Treatment of Mild Hypertension with Low Once‐Daily Doses of a Sustained‐Release Capsule Formulation of Verapamil

Abstract

The efficacy and safety of a low dose (120 mg) of a sustained-release capsule formulation of verapamil administered once daily in the treatment of 42 patients with mild hypertension were assessed in this clinical trial. After a 4-week placebo washout period (baseline), patients with diastolic clinic blood pressures of 91 to 100 mm Hg inclusive were treated for 4 weeks with once-daily verapamil sustained-release 120 mg capsules. Clinic blood pressure was measured and 24-hour ambulatory blood pressure monitoring was performed at the end of both the baseline and the 4-week treatment periods. Twenty-four hour, day, and night systolic and diastolic ambulatory blood pressure were significantly (P < 0.01) reduced in the entire study population (24-hour, -5/-4 mm Hg; day, -6/-4 mm Hg; night, -4/-3 mm Hg). On the basis of mean daytime (6 AM to 6 PM) ambulatory diastolic blood pressure, patients were stratified into subgroups of patients with confirmed (> 85 mm Hg) and unconfirmed mild hypertension (< or = 85 mm Hg). The magnitude of the mean change in systolic and diastolic blood pressure was greater in the group of patients with confirmed mild hypertension than the group with unconfirmed hypertension. The incidence of adverse experiences was low in frequency and events were of mild severity; quality of life scores improved (P = 0.02). Low daily doses (120 mg) of verapamil sustained-release capsules provide a well-tolerated and sustained antihypertensive effect over 24 hours in patients with mild hypertension.