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Positive Results for Fixed-Dose Drug Combination in Phase III Hypertension Trial

Perindopril/amlodipine combo more effective than either compound alone (Nov. 20)

The phase III Perindopril–Amlodipine for the Treatment of Hypertension (PATH) trial has shown that a fixed-dose combination of perindopril arginine and amlodipine besylate (XOMA Corporation) is significantly more effective than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after 6 weeks of treatment. The drug combination is marketed as Coveram outside the U.S.

The most common adverse events included mild-to-moderate edema, cough, and headache, which are known side effects of perindopril and amlodipine.

Perindopril, an angiotensin-converting enzyme (ACE) inhibitor, has been studied in more than 54,000 patients. This body of clinical evidence supports the drug’s beneficial effect in patients with essential hypertension and stable coronary artery disease. Amlodipine, a calcium channel blocker (CCB), is the most-prescribed antihypertensive agent in the U.S. Because ACE inhibitors and CCBs target different cardiovascular functions, physicians often use them in combination to treat hypertensive patients.

Hypertension affects approximately 1 billion people worldwide. As the population ages, the prevalence of the disorder will increase even further. Hypertension is a major risk factor for atherosclerotic vascular diseases. The relationship between blood pressure and the 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 be accomplished only with a combination of multiple antihypertensive drugs. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) recommends that clinicians consider initiating treatment with two drugs in combination if the patient's blood pressure is more than 20/10 mm Hg above goal (i.e., stage 2 hypertension). The primary objectives of this recommendation are to accelerate patients to goal and to avoid multiple drug-titration steps and multiple patient visits.

Source: XOMA Corporation; November 20, 2012.

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