which all other modalities
Immunochemical Testing (FIT).
in the United States. It is the second leading
of colon cancer screening are measured.
Annual
cause of cancer-related deaths after lung
However, as Table 1 demonstrates, there
(FIT). In this exam, two separate bowel
cancer. In 2014, there were 137,000 new
are other approved colon cancer screening
movements are sampled with a brush (if
cases leading to 50,000 deaths. There
modalities available. Despite their inferiority
loose, the toilet water may be sampled).
is approximately a 5% lifetime risk of
when compared to colonoscopy, they
No dietary or medication restrictions are
developing colon cancer as a person living
are acceptable alternatives in individuals
required. The sensitivity of FIT for colon
in the United States. Based on these facts,
who are unable or unwilling to undergo
cancer is approximately 80%. Due to its
colon cancer screening is recommended for
a colonoscopy. These alternatives are as
ease of use and improved sensitivity, FIT
average risk individuals starting at age 50.
follows:
has largely replaced gFOBT as a stool-
Clearly, high risk-individuals (i.e. those with
Fecal
Immunochemical
Testing
based colon cancer screening method.
a family history of colon cancer or polyps,
Annual Guaiac Fecal Occult Blood Test
inflammatory bowel disease, or a personal
(gFOBT). In this test, two stool samples
Flexible Sigmoidoscopy every 5 years.
history of colon cancer/polyps) benefit from
are obtained from three consecutive
In this exam, a preparation consisting of
earlier and/or more frequent colonoscopies.
bowel movements. One must avoid meats,
two enemas removes stool from the last
Despite the fact that colon cancer is almost
vitamin C, and citrus for three days prior
40 cm of the colon. A flexible instrument
entirely preventable through screening, only
to the collection. Also, non-steroidal anti-
is inserted through the rectum (typically
approximately 60% of Americans undergo
inflammatory drugs (other than aspirin 81
without anesthesia) and any visualized pre-
colon cancer screening. Within the state of
mg/day) are to be avoided for seven days.
cancerous polyps are removed. If a pre-
Florida, Miami-Dade county has amongst the
This test’s sensitivity for colon cancer is
cancerous polyp (i.e. adenoma) is found,
lowest screening rates with only 43-55% of
approximately 35%. Due to this suboptimal
then a complete colonoscopy is typically
residents being screened.
sensitivity, along with the need for dietary
recommended. The main limitation of a
flexible sigmoidoscopy is its lack of complete colonic examination.
Stool DNA every 3 years. The most recently approved method for
Its benefit is a simpler preparation when compared to a colonoscopy,
colon cancer screening is stool DNA testing. This exam consists of
lack of requirement for anesthesia, and lower procedural risk versus
testing a stool sample for DNA mutations associated with colon
colonoscopy.
cancer. A study performed in 2014 revealed that stool DNA testing demonstrated a sensitivity of 92% for colorectal cancer. However,
Air-contrast Barium Enema (ACBE) every 5 years. In this radiologic
the cost associated with stool DNA testing is significantly greater
exam, an oral laxative is used to prepare the colon. A radiologist or
than that of other approved stool exams (i.e. gFOBT, FIT).
radiology technician inserts a small tube into the rectum and the colon is filled with contrast and air. The exam is performed without
In summary, although colonoscopy is the gold standard for colon
anesthesia and typically last 20-40 minutes. Its sensitivity for colon
cancer screening given its proven effectiveness in decreasing
cancer is between 85 and 97%. The benefit of ACBE is that it does not
incidence of this cancer by 30% over the past decade, other
require anesthesia and can be performed in patients with anatomic
alternatives do exist. Adherence to colon cancer screening
limitations (i.e. adhesions) making a traditional colonoscopy difficult.
recommendations, regardless of the method, is the most important
However, it can be limited by a suboptimal colonic preparation that
factor leading to a reduction of this common malignancy.
can adversely affect its sensitivity. CT Colonography (Virtual Colonoscopy) every 5 years. In this
Table 1. Colon cancer screening methods
radiologic study, an oral laxative is once again used to prepare
Exam
the colon. A small tube is inserted in the rectum and air is used to
Colonoscopy Every 10 years
distend the colon. Subsequently, a CT scan is performed allowing
gFOBT
visualization of the distended colonic lumen. This exam typically lasts
FIT Every 1 year
10 minutes and is performed without anesthesia. It has a sensitivity
Flexible sigmoidoscopy
of 96% for colon cancer. Although its sensitivity for colon cancer
ACBE Every 5 years
is good, it does entail receiving radiation as part of a radiologic
Virtual Colonoscopy
Every 5 years
exam. Clearly, if an abnormality is found on this exam, a traditional
Stool DNA testing
Every 3 years
Frequency Every 1 year Every 5 years
colonoscopy is required for further evaluation.
