TY - JOUR
T1 - Effects of Dapagliflozin on Hospitalizations in Patients with Chronic Kidney Disease
T2 - A Post Hoc Analysis of DAPA-CKD
AU - Schechter, Meir
AU - Jongs, Niels
AU - Chertow, Glenn M.
AU - Mosenzon, Ofri
AU - McMurray, John J.V.
AU - Correa-Rotter, Ricardo
AU - Rossing, Peter
AU - Langkilde, Anna Maria
AU - Sjöström, C. David
AU - Toto, Robert D.
AU - Wheeler, David C.
AU - Heerspink, Hiddo J.L.
N1 - Funding Information:
The authors thank all of the investigators, trial teams, and patients for their participation in the trial. They also thank Nicola Truss (inScience Communications, London, United Kingdom) for assistance with the editing of the draft report and preparation of the figures (support funded by AstraZeneca). By AstraZeneca.
Publisher Copyright:
© 2022 American College of Physicians.
PY - 2023/1/1
Y1 - 2023/1/1
N2 - Background: Acute 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. Objective: To determine the effects of dapagliflozin on first hospitalizations and all (first and subsequent) hospitalizations and to explore effects on cause-specific hospitalizations. Design: Post hoc analysis of a randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov: NCT03036150) Setting: 386 ambulatory practice sites in 21 countries from 2 February 2017 through 12 June 2020. Participants: Adults 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. Intervention: Dapagliflozin, 10 mg once daily, or matching placebo (1:1 ratio). Measurements: The 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). Results: The 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. Limitations: This 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. Conclusion: Dapagliflozin reduced the risk for hospitalization for any cause in patients with CKD with and without type 2 diabetes.
AB - Background: Acute 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. Objective: To determine the effects of dapagliflozin on first hospitalizations and all (first and subsequent) hospitalizations and to explore effects on cause-specific hospitalizations. Design: Post hoc analysis of a randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov: NCT03036150) Setting: 386 ambulatory practice sites in 21 countries from 2 February 2017 through 12 June 2020. Participants: Adults 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. Intervention: Dapagliflozin, 10 mg once daily, or matching placebo (1:1 ratio). Measurements: The 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). Results: The 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. Limitations: This 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. Conclusion: Dapagliflozin reduced the risk for hospitalization for any cause in patients with CKD with and without type 2 diabetes.
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U2 - 10.7326/M22-2115
DO - 10.7326/M22-2115
M3 - Article
C2 - 36469914
AN - SCOPUS:85146365407
SN - 0003-4819
VL - 176
SP - 59
EP - 66
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
IS - 1
ER -