The Phase 4 Randomized, Public, Parallel, Comparative, Clinical Trial to Compare Efficacy and Safety of S-(-)-Amlodipine Nicotinate with Ramipril in Hypertensive Patients

ABSTRACT

BACKGROUND: The aim of this study was to compare the antihypertensive effect of S-(-)-amlodipine nicotinate with ramipril in patients with essential hypertension. METHODS: Total 138 patients (54.5 +/- 10.5 years, 69 males) were enrolled in this study between 2008 and 2010. Amlodipine 2.5 mg or ramipril 2.5 mg was treated once in a day for 8 weeks. Epidemiologic analysis was performed in intend-to-treat (ITT) group. Efficacy analysis was performed in the differences of diastolic blood pressure in study groups. Abnormal reactions were divided with severities and drug-relationship. RESULTS: The change of diastolic blood pressures were more prominent with -12.7 +/- 7.02 mm Hg in amlodipine group, and -9.6 +/- 7.38 mm Hg in ramipril group (p = 0.023). The change of systolic blood pressures was higher in amlodipine group with -18.1 +/- 7.91 mm Hg, and -14.3 +/- 11.96 mm Hg in ramipril group (p = 0.047). Blood pressure normalization rates were 81.3% (48 of 59 patients) in amlodipine group, and 61.4% (35 of 57 patients) in ramipril group (p = 0.017). Abnormal reaction occurred in 5.8% (4 of 68 patients) of amlodipine group and 14.2% (10 of 70 patients) of ramipril group (p = 0.102). The most frequent abnormal reaction was respiratory symptom. CONCLUSIONS: S-Amlodipine-Nicotinate was more effective than ramipril in hypertensive patients without significant abnormal reaction.