sb56917

COPD/Emphysema & Cardiovascular Risk HZC113782

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STUDY:

◦ COPD/Emphysema in patients with significant cardiovascular risk. (≥50 and ≤70% predicted FEV1)

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PURPOSE:

◦ To determine if a combination of Fluticasone Furoate/Vilanterol can reduce arterial hardness and reduce the risk of stroke and heart attack.

COPD/Emphysema & Cardiovascular Risk HZC113782

METHOD:

â—Ś Time to CV event. â—Ś Arterial elasticity will be evaluated using central and distal pulse wave velocity testing.

COPD/Emphysema & Cardiovascular Risk HZC113782

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DESIGN:

◦ 16,000 participants across 1,100 study centers. ◦ Medications + Albuterol ◦ 25% will receive FF/VI 100mcg/25mcg QD ◦ 25% will receive FF 100mcg QD ◦ 25% will receive VI 25mcg QD ◦ 25% will Receive placebo QD

◦ If a patients breathing worsens, they will be “rescued” to Spiriva or Withdrawn from study drug and followed thru the duration of the study on their previous regimen.

COPD/Emphysema & Cardiovascular Risk HZC113782

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PATIENT:

◦ Over 40 ◦ 10 or more pack year history. ◦ One of the following if age 40 -59 ◦ Established coronary artery disease

◦ Established peripheral vascular disease ◦ History of stoke ◦ History of MI ◦ Diabetes with target organ disease

◦ Or if 60 or older 1 of the previous or 2 of the following ◦ Treated for hyperlipidemia ◦ Treated for hypertension ◦ Treated for diabetes (diet and exercise included)

COPD/Emphysema & Cardiovascular Risk HZC113782

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Benefits To Your Patients: ◦ ◦ ◦ ◦ ◦ ◦ ◦ ◦ ◦

$50.00 Per visit Pulmonary Function Tests Blood Work Albuterol Study Medications ECGs Pulse Wave Velocity Testing Education Re-education on “proper” inhaler technique.

COPD/Emphysema & Cardiovascular Risk HZC113782

Benefits To Your Patients: Monetary Benefit $1,150.00 Non Monetary Benefit $4,200.00 TOTAL $5,350.00