1. Open Comparative Study to Assess the Efficacy and Safety of Two Calcium Antagonists
- Author
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Canale, C., Terrachini, V., Masperone, M. A., and Caponnetto, S.
- Abstract
The efficacy and safety of amlodipine 510 mg once daily and diltiazem 3060 mg three times daily were compared in 40 patients with symptomatic myocardial ischemia. A 2week placebo runin period was followed by 10 weeks of open treatment with amlodipine n20 or diltiazem n20. Concomitant treatment with other antianginal drugs except other calcium antagonists was permitted throughout the study. The baseline blood pressures were 16693 and 16091 mm Hg for the amlodipine group and diltiazem groups, respectively. Amlodipine mean final daily dose of 9.25 mg reduced blood pressure by 27 11 mm Hg compared with a reduction of 178 mm Hg for diltiazem mean final daily dose of 180 mg, with no significant effects on heart rate. A significantly greater reduction in the mean ratepressure product was observed after amlodipine 20.8 when compared with diltiazem 13.1 p< 0.05. Amlodipine reduced the mean weekly angina attacks to zero after 6 weeks of treatment baseline of 3.4 attacksweek compared with a reduction from 3.3 to 0.35 attacksweek after 10 weeks of treatment with diltiazem. The amlodipine group had a reduction in mean nitroglycerin consumption from baseline of 1.1 mgweek to zero by week 6, whereas the diltiazem group had reduced mean weekly intake from 0.9 to 0.1 mg at the end of the study. The overall assessment of clinical efficacy was excellent for 100 of amlodipine patients compared with 40 of diltiazem patients. The highdensity lipoprotein cholesteroltotal cholesterol ratio increased by 15.8 with amlodipine compared to diltiazem, which produced a 4.5 decrease. Amlodipine decreased triglycerides by 7.1 compared to 4.5 with diltiazem. The incidence and severity of side effects was comparable for both treatments. Amlodipine once daily was effective and well tolerated in the treatment of patients with symptomatic myocardial ischemia and was comparable with diltiazem three times daily. more...
- Published
- 1991