医学
射血分数
达帕格列嗪
心力衰竭
肾功能
安慰剂
射血分数保留的心力衰竭
内科学
心脏病学
透析
肾脏疾病
糖尿病
危险系数
2型糖尿病
内分泌学
置信区间
病理
替代医学
作者
Finnian R. Mc Causland,Brian Claggett,Muthiah Vaduganathan,Akshay S. Desai,Pardeep S. Jhund,Orly Vardeny,James C. Fang,Rudolf A. de Boer,Kieran F. Docherty,Adrian F. Hernandez,Silvio E. Inzucchi,Mikhail Kosiborod,Carolyn S.P. Lam,Felipe Martínez,José Francisco Kerr Saraiva,Martina M. McGrath,Sanjiv J. Shah,Subodh Verma,Anna Maria Langkilde,Magnus Petersson,John J.V. McMurray,Scott D. Solomon
出处
期刊:JAMA Cardiology
[American Medical Association]
日期:2024-02-01
卷期号:9 (2): 144-144
被引量:3
标识
DOI:10.1001/jamacardio.2023.4664
摘要
An initial decline in estimated glomerular filtration rate (eGFR) is expected after initiating a sodium-glucose cotransporter-2 inhibitor (SGLT2i) and has been observed across patients with diabetes, chronic kidney disease, and heart failure.To examine the implications of initial changes in eGFR among patients with heart failure with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF) enrolled in the Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure (DELIVER) trial.This was a prespecified analysis of the results of the DELIVER randomized clinical trial, which was an international multicenter study of patients with EF greater than 40% and eGFR greater than or equal to 25. The DELIVER trial took place from August 2018 to March 2022. Data for the current prespecified study were analyzed from February to October 2023.Dapagliflozin, 10 mg per day, or placebo.In this prespecified analysis, the frequency of an initial eGFR decline (baseline to month 1) was compared between dapagliflozin and placebo. Cox models adjusted for baseline eGFR and established prognostic factors were fit to estimate the association of an initial eGFR decline with cardiovascular (cardiovascular death or heart failure event) and kidney (≥50% eGFR decline, eGFR<15 or dialysis, death from kidney causes) outcomes, landmarked at month 1, stratified by diabetes.Study data from 5788 participants (mean [SD] age, 72 [10] years; 3253 male [56%]) were analyzed. The median (IQR) change in eGFR level from baseline to month 1 was -1 (-6 to 5) with placebo and -4 (-9 to 1) with dapagliflozin (difference, -3; P < .001). A higher proportion of patients assigned to dapagliflozin developed an initial eGFR decline greater than 10% vs placebo (1144 of 2892 [40%] vs 737 of 2896 [25%]; odds ratio, 1.9; 95% CI, 1.7-2.1; P difference <.001). An initial eGFR decline of greater than 10% (vs ≤10%) was associated with a higher risk of the primary cardiovascular outcome among those randomized to placebo (adjusted hazard ratio [aHR], 1.33; 95% CI, 1.10-1.62) but not among those randomized to dapagliflozin (aHR, 0.90; 95% CI, 0.74-1.09; P for interaction = .01). Similar associations were observed when alternative thresholds of initial eGFR decline were considered and when analyzed as a continuous measure. An initial eGFR decline of greater than 10% was not associated with adverse subsequent kidney composite outcomes in dapagliflozin-treated patients (aHR, 0.94; 95% CI, 0.49-1.82).Among patients with HFmrEF or HFpEF treated with dapagliflozin, an initial eGFR decline was frequent but not associated with subsequent risk of cardiovascular or kidney events. These data reinforce clinical guidance that SGLT2is should not be interrupted or discontinued in response to an initial eGFR decline.ClinicalTrials.gov Identifier: NCT03619213.