Comparative efficacy and safety ofnisoldipine extended-release (ER) andamlodipine (CESNA-III study) in African American patients with hypertension

Abstract Background This study evaluates the efficacy of the new dihydropyridine calcium antagonist nisoldipine extended-release (ER) compared to amlodipine on ambulatory and clinic blood pressures (BP) and heart rates in African American patients with hypertension. Methods This prospective, double-blind trial randomized 192 patients with office diastolic BP of 95 to 114 mm Hg to receive either nisoldipine (20 to 60 mg once daily) or amlodipine (5 to 10 mg once daily) for 12 weeks in a titration-to-effect design. Using ambulatory monitoring, efficacy was assessed by measuring change from baseline in systolic and diastolic BP and heart rate during three time intervals: 24-h mean period, awake, and sleep. In addition, a subanalysis was performed to evaluate patients whose nocturnal decline in BP was elevated (nondippers) versus those whose BP declined by 10% or more (dippers). Results Substantial and significant mean changes from baseline in 24-h BP were observed for patients treated with nisoldipine ER (−23/−16 ± 3/2 mm Hg) and amlodipine (−20/15 ± 3/2 mm Hg) (between-group comparisons, P = .07 for systolic BP; P = .50 for diastolic BP). Significant and similar reductions also were observed for clinic, awake, and sleep BP. Reductions in BP in the nondippers was substantially greater than in patients with a dipper profile. Neither agent had a significant effect on ambulatory heart rate. Adverse events were mild and infrequent (headache, edema, and dizziness at rates of 4% to 15%), and similar for both agents. Conclusions Nisoldipine ER was as effective as amlodipine in reducing 24-h BP in African-American patients with hypertension, with a similar adverse effect profile. Thus, this new therapy for delivery of a dihydropyridine calcium channel blocker is a useful antihypertensive strategy for African-American patients with hypertension.