A Comparative Study on Antianginal Effects of Single Topical Application of 5 mg NT-1 and 10 mg NT-1 in Patients with Stable Effort Angina Pectoris

NT-1 is a transdermal tape containing 5 mg nitroglycerin and is expected to havesustained efficacy of nitroglycerin.In order to compare the antianginal effects of 5mg NT-1 and 10 mg NT-1 on exercisetolerance, a ramdomised double-blind cross-over study was carried out in 19 patientswith stable effort angina pectoris. Multistage treadmill exercise testing was performedin all patients before and at 2 hours after a single topical application of 5 mg NT-1 or 10mg NT-1. It was also performed in 12 out of the 19 patients, as a open study, before andat 2 hours after a single topical application of a placebo tape. The exercise testing wasterminated at moderate anginal pain.Before topical application, there were no significant differences in treadmill exerciseduration, heart rate, systolic blood pressure, or ST deviation between 5 mg NT-1 or 10mg NT-1. At 2 hours after the application, systolic blood pressure at rest was morereduced with 10 mg NT-1 than with 5 mg NT-1. However, there were no significantdifferences in treadmill exercise duration, heart rate, systolic blood pressure at peakexercise, or ST deviation between 5 mg NT-1 and 10 mg NT-1. At 2 hours after a singletopical application of NT-1, the mean plasma level of nitroglycerin was twice as highwith 10 mg NT-1 as with 5 mg NT-1.In all 12 patients who were subjected to the placebo open study, treadmill exerciseduration was significantly longer with NT-1 than with placebo, irrespective of dosagestudied. However, there were no significant differences in systolic blood pressure, pressure-rate product, or ST deviation at peak exercise between NT-1 and placebo.These results indicate that the topical application of NT-1 significantly increasesexercise tolerance in patients with stable effort angina pectoris, and that the antianginaleffects of 5 mg NT-1 are approximately equal to those of 10 mg NT-1.