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European Heart Journal 1992 13(5):671-678;
Copyright © 1992 by the European Society of Cardiology.
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© 1992 The European Society of Cardiology

Efficacy, safety and duration of nitrate-free interval to prevent tolerance to transdermal nitroglycerin in effort angina

T. GUMBRIELLE, S. B. FREEDMAN, L. FOGARTY, S. OGASAWARA, P. SOBB and D. T. KELLY

Hallstrom Institute of Cardiology, University of Sydney, Royal Prince Alfred Hospital Sydney, Australia

Received 26 November 1990; revised 20 June 1991; .

Correspondence. Dr S. B Freedman, Associate Professor in Cardiology, Hallstrom Institute of Cardiology, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, Sydney, NSW 2050, Australia.

Abstract

The magnitude of tolerance to the anti-anginal efficacy of transdermal nitroglycerin and the efficacy and safety of short (4h) and long (Wh) nitrate-free intervals for its prevention, were investigated in a randomized, double-blind, placebo-controlled crossover trial of 4 week-long treatment regimes: placebo, continuous therapy with a 50 mg patch (10 mg. 24 h–1), and 4 h and 10 h nitrate-free periods. Only patients showing>1 min increase in time to 1 mm ST depression after acute patch administration were eligible. Twelve men completed the study. One other anti-anginal medication (a beta-blocker in nine and calcium antagonist in two) was permitted in a constant dose throughout the study. Patients underwent exercise testing on days 1 and 7 of each treatment period, and 24 h ambulatory ECG monitoring on day 6.

Compared to placebo, transdermal nitroglycerin on day 1 significantly improved time to 1 mm ST depression by 35%, and time to angina, exercise duration and maximal workload by 21 %, 13% and 9% respectively. These improvements were totally lost after 7 days' continuous therapy, but completely maintained by a 10 h nitrate-free period (improvements of 35%, 25%, 16% and 11% respectively) but not by a4h nitrate-free period (non-significant improvements of 15%, 2%, 4% and 1% respectively). The differences between 10 and 4 h nitrate-free were significant for each end-point. Neither duration of ambulatory ischaemia, nor the proportion of patients experiencing<5 min ischaemia during the scheduled nitrate-free interval differed between treatments. Thus, tolerance to transdermal nitroglycerin is complete after only 1 week of continuous therapy, but can be completely prevented by a 10 h nitrate-free period without an increase in spontaneous ischaemia, while a 4 h nitrate-free period is insufficient to prevent tolerance.

Key Words: Angina pectoris • nitroglycerin • transdermal • tolerance • nitrate-free period


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