Abstract | PURPOSE: METHODS: In VERTIS CV, patients ≥ 40 years with T2D and atherosclerotic CV disease (ASCVD) were randomized to ertugliflozin 5 or 15 mg or placebo. The primary endpoint was the composite of major adverse CV events. This exploratory analysis evaluated the impact of ertugliflozin (5 and 15 mg pooled) on incident OSA. Patients with prevalent OSA were excluded. Incident OSA events were based on investigator-reported events using the MedDRA SMQ term " sleep apnea syndrome." A multivariable Cox proportional hazards regression model was constructed to assess the association between ertugliflozin and incident OSA. RESULTS: Of 8246 patients enrolled, 7697 (93.3%) were without baseline OSA (placebo, n = 2561; ertugliflozin, n = 5136; mean age 64.4 years; BMI 31.7 kg/m2; HbA1c, 8.2%; 69.2% male; 88.3% White). The OSA incidence rate was 1.44 per 1000 person-years versus 2.61 per 1000 person-years among patients treated with ertugliflozin versus placebo, respectively, corresponding to a 48% relative risk reduction (HR 0.52; 95% CI 0.28-0.96; P = 0.04). CONCLUSIONS: In VERTIS CV, ertugliflozin reduced by nearly half the incidence of OSA in patients with T2D and ASCVD. These data contribute to the literature that SGLT2is may have a significant beneficial impact on OSA. TRIAL REGISTRATION: CLINICALTRIALS: gov identifier: NCT01986881.
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Authors | Brian S Wojeck, Silvio E Inzucchi, Ian J Neeland, James P Mancuso, Robert Frederich, Urszula Masiukiewicz, Nilo B Cater, Darren K McGuire, Christopher P Cannon, Henry Klar Yaggi |
Journal | Sleep & breathing = Schlaf & Atmung
(Sleep Breath)
Vol. 27
Issue 2
Pg. 669-672
(05 2023)
ISSN: 1522-1709 [Electronic] Germany |
PMID | 35596030
(Publication Type: Randomized Controlled Trial, Journal Article)
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Copyright | © 2022. Pfizer Inc. and The Author(s). |
Chemical References |
- ertugliflozin
- Sodium-Glucose Transporter 2 Inhibitors
- Bridged Bicyclo Compounds, Heterocyclic
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Topics |
- Humans
- Male
- Middle Aged
- Female
- Diabetes Mellitus, Type 2
(drug therapy, epidemiology)
- Sodium-Glucose Transporter 2 Inhibitors
(therapeutic use, adverse effects)
- Bridged Bicyclo Compounds, Heterocyclic
(adverse effects)
- Cardiovascular Diseases
(epidemiology)
- Sleep Apnea, Obstructive
(drug therapy, epidemiology, chemically induced)
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