Why the study?
Does nisoldipine extended release reduce blood pressure compared to amlodipine in patients with mild to moderate hypertension?
Does nisoldipine extended release reduce blood pressure compared to amlodipine in patients with mild to moderate hypertension?
Nisoldipine ER provides clinically equivalent antihypertensive efficacy to amlodipine but at a lower acquisition cost.
Amlodipine yields modestly greater DBP reduction than nisoldipine ER; extends comparative CCB data for agent selection in mild-moderate hypertension.
This multicentre, double-blind, double-dummy, randomised trial compared the efficacy and tolerability of nisoldipine extended release (10-40 mg) and amlodipine (2.5-10 mg) in 161 patients. The primary end point was a between-treatment comparison of change from baseline to week 8 in mean office diastolic blood pressure (DBP). The least squares mean reductions in systolic (S)BP/DBP (+/- standard error) for nisoldipine and amlodipine were -11.7/-9.3 +/- 1.4/0.8 and -14.3/-12.0 +/- 1.4/0.8 mmHg, respectively. The DBP treatment difference was 2.7 mmHg (90% confidence interval: 1.1 to 4.3 mmHg; p = 0.005). Tolerability profiles were similar between treatments. The drug acquisition cost per mmHg DBP reduction was 40% lower with nisoldipine; an acquisition cost analysis revealed that amlodipine was 80% more expensive than nisoldipine for treating hypertension. In summary, nisoldipine and amlodipine provide clinically equivalent antihypertensive efficacy; however, nisoldipine is more economical than amlodipine.
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Whitcomb et al. (2000) studied this question.
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