An Open Multicenter Efficacy and Safety Evaluation of Amlodipine in the Treatment of Symptomatic Myocardial Ischemia

The efficacy and safety of amlodipine (5-10 mg) once daily were studied in an open study in patients with symptomatic myocardial ischemia. The study is ongoing and this report is based on an interim analysis of data from 78 patients. A 2-week baseline period in which patients maintained their current antianginal therapy was followed by a 10-week treatment period with 5-10 mg of amlodipine/day. Both the median number of angina attacks per week and the median number of nitroglycerin (NTG) tablets consumed/week were significantly reduced after amlodipine (mean daily dose of 8.6 mg) when compared with baseline (p < 0.05). A total of 98.4% of patients (63/64) experienced a reduction in the frequency of angina attacks/week and 91% of patients (58/64) had angina attacks reduced to < or = 2/week. In self-assessments, 95% of patients (55/58) reported improved angina control and 91% (53/58) felt their ability to perform usual activities had improved. Twenty-seven patients experienced adverse events reported as drug related. The most common adverse event noted was edema. Amlodipine once daily significantly reduced the incidence of angina attacks and the concomitant need of nitroglycerin for relief of symptoms and thus improved the patients' ability to perform daily activities. Most adverse events reported were mild or moderate and the incidence is as would be expected in this patient population.