Randomized, double-blind, placebo-controlled trial of diazepam, nitroglycerin, or both for treatment of patients with potential cocaine-associated acute coronary syndromes

Introduction: To the authors' knowledge, treatment of patients with cocaine -associated acute coronary syndromes has not been rigorously investigated i n symptomatic patients. Objective: To perform a randomized double-blind tri al of diazepam, nitroglycerin, or both for treatment of patients with poten tial cocaine-associated acute coronary syndromes. Methods: Patients with po tential cocaine-associated acute coronary syndromes were randomized to trea tment with either diazepam, nitroglycerin, or both every 5 minutes or until symptom resolution. Outcomes were chest pain resolution (measured by visua l analog scale), and changes in blood pressure, pulse rate, cardiac output (L/min), cardiac index (L/min/m(2)), stroke volume (mL/beat), and stroke in dex (mL/beat/m(2)) over the 15-minute treatment period. To adjust for seven outcomes using the Bonferroni correction, alpha was set at 0.007. Results: Forty patients were enrolled (diazepam, 12; nitroglycerin, 13; both, 15). Patients had a mean age (+/-SD) of 35.4 (+/-7.5) years; 75% were male. They presented a mean of 5 hours and 37 minutes after cocaine use. Baseline dem ographics, cocaine use patterns, chest pain characteristics, and initial el ectrocardiograms were similar for all groups. Chest pain severity improved similarly in the three groups [-33.3 mm (+/-8.0); -30.7 mm (+/-7.1); -33.0 mm (+/-7.9); p = 0.6]. The stroke index decreased during the 15-minute trea tment period for all groups (diazepam, -8.7 (+/-3.3); nitroglycerin, -3.1 /- 2.8; both, -1.8 (+/-3.1) mL/beat/m(2); p = 0.03). After adjustment for d ifferences between baseline hemodynamic and cardiac profiles and multiple c omparisons, there was no difference in any response to therapy over time fo r the different treatments. Conclusions: For treatment of patients with pot ential cocaine-associated acute coronary syndromes, chest pain resolutions and changes in cardiac performance are not different in patients treated wi th diazepam or nitroglycerin. In this study, the use of both agents did not ; offer any advantage over either agent alone.