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Prestalia (Perindopril Arginine/Amlodipine) Gets Green Light for Treatment of Hypertension

Product slated for launch in first quarter of 2015

The FDA has approved Prestalia (perindopril arginine and amlodipine, Symplmed Pharmaceuticals) for the treatment of hypertension. The product is the first fixed-dose combination of these two medications.

Prestalia may be used in patients whose blood pressure is not adequately controlled on monotherapy, or as initial therapy if a patient is likely to need multiple drugs to achieve their blood pressure goals.

The FDA’s approval was based on data from the phase III Perindopril Amlodipine for the Treatment of Hypertension (PATH) trial, which included 837 patients with hypertension. The study demonstrated that the fixed-dose combination of perindopril arginine with amlodipine besylate in a single pill was significantly more effective than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after 6 weeks of treatment. The findings also suggested that the combination may provide a better risk–benefit ratio than either treatment alone. Other clinical studies have shown that the use of these classes of drugs together may reduce cardiovascular events.

Prestalia is expected to be available to physicians and patients within the first quarter of 2015.

Prestalia contains perindopril arginine, an angiotensin-converting enzyme (ACE) inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, and is indicated for the treatment of hypertension. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a variety of pharmacologic classes, including the ACE inhibitor class to which perindopril principally belongs. No controlled trials have demonstrated a risk reduction with Prestalia.

Patients with moderate-to-severe hypertension are at a relatively high risk of cardiovascular events (e.g., stroke, heart attack, and heart failure), kidney failure, and vision problems. Therefore, prompt treatment is clinically relevant. Clinicians should consider the patient’s baseline blood pressure and target goal, as well as the incremental likelihood of achieving the goal with a combination product, such as Prestalia, compared with a monotherapy product when deciding on initial therapy. Individual blood pressure goals may vary based on the patient’s risk.

Prestalia tablets are contraindicated in patients with hereditary or idiopathic angioedema, with or without previous ACE inhibitor treatment, and in patients who are hypersensitive to perindopril, to any other ACE inhibitor, or to amlodipine. Clinicians should not co-administer aliskiren (Tekturna, Novartis) with ACE inhibitors, including Prestalia, in patients with diabetes.

Source: Pipeline Review; January 26, 2015.

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