MARCH IS COLON CANCER AWARNESS MONTH GUIDELINES FOR COLORECTAL CANCER SCREENING
LOW RISK
HIGH RISK
OTHER
PATIENT DESCRIPTION
EVALUATION INDICATED
AGE 50 No Risk Factors
Colonoscopy beginning at age 50 (for African-Americans beginning at the age of 45)
Family history of colon cancer or polyps
Colonoscopy beginning 10 years younger than the age the relative was diagnosed
Blood in stool or iron deficiency anemia, rectal bleeding, or a change in bowel habits
Colonoscopy now
Ulcerative Colitis or Crohn’s Disease
Yearly colonoscopy, after 10 years of disease
Personal history of colon cancer or polyps
Regular screening colonoscopy as determined by your physician*
INDIVIDUALIZED APPROACH Other gastrointestinal symptoms which may include: abdominal pain, narrow stools, constipation, diarrhea, "gas" or bloating, family history of breast, gynecological, abdominal, colon or other gastrointestinal cancers.
#2
1 IN 3
Colorectal cancer is the #2 leading cause of death in the US
1 in 3 adults aged 50-75 are NOT up-to-date with recommended colorectal cancer screenings
140,000 Approximately 140,000 new cases of colorectal cancer will be diagnosed this year
90%
60%
Overall 90% of new cases and 93% of deaths occur in people 50 and older
Early screening can prevent up to 60% of colon cancer deaths
*Call Gastro Health and discuss with your physician.
21
BY Leslie H Perla, MD MPH Gastroenterologist
WINTER 2017 ISSUE GASTRO MAGAZINE
Gastroesophageal Reflux Disease - A Clinical Discussion on the Pathophysiology, Symptoms, Diagnosis and Treatment
G
astroesophageal reflux is a condition
enamel, wheezing, globus, pulmonary fibrosis,
a hiatal hernia have been associated with
characterized by the backward flow of
tracheal stenosis, otitis, and apnea in infants.
the development of gastroesophageal reflux
gastric acid and at times gastric contents
Patients who suffer from Gastroesophageal
disease.
into
regurgitated
reflux disease often report a lower quality
contents may extend as far proximally as the
of life as assessed by the Psychologic Well
Diagnostic testing for the evaluation of
pharynx.
Being Index.
patients
the
esophagus.
The
Gastroesophageal reflux disease
with
Gastroesophageal
reflux
disease includes endoscopy as well as
(GERD) refers to the symptoms as well The etiology of gastroesophageal reflux
esophageal
regurgitated contents. The typical symptoms
disease may be multifactorial.
Transient
testing may also be performed to assist
of gastroesophageal reflux may be heartburn
relaxation of the lower esophageal sphincter
with differentiating acid reflux disease from
(retrosternal burning) as well as a feeling
muscle has been proposed to be the
nonacid reflux conditions commonly referred
of acid regurgitation (sour taste in the
predominant mechanism.
to as NERD.
as damage that occurs secondary to the
Other potential
PH
monitoring.
