The long-term efficacy and tolerability of nisoldipine in patients with mild-to-moderate hypertension

Abstract

The long-term antihypertensive efficacy and tolerability of a controlled-release (coat core [CC]) tablet formulation of nisoldipine, a second-generation dihydropyridine calcium-channel blocker, was evaluated in three open-label, multicenter trials of up to 1 year in duration. A total of 365 patients with mild-to-moderate essential hypertension received nisoldipine CC 10 mg, 20 mg, 30 mg, or 40 mg once daily, with or without concomitant antihypertensive therapies. Blood pressure measurements (supine and standing, both diastolic and systolic) were taken at baseline; at weeks 2, 4, and 6; and then at 1- or 2-month intervals for up to 1 year. Adverse events were also monitored. During short-term therapy, nisoldipine CC produced a clinically significant reduction in blood pressure, which was maintained throughout the 1-year treatment period. Nisoldipine CC was effective in a broad range of patients, including the elderly and young adults, men and women, and nonwhite and white patients. Overall, treatment was well tolerated and there were no changes in metabolic variables following long-term treatment with nisoldipine CC. Adverse events, which were generally mild and transient, were the type usually associated with the dihydropyridine class of calcium-channel blockers. There were no clinically relevant changes in heart rate with nisoldipine CC therapy. This study suggests that nisoldipine CC is effective and well tolerated as long-term treatment for mild-to-moderate hypertension. When used in short-term therapy, it produces a clinically relevant reduction in blood pressure, which is maintained during longer treatment periods.