ABSTRACT
The efficacy and safety of the dihydropyridine calcium antagonists amlodipine and nitrendipine as single-agent therapy of mild to moderate hypertension were compared in an open, parallel-group study. Interim analysis of data from 74 patients (43 male, 31 female) from an expected final total of 96 patients is reported. Amlodipine normalized blood pressure (< or = 90 mm Hg) in 94.7% of patients with a mean final dose of 8.3 mg/day, compared with normalization of blood pressure in 83.3% of patients treated with nitrendipine with a mean final dose of 28.3 mg/day. Only nitrendipine produced a statistically significant increase in heart rate after 2 and 4 weeks of therapy. Nitrendipine-treated patients reported more adverse events (47.2%) than the amlodipine-treated group (26.3%). Two patients from the nitrendipine group discontinued treatment due to treatment-related adverse events and one patient required a dose reduction. In the amlodipine-treated group, all adverse events were mild to moderate and dose reduction was required in one patient. In conclusion, although amlodipine and nitrendipine have comparable antihypertensive efficacy, in this study amlodipine was associated with fewer adverse effects.
Subject(s)
Amlodipine/therapeutic use , Antihypertensive Agents/therapeutic use , Blood Pressure/drug effects , Hypertension/drug therapy , Nitrendipine/therapeutic use , Amlodipine/administration & dosage , Amlodipine/adverse effects , Antihypertensive Agents/administration & dosage , Antihypertensive Agents/adverse effects , Blood Pressure Monitoring, Ambulatory , Drug Administration Schedule , Female , Humans , Male , Nitrendipine/administration & dosage , Nitrendipine/adverse effects , Severity of Illness IndexABSTRACT
This study compared the efficacy and safety of 8 weeks of open treatment with the dihydropyridine calcium antagonists amlodipine and nitrendipine in mild-to-moderate hypertension. Interim analysis of data from 74 patients (43 male, 31 female) showed that amlodipine normalized diastolic blood pressure (less than or equal to 90 mmHg) in 95% of patients compared with 83% of nitrendipine-treated patients. Nitrendipine produced a statistically significant increase in heart rate at 2 and 4 weeks of therapy but there was no significant change in heart rate in amlodipine-treated patients. Amlodipine-treated patients reported fewer adverse events (26%) than did the nitrendipine-treated group (47%), with two patients from the nitrendipine group discontinuing treatment due to treatment-related adverse events. Adverse events in the amlodipine-treated group were mild to moderate. The incidence of flushing was higher in nitrendipine-treated patients (25%) than in amlodipine-treated patients (10%). This relative difference in the incidence of vasodilator-related side effects is probably explained by the gradual onset of effect with amlodipine.