Impedance
Contrast studies such as an
mouth). Forty percent of adults in the United
contributing causes include esophageal and
upper gastrointestinal series may be utilized
States have reported regular symptoms of
gastric motility disorders. Delayed gastric
to identify findings such as a hiatal hernia
heartburn and regurgitation. Twenty percent
emptying
and
dysmotility
and an esophageal stricture. However, the
of the western population have reported at
arising
conjunction
connective
upper gastrointestinal series is generally not
least weekly symptoms.
tissue disorders such as scleroderma would
recommended as the first line testing for the
Other esophageal
in
esophageal with
odynophagia
be examples of these. Decreased resting
diagnosis of Gastroesophageal reflux disease
(pain on swallowing), dysphagia (difficulty
tone of the lower esophageal sphincter,
secondary to its limitations. Endoscopy
swallowing), chest pain and water brash
impaired
clearance,
does allow for the differentiation of reflux
(hypersalivation). Atypical presentations of
decreased salivation, increased gastric acid
esophagitis from other potential causes of
gastroesophageal reflux may include, but are
production as well as impaired esophageal
esophagitis.
not limited to cough, throat clearing, hoarse
tissue resistance may be other contributing
voice laryngitis, sinusitis, erosion of teeth
factors. Obesity along with the presence of
symptoms
may
include
esophageal
acid
It also allows for the dilation of strictures and the identification,
Allowing four hours prior to reclining, sleeping with the head of
biopsy and confirmation of pathologic conditions such as Barrett’s
the bed elevated, avoiding tight fitting clothing, not smoking and
esophagus and neoplastic processes such as malignancies.
maintaining a healthy weight have also been included in these
Therapeutic trials of acid suppressive therapy have been used as
measures. Acid reducing agents such over the counter antacids and
well as a diagnostic approach. However, it should be recognized
proton pump inhibitors and H2 blockers are classes of medications
that a response to acid suppressive therapy may not be specific to
that have been commonly used to treat Gastroesophageal reflux
gastroesophageal reflux disease as other acid peptic disorders may
disease.
have a similar response to such therapy. Endoscopy is indicated in the evaluation of Gastroesophageal reflux disease when such alarm
Prokinetic agents have also been used as adjunct therapy in some
symptoms as dysphagia and weight loss are present. Patients who
patients who also have underlying motility issues. Fundoplication
have refractory reflux symptoms also warrant endoscopy. Patients
procedures, and more recently, a magnetic device implanted
who are at risk for a condition known as Barrett’s esophagus
around the lower esophageal sphincter have also been proposed
(Risk factors include age greater then 50, multiple years of reflux
to treat patients with chronic reflux symptoms. Clinical response to
symptoms , being a Caucasian male and/or obesity) should be
the different therapeutic options may be impacted by how typical
advised to undergo a screening endoscopy as well.
the reflux symptoms are at presentation as well as the objective findings ( i.e., results of EGD and PH studies). The patient should be
The treatment of Gastroesophageal reflux disease has evolved into
advised to consult with his or her physician regarding selecting the
a multidisciplinary approach. Lifestyle modifications have been
most appropriate course of therapy.
proposed as part of the treatment regimen. These modifications have incorporated dietary changes such as eating smaller meals as well as avoiding trigger foods such as chocolate, mints, tomatoes, caffeine, carbonated beverages, fatty and fried foods and citrus.
Sat. April 29, 9:30 am
23
backyard barbecue.
WINTER 2017 ISSUE GASTRO MAGAZINE
lunch date.
If other treatments haven’t worked well enough, ask your gastroenterologist about ENTYVIO.® Uses of ENTYVIO® (vedolizumab): ENTYVIO is a prescription medicine used in adults: • With moderate to severe ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, induce and maintain remission, reduce or stop the use of corticosteroids, and improve the way the lining of your large intestine looks to your healthcare provider. • With moderate to severe Crohn’s disease (CD) when certain other CD medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, achieve remission, and reduce or stop the use of corticosteroids.
Important Safety Information about ENTYVIO® • Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients. • ENTYVIO may cause serious side effects, including: • Infusion and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you
have an allergic reaction. Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash; itching; swelling of your lips, tongue, throat or face; shortness of breath or trouble breathing; wheezing; dizziness; feeling hot; or palpitations (feel like your heart is racing). • ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or symptoms of an infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination. • Although it has not been reported with ENTYVIO, it may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML, which can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms:
ENTYVIO is a trademark of Millennium Pharmaceuticals, Inc., registered with the U.S. Patent and Trademark Office, and is used under license by Takeda Pharmaceuticals America, Inc. © 2016 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.
Printed in U.S.A./January 2017 USD/VED/15/0279(1)a
outdoor concert.
MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN’S SYMPTOMS LEAVING YOU WITH THE SAME VIEW? It may be time for a different perspective.
