23 minute read
Novel treatment for ulcerative colitis
for ulcerative colitis
Dr Barney Hawthorne, a consultant gastroenterologist at the University Hospital of Wales in the UK, reviewed the Multimatrix System (MMX) mesalazine in the management of ulcerative colitis.
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MMX MESALAZINE IS a new studies showed high rates of remission in the active treatment trials. The drug is formulation of 5-aminosalicylic acid maintained at one year with 1.2g twice safe and effective in colitis. The high tablet (5-ASA) – a novel 5-ASA delivery daily (68%) and 2.4g once daily (64%) strength, and once-daily dosage make this tablet that starts to release the drug in the using the strict definition of remission formulation a welcome addition to therapy terminal ileum and caecum, and then allows (including mucosal healing) that was used options for patients with colitis. the slow release of this drug during passage through the colon. An ideal drug delivery system it does not release the drug at all in the upper small bowel but starts to release the drug gradually in the ileocaecal region, and then progressively throughout the colon. The delayed-release mesalazine formulation has a high-strength 1.2g tablet for the treatment of active mild to moderate colitis and maintenance of remission. In vitro and in vivo studies show initiation of drug release in the terminal ileum and caecum with gradual release of 5-ASA as the tablet passes through the colon. Mesalazine or 5-ASA remains the first-line therapy for treatment of mild to moderately active ulcerative colitis, and maintenance of mucosal healing. The drug exerts a topical anti-inflammatory effect on colonic mucosa. In mild and moderate colitis, the product shows high rates of remission and mucosal healing in clinical trials with stringent endpoints. Once-daily dosing is as effective as divided doses, and the 2.4g dose appears as effective as 4.8g daily. It is becoming clear that once daily therapy is effective for other formulations of 5-ASA, and this benefit is not exclusive to MMX mesalazine. Other considerations, particularly cost and patient preference, must be taken into consideration in choosing a formulation for individual patients, but there is no doubt that this drug is a welcome addition to the therapeutic armamentarium. The left colon in normal patients, and certainly in active colitis, is generally relatively empty, and represents a much more challenging area for drug delivery. This study showed that oral MMX mesalazine is as effective as enemas in left-sided disease, confirming delivery of the drug in significant amounts to the left colon. Pharmacokinetic data are comparable to other 5-ASA formulations with low systemic absorption and high levels in faeces and in mucosal biopsies in the left colon. Clinical trials have shown high rates of clinical and endoscopic remission in active mild to moderate colitis over eight weeks with a 2.4g once-daily dose. There do not appear to be higher remission rates with the 4.8g dose. Prolongation of treatment with a further eight weeks of 2.4g twice daily can induce remission in those failing the initial eight weeks of therapy. A maintenance study enrolling patients who achieved remission in the acute
REFERENCE
Hawthorne AB. A Review of Multimatrix System (MMX) Mesalazine in the Management of Ulcerative Colitis. Clinical Medicine Therapeutics. 2009. doi:10.4137/CMT.S38
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Mezavant® is a valuable option in the management of patients with mild to moderate ulcerative colitis1
MMX® TECHNOLOGY FOR PROLONGED DRUG RELEASE2-5 DELIVERS MESALAZINE (5-ASA) THROUGHOUT THE COLON2-5 HIGH-DOSE FORMULATION REDUCES THE DAILY TABLET BURDEN1
ALWAYS ONCE DAILY2 IMPROVED ADHERENCE TO TREATMENT6
MEZAVANT IS INDICATED FOR:2
The approved Mezavant professional information should be consulted before prescribing. 5-ASA: 5-acetyl salicylic acid References: 1. Yang LPH, McCormack PL. MMX® Mesalazine: A review of its use in the management of mild to moderate ulcerative colitis. Drugs 2011;71(2):221-235. 2. Mezavant approved package insert, August 2013. 3. Brunner M, Assandri R, Kletter K, Tschurlovits M, Corrado Me, Villa R, et al. Gastrointestinal transit and 5-ASA release from a new mesalazine extended-release formulation. Aliment Pharmacol Ther. 2003;17:395–402. 4. Tenjarla S, Romasanta V, Zeijdner E, Villa R, Moro L. Release of 5-aminosalicylate from an MMX mesalamine tablet during transit through a simulated gastrointestinal tract system. Advances in Therapy 2007;24(4):826-840. 5. Tenjarla S, Abinusawa A. In-vitro characterization of 5-aminosalicylic acid release from MMX mesalamine tablets and determination of tablet coating thickness. Adv Ther 2011;28(1):6272. 6. Simoni SE, Felipsen SF, Conegero Sanches AC, Vasconcelos HL. Multi-Matrix 5-Aminosalicylic Acid Efficacy in Induction of Remission in Mild-to-Moderate Ulcerative Colitis: A Systematic Review. International Journal of Health Sciences, September 2019;7(3): 42-51. Mezavant® (enteric coated, prolonged release tablet.) Each tablet contains mesalazine 1 200 mg. Reg. No. 45/11/0463. For full prescribing information refer to the professional information approved by the medicines regulatory authority.
