PMID- 30227433 OWN - NLM STAT- MEDLINE DCOM- 20191018 LR - 20191018 IS - 1423-0356 (Electronic) IS - 0025-7931 (Linking) VI - 96 IP - 4 DP - 2018 TI - LABA/LAMA Fixed Dose Combination in Chronic Obstructive Pulmonary Disease: The Impact on Health-Related Quality of Life. PG - 370-381 LID - 10.1159/000491673 [doi] AB - BACKGROUND: While fixed dose combinations (FDCs) of long-acting beta 2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) are increasingly tested on their efficacy in improving lung function, their effectiveness on Patient Reported Outcomes (PROs) such as Health Related Quality of Life (HRQoL) and Health Status (HS) deserve more attention. OBJECTIVES: To review current available evidence about the treatment effect of fixed LABA/LAMA FDCs on HRQoL. METHODS: A systematic literature search for randomized controlled trials (RCTs) about the impact of LABA/LAMA FDCs versus placebo, LABA or LAMA or LABA/ICS on HRQoL in Chronic obstructive pulmonary disease (COPD) patients has been performed. RESULTS: Twenty-eight RCTs (n = 32, 165 COPD patients) investigating the impact of fixed LABA/LAMA combinations on HRQoL were included. Using the St George' s Respiratory Questionnaire, 27 out of 28 trials assessed HRQoL. LABA/LAMA FDCs significantly improved HRQoL versus placebo in 9 out of 11 trials, while change when compared to other LABA or LAMA monocomponents was significantly better in 11 out 24. In 5 out of 6 RCTs having LABA/ICS as comparators, LABA/LAMA FDC had a similar effect and only 1 showed significant improvement in HRQL compared to LABA/ICS FDC. CONCLUSION: LABA/LAMA FDCs may be helpful in improving HRQoL, but because of the heterogeneity of performed trials, strong conclusions cannot be drawn. Moreover, due to the different molecule properties, treatment schedule, and device characteristics of each FDC, a generalized judgment seems inappropriate. Pragmatic trials powered to detect real-life differences in HRQoL and head-to-head comparison are needed to guide clinical practice in terms of PROs. CI - (c) 2018 S. Karger AG, Basel. FAU - Labor, Marina AU - Labor M AD - Department of Pulmonology, University Hospital Center Osijek, Osijek, Croatia, Faculty of Medicine, J.J. Strossmayer University of Osijek, Osijek, Croatia. FAU - Braido, Fulvio AU - Braido F AD - Department of Internal Medicine, Respiratory Diseases and Allergy Clinic, University of Genova, Azienda Policlinico IRCCs San Martino, Genoa, Italy. FAU - Bikov, Andras AU - Bikov A AD - NIHR Manchester Clinical Research Facility, Manchester University NHS Foundation Trust, Manchester, United Kingdom. FAU - Lahousse, Lies AU - Lahousse L AD - Department of Bioanalysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium. FAU - Rogliani, Paola AU - Rogliani P AD - Dipartimento di Medicina Sperimentale e Chirurgia Universita di Roma "Tor Vergata,", Roma, Italy. FAU - Baiardini, Ilaria AU - Baiardini I AD - Department of Biomedical Sciences, Humanitas University, Milano, Italy. LA - eng PT - Journal Article PT - Review DEP - 20180918 PL - Switzerland TA - Respiration JT - Respiration; international review of thoracic diseases JID - 0137356 RN - 0 (Adrenergic beta-2 Receptor Agonists) RN - 0 (Drug Combinations) RN - 0 (Muscarinic Antagonists) SB - IM MH - Adrenergic beta-2 Receptor Agonists/*therapeutic use MH - Drug Combinations MH - Humans MH - Muscarinic Antagonists/*therapeutic use MH - Pulmonary Disease, Chronic Obstructive/*drug therapy/psychology MH - Quality of Life OTO - NOTNLM OT - Chronic obstructive pulmonary disease treatment OT - Health-related quality of life OT - Long-acting beta 2-agonists /long-acting muscarinic antagonists fixed dose combinations OT - Patient reported outcomes OT - Randomized controlled trials EDAT- 2018/09/19 06:00 MHDA- 2019/10/19 06:00 CRDT- 2018/09/19 06:00 PHST- 2018/03/02 00:00 [received] PHST- 2018/06/26 00:00 [accepted] PHST- 2018/09/19 06:00 [pubmed] PHST- 2019/10/19 06:00 [medline] PHST- 2018/09/19 06:00 [entrez] AID - 000491673 [pii] AID - 10.1159/000491673 [doi] PST - ppublish SO - Respiration. 2018;96(4):370-381. doi: 10.1159/000491673. Epub 2018 Sep 18.