• DEVELOPED ONLY FOR UC AND CROHN’S • GI-FOCUSED • PROVEN TO PROVIDE RELIEF AND REMISSION Individual results may vary.
confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision. • Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your abdomen, dark urine, or yellowing of the skin and eyes (jaundice). • The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.
with TB; have recently received or are scheduled to receive a vaccine; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed. Please see the Medication Guide for ENTYVIO on the adjacent page and talk with your healthcare provider. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
• Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; have liver problems; have tuberculosis (TB) or have been in close contact with someone
Learn more at ENTYVIO.com
Relief and Remission within reach.25
WINTER 2017 ISSUE GASTRO MAGAZINE
Medication Guide ENTYVIO (en ti' vee oh) (vedolizumab) What is the most important information I should know about ENTYVIO? ENTYVIO may cause serious side effects, including: • Infusion and serious allergic reactions. These reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing). • Infections. ENTYVIO may increase your risk of getting a serious infection. Before receiving ENTYVIO and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or have symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination. • Progressive Multifocal Leukoencephalopathy (PML). Although it has not been reported with ENTYVIO, it may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision. • Liver Problems. Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your stomach (abdomen), dark urine, or yellowing of the skin and eyes (jaundice). See “What are the possible side effects of ENTYVIO?” for more information about side effects. What is ENTYVIO? ENTYVIO is a prescription medicine used in adults: • with moderate to severe active ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated: ° to begin helping some of your symptoms ° in people who respond to ENTYVIO, to help get UC under control (induce remission) and keep UC under control (maintain remission) ° for people who respond to ENTYVIO, you may be able to reduce or stop the use of corticosteroid medicines ° to improve the way the lining of your large intestine looks to your healthcare provider during colonoscopy • with moderate to severe active Crohn’s disease when certain other Crohn’s disease medicines have not worked well enough or cannot be tolerated: ° to begin helping some of your symptoms ° in people who respond to ENTYVIO, to help get Crohn’s disease under control (achieve remission) ° for people who respond to ENTYVIO, you may be able to reduce or stop the use of corticosteroid medicines It is not known if ENTYVIO is safe and effective in children under 18 years of age. Who should not receive ENTYVIO? Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of the ingredients in ENTYVIO. See the end of this Medication Guide for a complete list of ingredients in ENTYVIO.
Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: • have an infection, think you may have an infection or have infections that keep coming back (see “What is the most important information I should know about ENTYVIO?”). • have liver problems • have tuberculosis (TB) or have been in close contact with someone with TB. • have recently received or are scheduled to receive a vaccine. Talk to your healthcare provider about bringing your vaccines up-to-date before starting treatment with ENTYVIO. • are pregnant or plan to become pregnant. It is not known if ENTYVIO will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving ENTYVIO. • are breastfeeding or plan to breastfeed. It is not known if ENTYVIO passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take or have recently taken Tysabri (natalizumab), a Tumor Necrosis Factor (TNF) blocker medicine, a medicine that weakens your immune system (immunosuppressant), or corticosteroid medicine. How will I receive ENTYVIO? • ENTYVIO is given through a needle placed in a vein (intravenous infusion) in your arm. • ENTYVIO is given to you over a period of about 30 minutes. • Your healthcare provider will monitor you during and after the ENTYVIO infusion for side effects to see if you have a reaction to the treatment. What are the possible side effects of ENTYVIO? ENTYVIO may cause serious side effects, See “What is the most important information I should know about ENTYVIO?” The most common side effects of ENTYVIO include: common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all of the possible side effects of ENTYVIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about ENTYVIO Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about ENTYVIO that is written for health professionals. Do not use ENTYVIO for a condition for which it was not prescribed. What are the ingredients in ENTYVIO? Active ingredient: vedolizumab Inactive ingredients: L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose and polysorbate 80 Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015 U.S. License No. 1898 For more information, go to www.ENTYVIO.com or call 1-877-825-3327 This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: May 2014 ENTYVIO is a trademark of Millennium Pharmaceuticals Inc. and is used under license by Takeda Pharmaceuticals America, Inc. All other trademark names are the property of their respective owners. ©2014 Takeda Pharmaceuticals America, Inc. VMB245 R1_CFBS L-BZV-0514-4
BY Jon Stensloff, CRNA, MSN, ARNP
Comfort and Care for Endoscopic Procedures
G
astro Health physicians perform a wide range of endoscopic procedures varying from gastroscopies and colonoscopies to more complex endoscopic ultrasounds of internal organs. The use of these procedures is increasing in South Florida and worldwide. While the thought of these procedures may seem unpleasant, be assured that your experience will not be thanks to the anesthetic care you will receive with Galloway Anesthesia Associates. High quality procedural sedation is very important for GI procedures. Patient comfort allows for a more thorough examination of the GI tract and allows for ease of necessary interventions. Every anesthetic is personalized and tailored to your specific needs. Physiologic disease processes such as heart and lung disease along with psychological and emotional needs such as procedural anxiety are all addressed. Your excellent anesthesia care begins in the preoperative area where a thorough interview and assessment helps determine your specific anesthetic needs. Although some questions may overlap with others you have recently answered, rest assured that these questions are very important to your care. Your health issues, recent medical testing and a review of your current medications and allergies are vital to choosing the best anesthetic plan for you.
