Abstract:
Objective To compare the effects of levoamlodipine maleate and amlodipine besylate in patients with hypertension complicated with coronary heart disease and the incidence of side effects. Methods Patients with hypertension complicated with coronary heart disease were enrolled from the participants of LEADER(levamlodipine maleate or amlodipine besylate for treatment of hypertension: a comparative effectiveness research) study. According to the antihypertensive drugs, patients were divided into amlodipine besylate group(666 cases) and levoamlodipine maleate group(648 cases). Major adverse cardiac cerebrovascular events(MACCE), blood pressure changes, and adverse reactions were compared between the two groups. Cox regression model was used to analyze the influencing factors of MACCE. Results At 12 months, the incidence of MACCE in amlodipine besylate group and levamlodipine maleate group was 5.7% and 3.2%, respectively(χ~2=4.643, P=0.031). Cox analysis revealed that use of levamlodipine maleate HR(95%CI) 0.56(0.32-0.96), P=0.034, diabetes 2.48(1.48-4.17), P=0.001, family history of coronary heart disease 2.04(1.08-3.86), P=0.028 and control of blood pressure 0.39(0.22-0.71), P=0.002 were independent influencing factors of MACCE. Compared with baseline, systolic and diastolic blood pressure decreased significantly in both groups, and the decrease in levamlodipine maleate group was more significant than that in amlodipine besylate group during follow-up at the 12 months, median(P
25 to P
75) value of systolic blood pressure decrease:-17.5(-30.0 to-4.0) vs-10.0(-22.5 to-1.0) mm Hg, Z=4.997, P<0.001; diastolic blood pressure decrease:-7.5(-15.0 to 0) vs-5.0(-11.0 to 0)mm Hg, Z=3.510, P<0.001. The incidence of adverse reaction in amlodipine besylate and levamlodipine maleate group was 7.4% and 3.4%(χ~2=10.088, P=0.001), and the incidence of lower extremity edema(0.5% vs 2.3%, χ~2=7.783, P=0.005), dizziness(1.1% vs 2.7%, χ~2=4.632, P=0.031) and fatigue(0 vs 0.9%, P
Fisher=0.031) in levamlodipine maleate group was significantly lower than that in amlodipine besylate group. Conclusion Compared with amlodipine besylate, levoamlodipine maleate is more effective and safer in the treatment of hypertension complicated with coronary heart disease.