Download ACEON® (perindopril erbumine)

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ACEON® (perindopril erbumine)
ACEON® (perindopril erbumine tablets) is an antihypertensive medication used to treat patients with high blood pressure (hypertension)
and to reduce the risk of heart attack. ACEON may be used alone or given with other classes of blood-pressure-reducing medications.
ACEON is indicated for the treatment of patients with essential hypertension. ACEON is also indicated for the treatment of patients with
stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction.
WARNING: FETAL TOXICITY
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When pregnancy is detected, discontinue ACEON as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Please see the full prescribing information at www.aceon.com.
ACEON has proven benefits across the cardiovascular continuum in seven large‐scale, successful cardiovascular and cerebrovascular
risk reduction trials in more than 50,000 patients.
ASCOT in hypertensive patients:
A multicenter, randomized trial designed to compare two antihypertensive treatment strategies (amlodipine ± perindopril vs atenolol±bendroflumethiazide) in the prevention of CHD events in 19,257 hypertensive patients who have no history of CHD and at least 3’ others CV risk factors.
The study was stopped early in December 2004 upon recommendation of the data safety monitoring board due to a significant 24% reduction
of mortality in the amlodipine/perindopril arm as compared to the atenolol diuretic arm. The median follow‐up was 5.5 years.
ADVANCE in diabetes patients:
A total of 11,140 patients with type 2 diabetes were randomized to treatment with a fixed combination of perindopril and indapamide or
matching placebo, in addition to current therapy. After a mean follow-up of 4.3 years, the active treatment arm reduced the risk of major
vascular events by 9% and the risk of death from cardiovascular disease by 18%.
HYVET in elderly patients:
A total of 3,845 patients who were 80 years of age or older and had a sustained systolic blood pressure of 160 mm Hg or more received either
the diuretic indapamide (sustained release, 1.5mg) or matching placebo. The ACE inhibitor perindopril (2 or 4 mg), or matching placebo, was
added if necessary to achieve the target blood pressure of 150/80 mm Hg. Active treatment was associated with a 39% reduction in the rate
of fatal or nonfatal stroke.
EUROPA in stable CAD patients:
A multicenter, randomized, double‐blind, placebo‐controlled study conducted in 12,218 patients who had evidence of stable coronary artery
disease without clinical heart failure showed that perindopril exclusive of blood pressure change by 20%, largely attributable to a reduction in
the risk of nonfatal myocardial infarction. This beneficial effect of perindopril on the primary outcome was evident after about one year
of treatment.
PROGRESS in stroke patients:
A total of 6,105 patients were randomly assigned to either active treatment (n=3051) or placebo (n=3054). Active treatment comprised a
flexible regimen based on perindopril (4 mg daily), with the addition of the diuretic indapamide at the discretion of treating physicians.
Combination therapy with perindopril plus indapamide reduced blood pressure by 12/5 mm Hg and lowered stroke risk by 43%.
PREAMI in post‐MI patients:
A total of 1,252 patients 65 years or older with a left ventricular ejection fraction of 40% or higher and recent acute myocardial infarction were
randomized to receive perindopril erbumine or placebo (8 mg/d) for 12 months. The primary end point showed a reduction of left ventricular
end diastolic volume change after one year of more than 8% was 22% less than placebo with perindopril. PEPCHF in heart failure:
Perindopril, 4 mg/day was compared to placebo in 850 patients aged ≥ 70 years with a diagnosis of heart failure, treated with diuretics and
an echocardiogram suggesting diastolic dysfunction and excluding substantial LV systolic dysfunction or valve disease. Improved symptoms,
exercise capacity and fewer hospitalizations for heart failure in the first year were observed with perindopril.
The most common adverse events include:
Hypertension: Common adverse events (incidence greater than or equal to 5%) are cough, dizziness and back pain. ACEON
is also contraindicated in patients with hereditary or idiopathic angioedema. Rare cases of angioedema, including intestinal
angioedema, have been reported. ACEON is contraindicated in patients known to be hypersensitive (including angioedema)
to this product or to any other ACE inhibitor.
Stable coronary artery disease: Common adverse events leading to discontinuation were cough, drug intolerance and
hypotension. Rare cases of angioedema, including intestinal angioedema, have been reported. ACEON is contraindicated in
patients known to be hypersensitive (including angioedema) to this product or to any other ACE inhibitor.
Do not use ACEON if you are pregnant. Stop using this medication and tell your doctor right away if you
become pregnant.