To report an Adverse Event, e-mail Adcock.AEReports@adcock.com or call 011 635 0134 To request a copy of the current approved professional information or references, e-mail:Helpdesk.MedicalAffairs@adcock.com
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IBD Africa, headed by gastroenterologist Dr David Epstein, is a recently launched non-profi t organisation that hopes to improve infl ammatory bowel disease (IBD) care in SA through research, education and advocacy. The organisation held a panel discussion with international IBD expert, Prof Stefan Schreiber, to bring awareness to this condition.
ROHN’S DISEASE AND ulcerative low- and middle-income countries including common in all people from time to time, “There is an exponential increase in new C HELPING PEOPLE LIVE BETTER LIVESHow to download and use the IBD Health Diary app from Ferring HELPING PEOPLE LIVE BETTER LIVESHow to download and use the IBD Health Diary app from Ferring HELPING PEOPLE LIVE BETTER LIVES How to download and use the IBD Health Diary app from FerringHELPING PEOPLE LIVE BETTER LIVESHow to download and use the IBD Health Diary app from Ferring HELPING PEOPLE LIVE BETTER LIVESHow to download and use the IBD Health Diary app from Ferring HELPING PEOPLE LIVE BETTER LIVES How to download and use the IBD Health Diary app from Ferring colitis, collectively known as IBD, is a SA. “Crohn’s disease is impactful. Patients which makes diagnosis di cult,” said Prof cases of IBD diagnosed each year in Cape chronic autoimmune disease a ecting su er from pain, weakness, utter exhaustion Schreiber, Professor of Medicine at Kiel Town,” said Dr Epstein, discussing data the gut. IBD is increasing exponentially in and diarrhoea. These symptoms can be University in Germany. from fi ve practices in Cape Town, "with the majority of people being diagnosed in their 20s and 30s." The average age of diagnosis is late DIFFERENT PEOPLE, 20s for Crohn’s and 35 for ulcerative colitis. However, IBD can be found in patients as young as fi ve, and in others it Diary app from Ferring DIFFERENT CHOICES.HOW • Go to Google Play or the App Store • Search for the IBD Health Diary • Download the app to your phone or tablet • Fill in your personal details • Explore the features HOW • Go to Google Play or the App Store • Search for the IBD Health Diary • Download the app to your phone or tablet • Fill in your personal details • Explore the features HOW • Go to Google Play or the App Store • Search for the IBD Health Diary • Download the app to your phone or tablet • Fill in your personal details • Explore the features HOW • Go to Google Play or the App Store • Search for the IBD Health Diary • Download the app to your phone or tablet • Fill in your personal details • Explore the features HOW • Go to Google Play or the App Store • Search for the IBD Health Diary • Download the app to your phone or tablet • Fill in your personal details • Explore the features HOW • Go to Google Play or the App Store • Search for the IBD Health Diary • Download the app to your phone or tablet • Fill in your personal details • Explore the features emerges in old age. While we don’t know what the cause is, evidence seems to point to modern living in terms of our lifestyle, eating habits and stress. This change the microbiome, commented Prof Schreiber. “There will be more diseases coming from the intestines and microbiomes, IBD is not the end,” APP FEATURES Overview Scheduler Personal Health Diary APP FEATURES Overview Scheduler Personal Health Diary with the IBD Health Diary app from Ferring TAKE CONTROL APP FEATURES Overview Scheduler Personal Health Diary APP FEATURES Overview Scheduler Personal Health Diary with the IBD Health Diary app from Ferring TAKE CONTROL PENTASA® SACHETS PENTASA® 500 mg PENTASA® 1 g ReportReportReportReport he stated. Ulcerative Colitis & Crohn’s Disease TABLETS SUPPOSITORIES Ulcerative Colitis Ulcerative Proctitis Knowledge BaseKnowledge BaseKnowledge BaseKnowledge Base
