PMID- 34875569 OWN - NLM STAT- MEDLINE DCOM- 20220502 LR - 20220502 IS - 1527-3288 (Electronic) IS - 0147-9563 (Linking) VI - 52 DP - 2022 Mar-Apr TI - Safety evaluation of revefenacin at the approved dose in patients with chronic obstructive pulmonary disease: A meta-analysis. PG - 52-60 LID - S0147-9563(21)00272-7 [pii] LID - 10.1016/j.hrtlng.2021.11.004 [doi] AB - BACKGROUND: Revefenacin is the first once-daily long-acting muscarinic antagonist (LAMA) for nebulization use in maintenance therapy for patients with chronic obstructive pulmonary disease (COPD). OBJECTIVE: To investigate the safety and tolerability profile of revefenacin at the approved dose (175 mug), compared with placebo and a lower dose (88 mug), for the treatment of COPD. METHODS: Available randomized controlled trials (RCTs), both published and unpublished, were identified via databases. Risk differences (RDs) and risk ratios (RRs), with their corresponding 95% confidence intervals (CIs) were calculated as effect sizes. RESULTS: One unpublished RCT and four articles containing 5 RCTs were included. Combined results showed that there were no significant differences between COPD patients receiving 175 mug revefenacin and those receiving a placebo, concerning the risk of discontinuation due to adverse events (AEs), any all-grade AE, or any serious AE. 175 mug revefenacin also did not significantly increase the risk of antimuscarinic-related AEs, cardiovascular AEs, or 12 commonly reported AEs. Plus, a lower dose of 88 mug was shown to share a comparable safety profile with the 175 mug revefenacin. A non-significant trend towards a decrease in risks of AEs for 175 mug revefenacin was observed. The most frequently reported AE for each group was COPD worsening/exacerbation. CONCLUSION: Revefenacin at the approved dose is generally well-tolerated and safe with minimal AEs, which supports its use as a once-daily nebulized LAMA for the treatment of moderate to severe stable COPD. Additional studies are needed to complete the safety and tolerability profile. CI - Copyright (c) 2021 Elsevier Inc. All rights reserved. FAU - Liu, Baofeng AU - Liu B AD - Tianjin Fourth Central Hospital, No.1 Zhongshan Road, Tianjin, Hebei 300140, China. FAU - Zan, Shuangjiang AU - Zan S AD - Tianjin Fourth Central Hospital, No.1 Zhongshan Road, Tianjin, Hebei 300140, China. Electronic address: zansj213@126.com. FAU - Luo, Weishun AU - Luo W AD - Tianjin Fourth Central Hospital, No.1 Zhongshan Road, Tianjin, Hebei 300140, China. LA - eng PT - Journal Article PT - Meta-Analysis DEP - 20211204 PL - United States TA - Heart Lung JT - Heart & lung : the journal of critical care JID - 0330057 RN - 0 (Benzamides) RN - 0 (Bronchodilator Agents) RN - 0 (Carbamates) RN - 0 (Muscarinic Antagonists) RN - G2AE2VE07O (revefenacin) SB - IM MH - Administration, Inhalation MH - Benzamides MH - *Bronchodilator Agents MH - Carbamates MH - Humans MH - Muscarinic Antagonists/adverse effects MH - Nebulizers and Vaporizers MH - *Pulmonary Disease, Chronic Obstructive/drug therapy OTO - NOTNLM OT - Antimuscarinic agent OT - Chronic obstructive pulmonary disease OT - Meta-analysis OT - Nebulizer OT - Safety COIS- Declaration of Competing Interest None declared. EDAT- 2021/12/08 06:00 MHDA- 2022/05/03 06:00 CRDT- 2021/12/07 20:25 PHST- 2021/08/29 00:00 [received] PHST- 2021/11/07 00:00 [accepted] PHST- 2021/12/08 06:00 [pubmed] PHST- 2022/05/03 06:00 [medline] PHST- 2021/12/07 20:25 [entrez] AID - S0147-9563(21)00272-7 [pii] AID - 10.1016/j.hrtlng.2021.11.004 [doi] PST - ppublish SO - Heart Lung. 2022 Mar-Apr;52:52-60. doi: 10.1016/j.hrtlng.2021.11.004. Epub 2021 Dec 4.