INSPRA approved as adjunct to standard therapy to reduce risk of death following a heart attack

    First in this class of drugs in Canada to be approved for improving
    survival rate following a heart attack

    KIRKLAND, QC, June 3 /CNW/ - A new treatment option is now available in
Canada as an adjunct to standard therapy, to reduce the risk of death
following a heart attack in clinically stable patients who have evidence of
heart failure and left ventricular systolic dysfunction: INSPRA (eplerenone
tablets) is the first aldosterone receptor blocker to be approved for this
indication in Canada.
    In the landmark Eplerenone Post-acute myocardial infarction Heart failure
Efficacy and SUrvival Study (EPHESUS),(1) INSPRA provided significant early
and sustained all-cause mortality benefits above and beyond standard
therapies, including angiotensin converting enzyme (ACE) inhibitors,
angiotensin receptor blockers (ARBs) and beta blockers in patients with acute
myocardial infarction (AMI) complicated by heart failure.
    "Pfizer Canada is pleased to introduce INSPRA as part of our established
portfolio of cardiovascular treatment options. This innovative medication will
provide Canadians afflicted by congestive heart failure after a myocardial
infarcation, with a proven and effective treatment," said Dr. Bernard Prigent,
Vice President and Medical Director, Pfizer Canada Inc. "We are confident that
INSPRA will become an essential, life-saving component of standard
post-myocardial infarction care in Canada, based on the 2009 American College
of Cardiology and American Heart Association guidelines that recommend
short-term and long-term use of aldosterone blockade."

    Congestive Heart Failure; An Unmet Medical Need

    In Canada, congestive heart failure (CHF) is a major public health
problem that currently affects more than 500,000 Canadians;(2) over five
years, 45 per cent of people diagnosed with the condition may die.(3) CHF is
associated with significant morbidity, mortality and healthcare costs.
    Much attention has been focused on care for the chronic phase of
congestive heart failure, yet a substantial proportion of new cases occur at
the time of acute ventricular damage, after a heart attack. Increasing efforts
to reduce the extent of cardiac damage at the time of myocardial infarction
complicated by heart failure through rapid thrombolysis or primary coronary
intervention has helped to reduce the subsequent burden of heart failure.(4)
However, early identification and treatment of cardiac damage after myocardial
infarction complicated by heart failure needs to be improved.

    The Role of Aldosterone

    Aldosterone is a hormone that plays an important role in the mechanics of
heart failure.(5) Aldosterone binds to mineralocorticoid receptors at specific
sites in the heart, brain, and blood vessels, which can contribute to the
development of cardiovascular disease. Elevated levels of aldosterone are
associated with an increased risk of death.(6)
    Treatment with ACE inhibitors or angiotensin-II receptor blockers (ARBs)
improves survival rates and hospitalization in patients with heart failure
and/or AMI. However, recent trials have shown that even with these therapies,
aldosterone levels rise back to baseline over time(6), because neither ARBs,
nor ACE inhibitors block aldosterone at the mineralocorticoid receptor level.
As a result, most patients receiving current standard of care are still at
risk for cardiovascular death and disease due to constant exposure to
    "Evidence of heart failure compounds the risk associated with AMI, and
elevated levels of aldosterone have been linked to a wide range of serious
cardiovascular consequences," said Dr. Serge Lepage, Professor, Cardiology,
University of Sherbrooke and President of the Quebec Heart Failure Society.
"The introduction of INSPRA will help save lives in Canada."

    About INSPRA

    INSPRA (eplerenone) binds to mineralocorticoid receptors, a class of
hormone receptors, and blocks the binding of aldosterone.
    INSPRA is indicated as an adjunct to standard therapy, to reduce the risk
of death following a heart attack, in clinically stable patients who have
evidence of heart failure and left ventricular systolic dysfunction (ejection
fraction less than or equal to 40 per cent), where the left ventricle fails to
contract sufficiently to pump blood effectively.
    In EPHESUS, the overall incidence of adverse events reported with INSPRA
was similar to placebo.(7) Serum potassium should be measured before
initiating therapy and within the first week after the first dose, or after
increasing the dose. Serum potassium should be measured periodically
thereafter. Tablets are available in 25 mg and 50 mg strengths and can be
administered with or without food.
    The most serious adverse events in EPHESUS were endpoint events (e.g.,
death, cardiac failure) and these were significantly more frequent in the
placebo treatment group. Serious adverse events that were significantly
associated with eplerenone treatment included dehydration, arterial leg
thrombosis, increased creatinine, and pyelonepphritis; the incidence of these
was low (less than or equal to 1.5 per cent).

    About Pfizer Canada

    Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., the world's
leading pharmaceutical company. Pfizer discovers, develops, manufactures and
markets prescription medicines for humans and animals. Pfizer Canada's
commitment to helping Canadians live happier, healthier and longer lives
extends beyond medication. To learn more about Pfizer Canada's More Than
Medication philosophy and programs, visit

    (1) Pitt B, Remme W, Zannad F, et al, for the Eplerenone Post-Acute
        Myocardial Infarction Heart Failure Efficacy and Survival Study
        Investigators. Eplerenone, a selective aldosterone blocker, in
        patients with left ventricular dysfunction after myocardial
        infarction. N Engl J Med 2003;348:1309-1321.
    (2) H Ross, J Howlett, JMO Arnold, et al; for the Canadian Cardiovascular
        Society Access to Care Working Group. Treating the right patient at
        the right time: Access to heart failure care. Can J Cardiol 2006;
        22(9):749-754. Available at
        Last accessed March 9, 2009.
    (3) Ibid.
    (4) Martin R Cowie, Larry Lacey, and Maggie Tabberer. Heart Failure After
        Myocardial Infarction: A Neglected Problem?: Conclusions. British
        Journal of Cardiology. 2005;12(3):205-208. (C) 2005 Sherborne Gibbs
    (5) Swedberg K et al; for the CONSENSUS Trial Study Group. Hormones
        regulating cardiovascular function in patients with severe congestive
        heart failure and their relation to mortality. Circulation 1990;
    (6) Yan RT, White M, Yan AT, Yusuf S, Rouleau JL, et al, for the
        Randomized Evaluation of Strategies for Left Ventricular Dysfunction
        (RESOLVD) Investigators. Usefulness of temporal changes in
        neurohormones as markers of ventricular remodeling and prognosis in
        patients with left ventricular systolic dysfunction and heart failure
        receiving either candesartan or enalapril or both. Am J Cardiol.
        2005 Sep 1;96(5):698-704.
    (7) INSPRA Product Monograph, p. 7.

For further information:

For further information: Carolyn Santillan, Edelman, (416) 979-1120,
ext. 351,; Safia Généreux-Khali, Pfizer Canada
Inc., (514) 693-4657,

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