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Journal of Cardiovascular Pharmacology and Therapeutics
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Efficacy and Safety of Nifedipine Coat-Core versus Amlodipine in Patients With Mild to Moderate Essential Hypertension: Comparison of 24-Hour Mean Ambulatory Diastolic Blood Pressure

Richard L. Byyny

University of Colorado Health Sciences Center, Denver, Colorado

Timothy Shannon

Bayer Corporation Pharmaceutical Division, West Haven, Connecticut

Lawrence A. Schwartz

Bayer Corporation Pharmaceutical Division, West Haven, Connecticut

Christa Rotolo

Bayer Corporation Pharmaceutical Division, West Haven, Connecticut

Steven Jungerwirth

Bayer Corporation Pharmaceutical Division, West Haven, Connecticut

Background: Calcium channel blockers have been successfully used for the treatment of hypertension. In this study, the antihypertensive efficacy and safety of the dihydropyridine calcium channel blockers nifedipine coat-core 30 mg and amlodipine 5 mg were evaluated. Methods: This multicenter, double-blind, prospective, randomized, parallel-arm study com pared once daily administration of nifedipine coat-core 30 mg with once daily amlodipine 5 mg in subjects with mild-to-moderate essential hypertension. A 4-week placebo run-in period was followed by an 8-week active treatment period. Blood pressure reduction was measured by ambulatory blood pressure monitoring and casual office blood pressure measured by mer cury sphygmomanometer.

Results: Nifedipine coat-core and amlodipine produced equivalent reductions in mean dias tolic blood pressure, as determined by 24-hour ambulatory blood pressure monitoring. Mean reduction in diastolic blood pressure was 5.4 mmHg and 5.8 mmHg for nifedipine coat-core and amlodipine, respectively. Both drugs were well tolerated and neither treatment resulted in a significant change in heart rate.

Conclusions: Nifedipine coat-core 30 mg once-daily is comparable to amlodipine 5 mg once-daily for blood pressure reduction.

Key Words: nifedipine coat-core • amlodipine • hypertension • ambulatory blood pressure monitoring.

Journal of Cardiovascular Pharmacology and Therapeutics, Vol. 2, No. 2, 77-83 (1997)
DOI: 10.1177/107424849700200201
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