A Clinical Study on Antihypertensive Effects and Safety of Benidipine

ABSTRACT

BACKGROUND: This study was designed to evaluate the antihypertensive efficacy and safety of benidipine hydrochloride, a Ca(++)-channel blocker, in patients with mild to moderate essential hypertension. METHODS: Benidipine was administered in 2-8mg once daily for 10 weeks in 16 hypertensive patients with diastolic blood pressure over 95mmHg and adverse effects were checked every two weeks after benidipine administration. Chest X-ray, ECG, funduscopy, and laboratory examination were performed before and after benidipine administration. RESULTS: The antihypertensive effect of benidipine was evaluated in 15 patients and the safety in 16 patients. The blood pressure significantly reduced from 170+/-12mmHg/102+/-5mmHg to 137+/-15mmHg/86+/-8mmHg at 10-week administration of benidipine and the overall effective rate was 100%. Heart rate was not affected by benidipine. The slight increase of total protein, BUN, potassium, and glucose was observed at 10 weeks of benidipine administration. Four cases of headache and 1 case of frequent urination were observed and the medication was discontinued in one patient due to headache. CONCLUSION: Benidipine proved effective and safe in the treatment of essential hypertension.