FDA Approves Polypill for Initial Hypertension Treatment

The U.S. Food and Drug Administration (FDA) has approved Widaplik, a triple-combination medication, as the first polypill for initial hypertension treatment in adults. The drug combines telmisartan, amlodipine, and indapamide, offering a single-dose option for patients likely needing multiple medications to achieve blood pressure goals.
Traditionally, initial monotherapy has been the default approach for hypertension, but it often leads to suboptimal results due to treatment inertia. "Single pill combination antihypertensive therapy has great potential to improve hypertension control in the U.S. and worldwide," said Paul Whelton, MD, of Tulane University, emphasizing that most patients require multiple therapies to meet blood pressure targets.
The approval was based on two clinical trials showing significant blood pressure reductions. For initial therapy, patients start with lower doses (10 mg/1.25 mg/0.625 mg or 20 mg/2.5 mg/1.25 mg) and can gradually increase to the maximum dose (40 mg/5 mg/2.5 mg) after two weeks.
Common adverse reactions include symptomatic hypotension. The drug is contraindicated for individuals with anuria or hypersensitivity to its components. Monitoring of serum electrolytes, glucose, and renal function is recommended. People with diabetes should avoid combining Widaplik with aliskiren, and NSAIDs may reduce its effectiveness.
Widaplik is expected to be available in the last quarter of 2023.

Published: 6/9/2025