• Meir Schechter, Niels Jongs, Glenn M Chertow, Ofri Mosenzon, McMurrayJohn J VJJV0000-0002-6317-3975Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (J.J.V.M.)., Ricardo Correa-Rotter, Peter Rossing, Anna Maria Langkilde, C David Sjöström, Robert D Toto, David C Wheeler, and Hiddo J L Heerspink.
• Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands, Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Jerusalem, Israel, and Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel (M.S.).
• Ann. Intern. Med. 2023 Jan 1; 176 (1): 596659-66.

BackgroundAcute hospitalizations are common in patients with chronic kidney disease (CKD) and often lead to decreases in health-related quality of life and increased care costs.ObjectiveTo determine the effects of dapagliflozin on first hospitalizations and all (first and subsequent) hospitalizations and to explore effects on cause-specific hospitalizations.DesignPost hoc analysis of a randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov: NCT03036150).Setting386 ambulatory practice sites in 21 countries from 2 February 2017 through 12 June 2020.ParticipantsAdults with an estimated glomerular filtration rate of 25 to 75 mL/min/1.73 m2 and a urinary albumin-creatinine ratio of 200 to 5000 mg/g, with and without type 2 diabetes.InterventionDapagliflozin, 10 mg once daily, or matching placebo (1:1 ratio).MeasurementsThe effects of dapagliflozin on first hospitalizations for any cause, all hospitalizations, and cause-specific (first and recurrent) hospitalizations were determined. The reported system organ class was used to evaluate reasons for admission. Hospitalizations were analyzed using Cox proportional hazards regression models (first hospitalization), the Lin-Wei-Yang-Ying method (all hospitalizations or death), and negative binomial models (cause-specific hospitalizations).ResultsThe study included 4304 patients (mean age, 61.8 years; 33.1% women). During a median follow-up of 2.4 years, 2072 hospitalizations were reported among 1224 (28.4%) participants. Compared with placebo, dapagliflozin reduced risk for a first hospitalization (hazard ratio, 0.84 [95% CI, 0.75 to 0.94]) and all hospitalizations or death (rate ratio, 0.79 [CI, 0.70 to 0.89]). There was no evidence that the effects of dapagliflozin on first and all hospitalizations varied by baseline presence of type 2 diabetes (P for interaction = 0.60 for each). Compared with placebo, dapagliflozin reduced the rate of admissions due to cardiac disorders, renal and urinary disorders, metabolism and nutrition disorders, and neoplasms.LimitationsThis was a post hoc analysis and should be viewed as hypothesis-generating. Hospitalizations and causes were reported by site investigators and were not centrally adjudicated.ConclusionDapagliflozin reduced the risk for hospitalization for any cause in patients with CKD with and without type 2 diabetes.Primary Funding SourceAstraZeneca.

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