Efficacy and safety of isradipine in hypertension

Abstract

Of the calcium channel blocking drugs, only verapamil is approved in the United States for treatment of hypertension. Isradipine is a 1,4-dihydropyridine calcium blocker that may be given on a twice-daily basis. It causes peripheral vasodilation with minimal cardiodepressant activity. We undertook a double-blind, parallel group randomized, multicenter study of 203 hypertensive subjects to examine the efficacy and safety of isradipine in treatment of hypertension. Subjects were given 0, 2.5, 5, 7.5, or 10 mg isradipine twice daily for up to 5 weeks. There was a significant dose-response relationship between isradipine dose and decrease in systolic blood pressure (SBP) and diastolic blood pressure (DBP). Isradipine 15 mg/day reduced supine pressure by 16/15 mm Hg in patients with starting DBP less than 105 mm Hg and by 38/22 mm Hg in those with starting DBP greater than or equal to 105 mm Hg. There was no significant orthostatic fall in blood pressure at any dose. Heart rate (HR) increased on an average by only a maximum of four beats/min. The drug was slightly more effective in the elderly in the standing position than in the young in the standing position. Adverse effects were mild, and only six patients were discontinued from the study because of adverse effects. Isradipine appears to be a safe, effective drug in monotherapy of hypertension at a wide range of patient ages.