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European Heart Journal 1985 6(1):50-56;
Copyright © 1985 by the European Society of Cardiology.
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© 1985 The European Society of Cardiology

A double-blind multiple crossover trial evaluating a transdermal nitroglycerin system vs placebo

K. DICKSTEIN and H. KNUTSEN

Medical Department, Central Hospital in Rogaland Stavanger, Norway

Received 17 April 1984; revised 14 September 1984; .

Dr Kenneth Dickstein. Medical Department, Central Hospital in Rogaland, N-4000 Stavanger, Norway.

Abstract

Fifty-six patients with angina pectoris on effort participated in a 28-day study comparing a transdermal nitroglycerin system (TNS) against placebo. The protocol was based on a regular double-blind multi-crossover pattern. The variables recorded included daily sublingual nitroglycerin requirement, daily anginal attack frequency, and a subjective patient evaluation of each day on a visual analog scale. TNS dosage ranged from 10 cm2 (5 mg per 24 h) to 60 cm2 (30 mg per 24 h) based on the patient's dosage prior to commencement of the study. All other medication was continued unchanged. The results demonstrate improvement on active therapy in the patient group using ≥20 cm2 TNS whereas no significant improvement in patients using 10 cm2 TNS was seen. In the higher dose group, the mean number of daily anginal attacks was 2.5 on placebo and 1.4 on active therapy (P<0.0001). Corresponding mean daily sublingual nitroglycerin requirement was 3.6 on placebo and 2.3 on active therapy (P<0.0001). Although TNS therapy was associated with significant improvement in the group using the higher dosage, the results suggest the development of tolerance on active therapy. The possibility of rebound effect and the absence of demonstrable efficacy in the low dose group require further investigation.

Key Words: Angina pectoris, • transdermal nitroglycerin therapy.


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