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  ["project_title"]=>
  string(62) "SGLT-2 Inhibitors in Women and Men with Chronic Kidney Disease"
  ["project_narrative_summary"]=>
  string(621) "Sex-related differences are increasingly recognized in CKD populations, influencing CKD progression, cardiovascular events, and treatment responses. This highlights the importance of sex-specific evaluations of newly developed CKD therapies. By analyzing major cardiovascular and kidney outcomes in women and men with CKD after synthesizing individual participant data (IPD), we aim to determine whether SGLT-2 inhibitors have differing impacts based on sex. These findings will enhance our understanding of the interplay between sex, CKD, and cardio-renal outcomes, helping to guide individualized treatment strategies. "
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  array(7) {
    ["first_name"]=>
    string(8) "Bernhard"
    ["last_name"]=>
    string(7) "Schmidt"
    ["degree"]=>
    string(7) "MD, MSc"
    ["primary_affiliation"]=>
    string(23) "Hannover Medical School"
    ["email"]=>
    string(31) "schmidt.bernhard@mh-hannover.de"
    ["state_or_province"]=>
    string(12) "Lower Saxony"
    ["country"]=>
    string(7) "Germany"
  }
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      ["p_pers_f_name"]=>
      string(6) "Zhejia"
      ["p_pers_l_name"]=>
      string(4) "Tian"
      ["p_pers_degree"]=>
      string(2) "MD"
      ["p_pers_pr_affil"]=>
      string(24) "Hannover Medical School "
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      string(6) "Anette"
      ["p_pers_l_name"]=>
      string(4) "Melk"
      ["p_pers_degree"]=>
      string(7) "MD, PhD"
      ["p_pers_pr_affil"]=>
      string(23) "Hannover Medical School"
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      ["requires_data_access"]=>
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    }
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    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
  }
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  ["property_scientific_abstract"]=>
  string(1597) "Background: There is some evidence on treatment response to SGLT-2 inhibitors based on sex. However, data on sex-specific effects in CKD patients remain limited, and it is unclear whether findings from RCTs align with real-world evidence.

Objective: Effect of sex on the efficacy of SGLT-2 inhibitors in CKD patients.

Study Design: We will use IPD of large RCTs (≥2000 participants) comparing SGLT-2 inhibitors to placebo for major cardiovascular and kidney outcomes. Each outcome will first be analyzed separately by sex within each trial. We will then conduct an IPD meta-analysis. In addition, we will assess sex-stratified efficacy in a retrospective cohort study using electronic medical records.

Participants: The entire populations with CKD enrolled in the selected RCTs for IPD meta-analysis and CKD patients with eGFR≥ 20ml/min/1.73m² either receiving SGLT-2 inhibitors or not for cohort study.  

Primary and Secondary Outcome Measure(s): The primary outcome is a composite of major cardiovascular outcomes (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke). Secondary outcomes are a composite of major kidney outcomes (renal replacement therapy, an eGFR<15ml/min/1.73m² sustained for at least 28 days, or renal death), eGFR-slope, and worsening of UACR.

Statistical Analysis: Cox models will be used to analyze outcomes within each trial, followed by a one-stage IPD meta-analysis using frailty models. We will also consider mediation analysis to explore the link between sex and treatment response.

"
  ["project_brief_bg"]=>
  string(2753) "In recent years, research interest in sex and gender medicine concerning chronic kidney disease (CKD) has increased (1). Epidemiological data indicate sex differences in cardiovascular health both in the general population and among patients with CKD (2–6). In an analysis from the TriNetX network we could show an increased excess risk for CV events in women with CKD compared to men with CKD(7). More controversially, sex has been suggested to influence treatment response (8,9). Several post-hoc analyses of large randomized controlled trials focusing on cardiovascular and kidney health provide evidence in this regard (10–13). However, most of these analyses have primarily focused on patients with heart failure, leaving a gap in understanding the sex-specific effects in CKD patients. CKD is well established as a major and independent risk factor for cardiovascular disease, as it is consistently associated with increased cardiovascular events and mortality (14,15). In recent years, SGLT-2 inhibitors have become a cornerstone therapy for CKD due to their significant effects in reducing cardiovascular events and slowing disease progression(16). Thus, exploring the response pattern in women and men is fundamental to improve individualized patient care.

