RESUMO
The cardiovascular safety of revefenacin, an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive lung disease (COPD), was evaluated in phase 3 trials in patients with moderate to very severe COPD. No clinically meaningful changes in 12-lead electrocardiogram recordings were observed with up to 52 weeks of once-daily revefenacin 88 or 175⯵g. In a pooled analysis of Studies 0126 and 0127, the incidence of prolonged QT interval corrected for heart rate using the Fridericia correction formula (QTcF; >450 msec) for revefenacin 88⯵g (nâ¯=â¯23, 5.6%) and revefenacin 175⯵g (nâ¯=â¯23, 5.9%) was similar to that for placebo (nâ¯=â¯22, 5.3%). In Study 0128, the incidence of prolonged QTcF was similar in the revefenacin 175⯵g (nâ¯=â¯25, 7.7%) and tiotropium (nâ¯=â¯26, 7.3%) groups and lower in the revefenacin 88⯵g (nâ¯=â¯15, 4.2%) group. There were four major adverse cardiac events (MACEs) in Study 0126 (one, two, and one in the placebo, revefenacin 88⯵g, and revefenacin 175⯵g groups, respectively), no MACEs in Study 0127 and 26 MACEs in Study 0128 (9, 10 and 7 in the revefenacin 88⯵g, revefenacin 175⯵g and tiotropium groups, respectively). In Study 0128, only one MACE was considered possibly/probably related to revefenacin (atrial fibrillation in the revefenacin 175⯵g group). Thus, revefenacin may provide beneficial nebulized therapy for patients with COPD without further elevating their risk of cardiovascular events.