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130 Chapter 5 Additional end points A primary composite end-point event as defined in the first LoDoCo trial (sudden cardiac death, nonfatal out-of-hospital cardiac arrest, acute coronary syndrome [myocardial infarction or unstable angina irrespective of revascularization], or atherosclerotic ischemic stroke) occurred in 201 patients in the colchicine group and in 290 patients in the placebo group, with incidence rates of 2.7 and 4.0 events, respectively, per 100 person-years (hazard ratio, 0.67; 95%CI, 0.56 to 0.81) (Figure 3). The results with respect to the occurrence of new onset or first recurrence of atrial fibrillation, deep-venous thrombosis or pulmonary embolism or both, and new-onset diabetes did not differ significantly between the trial groups. Adverse events Noncardiovascular deaths occurred more frequently among the patients who received colchicine than among thosewho received placebo, with incidence rates of 0.7 and 0.5 events, respectively, per 100 person-years (hazard ratio, 1.51; 95% CI, 0.99 to 2.31) (Table 2 and Table S7). We observed similar rates of cancer diagnosis, hospitalization for infection, hospitalization for pneumonia, and hospitalization for a gastrointestinal reason in the two trial groups, in both the intention-to-treat analysis and the on-treatment analysis (Table 2 and Table S8). Gout occurred in 38 patients (1.4%) in the colchicine group and in 95 patients (3.4%) in the placebo group (cumulative incidence ratio, 0.40; 95% CI, 0.28 to 0.58). Neutropenia and myotoxic effects were uncommon in both trial groups. Among the patients from the Netherlands, myalgia was reported in 384 (21.2%) in the colchicine group and 334 (18.5%) in the placebo group (cumulative incidence ratio, 1.15; 95% CI, 1.01 to 1.31). Dysesthesia was reported in 143 patients (7.9%) in the colchicine group and in 150 patients (8.3%) in the placebo group (cumulative incidence ratio, 0.95; 95% CI, 0.76 to 1.18). Subgroup analyses The effects of colchicine, as compared with placebo, on the primary end point were consistent in the prespecified subgroups defined according to sex, age (>65 years vs. ≤65 years), smoking status (current vs. former or never), hypertension (yes vs. no), diabetes (yes vs. no), renal function (stage 1 or 2 vs. stage 3a [stages are based on the KDIGO Clinical Practice Guideline for Acute Kidney Injury 14 ]), prior acute coronary syndrome (yes vs. no), prior coronary revascularization (yes vs. no), atrial fibrillation (yes vs. no), statin dose (high dose vs. low or moderate dose), and ezetimibe use (yes vs. no). When examined according to country, the