Studies analyzing the sex-specific efficacy of SGLT-2 inhibitors so far have primarily consisted of post-hoc pooled analyses of one or two trials or meta-analyses using aggregated trial-level data (10,11,17,18), both of which may introduce significant bias. In contrast, a meta-analysis using individual participant data can substantially improve both the quantity and quality of data while also enabling the standardization of outcomes across trials (19). Moreover, individual participant data offer greater flexibility in analyses, enabling the assessment of whether SGLT-2 inhibitors are more or less effective in different participant subgroups. 

In addition, previous analyses on the interaction between sex, the efficacy of SGLT-2 inhibitors, and cardiorenal outcomes have mainly relied on data from randomized controlled trials. Evidence based on real-world data is currently lacking, and it remains unknown whether findings from trial-level data can be translated to real-world settings.

Therefore, we will conduct a predefined evaluation of SGLT-2 inhibitor efficacy in women and men with CKD through an individual participant data meta-analysis to address the existing gap. Additionally, a parallel cohort study using real-world data will enhance our understanding of sex-specific response patterns to SGLT-2 inhibitors. Our findings will help clinicians provide individualized patient care and reduce unnecessary overtreatment in CKD patients.

"
  ["project_specific_aims"]=>
  string(1131) "Aim 1. Compare major cardiovascular and kidney outcomes between women and men with CKD receiving SGLT-2 inhibitors or placebo using individual participant data from large scale randomized controlled trials, and assess sex-specific treatment responses to SGLT-2 inhibitors.

Aim 2. Perform subgroup analyses stratified by age, using the average age of menopause as a cutoff, as well as by baseline eGFR, baseline albuminuria level, and baseline comorbidities (CKD with diabetes, CKD with heart failure, and CKD with both diabetes and heart failure).

Aim 3. Compare cardiovascular and kidney outcomes between women and men with CKD treated with or without SGLT-2 inhibitors using real-world data from electronic medical records, examining the alignment of randomized controlled trial findings with real-world evidence. 

Hypothesis: Overall, SGLT-2 inhibitors reduce the risk of major cardiovascular and kidney outcomes to a lesser extent in women than in men with CKD, and this effect is expected to be consistent in real-world practice. In addition, treatment responses may vary among specific subgroups.

"
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(7) "meta_an"
    ["label"]=>
    string(52) "Meta-analysis (analysis of multiple trials together)"
  }
  ["project_purposes"]=>
  array(3) {
    [0]=>
    array(2) {
      ["value"]=>
      string(56) "new_research_question_to_examine_treatment_effectiveness"
      ["label"]=>
      string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(22) "participant_level_data"
      ["label"]=>
      string(36) "Participant-level data meta-analysis"
    }
    [2]=>
    array(2) {
      ["value"]=>
      string(56) "participant_level_data_meta_analysis_from_yoda_and_other"
      ["label"]=>
      string(69) "Meta-analysis using data from the YODA Project and other data sources"
    }
  }
  ["project_research_methods"]=>
  string(1136) "Data from CANVAS (NCT01032629), CANVAS-R (NCT01989754), and CREDENCE (NCT02065791) will be required and all participants enrolled in these trials will be eligible for our study once they have chronic kidney disease. Participants with normal kidney function will be excluded from the analysis.

We will also request access to individual participant data from EMPA-REG OUTCOME (NCT01131676), EMPA-KIDNEY (NCT03594110), EMPEROR-Reduced (NCT03057977), EMPEROR-Preserved (NCT03057951), DAPA-HF (NCT03036124), DAPA-CKD (NCT03036150), and DELIVER (NCT03619213). Individual participant data from Empagliflozin and Dapagliflozin will be available on Vivli platform (https://vivli.org/). If all organizations approve our requests, we will pool all data from those studies and perform our analyses on Vivli platform.

Data extracted from TriNetX platform based on electronic medical records for our cohort study will not be merged with data from randomized controlled trials. We will include participants aged between 18 and 90 years with diagnosed CKD with estimated GFR ≥ 15 ml/min/1.73m²with or without SGLT-2 inhibitor therapy. "
  ["project_main_outcome_measure"]=>
  string(554) "The primary outcome of our individual participant data meta-analysis will be a composite of major cardiovascular outcomes (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) in women and men receiving SGLT-2 inhibitor or placebo. Secondary outcome will include a composite of major kidney outcomes (renal replacement therapy, an estimated GFR < 15 ml/min/1.73m² sustained for at least 28 days, or renal death) and progression of kidney disease with change in eGFR (eGFR slope) and in urine albumin creatinine ratio."
  ["project_main_predictor_indep"]=>
  string(73) "The main predictor of our study will be sex, as recorded in the trial CRF"
  ["project_other_variables_interest"]=>
  string(231) "Covariates to be considered in the multivariable regression analyses will be age (linear), eGFR (linear), UACR (linear), LDL cholesterol (linear), systolic blood pressure (linear), comorbidities (diabetes mellitus, heart failure)  "
  ["project_stat_analysis_plan"]=>
  string(1204) "All statistical analyses will be conducted using R and RStudio. To compare the effects of SGLT-2 inhibitors versus placebo by sex for each randomized controlled trial, time-to-event data were analyzed using Kaplan-Meier curves and Cox proportional hazards regression models, stratified by baseline estimated GFR and incorporating treatment assignment as a fixed effect. Results will be presented as hazard ratios with 95% confidence intervals. We will then perform a one-stage individual participant data meta-analysis from included trials using frailty models. To further investigate the link between exposure and outcomes, we will also conduct a mediation analysis with sex as a mediator.