THERE IS ALSO A GENETIC COMPONENT
From the fi rst symptom to a diagnosis, it takes the average Crohn’s patient almost 2½ years to be diagnosed, and one year for the average ulcerative colitis patient. Diagnosis can be tricky as there is no single diagnostic test, symptoms may come and go at the onset and be confused with very common gut problems such as irritable bowel syndrome (IBS). In SA there are 88 gastroenterologists only, so the country is under resourced in terms of people having access to a specialist. According to Sr Karin Davidson, a specialist IBD nurse in IBD Africa, “Every patient is unique. This also makes it a di cult condition to manage. Every patient needs to be dealt with individually. Kids are ostracised, teachers get angry at child leaving class to go to toilet often, and the child can’t play sports for same reason. Nurses such as Sr Davidson meet with the school and the team to manage the
SCAN QR CODE AT THE BOTTOM OF THE PAGE TO ACCESS APP SCAN QR CODE AT THE BOTTOM OF THE PAGE TO ACCESS APP SCAN QR CODE AT THE BOTTOM OF THE PAGE TO ACCESS APP SCAN QR CODE AT THE BOTTOM OF THE PAGE TO ACCESS APP SCAN QR CODE AT THE BOTTOM OF THE PAGE TO ACCESS APP SCAN QR CODE AT THE BOTTOM OF THE PAGE TO ACCESS APP
PENTASA® 1 g ENEMA
Ulcerative Proctosigmoiditis & Left-sided Colitis
BENEFITS OF PENTASA® ORAL FORMULATIONS
Mesalazine is released throughout the GI tract?
Release of mesalazine at all pH values in the GI tract? Does diarrhoea affect the release of mesalazine? PERSONAL HEALTH DIARY REPORTPERSONAL HEALTH DIARY REPORT PERSONAL HEALTH DIARYREPORT PERSONAL HEALTH DIARY REPORTPERSONAL HEALTH DIARY REPORT PERSONAL HEALTH DIARYREPORT
PENTASA®
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KNOWLEDGE BASE KNOWLEDGE BASE SCHEDULERKNOWLEDGE BASE KNOWLEDGE BASE SCHEDULER
Any peak plasma concentrations of mesalazine? ✗Answer pre-selected questions about your Answer pre-selected questions about your Answer pre-selected questions about your Answer pre-selected questions about your Answer pre-selected questions about your Answer pre-selected questions about your NO4 No endless browsing on the Internet to No endless browsing on the Internet to Get an alert when it's time for your No endless browsing on the Internet to No endless browsing on the Internet to Get an alert when it's time for your May be taken with or without food? symptoms and get a colour-coded indication symptoms and get a colour-coded indication symptoms and get a colour-coded indication symptoms and get a colour-coded indication symptoms and get a colour-coded indication symptoms and get a colour-coded indication YES1,2 find reliable information. Scroll through find reliable information. Scroll through meds or your next doctor's visitfind reliable information. 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Scroll through meds or your next doctor's visit *Although the disposition from Pentasa® is impaired in case of diarrhoea, the changes were not substantial, and the disposition remains rather favourable.Automated report will be of your disease status • Contact your health care professional for advice Automated report will be of your disease status • Contact your health care professional for adviceAutomated report will be of your disease status • Contact your health care professional for adviceAutomated report will be of your disease status • Contact your health care professional for advice Automated report will be of your disease status • Contact your health care professional for