SUSTAINED-RELEASE NICARDIPINE IN MILD-TO-MODERATE HYPERTENSION

Study Objective: To evaluate the antihypertensive effects and tolerabi lity of a sustained release preparation of nicardipine (NIC SR), a dih ydropyridine calcium channel antagonist. Design and Interventions: Aft er at least 1 week without receiving antihypertensive medications and 2 weeks of single-blind placebo treatment, the patients were randomize d to receive in a double-blind fashion, either placebo or NIC SR 30, 4 5, or 60 mg twice daily at 12-h intervals for 12 weeks. Supine and sta nding blood pressure were measured in all patients and 24-h ambulatory blood pressure monitoring was performed in a subset of 75 patients at baseline during treatment with single-blind placebo and during the do uble-blind treatment period. Setting: Academic and private hypertensio n research clinics. Patients: Two hundred sixty-four patients with sup ine diastolic blood pressures of 95 to 114 mm Hg, ranging in age from 22 to 75 years and in weight from 50 to 137 kg, approximately evenly d ivided by gender; one third were black. Results: In comparison with pl acebo, all doses of NIC SR significantly reduced systolic and diastoli c blood pressures, with a trend toward greater effects from 45 and 60 mg twice daily than with 30 mg twice daily. At all doses, reduction of blood pressure from baseline levels was fully apparent within the fir st 2 weeks of therapy and was maintained throughout the remaining 10 w eeks of the trial. Ambulatory blood pressure monitoring demonstrated t hat the antihypertensive effect was maintained throughout the dosing i nterval. Adverse effects were primarily extensions of pharmacologic ac tivity (eg, pedal edema, flushing). Six percent of the placebo group a nd 10 percent of the combined NIC SR groups experienced at least one a dverse event that was judged to be probably related to therapy. Withdr awals due to unacceptably high blood pressure totaled 5 percent of the combined NIC SR groups and 25 percent of the placebo group. Conclusio ns: Sustained-release nicardipine at a dose of 30 to 60 mg every 12 h provided effective and generally well-tolerated antihypertensive contr ol throughout the day in most patients with mild-to-moderate essential hypertension.