Health Canada approves advanced treatment for heart attack and chest pain

Effient(TM) reduces the risk of cardiovascular death, heart attack and stroke in patients managed with common artery-opening procedure by 19 per cent compared with current standard of treatment(1)

TORONTO, April 21 /CNW/ - Health Canada has taken an important step in helping to improve the health and quality of life of Canadians who suffer from heart attack and chest pain, with the approval of Effient(TM) (prasugrel hydrochloride). Effient is a new treatment that works quicker than the current standard of care for patients who suffer from Acute Coronary Syndromes (ACS) - an umbrella term for heart attack and unstable angina - who are being managed with a common artery-opening procedure called percutaneous coronary intervention (PCI). Effient will be available in Canada in the near future.

"One of the problems with the current antiplatelet therapies available in Canada is that for some patients, they're just not effective," said cardiologist Dr. Jean-François Tanguay, MD, Senior Research Scientist at the Montreal Heart Institute and Associate Professor in the Faculty of Medicine at the University of Montreal. "In fact, there is evidence that suggests a significant number of patients are not responding adequately, or not responding at all, to their current antiplatelet therapy. There is a clear need for a new treatment alternative for Canadians with ACS. For the right patient, Effient represents an effective treatment that works quickly, which can help them get back to living full and healthy lives after their PCI procedure," added Dr. Tanguay.

Effient is a new antiplatelet agent to help prevent heart attacks and strokes in patients with ACS undergoing PCI procedures. Effient prevents platelets (the blood particles responsible for clotting and stopping bleeding) from sticking or clumping together by blocking a specific receptor on the platelet surface. Sticking or clumping of platelets can result in clogged arteries and may lead to a heart attack or stroke.

In a landmark, head-to-head clinical study (TRITON-TIMI 38), treatment with Effient compared to Plavix(R) reduced the relative risk of cardiovascular death, heart attack and stroke by 19 per cent, in patients with ACS who had a PCI procedure.(1) The benefit of Effient compared to Plavix was seen in as early as three days following the PCI procedure and continued over the entire 15 months of the trial.(1)

Clinical studies also suggest that Effient is metabolized in the body more quickly than Plavix. Both medicines are taken in an inactive form and need to be converted into their active form in the body. Studies suggest Effient is converted into its active form (metabolite) in one step in the liver, producing a faster and stronger slowing of the chemical reaction that causes blood to clot, whereas Plavix is converted into its active metabolite in two steps in the liver.(2,3)

In addition, other data have shown that a significant number of patients carry certain genetic variants causing them not to respond adequately to Plavix, which can lead to an increased risk of cardiovascular events.(4) Effient has been shown not to be affected by these variants.(5)

In Canada, ACS represents a growing health concern with staggering human and economic costs. There are an estimated 70,000 heart attacks each year in Canada - that's one heart attack every seven minutes. Over 17,000 Canadians die each year as the result of a heart attack.(6) Cardiovascular disease, which includes acute coronary syndromes, costs the Canadian economy more than $22 billion every year, in physician services, hospital costs, lost wages and decreased productivity.(6)

ACS in Canada - A growing concern

Despite the devastating impact that ACS can have, a survey by Leger Marketing shows that Canadians still have a lot to learn about the condition. According to the survey, 63 per cent of Canadians 50+ would not know what to do if they themselves or a loved one was experiencing symptoms of ACS, which could mean a costly delay in getting potentially life-saving treatment.(7)

"There is a need for increased awareness of ACS, risk factors and management in Canada," said Dr. Tanguay. "This is especially important for certain communities, who are at an increased risk. For example, in the South Asian community, there are higher rates of high blood pressure and diabetes, which leads to a greater risk of heart problems. The good news is that with the right knowledge and the right management strategies, patients can still live full, healthy and active lives after a heart attack or other cardiac event."

Superiority Trial Versus Plavix

The approval of Effient was based on data from the TRITON-TIMI 38 clinical trial, which included 13,608 patients from around the world. In the trial, which included Canada, treatment with Effient compared to Plavix reduced the relative risk of major cardiovascular CV events - CV death, nonfatal heart attack or nonfatal stroke - by a highly significant 19 per cent.(1) In the TRITON trial, the benefit of Effient compared to Plavix was seen in as early as three days after a PCI procedure, and continued to increase over the entire 15 months of the trial.(1)

The efficacy benefits were compared with the risk of bleeding events in the entire patient population; for every 1,000 people treated with Effient compared with Plavix, there were six more bleeding events; however, in the Effient groups, there were also 23 fewer heart attacks.(1)

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Eli Lilly Canada, headquartered in Toronto, Ontario, employs more than 500 people across the country. Additional information about Eli Lilly Canada can be found at www.lilly.ca.

    
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    References

    1.  Wiviott, S, Braunwald, E, et al. Prasugrel vs. versus Clopidogrel in
        Patients with Acute coronary syndromes. New England Journal of
        Medicine. November 2007;357:2001-2014.
    2.  Brandt, J, Payne, C, et al. A comparison of prasugrel and clopidogrel
        loading doses on platelet function: magnitude of platelet inhibition
        is relative to active metabolite formation. American Heart Journal.
        2007;153:66.e9-66.e16.
    3.  Payne, Christopher, D., et al. Increased Active Metabolite Formation
        Explains the Greater Platelet Inhibition With Prasugrel Compared
        to High-dose Clopidogrel. Journal of Cardiovascular Pharmacology.
        Volume 5, Number 5, 2007.
    4.  Mega, Jessica L., et al., Cytochrome P450 Genetic Polymorphisms and
        the Response to Prasugrel - Relationship to Pharmacokinetic,
        Pharmacodynamic, and Clinical Outcomes, Circ., 2009; 119: 1-8.
    5.  Mega, Jessica, L., et al. ABCB1 Genetic Variants, Pharmacodynamic
        Response, and Cardiovascular Outcomes Following Treatment With
        Clopidogrel and Prasugrel. Abstract of poster presentation at the
        American College of Cardiology Annual Scientific Session. Presented
        March 14, 2010.
    6.  Heart and Stroke Foundation of Canada. Statistics. URL:
   
http://www.heartandstroke.com/site/c.ikIQLcMWJtE/b.3483991/k.34A8/Statistics.htmNo.coronaryangio.
Accessed April 13, 2010.
    7.  Leger Marketing. Canadian Acute Coronary Syndrome Survey. Conducted
        between October 6 and October 14, 2008.
    

For further information: Jennifer Gordon, Eli Lilly Canada Inc., [phone]; Laura Grice, MS&L, [phone]