A Clinical Study on the Hypotensive Effect of Nilvadipine in Patients with Essential Hypertension

ABSTRACT

BACKGROUND: As an antihypertensive drug, Nifedipine, a calcium channel blocker was introduced recently, which also has antianginal effect. But due to the relatively short duration of action, another antihypertensive agents having longer duration of action and stronger hypertensive effect were under investigation. Nilvadipine, a new calcium channel blocker, was introduced to have more prologned duration of action and to act more specifically on vascular smooth muscle. So the efficacy and safety of oral Nilvadipine on essestial hypertension was investigated and represented by our institute. METHODS: In order to investigate the efficacy and safety of oral Nilvadipine, daily doses of 4mg twice a day were administered in 30 hypertensive patients whose states were compatible to the criteria 1) severity of hypertension rated in Stage I and Stage II according to the classification by WHO, 2) ages ranging from 30 to 74 years regardless of sex, 3) blood pressure with 95mmHg or higher but less than 115mmHg in diastolic pressure which was the mean in a sitting position at the last two out of not less three consultations in the 2 week observation period, 4) outpatients with informed consent for 6 weeks. Blood pressure and heart rate were measured every 2 weeks. The complete with blood count with platelet, uronalysis and the electrocardiography were performed at the beginning period and the 6th weeks of therapy. And kinds of side effects were questioned by examining physicians. RESULTS: The following results were obtained 1) Blood pressure fell significantly in 6 weeks of treatment with Nilvadipine(Mean pressure+/-S.D., 6.00mmHg vs 108.90+/-9.68mmHg p<0.05), 2) There was no significant change in EKG in 6 weeks of treatment with Nilvadipine, 3) Pulse rate was decreased in 6 weeks of treatment with Nilvadipine(80.14+/-11.90/min vs 75.39+/-6.47/min, p<0.05). 4) No significant chsange in body weight was observed(64.50+/-8.7kg vs 63.50+/-10.25kg, p<0.05). 5) There were no significant changes in blood chemistry including blood sugar, cholesterol, electrolytes, serum creatinine and alkaline phosphatase values, 6) Hematologic findings and urinalysis findings reamained unchanged, 7) Total 10 patients(33.30%) had various side effects;facial flushing 30.00%, palpitation 23.33%, headache 20.00%, nausea 10.00%, drowsiness 3.33%, heaviness 3.33% and indigestion 3.33%. But there was no serious side effect that requires to discontinue the medication of the test drug. And there was no need to reduce the dosage due to the side effect, 8) The antihypertensive effect was judged to decrease markedly in 76.70%, decrease 20.00%, unchange 3.30% and increase 0.00%, 9) The utility which was assessed with the data from the overall safety and antihypertensive effect, the drug was judged to be very useful in 60.00%, useful 33.30%, useless 6.67% and inhibited 0.00%. CONCLUSION: From the above results, Nilvadipine in doses of 4mg twice a day was effective and useful in most cases without severe side effects in essential hypertensive patients with diastolic blood pressure of 95 to 115mmHg.