Levamlodipine Besylate Tablets treatment of mild and moderate primary hypertension clinical research
|Keywords||Essential hypertension L-amlodipine besylate Amlodipine maleate Randomised active-control clinical trial|
Objective:To evaluate the effectiveness and safety of L-amlodipine besylate in patients with mild to moderate essential hypertension.Method:A total of 1051 mild to moderate essential hypertensives was selected from 22 centres and randomized into three groups and were given low-dose L-amlodipine besylate (2.5mg/d, group A), amlodipine maleate (5mg/d, group B), and high-dose L-amlodipine besylate (5mg/d, group C) on the principle of double-blind and parellel control. The study drugs were administered 8 weeks and evaluated.Results:After 8 weeks treatment, the response rate of the three groups were 68.1%,69.1%, and 79.4%, respectively. The rate difference between group A and B was-1.1%, with-7.9% and 5.8%as 95%confidence interval. It met the bound of non-inferiority test, which was 10%. The rate diference between group C and B was statistically significant (P=0.0014). The event rates of the three groups were 4.3%,5.1%, and 4.6%, respectively, with no statistically difference.Conclusion:Low-dose L-amlodipine besylate showed non-inferiority with amlodipine maleate on the effectivel effectiveness in patients with mild to moderate essential hypertension, while high-dose L-amlodipine besylate was superior than amlodipine maleate. There was no significant difference between the safety profiles of the three groups.