Use of glyceryl trinitrate patches in patients with ureteral stones: A randomized, double-blind, placebo-controlled study

Objectives. To report a randomized, double-blind, placebo-controlled trial of glyceryl trinitrate (GTN) patches, The primary outcome measure was stone passage at 6 weeks. GTN is a potent smooth muscle relaxant that may offer benefit by both reducing pain and facilitating ureteral stone passage. Methods. Fifty consecutive patients, with a single radiopaque calculus less than 10 mm, were randomized to receive a 6-week course of patches containi ng either 5 mg GTN or placebo. Patients used a diary to record pain episode s during the 6-week study period and were reviewed weekly with x-ray imagin g. Analysis was by intention to treat. Results. Twenty-six patients were randomized to the GTN group and 24 to the placebo group. Seven patients in the GTN group discontinued therapy becaus e of headaches. One patient in the placebo group discontinued because of a skin reaction to the patches. No serious adverse events were recorded. No d ifference was observed in the stone-free rate at 6 weeks (18 patients in ea ch group), interval to stone passage (median GTN 11.5 days versus placebo 1 3 days), or interventions performed (5 patients each). Although the GTN gro up reported fewer pain episodes (median 3.5 versus 6.0), this did not achie ve statistical significance. Conclusions. Our preliminary results did not demonstrate a significant adva ntage in using GTN compared with placebo, with regard to the stone-free rat e at 6 weeks, interval to stone passage, or number of episodes of pain expe rienced. (C) 2001, Elsevier Science Inc.