For the cohort study using real world data, survival probabilities will be estimated using the Kaplan-Meier method, while differences in all outcomes were analyzed using a Cox proportional hazards regression model. A series of Cox proportional hazards models will further be developed sequentially. The models will begin with age and incrementally incorporated sociodemographic factors, cardiovascular risk factors, CKD-specific factors, laboratory measurements, medication use, and history of CVD.

"
  ["project_software_used"]=>
  array(1) {
    [0]=>
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      string(7) "rstudio"
      ["label"]=>
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  ["project_timeline"]=>
  string(426) "We plan to complete all analyses within approximately 1.5 years, 2025 March – 2026 October. 

2025 March – 2026 February: data extraction from all included randomized controlled trials and data analysis.

2026 March – 2026 August: performing the cohort study using the real-world data.

2026 September – 2026 October: Drafting and submitting the manuscript for consideration for publications.

"
  ["project_dissemination_plan"]=>
  string(231) "Publication is planned on international meetings (AHA, ASN, ESC) and as a full paper in a renowned journal (Circulation, JAMA Cardiology, European Heart Journal, Journal of the American Society of Nephrology, Kidney International)."
  ["project_bibliography"]=>
  string(6333) "

Carrero JJ, Hecking M, Chesnaye NC, Jager KJ. Sex and gender disparities in the epidemiology and outcomes of chronic kidney disease. Nat Rev Nephrol [Internet]. 2018 Mar 1 [cited 2024 Dec 29];14(3):151–64. Available from: https://pubmed.ncbi.nlm.nih.gov/29355169/
D’Agostino RB, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, et al. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation [Internet]. 2008 Feb [cited 2024 Dec 28];117(6):743–53. Available from: https://pubmed.ncbi.nlm.nih.gov/18212285/
Müller-Nordhorn J, Binting S, Roll S, Willich SN. An update on regional variation in cardiovascular mortality within Europe. Eur Heart J [Internet]. 2008 May [cited 2024 Dec 28];29(10):1316–26. Available from: https://pubmed.ncbi.nlm.nih.gov/18256043/
Hecking M, Bieber BA, Ethier J, Kautzky-Willer A, Sunder-Plassmann G, Säemann MD, et al. Sex-specific differences in hemodialysis prevalence and practices and the male-to-female mortality rate: the Dialysis Outcomes and Practice Patterns Study (DOPPS). PLoS Med [Internet]. 2014 [cited 2024 Dec 31];11(10). Available from: https://pubmed.ncbi.nlm.nih.gov/25350533/
De La Mata NL, Rosales B, Macleod G, Kelly PJ, Masson P, Morton RL, et al. Sex differences in mortality among binational cohort of people with chronic kidney disease: population based data linkage study. BMJ [Internet]. 2021 Nov 16 [cited 2024 Dec 28];375. Available from: https://www.bmj.com/content/375/BMJ-2021-068247
Faucon AL, Lambert O, Massy Z, Drüeke TB, Combe C, Fouque D, et al. Sex and the Risk of Atheromatous and Nonatheromatous Cardiovascular Disease in CKD: Findings From the CKD-REIN Cohort Study. Am J Kidney Dis [Internet]. 2024 Nov 1 [cited 2024 Dec 28];84(5). Available from: https://pubmed.ncbi.nlm.nih.gov/38925506/
Tian Z, Hillebrand UC, Casper J, Schmidt-Ott KM, Melk A, Schmidt BMW. Chronic Kidney Disease Confers Increased Excess Risks of Mortality and Cardiovascular Events in Women When Compared to Men. 2025 Jan. Submitted to J Am Soc Nephrol.
