PULMONARY EFFECT OF AMIODARONE IN PATIENTS WITH HEART-FAILURE

Objectives. The purpose of this study was to evaluate the pulmonary ef fects of amiodarone in patients with heart failure, in those with chro nic obstructive pulmonary disease (COPD) and in those undergoing a sur gical procedure. Background. Amiodarone has been known to cause pulmon ary complications, especially in those with COPD and in those undergoi ng a surgical procedure. Methods. Patients receiving vasodilator thera py for congestive heart failure were prospectively randomized to place bo or amiodarone at 800 mg/day for 14 days, 400 mg/day for 50 weeks an d then 300 mg/day thereafter, Chest X-ray film and pulmonary function tests with diffuse capacity of carbon monoxide (DLCO) were obtained at baseline and annually, The power to detect a 20% difference in DLCO a t 1 year exceeded 90% in all patients and in those with COPD (two-side d alpha = 0.05), The sample allowed a 75% power to detect pulmonary co mplications (1% vs, 5%) between the two treatment groups. Results. The re was no difference in baseline characteristics between patients rand omized to amiodarone (n = 269) or placebo (n = 250), The DLCO measurem ents at randomization were 18.3 +/- 6.9 and 17.7 +/- 7.6 ml/min per mm Hg for the amiodarone and placebo groups, respectively (p = 0.3), At 1 and 2 years, DLCO measurements were 17.7 +/- 7.0 and 18.3 +/- 7.7 ml /min per mm Hg for the amiodarone group and 17.9 +/- 7.2 and 18.2 +/- 7.2 for the placebo group, respectively, There were no significant dif ferences between the groups, with corresponding p values of 0.73 and 0 .96 at years 1 and 2, respectively, Among patients with COPD, DLCO mea surements at randomization were 17.9 +/- 6.7 and 15.8 +/- 6.8 ml/min p er mm Hg for the amiodarone and placebo groups, respectively. At years 1 and 2, DLCO measurements were 16.6 +/- 7.8 and 17.8 +/- 9.5 ml/min per mm Hg for the amiodarone group and 16.5 +/- 6.6 and 16.3 +/- 7.0 m l/min per mm Hg for the placebo group, with corresponding p values of 0.95 and 0.38, respectively, There was no difference in survival free of noncardiac or perioperative deaths between patients assigned to ami odarone or placebo, Pulmonary fibrosis was diagnosed in four patients (1.1%) treated with amiodarone and in three patients (0.8%) receiving placebo. Conclusions. Our study shows that amiodarone can be safely us ed, with an acceptable pulmonary toxicity, in patients with heart fail ure. (C) 1997 by the American College of Cardiology.