Novartis looks to single-pill BP drugs after study

Swiss drug major Novartis has published the final results of the ACCOMPLISH study, which demonstrated that its single-pill blood pressure medication Lotrel (amlodipine/ benazepril) reduced cardiovascular events by 20% in high-risk patients with elevated BP compared with a benazepril/hydrochlorothiazide combination, in the New England Journal of Medicine.

ACCOMPLISH was a randomized, double-blind, multicenter trial that included more than 11,000 patients from around 550 centers in the USA and Scandinavia. The composite endpoint included heart attacks, strokes, hospitalizations for unstable angina and CV death in high-risk patients with elevated BP. Patients received a single-pill combination of Lotrel or benazepril/HCT. In the first two months of the study, doses of study medications were increased: benazepril was titrated up to 40mg and then, for patients not at goal BP, HCT was increased to 25mg and amlodipine to 10mg.

Only 37% of patients were at the systolic BP goal of <140mmHg at study entry. After switching to a single-pill combination and dose titration, 72% (HCT combination) and 75% (amlodipine combination) of patients achieved BP goal, with a mean systolic BP of around 130mmHg. Both single-pill combinations were well tolerated. The incidence of adverse events that led to study discontinuation was low; around 15% for both groups with only 0.5% (HCT combination) and 0.4% (amlodipine combination) experiencing hypotension.