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Emerging Therapies: Drugs and Regimens

The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial

  1. Ian J. Neeland1⇑,
  2. Bjorn Eliasson2,
  3. Takatoshi Kasai3,
  4. Nikolaus Marx4,
  5. Bernard Zinman5,
  6. Silvio E. Inzucchi6,
  7. Christoph Wanner7,
  8. Isabella Zwiener8,
  9. Brian S. Wojeck6,
  10. Henry K. Yaggi9 and
  11. Odd Erik Johansen10, on behalf of the EMPA-REG OUTCOME Investigators
  1. 1University Hospitals Harrington Heart and Vascular Institute and Case Western Reserve University School of Medicine, Cleveland, OH
  2. 2Department of Medicine, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden
  3. 3Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
  4. 4Department of Internal Medicine I (Cardiology), RWTH University Hospital, Aachen, Germany
  5. 5Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
  6. 6Section of Endocrinology, Yale School of Medicine, Yale University, New Haven, CT
  7. 7Department of Medicine, Wuerzburg University Clinic, Wuerzburg, Germany
  8. 8Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany
  9. 9Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, Yale University, New Haven, CT
  10. 10Boehringer Ingelheim Norway KS, Asker, Norway
  1. Corresponding author: Ian J. Neeland, ian.neeland{at}uhhospitals.org
  1. H.K.Y. and O.E.J. contributed equally to this work.

Diabetes Care 2020 Dec; 43(12): 3007-3015. https://doi.org/10.2337/dc20-1096
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Abstract

OBJECTIVE To explore the effects of empagliflozin on the incidence of obstructive sleep apnea (OSA) and its effects on metabolic, cardiovascular (CV), and renal outcomes among participants with or without OSA in the EMPA-REG OUTCOME trial.

RESEARCH DESIGN AND METHODS Participants with diabetes and CV disease were randomized to empagliflozin (10 and 25 mg) or placebo daily in addition to standard of care. OSA was assessed by investigator report using Medical Dictionary for Regulatory Activities version 18.0, and CV outcomes were independently adjudicated. Analyses were performed using multivariable-adjusted Cox regression models.

RESULTS OSA was reported in 391 of 7,020 (5.6%) participants at baseline. Those with OSA were more likely to be male (83% vs. 71%) and to have moderate to severe obesity (BMI ≥35 kg/m2; 55% vs. 18%). Over a median of 3.1 years, empagliflozin had similar placebo-adjusted reductions in HbA1c, waist circumference, and systolic blood pressure, regardless of OSA status, but a larger effect on weight (adjusted mean ± SE difference at week 52: OSA vs. no OSA −2.9 ± 0.5 vs. −1.9 ± 0.1 kg). Incidence of 3-point major adverse CV events, CV death, heart failure hospitalization, and incident or worsening nephropathy in the placebo group was 1.2- to 2.0-fold higher for those with baseline OSA compared with those without. Empagliflozin significantly reduced the risk for outcomes regardless of OSA status (P-interaction all >0.05). Fifty patients reported a new diagnosis of OSA through 7 days after medication discontinuation, and this occurred less often with empagliflozin treatment (hazard ratio 0.48 [95% CI 0.27, 0.83]).

CONCLUSIONS In EMPA-REG OUTCOME, participants with OSA had greater comorbidity and higher frequency of CV and renal events. Empagliflozin had favorable effects on risk factors and CV and renal outcomes regardless of preexisting OSA and may also reduce the risk for new-onset OSA.

Footnotes

  • Clinical trial reg. no. NCT01131676, clinicaltrials.gov

  • This article contains supplementary material online at https://doi.org/10.2337/figshare.12970550.

  • Received May 10, 2020.
  • Accepted September 14, 2020.
  • © 2020 by the American Diabetes Association
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The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial
Ian J. Neeland, Bjorn Eliasson, Takatoshi Kasai, Nikolaus Marx, Bernard Zinman, Silvio E. Inzucchi, Christoph Wanner, Isabella Zwiener, Brian S. Wojeck, Henry K. Yaggi, Odd Erik Johansen
Diabetes Care Dec 2020, 43 (12) 3007-3015; DOI: 10.2337/dc20-1096

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The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial
Ian J. Neeland, Bjorn Eliasson, Takatoshi Kasai, Nikolaus Marx, Bernard Zinman, Silvio E. Inzucchi, Christoph Wanner, Isabella Zwiener, Brian S. Wojeck, Henry K. Yaggi, Odd Erik Johansen
Diabetes Care Dec 2020, 43 (12) 3007-3015; DOI: 10.2337/dc20-1096
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