PMID- 29505318 OWN - NLM STAT- MEDLINE DCOM- 20180528 LR - 20190222 IS - 1744-764X (Electronic) IS - 1474-0338 (Linking) VI - 17 IP - 5 DP - 2018 May TI - A safety comparison of LABA+LAMA vs LABA+ICS combination therapy for COPD. PG - 509-517 LID - 10.1080/14740338.2018.1448786 [doi] AB - INTRODUCTION: LABA+LAMA and LABA+ICS combinations are key pharmacological approaches to the treatment of COPD. However, both combination types can induce adverse events (AEs). AREAS COVERED: Current literature on LABA+LAMA and LABA+ICS combinations has been reviewed with a specific focus on their safety profile in the treatment of COPD. EXPERT OPINION: Several meta-analyses have compared the pooled safety data from randomized clinical trials (RCTs) of LABA+LAMA combinations with LABA+ICS combinations. LABA+LAMA caused significantly less AEs and SAEs. However, this evidence in real life is less solid because of the lack of appropriate studies. A statistically significant reduction in the risk for pneumonia with LABA+LAMA compared with LABA+ICS has been repeatedly documented by various meta-analyses. The meta-analytic signal indicates that an equal number of patients would die or have cardiac SAEs on LABA+LAMA or LABA+ICS, and in an observational, real-life study the LABA+LAMA combination had similar or lower risk of these events in comparison to LABA+ICS. Nonetheless, since RCTs are conducted under widely varying conditions and, consequently, AE rates of a drug observed in a RCT cannot be directly compared with rates in the RCTs of another drug and may not reflect the rates observed in practice, we need more specific data. FAU - Matera, Maria Gabriella AU - Matera MG AD - a Department of Experimental Medicine, Unit of Pharmacology , University of Campania Luigi Vanvitelli , Naples , Italy. FAU - Calzetta, Luigino AU - Calzetta L AUID- ORCID: 0000-0003-0456-069X AD - b Department of Experimental Medicine and Surgery, Unit of Respiratory Medicine , University of Rome Tor Vergata , Rome , Italy. FAU - Puxeddu, Ermanno AU - Puxeddu E AD - b Department of Experimental Medicine and Surgery, Unit of Respiratory Medicine , University of Rome Tor Vergata , Rome , Italy. FAU - Rogliani, Paola AU - Rogliani P AD - b Department of Experimental Medicine and Surgery, Unit of Respiratory Medicine , University of Rome Tor Vergata , Rome , Italy. FAU - Cazzola, Mario AU - Cazzola M AUID- ORCID: 0000-0003-4895-9707 AD - b Department of Experimental Medicine and Surgery, Unit of Respiratory Medicine , University of Rome Tor Vergata , Rome , Italy. LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial DEP - 20180308 PL - England TA - Expert Opin Drug Saf JT - Expert opinion on drug safety JID - 101163027 RN - 0 (Adrenal Cortex Hormones) RN - 0 (Adrenergic beta-2 Receptor Agonists) RN - 0 (Delayed-Action Preparations) RN - 0 (Muscarinic Antagonists) SB - IM MH - Administration, Inhalation MH - Adrenal Cortex Hormones/administration & dosage/*adverse effects MH - Adrenergic beta-2 Receptor Agonists/administration & dosage/*adverse effects MH - Delayed-Action Preparations MH - Drug Therapy, Combination MH - Humans MH - Muscarinic Antagonists/administration & dosage/*adverse effects MH - Pulmonary Disease, Chronic Obstructive/drug therapy MH - Randomized Controlled Trials as Topic OTO - NOTNLM OT - Adverse events OT - COPD OT - ICS OT - LABA OT - LAMA OT - combination therapy EDAT- 2018/03/06 06:00 MHDA- 2018/05/29 06:00 CRDT- 2018/03/06 06:00 PHST- 2018/03/06 06:00 [pubmed] PHST- 2018/05/29 06:00 [medline] PHST- 2018/03/06 06:00 [entrez] AID - 10.1080/14740338.2018.1448786 [doi] PST - ppublish SO - Expert Opin Drug Saf. 2018 May;17(5):509-517. doi: 10.1080/14740338.2018.1448786. Epub 2018 Mar 8.