FDA Approves Single-Pill Combination of Aliskiren, Amlodipine for Hypertension

(Doctor’s Guide) — The US Food and Drug Administration (FDA) has approved a single-pill combination of aliskiren and amlodipine (Tekamlo) for the treatment of hypertension.

The FDA approval was based on clinical trial data involving more than 5,000 patients with mild-to-moderate hypertension. An 8-week, randomised, double-blind, placebo-controlled, multi-factorial study showed that the combination tablet resulted in decreases in systolic/diastolic blood pressure at trough of 14 to 17/9-11 mmHg, compared with 4 to 9/3-4 mmHg for aliskiren alone, and 9 to 14/6-8 mmHg for amlodipine alone.

In 2 additional double-blind, active-controlled studies of similar design evaluating patients with moderate-to-severe high blood pressure (SBP, 160-200 mmHg), the combination tablet demonstrated significantly greater reductions in systolic and diastolic blood pressures when compared with amlodipine alone.


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