adviceAutomated report will be of your disease status • Contact your health care professional for advice Remsima Ad the most relevant and important information about IBD. the most relevant and important information about IBD. the most relevant and important information about IBD. the most relevant and important information about IBD. Dr David Epstein, head of IBD Africa PENTASA’s different dosage forms & strengths allow you to Monitor your symptoms closely and call your health care professional if symptoms worsen • Disease appears to be under control generated when a date range is selected. You have an option to e-mail the report to your health care professional with just one tap Monitor your symptoms closely and call your health care professional if symptoms worsen • Disease appears to be under control generated when a date range is selected. You have an option to e-mail the report to your health care professional with just one tap Monitor your symptoms closely and call your health care professional if symptoms worsen • Disease appears to be under control generated when a date range is selected. You have an option to e-mail the report to your health care professional with just one tap Monitor your symptoms closely and call your health care professional if symptoms worsen • Disease appears to be under control generated when a date range is selected. You have an option to e-mail the report to your health care professional with just one tap Monitor your symptoms closely and call your health care professional if symptoms worsen • Disease appears to be under control generated when a date range is selected. You have an option to e-mail the report to your health care professional with just one tap Monitor your symptoms closely and call your health care professional if symptoms worsen • Disease appears to be under control generated when a date range is selected. You have an option to e-mail the report to your health care professional with just one tap choose the best fi t for your patient. Be The IBD Health Diary is another innovation by Ferring. The IBD Health Diary is another innovation by Ferring. The IBD Health Diary is another innovation by Ferring. The IBD Health Diary is another innovation by Ferring. The Be GUTsi campaign & IBD Health Diary The IBD Health Diary is another innovation by Ferring. The IBD Health Diary is another innovation by Ferring. are the latest innovations by Ferring. A NEW approach in empowering patients! Improving outcomes in the palm of your hands. A NEW approach in empowering patients! Improving outcomes in the palm of your hands.A NEW approach in empowering patients! Improving outcomes in the palm of your hands.A NEW approach in empowering patients! Improving outcomes in the palm of your hands. A NEW approach in empowering patients! Improving outcomes in the palm of your hands.A NEW approach in empowering patients! Improving outcomes in the palm of your hands. A NEW approach in empowering patients! Ferring (Pty.) Ltd. Route 21 Corporate Park, 6 Regency Drive, Irene Ext 30, Pretoria, South Africa. Tel: +27 12 345 6358. Fax: +27 12 345 1156. www.ferring.co.za. FERRING, and the Ferring (Pty.) Ltd. Route 21 Corporate Park, 6 Regency Drive, Irene Ext 30, Pretoria, South Africa. Tel: +27 12 345 6358. Fax: +27 12 345 1156. www.ferring.co.za. FERRING, and the Ferring (Pty.) Ltd. Route 21 Corporate Park, 6 Regency Drive, Irene Ext 30, Pretoria, South Africa. Tel: +27 12 345 6358. Fax: +27 12 345 1156. www.ferring.co.za. FERRING, and the Ferring (Pty.) Ltd. Route 21 Corporate Park, 6 Regency Drive, Irene Ext 30, Pretoria, South Africa. Tel: +27 12 345 6358. Fax: +27 12 345 1156. www.ferring.co.za. FERRING, and the Ferring (Pty.) Ltd. Route 21 Corporate Park, 6 Regency Drive, Irene