Multicenter Clinical Study of the Efficacy and Safety of Levamlodipine Besylate in Treatment of Mild to Moderate Essential Hypertension (Randomized, Open, Positive Drug Parallel Control)

Abstract

Objectives: To observe the antihypertensive effect, safety and economy of S-amlodipine versus extended release nifedine in patients with essential hypertension. Methods: From July to September 2017, 500 patients with mild to moderate essential hypertension managed by 5 hospitals in Tianjin were enrolled, and 490 patients were effective. The observation group were given S-amlodipine (2.5~5mg/d, n=247). The control group were given extended release nifedine (30~60 mg/d, n=243). According to blood pressure control, the drug was adjusted within 2 weeks until the optimal dose for 12 weeks. Blood pressure was measured at 0, 2, 8 and 12 weeks respectively. Routine indexes such as blood and urine were tested at baseline and 8 weeks respectively, and adverse reactions were recorded. If there was abnormal heart rate, electrocardiogram was examined. Results: There was no significant difference (Z= –1.89, P=0.59) in the total effective rate between the observation group and the control group, and the adverse reactions were less than those of the control group. 234 patients were treated with S-amlodipine 5 mg, and the utilization rate was 94.74%. Conclusions: S-amlodipine 5 mg has definite antihypertensive effect in patients with essential hypertension, which is more safe and economical than extended release nifedine.