PMID- 35915771 OWN - NLM STAT- MEDLINE DCOM- 20220803 LR - 20220803 IS - 1748-6718 (Electronic) IS - 1748-670X (Print) IS - 1748-670X (Linking) VI - 2022 DP - 2022 TI - Effects of Roflumilast on Patients with Chronic Obstructive Pulmonary Disease Treated with Inhaled Corticosteroid/Long-Acting beta2 Agonist: A Meta-analysis. PG - 8101099 LID - 10.1155/2022/8101099 [doi] LID - 8101099 AB - OBJECTIVE: Roflumilast is a novel therapeutic drug for chronic obstructive pulmonary disease (COPD). This study was designed to evaluate the efficacy and safety of roflumilast combining inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) in treating COPD patients through the meta-analysis. METHODS: Randomized controlled trials of roflumilast combining ICS/LABA in treating patients with severe and profound COPD were searched from PubMed, Cochrane Library, and Embase databases from their establishment to February 2022. The quality of included studies was assessed by Cochrane risk bias assessment tool. The main outcomes of these studies should include at least one of the following clinical outcome indicators: forced expiratory volume in one second (FEV(1)), exacerbation rate, and adverse events (AEs) such as diarrhea, nasopharyngitis, and headache. RESULTS: Six articles were included in the study, including 9,715 patients. Meta-analysis revealed that compared with placebo, roflumilast gained superiority for severe COPD patients treated with ICS/LABA combinations in FEV(1) before bronchodilator administration (MD = 46.62, 95% CI (30.69, 62.55), P < 0.00001), FEV(1) after bronchodilator administration (MD = 45.62, 95% CI (34.95, 56.28), P < 0.00001), and COPD exacerbation rate (RR = 0.90, 95% CI (0.87, 0.94), P = 0.001). In terms of safety, the incidence of diarrhea, headache, nausea, weight loss, back pain, loss of appetite, and insomnia was notably higher in the roflumilast group than in the placebo group. CONCLUSION: Roflumilast is suggested to be significantly effective for severe COPD patients with ICS/LABA combination therapy, which reduces the exacerbation rate but also leads to PDE4 inhibitor-related adverse reactions. CI - Copyright (c) 2022 Shasha Zeng et al. FAU - Zeng, Shasha AU - Zeng S AUID- ORCID: 0000-0002-2407-7171 AD - Department of Internal Medicine, Chongqing Nanan Traditional Chinese Medicine Hospital, Chongqing 400060, China. FAU - Bai, Haibing AU - Bai H AUID- ORCID: 0000-0003-1441-7483 AD - Department of Internal Medicine, Chongqing Nanan Traditional Chinese Medicine Hospital, Chongqing 400060, China. FAU - Zou, Mi AU - Zou M AUID- ORCID: 0000-0001-6501-0179 AD - Respiratory Department, The First Branch of the First Affiliated Hospital of Chongqing Medical University, Chongqing 400015, China. LA - eng PT - Journal Article PT - Meta-Analysis DEP - 20220723 PL - United States TA - Comput Math Methods Med JT - Computational and mathematical methods in medicine JID - 101277751 RN - 0 (Adrenal Cortex Hormones) RN - 0 (Adrenergic beta-2 Receptor Agonists) RN - 0 (Aminopyridines) RN - 0 (Benzamides) RN - 0 (Bronchodilator Agents) RN - 0 (Cyclopropanes) RN - 0P6C6ZOP5U (Roflumilast) SB - IM MH - Adrenal Cortex Hormones/adverse effects MH - Adrenergic beta-2 Receptor Agonists/adverse effects MH - Aminopyridines MH - Benzamides MH - *Bronchodilator Agents/adverse effects MH - Cyclopropanes MH - Diarrhea/chemically induced/drug therapy MH - Disease Progression MH - Headache/chemically induced/drug therapy MH - Humans MH - *Pulmonary Disease, Chronic Obstructive/drug therapy PMC - PMC9338846 COIS- The authors declare that they have no conflicts of interest with the contents of this article. EDAT- 2022/08/03 06:00 MHDA- 2022/08/04 06:00 PMCR- 2022/07/23 CRDT- 2022/08/02 01:49 PHST- 2022/04/26 00:00 [received] PHST- 2022/06/23 00:00 [revised] PHST- 2022/06/27 00:00 [accepted] PHST- 2022/08/02 01:49 [entrez] PHST- 2022/08/03 06:00 [pubmed] PHST- 2022/08/04 06:00 [medline] PHST- 2022/07/23 00:00 [pmc-release] AID - 10.1155/2022/8101099 [doi] PST - epublish SO - Comput Math Methods Med. 2022 Jul 23;2022:8101099. doi: 10.1155/2022/8101099. eCollection 2022.