Effect of oral sustained-release nitroglycerin on exercise capacity in angina pectoris: dose-response relation and duration of action during double-blind crossover randomized acute therapy.

Ten men with documented coronary artery disease and stable exertional angina underwent a double-blind crossover study to examine the benefit and the duration of action on their symptom-limited exercise capacity of 2 doses (2.5 and 6.5 mg) of sustained-release nitroglycerin (SRNG). A multistage bicycle test was performed in the sitting position by steps of 30 W each 3 minutes until the onset of typical angina pectoris. It was performed 24 hours before the start of the study; 1 and 5 hours after administration of placebo, and repeated after 2.5 and 6.5 mg of SRNG administered in a double-blind crossover study according to a 4 successive days protocol. No differences appeared between administration of placebo (1 and 5 hours) and the results obtained at the first exercise test. The dose of 2.5 mg of SRNG was effective on the symptom-limited working capacity but only at 1 hour (+9%; p less than 0.01). The dose of 6.5 mg was more effective both at 1 hour (+25%; p less than 0.001) and at 5 hours (+27%; p less than 0.001). All patients had angina at a higher heart rate (+5 to 8%; p = NS [not significant] and p less than 0.01), whereas systolic blood pressure and double product tended to be slightly but insignificantly increased. S-T depression at the onset of angina was insignificantly changed with placebo, and 2.5 and 6.5 mg of SRNG. It is concluded that 6.5 mg of orally administered SRNG is effective during at least 5 hours, and that the magnitude of the benefit and its duration are dose-related.