COPD Treatment With Revefenacin Offers Acceptable Cardiovascular Safety
A total of 26 major cardiovascular adverse events occurred in one of the studies, but only 1 was thought to be related to revefenacin.
This article is part of Pulmonology Advisor's coverage of the CHEST 2018 meeting, taking place in San Antonio, Texas. Our staff will report on medical research related to COPD, critical care medicine, and more conducted by experts in the field. Check back regularly for more news from CHEST 2018.
SAN ANTONIO — Once-daily revefenacin does not prolong QT interval and offers an acceptable 1-year cardiovascular safety profile for treatment of chronic obstructive pulmonary disease (COPD), according to a study presented at the CHEST Annual Meeting, held October 6-10, 2018, in San Antonio, Texas.
Because cardiovascular disease is common in people with COPD, researchers analyzed cardiovascular safety data from 3 randomized trials of revefenacin as well as data from a thorough QT study in healthy individuals.
Healthy individuals received once-daily therapeutic (175 μg) and supratherapeutic (700 μg) revefenacin doses in a phase 1, placebo-controlled study (n=48). The researchers assessed the association between daily revefenacin treatment at 88 μg and 175 μg with cardiovascular safety in patients with moderate to very severe COPD in 2 phase 3 trials of 12 weeks' duration (n=619 and n=611). An active-controlled phase 3 safety trial of 52 weeks' duration was also included in the analysis (n=699). Prespecified major cardiovascular adverse events (MACE) were evaluated in all patients with COPD receiving treatment.
There was no clinically meaningful effect of single-dose revefenacin on cardiac repolarization in healthy individuals. Additionally, in the 52-week trial, the investigators observed no changes in 12-lead electrocardiographic recordings associated with daily doses of revefenacin 88 μg and 175 μg in patients with COPD. Additionally, the incidences of prolonged cardiac repolarization in the 52-week trial were similar between the revefenacin 175 μg (7.7%) and tiotropium (7.3%) groups.
Treatment with revefenacin 175 μg and 700 μg in single doses did not result in any cardiovascular-related treatment-emergent adverse events in healthy individuals. Following adjudication by a clinical end point committee, the researchers identified 4 MACE in the 12-week study, with 2, 1, and 1 MACE in the 88-μg revefenacin, 175-μg revefenacin, and placebo groups, respectively. In addition, a total of 26 MACE were recorded in the 52-week trial, all of which were reported in the treatment groups. Of these, only 1 (atrial fibrillation) was thought to be related to revefenacin.
Disclosures: Several researchers report financial relationships with pharmaceutical companies.
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Donohue J, Feldman G, Sethi S, et al. Cardiovascular safety of revefenacin for nebulization: a review of randomized controlled trial data. Presented at: CHEST Annual Meeting 2018; October 6-10, 2018; San Antonio, TX.