Comparison of nisoldipine ER versus amlodipine for the treatment of African-American patients with hypertension

Abstract

Calcium channel blockers (CCBs) are widely used, either alone or in combination with other agents, to treat hypertension in the African-American population. Nisoldipine ER is a vasculoselective dihydropyridine CCB that is presently dosed from 10-60 mg daily and has a lower acquisition cost compared to most other CCBs. We studied nisoldipine ER (20 to 60 mg) and amlodipine (5 to 10 mg) in hypertensive African-American men and women (mean age, 52 years, baseline clinic BP range, 140-200/95-114 mmHg) using clinic and 24-hour ambulatory BP monitoring to compare their safety and efficacy in this population. There were 193 patients randomized to nisoldipine ER (n = 92) or amlodipine (n = 101) at 18 clinical sites in the USA. The design was titration to effect at 4 week intervals to achieve a seated office BP < 140/90 mmHg. This resulted in 74% of the patients on ≥ 40 mg of nisoldipine and 82% of the patients on 10 mg of amlodipine. Changes from baseline in ambulatory and clinic BP and heart rate in the modified intent-to-treat population are shown in the Table (mean ± SE). No significant differences were noted in the safety and tolerability between treatments. The most prevalent adverse events were headache (nisoldipine, 14%; amlodipine, 15%) and lower extremity edema (nisoldipine, 12%; amlodipine, 10%). These data show that substantial changes in BP occurred for both the clinic and ambulatory BP for each treatment arm. The reduction in 24-hour systolic BP was somewhat greater (3.2 mmHg) with nisoldipine ER compared to amlodipine in African-American patients with hypertension.