Forest Labs Presents Bystolic Phase IV Study Data

Results showed Bystolic reduced sitting systolic and diastolic blood pressure (BP) when used as monotherapy and was well tolerated. Bystolic is a beta blocker approved by the FDA for the treatment of mild to moderate hypertension and can be used alone or in combination with other antihypertensive treatments.

Forest Laboratories said that the study was an eight-week randomised, double-blind, placebo-controlled, dose-titration trial that was conducted in multiple centers in the US to evaluate the efficacy and safety of Bystolic in hispanic patients with stage I and II hypertension.

In the trial, the participants included 113 female and 164 male hispanic patients 18 years and older with stage I-II hypertension (sitting diastolic BP =95mmHg and =114mmHg). Patients were randomised to receive either Bystolic (5mg) or placebo and dose was titrated at 2-week intervals in patients who did not achieve BP control, to a maximum dose of 40mg.

Reportedly, patients treated with Bystolic achieved double digit blood pressure reductions in both systolic and diastolic blood pressure. At week 8, mean change from baseline was -14.1/-11.1mmHg for Bystolic versus -9.3/-7.3mmHg for placebo patients. The overall incidence of treatment-emergent adverse events was similar in the placebo (24.3%) and Bystolic (23.4%) groups.

Henry Punzi, clinical assistant professor of department of family and community medicine at University of Texas Southwestern Medical Center in Dallas and study investigator for Forest Laboratories, said: “Bystolic is one of the antihypertensives to have been evaluated for efficacy and safety in hispanic patients, which is important given the lack of awareness, poor control, and risk factors in this growing population.

“These positive results show Bystolic is an effective treatment option with good tolerability for hispanic patients with hypertension and add to the growing body of evidence in support of the clinical profile of the drug.”