Parallel comparative trial of amlodipine and nitrendipine monotherapy in patients with essential hypertension.

OBJECTIVES: To compare the blood pressure effects of two dihydropyridine calcium channel blockers, amlodipine and nitrendipine, in 488 patients with essential hypertension. METHODS: The study used a randomized, single-blind design of 4 weeks' duration conducted at four medical centres in China. Patients were randomized to receive either amlodipine monotherapy (5-10 mg once daily; n = 334) or nitrendipine (10 mg twice or three times daily; n = 1 54). Blood pressure was evaluated by standard blood pressure measurements before and after treatment, and by 24 h ambulatory blood pressure monitoring in a subgroup of patients (n = 18). RESULTS: Both systolic and diastolic blood pressures were reduced from baseline after 4 weeks of amlodipine and nitrendipine monotherapy. Diastolic blood pressure was reduced by 14.4% in the amlodipine group, which was significantly better than the 13.0% reduction in the nitrendipine group (P< 0.05). In addition, blood pressure response rates were significantly better with amlodipine monotherapy than with nitrendipine monotherapy. In the subgroup of patients undergoing 24 h ambulatory blood pressure monitoring, both systolic and diastolic blood pressure were reduced from baseline in the amlodipine and nitrendipine groups. Adverse effects were generally mild, with dizziness, flushing, palpitation, headache, drowsiness and ankle oedema being the most common. Rushing and headache were more frequent in the nitrendipine group than in the amlodipine group (P< 0.05 for flushing and P<0.01 for headache). CONCLUSIONS: Amlodipine monotherapy reduced blood pressure more effectively than nitrendipine monotherapy in patients with essential hypertension and was associated with fewer adverse events.