An acute double-blind placebo-controlled study of transdermal glyceryl trinitrate with 12 months' follow-up in patients with stable angina pectoris.
In an acute double-blind placebo-controlled randomized crossover study, 1 day of treatment with a glyceryl trinitrate transdermal patch releasing 10 mg glyceryl trinitrate daily was compared with placebo in 40 men with stable angina pectoris. Subsequently, the patients participated in an uncontrolled efficacy and tolerability study during which the transdermal patch was applied to the front of the chest for 22-23 hours daily for 12 months. In the acute study, one patch of glyceryl trinitrate or matching placebo was applied at 8.00 a.m. for 24 h; 48 h later the other treatment was applied. Bicycle ergometry was performed 24 and 16 h before the beginning of the treatment, and 8 and 24 h after each dose. Ergometry was repeated after 1, 3, 6 and 12 months' treatment with one patch daily of glyceryl trinitrate during the long-term open follow-up study. In the acute study, a significant reduction of ST-segment depression was observed with treatment compared with placebo. This reduction persisted throughout the 12 months of the open study. During this period also, the mean number of anginal attacks was reduced from 5.3 to 3.6 during week 1 of treatment, and this reduction was maintained throughout the 12 months of the study. No patient needed to be withdrawn because of systemic side-effects or local intolerance to the patch.
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000787:Angina Pectoris / Q000188:drug therapy*; D001794:Blood Pressure / Q000187:drug effects; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004562:Electrocardiography; D005500:Follow-Up Studies; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D005996:Nitroglycerin / Q000008:administration & dosage*
D005996:Nitroglycerin