most recognized sedative is Propofol. While other anesthetic agents are available, the pharmacological properties of Propofol make it safe and widely used for GI procedures. The rapid onset of sedation and short duration of effect lead to increased patient comfort for the duration of the procedure and quick awakening in recovery afterwards. This provides for a high level of safety and patient satisfaction while allowing for a more thorough and comfortable examination. As a patient, you can help ensure your safety during a procedure by closely following the instructions given by your GI doctor and his staff. The importance of remaining without any food or liquids before the procedure for the specified time is vital. Please remember that the anesthesia staff is always available to address any concerns you may have. Simply reach out to your doctor’s office staff. They can refer you to the anesthesia providers at your scheduled facility. We are available before and after your procedure to answer any questions you may have. As always, Gastro Health remains committed to providing outstanding medical care and an exceptional healthcare experience.
Intraprocedural care includes continual monitoring and administration of an IV sedative by our highly trained, professional anesthesia staff throughout the procedure. Our most popular and
27
DON’T LET DIARRHEA AND ABDOMINAL PAIN BOSS YOU AROUND. Your frustrating symptoms could be Irritable Bowel Syndrome with Diarrhea (IBS-D).
VIBERZI MAY HELP.
WINTER 2017 ISSUE GASTRO MAGAZINE
VIBERZI is a daily treatment for adults that helps proactively manage the core symptoms of IBS-D—diarrhea and abdominal pain—at the same time.
Stay ahead of your IBS-D. Talk to your doctor or visit VIBERZI.com. IMPORTANT RISK INFORMATION • A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal pain. Your risk of having a spasm is increased if you do not have a gallbladder. This spasm usually happens within the first week of treatment and usually goes away when treatment is stopped. • Inflammation of the pancreas (called pancreatitis). Symptoms of pancreatitis usually go away when treatment with VIBERZI is stopped. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Stop taking VIBERZI and call your doctor if you have new or worsening stomach-area (abdomen) pain or pain in the upper right side of your stomach-area that may move to your back or shoulder, with or without nausea and vomiting. Do not take VIBERZI if you: • Have or may have had a blockage in your gallbladder or a sphincter of Oddi problem • Have or had problems with alcohol abuse, alcohol addiction, or drink more than 3 alcoholic drinks a day • Have had pancreatitis or other pancreas problems, including if you have had or may have had a blockage in your pancreas
Allergan® and its design are trademarks of Allergan, Inc. VIBERZI™ and its design are trademarks of ©2016 Allergan. All rights reserved. VBZ50065 03/16
• Have severe liver problems • Have had long-lasting (chronic) or severe constipation, or problems caused by constipation • Have or may have had a bowel blockage (intestinal obstruction) Before taking VIBERZI, tell your doctor about all of your medical conditions, including if you do not have a gallbladder, have liver problems, or are nursing, pregnant, or plan to become pregnant. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. If you are taking VIBERZI you should not take medicines that cause constipation, including: Lotronex® (alosetron), anticholinergic medicines, and opioid pain medicines.
constipation, nausea, and abdominal pain. Stop taking VIBERZI and call your doctor if you have constipation that lasts more than 4 days. These are not all the
You are encouraged to report negative Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. Please see brief summary of Medication Guide on the next page.
