PMID- 35314257 OWN - NLM STAT- MEDLINE DCOM- 20220504 LR - 20220504 IS - 1872-8227 (Electronic) IS - 0168-8227 (Linking) VI - 186 DP - 2022 Apr TI - Empagliflozin in patients with type 2 diabetes mellitus and chronic obstructive pulmonary disease. PG - 109837 LID - S0168-8227(22)00649-0 [pii] LID - 10.1016/j.diabres.2022.109837 [doi] AB - AIMS: Type 2 diabetes mellitus (T2DM) and chronic obstructive pulmonary disease (COPD) often co-exist, yielding increased risk of cardiovascular (CV) complications including heart failure (HF). We assessed risk of cardiorenal outcomes, mortality and safety in patients with versus without COPD in the EMPA-REG OUTCOME trial. METHODS: Patients (n = 7,020) with T2DM and CV disease (CVD) were treated with empagliflozin (10 mg or 25 mg) or placebo. Cox regression was used to assess COPD subgroup (placebo only) associations with, and treatment effects of empagliflozin versus placebo on first hospitalization for HF (HHF), CV death, all-cause mortality, incident/worsening nephropathy, and all-cause hospitalization. RESULTS: At baseline, patients with COPD (n = 707) had more HF and used insulin more frequently than those without COPD. During follow-up in the placebo group, those with baseline COPD had increased risk of HHF (HR 2.15 [95% CI 1.32, 3.49]), HHF/CV death (1.60 [1.10, 2.33]), incident/worsening nephropathy (1.68 [1.26, 2.24]), all-cause hospitalization (1.44 [1.19, 1.74]) and all-cause death (1.60 [1.09, 2.35]) compared to those without COPD. Empagliflozin consistently reduced all clinical outcomes, irrespective of COPD status (interaction p-values 0.14 to 0.96), with a confirmed safety profile. CONCLUSIONS: In patients with T2DM and CVD, COPD increased the risk of mortality and cardiorenal outcomes, including HF. Empagliflozin consistently reduced these outcomes versus placebo regardless of COPD, suggesting that empagliflozin's benefits in patients with T2DM and CVD are not mitigated by the presence of COPD. CI - Copyright (c) 2022 The Author(s). Published by Elsevier B.V. All rights reserved. FAU - Anker, Stefan D AU - Anker SD AD - Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site, Berlin, Germany, Charite Universitatsmedizin Berlin, Berlin, Germany; Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland. Electronic address: s.anker@cachexia.de. FAU - Sander, Leif-Erik AU - Sander LE AD - Department of Infectious Diseases and Respiratory Medicine, Charite Universitatsmedizin Berlin, Berlin, Germany. FAU - Fitchett, David H AU - Fitchett DH AD - St Michael's Hospital, Division of Cardiology, University of Toronto, Toronto, ON, Canada. FAU - Zinman, Bernard AU - Zinman B AD - Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada. FAU - Pernille Ofstad, Anne AU - Pernille Ofstad A AD - Boehringer Ingelheim Norway KS, Asker, Norway. FAU - Wanner, Christoph AU - Wanner C AD - Wurzburg University Clinic, Wurzburg, Germany. FAU - Vedin, Ola AU - Vedin O AD - Boehringer Ingelheim AB, Stockholm, Sweden. FAU - Lauer, Sabine AU - Lauer S AD - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. FAU - Verma, Subodh AU - Verma S AD - St Michael's Hospital, Division of Cardiac Surgery, University of Toronto, Toronto, ON, Canada. FAU - Yaggi, Henry K AU - Yaggi HK AD - Section of Pulmonary, Critical Care & Sleep Medicine, Yale University School of Medicine, New Haven, CT, USA. FAU - Inzucchi, Silvio E AU - Inzucchi SE AD - Yale University School of Medicine, New Haven, CT, USA. LA - eng PT - Journal Article DEP - 20220318 PL - Ireland TA - Diabetes Res Clin Pract JT - Diabetes research and clinical practice JID - 8508335 RN - 0 (Benzhydryl Compounds) RN - 0 (Glucosides) RN - 0 (Hypoglycemic Agents) RN - HDC1R2M35U (empagliflozin) SB - IM MH - Benzhydryl Compounds/therapeutic use MH - *Cardiovascular Diseases/drug therapy MH - *Diabetes Mellitus, Type 2/complications/drug therapy MH - Female MH - Glucosides/adverse effects MH - *Heart Failure/drug therapy MH - Humans MH - Hypoglycemic Agents/therapeutic use MH - *Kidney Diseases/drug therapy MH - Male MH - *Pulmonary Disease, Chronic Obstructive/complications/drug therapy MH - Treatment Outcome OTO - NOTNLM OT - (5/6) OT - COPD OT - Cardiovascular diseases OT - Emphysema OT - Heart failure OT - Type 2 diabetes mellitus EDAT- 2022/03/23 06:00 MHDA- 2022/05/06 06:00 CRDT- 2022/03/22 05:34 PHST- 2021/12/14 00:00 [received] PHST- 2022/02/16 00:00 [revised] PHST- 2022/03/16 00:00 [accepted] PHST- 2022/03/23 06:00 [pubmed] PHST- 2022/05/06 06:00 [medline] PHST- 2022/03/22 05:34 [entrez] AID - S0168-8227(22)00649-0 [pii] AID - 10.1016/j.diabres.2022.109837 [doi] PST - ppublish SO - Diabetes Res Clin Pract. 2022 Apr;186:109837. doi: 10.1016/j.diabres.2022.109837. Epub 2022 Mar 18.