Discontinuous transdermal nitroglycerin as treatment for stable angina in the elderly: a double-blind multicentre study. The Transdermal TNG Trial Group of Istituto Nazionale Ricovero e Cura Anziani (I.N.R.C.A.).
A transdermal nitroglycerin (TNG) patch (10 mg.24 h-1), using a daily overnight 8-h free interval, was assessed by means of a multicentre trial in 96 elderly patients with stable angina (age greater than or equal to 65 years). The main entry requirement was a reproducible exercise-induced ST depression (greater than or equal to 1 mm) appearing at a load of 60 to 90 W, during an incremental bicycle ergometer test (10 W.min-1). During the study only one other antianginal drug and sublingual TNG tablets were allowed. The protocol consisted of a run-in period (mean 10 days), followed by a double-blind, randomized, parallel, placebo-controlled 28-day phase and a single-blind active treatment phase of the same duration. The exercise test parameters, the number of spontaneous anginal attacks and any unwanted effects were evaluated at the end of every study phase. In the double-blind phase, no ergometric values changed with placebo while transdermal TNG significantly improved total workload and double product by 36.4% and 7.7% at the maximal workload respectively and by 49.8% and 13.5% at the time to onset of 1 mm ST depression respectively and reduced ST depression (-58.8%) at the equivalent baseline workload. Anginal attacks decreased by 61.5% and 30.8% with TNG patch and placebo respectively. A similar trend was seen at the end of the single-blind active treatment period in patients who had received placebo in the double-blind phase. Nine patients failed to complete the study; six for unwanted effects (four in the active group and two in the placebo group) and three for other reasons.(ABSTRACT TRUNCATED AT 250 WORDS)
Paciaroni
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E
Cardiology Department, I.N.R.C.A. Institute, Ancona, Italy.
Luca
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C
D000279:Administration, Cutaneous; D000368:Aged; D000369:Aged, 80 and over; D000787:Angina Pectoris / Q000188:drug therapy*; D004311:Double-Blind Method; D005080:Exercise Test / Q000187:drug effects; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D008297:Male; D005996:Nitroglycerin / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D013997:Time Factors
D005996:Nitroglycerin