Ext 30, Pretoria, South Africa. Tel: +27 12 345 6358. Fax: +27 12 345 1156. www.ferring.co.za. FERRING, and the Ferring (Pty.) Ltd. Route 21 Corporate Park, 6 Regency Drive, Irene Ext 30, Pretoria, South Africa. Tel: +27 12 345 6358. Fax: +27 12 345 1156. www.ferring.co.za. FERRING, and the Be GUTsi Take ControlFERRING logo are registered trademarks of Ferring B.V. 2019/089 Date of preparation: November 2019. FERRING logo are registered trademarks of Ferring B.V. 2019/089 Date of preparation: November 2019. APPLE QR CODE FERRING logo are registered trademarks of Ferring B.V. 2019/089 Date of preparation: November 2019. FERRING logo are registered trademarks of Ferring B.V. 2019/089 Date of preparation: November 2019. APPLE QR CODEGOOGLE QR CODE Improving outcomes in the palm of your hands.APPLE QR CODE GOOGLE QR CODEAPPLE QR CODE GOOGLE QR CODE FERRING logo are registered trademarks of Ferring B.V. 2019/089 Date of preparation: November 2019. Google QR codeAPPLE QR CODE GOOGLE QR CODEAPPLE QR CODE GOOGLE QR CODE FERRING logo are registered trademarks of Ferring B.V. 2019/089 Date of preparation: November 2019. Apple QR code References: 1. Hardy JG, Harvey WJ, Sparrow RA, et al. Localization of drug release sites from an oral sustained-release formulation of 5-ASA (Pentasa®) in the gastrointestinal tract using gamma scintigraphy. J Clin Pharmacol. 1993;33:712-718. 2. Wilding IR. A scintigraphic study to evaluate what happens to Pentasa® and Asacol® in the human gut. Practical Gastroenterology. Suppl to November 1999:1-8. 3. Rijk MCM, van Schaik A, Van Tongeren JHM. Disposition of mesalazine from mesalazine-delivering drugs in patients with infl ammatory bowel disease, with and without diarrhoea. Scand J Gastroenterol 1992;27(10):863-868. 4. Christensen LA, Fallingborg J, Abildgaard K, et al. Topical and systemic availability of 5-aminosalicylate: comparisons of three controlled release preparations in man. Aliment Pharmacol Ther. 1990;4:523-533. S3 PENTASA® SACHETS 2 g. Each sachet contains 2 g mesalazine. Reg. No.: 43/11/0014.S3 PENTASA® 1 g Suppositories. Each suppository contains 1 g mesalazine. Reg. No.: A40/11/0374. S3 PENTASA® 500 mg Tablet. Each tablet contains 500 mg mesalazine. Reg. No.: 33/11/0088. S3 PENTASA® 1 g ENEMA. Each 100 ml rectal suspension contains 1 g mesalazine. Reg. No.: 44/11/0888. NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION: FERRING (Pty.) Ltd. Route 21 Corporate Park, 6 Regency Drive, Irene Ext 30. Pretoria, South Africa. Tel: +27 12 345 6358 Fax: +27 12 345 1156. www.ferring.co.za. PENTASA, FERRING, and the FERRING logo are registered trademarks of Ferring B.V. For full prescribing information please refer to the package insert approved by the medicines regulatory authority. 2020/019 Date of preparation: March 2020.
BOWEL PREP FOR COLONOSCOPY WHAT TO CONSIDER
Colonoscopy accuracy and therapeutic safety depends heavily on the quality of bowel cleansing. All current preparation strategies use a combination of dietary restrictions and laxative agents.
An effective and tolerable bowel preparation is important to secure quality of colonoscopies. It remains unclear if sodium picosulphate with magnesium citrate (SPMC), which is considered a tolerable bowel preparation agent, is also an effective alternative for polyethylene glycol (PEG) and sodium phosphate (NaP). A recent review article by van Lieshout et al (2016) compared effectiveness of SPMC to PEG and NaP through assessment of quality of bowel cleansing measured by validated tools.
The authors searched electronic databases up to January 2015. Only randomised controlled trials (RCTs) were included. Two authors independently performed selection of studies, risk of bias assessment and data extraction.