Brief Summary of the Medication Guide VIBERZI (vye BER zee), CIV (eluxadoline) tablets This information does not take the place of talking with your doctor about your medical condition or your treatment. What is VIBERZI? VIBERZI is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D). • VIBERZI is a controlled substance (CIV) because it contains eluxadoline that can be a target for people who abuse prescription medicines or street drugs. Keep your VIBERZI in a safe place to protect it from theft. Never give your VIBERZI to anyone else, because it may harm them. Selling or giving away this medicine is against the law. It is not known if VIBERZI is safe and effective in children. People 65 years old and older have had an increased number of side effects, including serious side effects and stomach problems, while taking VIBERZI than people younger than 65 years old have had. What is the most important information I should know about VIBERZI? VIBERZI can cause serious side effects, including: • Sphincter of Oddi spasm. A spasm in a muscular valve of the digestive system (called the sphincter of Oddi), which may cause new or worsening stomach area (abdomen) pain. Your risk of having a spasm is increased if you do not have a gallbladder. This spasm usually happens within the first week of treatment with VIBERZI and usually goes away when treatment with VIBERZI is stopped. • Inflammation of the pancreas (pancreatitis). Symptoms of pancreatitis usually go away when treatment with VIBERZI is stopped. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI. Stop taking VIBERZI and call your doctor if you have new or worsening stomach-area (abdomen) pain or pain in the upper right side of your stomach-area (abdomen) that may move to your back or shoulder, with or without nausea and vomiting. Who should not take VIBERZI? Do not take VIBERZI if you: • have or may have had a blockage in your gallbladder or a sphincter of Oddi problem • have or had problems with alcohol abuse, alcohol addiction, or drink more than 3 alcoholic drinks a day • have had inflammation of your pancreas (pancreatitis) or other pancreas problems, including if you have had or may have had a blockage in your pancreas • have severe liver problems • have had long-lasting (chronic) or severe constipation, or problems caused by constipation • have or may have had a bowel blockage (intestinal obstruction) Talk to your doctor if you are not sure if you have any of these conditions.
What should I tell my doctor before taking VIBERZI? Before taking VIBERZI, tell your doctor about all of your medical conditions, including if you: • do not have a gallbladder • have liver problems • are pregnant or plan to become pregnant. It is not known if VIBERZI will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if VIBERZI passes into your breast milk or could harm your baby. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine. VIBERZI and other medicines may affect each other causing side effects. If you are taking VIBERZI you should not take: • medicines that cause constipation including: o Lotronex® (alosetron) o anticholinergic medicines o opioid pain medicines Ask your doctor or pharmacist for a list of these medicines, if you are not sure. • Avoid taking loperamide, a medicine used to treat diarrhea, for a long time (chronic use). You may take loperamide occasionally to treat severe diarrhea. Stop taking loperamide right away if you become constipated. How should I take VIBERZI? • Take VIBERZI exactly as your doctor tells you to take it. • Take 1 tablet of VIBERZI 2 times each day with food. • If you miss a dose, take your next dose at your regular time. Do not take 2 doses at the same time to make up for a missed dose. • Do not change your dose or stop taking VIBERZI unless your doctor tells you to. • If you take too much VIBERZI, call your doctor or go to the nearest hospital emergency room right away. What should I avoid while taking VIBERZI? • Limit your use of alcoholic drinks while you are taking VIBERZI. • If you have liver problems, do not drive, operate machinery, or do other dangerous activities until you know how VIBERZI affects you. What are the possible side effects of VIBERZI? The most common side effects of VIBERZI include: constipation, nausea, and abdominal pain. Stop taking VIBERZI and call your doctor if you have constipation that lasts more than 4 days. These are not all the possible side effects of VIBERZI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Keep VIBERZI and all medicines out of the reach of children. Need more information? • This section summarizes the most important information about VIBERZI. If you would like more information, talk with your doctor. • Go to www.VIBERZI.com or call 1-800-272-5525 VIBERZITM and its design are trademarks of Furiex Pharmaceuticals, LLC, an Allergan affiliate. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA © Actavis 2015. All rights reserved. ELX38198 10/15
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BY Seth Rosen, MD Gastroenterologist
Do I Need to Stop My Heartburn Medication?
