The efficacy and safety of once-daily nifedipine coat-core in the treatment of mild-to-moderate hypertension. Adalat CC Cooperative Study Group.
The efficacy and safety of once-daily nifedipine coat-core, a new, extended-release formulation, were examined in 245 patients with essential hypertension in this 10-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Mean net reductions in trough supine diastolic blood pressure at endpoint were 6.5 mmHg, 7.7 mmHg, and 11.7 mmHg at 30, 60, and 90 mg/day of nifedipine, respectively. All reductions were statistically significant, compared with placebo. Trough-to-peak ratios for supine diastolic blood pressure change following the 30, 60, and 90 mg/day doses were 49%, 67%, and 61%, respectively. Adverse events were generally mild or moderate, and most reflected the vasodilatory properties of the drug (eg, headache, edema). Reports of adverse events decreased as treatment progressed. The nifedipine coat-core tablet provided good control of blood pressure for the entire 24-hour dosing interval and was well tolerated by the majority of patients in the study.
Feig
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Miles Inc., Pharmaceutical Division, West Haven, Connecticut.
Gibson
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Mac Carthy
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Pettis
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Schwartz
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D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006207:Half-Life; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D016037:Single-Blind Method; D013607:Tablets
D003692:Delayed-Action Preparations; D013607:Tablets; D009543:Nifedipine