Results: Thirteen RCTs were included, with overall good quality, but large heterogeneity. SPMC had slightly better quality of bowel cleansing than PEG (pooled RR 1.06; 95% CI 1.02 to 1.11). In most trials, SPMC was significantly better tolerated than PEG. There were no significant differences in effectiveness or tolerability between SPMC and NaP. Side effects were similar between agents, except for dizziness (pooled RR 1.71; 95% CI 1.32 to 2.21 in favour of PEG vs SPMC) and vomiting (pooled RR 0.35; 95% CI 0.13 to 0.95 in favour of single-dose SPMC vs splitdose). PEG-based electrolyte solutions (PEG-ELS) and the combination of SPMC are commonly used bowel preparation agents. The aim of another study (Leitao et al 2014) was to compare the two agents with regard to cleansing efficacy and tolerance among individuals scheduled for outpatient colonoscopy.
The 368 colonoscopy outpatients at three Norwegian hospitals were randomised to bowel lavage with either PEG-ELS or SPMC. Compliance and patient tolerance were evaluated using a patient questionnaire. Bowel cleansing was evaluated using the Ottawa Bowel Preparation Quality Scale (OBPS), a validated scoring system with scores between 0 (best) and 14.
Results: There was no difference in the cleansing quality between the PEG-ELS and SPMC groups (median OBPS 5.0 in both groups). The group that received SPMC reported better overall patient tolerance than the PEG-ELS group (72.6 % vs 59.0 % reporting no or slight discomfort, P < 0.01).
Compliance with the recommended total fluid intake (4L) was better in the SPMC group than in the PEG-ELS group (94% vs 81% respectively, P < 0.01). Moreover, the polyp detection rate was superior (34% vs 23%, P = 0.02). CONCLUSIONS
PEG-ELS and SPMC are equally effective in cleansing efficacy, but SPMC was better tolerated by patients and resulted in superior patient compliance and polyp detection rate.
The second trial concluded that SPMC is equally effective to NaP and little superior to PEG in terms of bowel cleansing. SPMC preparations were better tolerated than PEG preparations. SPMC may be considered as standard bowel preparation for colonoscopy.
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particular case. Often a child’s marks will drop, they can’t pay attention, and are then thought to have ADHD.”
“It should be a red fl ag in children don’t develop properly,” stated Prof Schreiber.
“There is shame around this disease.” She explained that patients need to go to the toilet often, there is urgency (sometimes a matter of 30 seconds), diarrhoea, and patients sometimes soil themselves if they can’t access a toilet quick enough.
“Some patients are so exhausted they can’t move or perform any tasks. This is a daily reality for many. Patients give up their jobs due to huge fatigue. People don’t understand, because the patient may appear normal,” emphasised Prof Schreiber.
He shared that 15 years ago, people with a stoma bag weren’t allowed in public pools, even though no stool escapes. Patients are often in the prime of their lives. Travel, studies and work are all impacted.
IBD is often mistaken for irritable bowel syndrome - the most common condition that gastroenterologists encounter.
“There is an unmet need in the disease. Before anti-TNF biologics, we could only put in hospital with parenteral nutrition. Even hospital bed availability is scarce, beds are given for other conditions. Even in the emergency rooms, it is not seen as a priority. When it comes to funding, IBD is not given attention, the intestines are not seen as a priority,” said Prof Schreiber.
TREATMENT
Biological drugs are a class of monoclonal antibody immune suppressant medications fi rst used to treat IBD in 1995. They are the most e ective of all the IBD medications and are life changing for many patients. However, after 25 years, these drugs remain largely inaccessible to the majority of IBD patients in South Africa. They can cost R200-300K a year and some come with some side e ects. “In private healthcare, patients with medical aid sometimes need to escalate treatment and their plan doesn’t cover the medications they need. Only the top echelon plans cover biologics. It becomes di cult to motivate and fi ght for these drugs, when the only next option is surgery,” said Sr Davidson.