Y
our doctor puts you on acid reduction
WINTER 2017 ISSUE GASTRO MAGAZINE
medication.
is likely a rare event but individuals who take
and generic and prescription and over the
Or you pick up an over the
PPIs for months and years should have their
counter. They also decrease acid production
counter medication to treat your heartburn.
kidney function monitored with blood tests.
in the stomach but are not as strong as the
And then you hear from your friend that
In addition, there are reports of a possible
PPIs. The H2 blockers were first introduced
these are bad medicines with lots of side
link to the development of dementia. This
over 35 years ago and there have been almost
effects, and now you’re scared. Are your
is not a proven cause and effect at this time
no reports of significant problems with either
bones going to break? Kidneys fail? Are you
but there has been an association with these
short term or long term use. However, they
going to develop dementia?! Let’s see if we
medications reported in some studies –
do not decrease acid as much the PPIs and
can make things a little clearer.
again only with long term use.
as a result might not relieve symptoms as effectively in some people.
Proton
pump
inhibitors
were
There have also been concerns about
initially introduced over 25 years ago. The
certain infections in patients who take
What’s the right medication for you? And
first was Prilosec (omeprazole) and now
these
a
how long should you take it? As with all
there’s Nexium (esomeprazole), Prevacid
diarrheal illness called clostridium difficile/
medications you should take the lowest
(lansoprazole), Dexilant (dexlansoprazole),
pseudomembranous
is
amount for the shortest duration that
Protonix
associated with antibiotic use.
It’s been
achieves the objective – whether relieving a
(rabeprazole). They are available in various
suggested that PPIs increase the risk of
symptom such as heartburn/reflux or healing
forms and strengths – brand name and
this infection. In the past there have been
an ulcer.
generic, prescription and over the counter.
concerns about an increased likelihood of
might have less potential for adverse effects?
These medications all work by significantly
developing pneumonia while on PPIs but
Discuss these issues with your doctor and
decreasing the normal acid produced in the
this has not been proven.
then make your decision.
(pantoprazole)
(“PPIs”)
and
Aciphex
medications
–
for
example
colitis
which
stomach. They are used to treat acid reflux and ulcers. Like almost all medications,
So, if you are on one of these medications,
they should not be considered “good” or
do you need to stop?
“bad”. They have positive benefits as well as
that needs to be asked is: Is the medication
potential short and long term side effects.
necessary. This should be a question you
The first question
ask about any and all medications you might For several years, there have been concerns
take either on your own or at the direction of
that
a physician.
these
medications
might
affect
And the follow up question is
calcium absorption and increase the risk of
how long should I be taking it? Two weeks?
osteoporosis when used for a prolonged
Two months? Indefinitely? What are the
period of time. It’s now felt that while this
benefits I am getting from this medication?
might be a concern for some patients, it
What are the specific risks for me? And are
will not affect everyone. For people who
there any alternatives that might be effective
require ongoing use, they should discuss
but without or with less risk of side effects or
this issue with their physician to assess
complications?
their risk and consider further evaluation or be on medication to mitigate this potential
In the case of proton pump inhibitors there
problem.
might be an alternative – the H2 blockers (histamine-2 blockers) – most commonly
More recently, there have been reports of
Zantac (ranitidine) and Pepcid (famotidine).
kidney injury with long term use of PPI. This
These drugs are also available by brand
And is there an alternative that
ADDRESSING THE TOUGHEST CHALLENGES IN GASTROENTEROLOGY
TAKES ALL OF US For over a decade, we’ve worked closely with physicians, investigators, and patients to take on the toughest health challenges. We’re studying new indications to address significant unmet needs. Creating programs proven to improve patient outcomes. Investing in next-generation research to keep advancing the frontiers of patient care. We’re determined to keep making a difference in gastroenterology. That’s why you can count on our continuing commitment to you and your patients.
LEARN MORE AT ABBVIE.COM
PEOPLE. PASSION. POSSIBILITIES. ©2015 AbbVie Inc. North Chicago, IL 60064 64E-1811604 November 2015 Printed in U.S.A.
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