Linde C, Cleland JGF, Gold MR, Claude Daubert J, Tang ASL, Young JB, et al. The interaction of sex, height, and QRS duration on the effects of cardiac resynchronization therapy on morbidity and mortality: an individual-patient data meta-analysis. Eur J Heart Fail [Internet]. 2018 Apr 1 [cited 2025 Feb 8];20(4):780–91. Available from: https://pubmed.ncbi.nlm.nih.gov/29314424/
McMurray JJV, Jackson AM, Lam CSP, Redfield MM, Anand IS, Ge J, et al. Effects of Sacubitril-Valsartan Versus Valsartan in Women Compared With Men With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF. Circulation [Internet]. 2020 Feb 4 [cited 2025 Feb 8];141(5):338–51. Available from: https://pubmed.ncbi.nlm.nih.gov/31736337/
Butler J, Filippatos G, Siddiqi TJ, Ferreira JP, Brueckmann M, Bocchi E, et al. Effects of Empagliflozin in Women and Men with Heart Failure and Preserved Ejection Fraction. Circulation [Internet]. 2022 Oct 4 [cited 2025 Feb 8];146(14):1046–55. Available from: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.059755
Yu MK, Vart P, Jongs N, Correa-Rotter R, Rossing P, McMurray JJV, et al. Effects of Dapagliflozin in Chronic Kidney Disease Across the Spectrum of Age and by Sex. J Gen Intern Med [Internet]. 2024 May 1 [cited 2025 Feb 8];39(6):921–30. Available from: https://pubmed.ncbi.nlm.nih.gov/38097862/
Verma S, Colhoun HM, Dicker D, Hovingh GK, Kahn SE, Kautzky-Willer A, et al. Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT): Outcomes by Sex. J Am Coll Cardiol [Internet]. 2024 Oct 22 [cited 2025 Feb 8];84(17). Available from: https://pubmed.ncbi.nlm.nih.gov/39217575/
Chimura M, Wang X, Jhund PS, Henderson AD, Claggett BL, Desai AS, et al. Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial. JAMA Cardiol [Internet]. 2025 Jan 1 [cited 2025 Feb 8];10(1):59–70. Available from: https://jamanetwork.com/journals/jamacardiology/fullarticle/2826714
Tonelli M, Wiebe N, Culleton B, House A, Rabbat C, Fok M, et al. Chronic kidney disease and mortality risk: A systematic review. Journal of the American Society of Nephrology [Internet]. 2006 [cited 2024 Dec 31];17(7):2034–47. Available from: https://journals.lww.com/jasn/fulltext/2006/07000/chronic_kidney_disease_and_mortality_risk__a.37.aspx
Bikbov B, Purcell C, Levey AS, Smith M, Abdoli A, Abebe M, et al. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet [Internet]. 2020 Feb 29 [cited 2024 Dec 31];395(10225):709–33. Available from: https://pubmed.ncbi.nlm.nih.gov/32061315/
Stevens PE, Ahmed SB, Carrero JJ, Foster B, Francis A, Hall RK, et al. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int [Internet]. 2024 Apr 1 [cited 2025 Feb 8];105(4S):S117–314. Available from: https://pubmed.ncbi.nlm.nih.gov/38490803/
Danielson C, Lileikyte G, Ouwerkerk W, S.P. Lam C, Erlinge D, Teng THK. Sex differences in efficacy of pharmacological therapies in heart failure with reduced ejection fraction: a meta-analysis. ESC Heart Fail [Internet]. 2022 Aug 1 [cited 2025 Feb 8];9(4):2753–61. Available from: https://pubmed.ncbi.nlm.nih.gov/35603531/
Wang X, Vaduganathan M, Claggett BL, Hegde SM, Pabon M, Kulac IJ, et al. Sex Differences in Characteristics, Outcomes, and Treatment Response With Dapagliflozin Across the Range of Ejection Fraction in Patients With Heart Failure: Insights From DAPA-HF and DELIVER. Circulation [Internet]. 2023 Feb 21 [cited 2025 Feb 8];147(8):624–34. Available from: https://pubmed.ncbi.nlm.nih.gov/36342789/
Tierney JF, Vale C, Riley R, Smith CT, Stewart L, Clarke M, et al. Individual Participant Data (IPD) Meta-analyses of Randomised Controlled Trials: Guidance on Their Use. PLoS Med [Internet]. 2015 Jul 1 [cited 2025 Feb 8];12(7):e1001855. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC4510878/

 
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