Short-term evaluation of isosorbide-5-mononitrate sustained-release in chronic coronary heart disease and stable exertional angina

Clinical and exercise responses to short-term treatment with two dosages (40 and 80 mg once daily) of a new sustained-release preparation of isosorbide-5-mononitrate were assessed in a open, single-blind, 5-week trial. The first two weeks were placebo lead-in and the remaining were active treatment. Fifty-four patients affected by chronic coronary artery disease and stable effort-induced angina were allocated, on the basis of body weight as well as both severity of angina and functional impairment (evaluated by means of Council of Cardiovascular Surgery and New York Heart Association classification, respectively) in two parallel groups of 27 subjects each. Circulatory (supine and standing blood pressure and heart rate) and clinical (weekly angina and short-term nitrate consumption frequency) parameters were comparatively assessed in both groups in the run-in period and at the second and third week of active medication. Seven patients in the 40-mg group and eight in the 80-mg group, who were free of resting electrocardiographic signs of myocardial ischemia, underwent, symptom-limited bicycle exercise tests at the same time periods and the related variables were comparatively assessed. Resting circulatory changes were characterized by a slight but significant decrease in blood pressure in the 40-mg group (P