A Randomized, Double-Blind, Placebo-Controlled, Crossover, Dose-Ranging Multicenter Study to Determine the Effect of Sublingual Nitroglycerin Spray on Exercise Capacity in Patients with Chronic Stable Angina

BACKGROUND: Sublingual nitroglycerin increases exercise duration in patients with stable angina. Brief results from this study were published previously in German. Here, we more fully describe the study methodology, patient characteristics, and detailed results. METHODS: This double-blind, crossover study enrolled 51 patients with stable angina. Patients were randomized to 1 of 5 treatment sequences and were administered placebo or nitroglycerin spray (0.2 mg, 0.4 mg, 0.8 mg, or 1.6 mg). Patients carried out 1 control exercise tolerance test (ETT) and 1 investigational ETT at each visit. RESULTS: Dose-dependent increases in time to onset of angina, time to onset of moderate angina, and the occurrence of a minimum 1.0-mm ST-segment depression were seen following administration of nitroglycerin spray. CONCLUSIONS: These results support the use of sublingual nitroglycerin spray in patients with stable angina who are being managed with medical therapy and in patients who have persistent angina post-revascularization.