FDA approves new combination pill for hypertension

The FDA announced Friday the approval of combination aliskiren and amlodipine as initial therapy or replacement therapy for patients with hypertension.

Approval was based on data from an 8-week, randomized, double blind, placebo-controlled, multifactorial trial that included more than 5,000 patients with mild-to-moderate hypertension. Researchers reported that combination aliskiren and amlodipine (Tekamlo, Novartis) decreased systolic/diastolic blood pressure from 14 mm Hg to 17 mm Hg/9 mm Hg to 11 mm Hg compared with 4 mm Hg to 9 mm Hg/3 mm Hg to 4 mm Hg for aliskiren alone and 9 mm Hg to 14 mm Hg/6 mm Hg to 8 mm Hg for amlodipine alone.

The combination was associated with significantly greater reductions in systolic and diastolic BP in two additional double blind, active-controlled studies in patients with moderate-to-severe hypertension. According to data from one study of 443 black patients, at 8 weeks, the treatment difference between the combination therapy and amlodipine alone was 5.2 mm Hg/3.8 mm Hg. Data from the other study of 484 patients demonstrated a 7.1 mm Hg/3.8 mm Hg treatment difference between the combination and amlodipine alone.

“Single-pill combination therapies provide a convenient treatment option while supporting physicians in addressing the complex needs of patients,” Alan Gradman, MD, professor of medicine at Temple University School of Medicine, said in a press release. “This new single-pill combination demonstrated greater BP reductions than either drug alone in clinical studies and therefore provides a new option to consider when choosing appropriate high BP therapies.”