The safety and efficacy of once-daily nifedipine coat-core in combination with atenolol in hypertensive patients. Adalat CC Cooperative Study Group

Abstract

The efficacy and safety of once-daily nifedipine coat-core when added to a regimen of atenolol (ATN; 50 mg/day) were compared with ATN and placebo in 251 patients with essential hypertension in this 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Mean net reductions (ATN effect subtracted) in supine diastolic blood pressure at endpoint were 7.9 mmHg, 9.4 mmHg, and 9.9 mmHg at 30, 60, and 90 mg/day of nifedipine coat-core, respectively, and 4.1 mmHg on ATN+placebo. Beyond the first week of double-blind therapy, all reductions produced by nifedipine coat-core combined with ATN were statistically significant (P < 0.05) compared with ATN+placebo. On ambulatory blood pressure monitoring, trough-to-peak ratios of the change in diastolic blood pressure for the 30, 60, and 90 mg/day doses were 41%, 68%, and 78%, respectively. Adverse events were generally mild or moderate and most reflected the vasodilatory properties of nifedipine (eg, edema, headache). Nifedipine coat-core, when combined with ATN in patients not controlled by ATN alone, had significant antihypertensive activity for the entire 24-hour dosing interval and was well tolerated by the majority of patients in the study.