"The perindopril/amlodipine FDC is an important asset in
The FDC appeared to be well tolerated in the trial, and there were no unexpected serious adverse events reported. The most common adverse events included mild to moderate edema, cough and headache, which are known side effects of the individual components of the FDC.
Perindopril, an angiotensin converting enzyme inhibitor (commonly called an ACE inhibitor), has been studied in seven landmark clinical trials involving more than 54,000 patients. This body of clinical evidence supports its beneficial impact in treating essential hypertension and stable coronary artery disease. Amlodipine, a calcium channel blocker (commonly called a CCB), is the most-prescribed antihypertensive in the U.S. Because ACE inhibitors and CCBs target different cardiovascular functions, physicians often use them in combination to treat their hypertensive patients.
About the Perindopril Franchise
ACEON is indicated for the treatment of patients with essential hypertension. ACEON may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. In clinical studies, the most common adverse events (incidence greater than or equal to 5%) were cough, dizziness and back pain.
ACEON is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. ACEON can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy. In clinical studies, the most common adverse events leading to discontinuation were cough, drug intolerance, and hypotension.
Perindopril erbumine has been available as a generic product in the U.S. since
IMPORTANT SAFETY INFORMATION
WARNING: AVOID USE IN PREGNANCY
When pregnancy is detected, discontinue ACEON as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury to or death of the developing fetus.
ACEON is contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ACE inhibitor.
ACEON is also contraindicated in patients with hereditary or idiopathic angioedema.
For complete prescribing information, please visit www.aceon.com.
Hypertension affects approximately one billion individuals worldwide. As the population ages, the prevalence of hypertension will increase even further. Hypertension is a major risk factor for atherosclerotic vascular diseases. The relationship between blood pressure and risk of cardiovascular events is continuous, consistent, and independent of other risk factors. Despite this evidence, current control rates of hypertension remain far below the Healthy People 2010 goal of 50%.
Recent clinical trials have demonstrated that effective blood pressure control can be achieved in most patients with hypertension; however, for many patients this can only be accomplished with a combination of multiple antihypertensive drugs.1,2,3 The Seventh Report of the
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Certain statements contained in this press release including, but not limited to, statements related to anticipated ability to license the perindopril/amlodipine fixed-dose combination to a third-party, continued sales of approved products, and anticipated regulatory approval of unapproved product candidates, or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. Potential risks to
1. Cushman WC, Ford CE, Cutler JA, et al. Success and predictors of blood pressure control in diverse North American settings: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). J Clin Hypertens 2002;4:393-404.
2. Julius S, Kjeldsen SE, Weber M, et al. Outcomes in hypertensive subjects at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet 2004;363:2022-2031.
3. Sever PS, Dahlöf B, Poulter NR et al. Rationale, design, methods and baseline demography of participants of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT). J Hypertens 2001;19:1139-1147.
4. Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the
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