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The Food and Drug Administration (FDA) has approved a new polypill that combines telmisartan, amlodipine, and indapamide for the treatment of hypertension in adults, including use as an initial therapy. This is the first FDA-approved triple-combination medication indicated for initial use in patients who are likely to require multiple drugs to reach their blood pressure goals, according to a press release from manufacturer George Medicines. Most patients with hypertension ultimately need 2 or more medications to achieve adequate blood pressure control, so the polypill could simplify drug regimens. The approval of the polypill was supported by 2 double-blind, randomized clinical trials. One study demonstrated that the polypill lowered systolic blood pressure by approximately 7–8 mm Hg compared to placebo in patients with mild-to-moderate hypertension. A second trial showed modest but statistically significant blood pressure reductions when compared to various dual-drug combinations. The polypill will be available in 3 dose combinations. For initial therapy, patients would begin with 1 of the 2 lower doses taken once daily. If more rapid blood pressure control is needed, the dosage may be increased to the maximum dose once daily after 2 weeks. The medication is expected to become available in the last quarter of this year. The international phase 3 studies for the new hypertension polypill were published in 2024 in the Journal of the American College of Cardiology and The Lancet.
Multiple treatments for hypertension: Typically, about 75% of patients with hypertension require combination medication because they cannot control their blood pressure adequately with monotherapy, as published in Advances in Therapy in 2013. Use of multiple antihypertensives rose from 36.8% to 47.7% from 2001 to 2010, according to a study published in Circulation in 2012.