Aernoud Fiolet

164 Chapter 6 TO THE EDITOR (2) The results of the LoDoCo2 trial confirm the efficacy and safety of low-dose colchicine that was observed in the Colchicine Cardiovascular Outcomes Trial (COLCOT) 1 and in the LoDoCo pilot study. However, the LoDoCo2 trial was limited by the low number of female patients, who accounted for only 15.3% of the trial population, a proportion that was even lower than that in COLCOT (19.2%) and in the LoDoCo pilot study (23%). In COLCOT and LoDoCo2 trials, the investigators provided sex-specific hazard ratios for the primary efficacy end points in the SupplementaryAppendix (available with the full text of the article at NEJM.org ) without further discussion in the text. The between-group difference in adverse cardiovascular events between colchicine and placebo was significant in men, but not in women. In addition, adverse effects were not broken down according to sex. The inadequate inclusion of women and the underreporting of sex-specific adverse effects, which would hamper later meta- analyses, is problematic, given the similar prevalence of chronic coronary disease in the target population, 2 the pathophysiologic differences between men and women, and worse outcomes among women with cardiovascular disease. Guidelines and policies of the National Institutes of Health, 3 the Food and Drug Administration, 4 the European Commission, and the International Committee of Medical Journal Editors 5 should be followed in order to report the real effectiveness and safety of colchicine in patients with chronic coronary disease. Catherine Gebhard, M.D., Ph.D. University of Zurich, Zurich, Switzerland Vera Regitz-Zagrosek, M.D. Charité Berlin, Berlin, Germany