However, she explained that if you look at the cost for medical schemes over 10 years if the patient doesn’t have access to the drugs, it’s a ‘no brainer’.
Biosimilar drugs are not yet registered for use in SA. “We need to build more patient advocacy. Patients and healthcare providers aren’t vocal enough. It is not a glamourous disease and we need to advocate this. The fi ght needs to be taken to SAHPRA. The length of time taken for meds to be approved is criminal. Patients and healthcare professionals need to fi ght for this. Drugs that are available all over the world are sitting in a pipeline here.
She emphasised that not all patients will be put on the same drugs. Treatment is tailored. “Newer biologics come in, but they won’t be for everyone. However, in some patients you can change an entire life of a young patient,” she said, emphasising the importance of a multidisciplinary approach, using a range of healthcare professionals.
THE GP’s ROLE
Dr Epstein’s take-home message for GPs is to have an awareness that IBD is common and increasing, and is often under recognised. Certain test such as stool calprotectin is a great screening tool to see if someone has infl ammation in their gut. It is a chemical tests done on stool, and if the level is high, it suggests there is infl ammation in the gut, possibly caused by IBD. That should raise an alarm that this young patient may have IBD. The IBD Africa website (ibdafrica.org) has a list of every gastroenterologist in the country, where patients can get appropriate care. “If you think a patient has IBD, refer that patient to a gastroenterologist,” he concluded.
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LASTING REMISSION1,3-5 MMX®† TECHNOLOGY1,2 ALWAYS ONCE DAILY1
MEZAVANT IS INDICATED FOR:1
The treatment and maintenance of remission in ulcerative colitis
The approved Mezavant package insert should be consulted before prescribing. Frequent adverse drug reactions: Hypersensitivity, headache, flatulence, nausea, abdominal distension, abdominal pain, colitis, diarrhoea, dyspepsia, vomiting, abnormal liver function test, arthralgia, back pain, asthenia, face oedema, fatigue, pyrexia. Less frequent adverse drug reactions: Dizziness, somnolence, tachycardia, hypertension, hypotension, pharyngolaryngeal pain, pancreatitis, rectal polyp, increased alanine aminotransferase, acne, alopecia, prurigo, pruritus, rash, urticaria, renal failure. Contraindications: History of hypersensitivity to salicylates (including mesalazine) or to any of the excipients, severe renal impairment and/or severe hepatic impairment. Warnings and special precautions for use: Renal impairment, chronic lung function impairment/asthma, hepatic impairment, allergy to sulphasalazine, blood dyscrasias, predisposure to myo- or pericarditis, acute intolerance syndrome, porphyria, elderly, obstruction in the upper gastrointestinal tract and nephrotoxicity.
It is recommended that all patients have an evaluation of renal function prior to initiation of therapy and at least twice a year, while on treatment.1 Mezavant® (enteric coated, prolonged release tablet.) Each tablet contains mesalazine 1 200 mg. Reg. No. 45/11/0463. For full prescribing information refer to the package insert approved by the medicines regulatory authority. 2019100310165518.
References: 1. Mezavant approved package insert, August 2013. 2. Brunner M, et al. Gastrointestinal transit and 5-ASA release from a new mesalazine extended-release formulation. Aliment Pharmacol Ther. 2003;17:395–402. 3. Kamm MA, et al. Once-Daily, High-Concentration MMX Mesalamine in Active Ulcerative Colitis. Gastroenterology. 2007;132:66–75. 4. Lichtenstein GR, et al. Effect of Once- or Twice-Daily MMX Mesalamine (SPD476) for the Induction of Remission of Mild to Moderately Active Ulcerative Colitis. Clin Gastroenterol Hepatol. 2007;5:95–102. 5. Kamm MA, et al. Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. Gut. 2008;57:893–902. *Mezavant is the registered trademark used under licence from Nogra Pharma Limited. †MMX and MMX Multi-Matrix System are registered trademarks of Cosmo Technologies Limited.
