A randomized placebo controlled, double-blind, crossover trial of transdermal nitroglycerin in stable angina pectoris

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Abstract
Clinical efficacy of 5 mg per 24 hours transdermal nitroglycerin was studied in a placebo controlled, randomized, double-blind crossover trial, with three days wash-out period at the beginning, in 40 patients with chronic stable angina pectoris during two periods of 14 days. Assessment was carried out by means of a diary method, by the multistage treadmill exercise test, five hours after dosing, and by 24-hour ambulatory ECG recordings. Nitroglycerin patch demonstrated significant improvement of exercise tolerance comparing to placebo, in exercise time to the onset of angina pectoris and ST-segment depression of ≥1·0 mm (+45% and +47%), in maximum walking time (+13%), as well as in diminished severity of maximum angina (−38%), in lower maximal ST-segment depression (−32%) and in faster recovery of ST-depression 3 and 6 minutes after the test (−28% and −44%). Nitroglycerin patch showed 33% less angina attacks, mainly severe and moderate, resulting in 37% less sublingual nitroglycerin consumption. A significant fall in the number of ST-segment depression episodes of 1·5 mm or more (−60%) was shown in the 24-hour ECG. All these changes were confirmed to be significant compared to placebo values, at a level of P < 0·01, by multivariate analysis. This study revealed a positive effect of low dose nitroglycerin patch on improvement of exercise functional capacity and signs of myocardial ischaemia after 14 days of continuous therapy.

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