(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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What are eight weeks in a lifetime?
Eight weeks are long enough to show the effect of the medication but may not be long enough to ‘prove’ that the pills work long-term. It would be interesting to find out what the results of a real ‘long-term’ study would be, one taken over several years.
It is a frightening thought that pills are approved based on such short trials as blood pressure medication must be be taken for the rest of a patient’s life.