Comparison of the effects of amlodipine and losartan on blood pressure and diurnal variation in hypertensive stroke patients: a prospective, randomized, double-blind, comparative parallel study.

Background: Lowering blood pressure (BP) and reducing diurnal variation are important for the prevention of stroke in patients with hypertension.

Objective: This study was conducted to compare the BP-lowering and diurnal BP variation effects of amlodipine and losartan on acute stroke patients.

Methods: Seventy-seven hypertensive patients with acute stroke were enrolled in this randomized, double-blind, single-center clinical trial. They were randomly assigned to receive either amlodipine or losartan daily. To evaluate whether amlodipine was noninferior to losartan, ambulatory BP monitoring was performed before the drugs were first administered and at the end of week 8. BP variables analyzed included the mean awake, sleep, morning, evening, and prewake BP values; the nocturnal dipping status; and the morning surge.

Results: Thirty-nine patients in the amlodipine group and 38 patients in the losartan group completed the follow-up. In the baseline characteristics, mean age was 63.6 years, and 68.8% were male. In the intention-to-treat analysis, the mean (SD) systolic BP decreased 14.82 (11.71) mm Hg in the amlodipine group and 13.11 (12.69) mm Hg in the losartan group, and amlodipine proved noninferior to losartan (mean difference, 1.71 mm Hg [95% CI, -3.83 to 7.26]). However, in the per-protocol analysis, noninferiority was not proven (BP reduction, 16.06 [11.33] vs 17.17 [11.85] mm Hg; mean difference, -1.11 mm Hg [95% CI, -6.88 to 4.65]). Amlodipine had a greater tendency than losartan to produce a blunt morning surge.

Conclusions: The noninferiority of amlodipine was not confirmed by the per-protocol analysis. However, amlodipine showed a favorable effect on the morning surge. ClinicalTrials.gov identifier: NCT01830517.