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  string(136) "The effect of SLGT-2 inhibitors in patients with chronic kidney disease with or without type 2 DM: a systematic review and meta-analysis"
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  string(700) "Sodium-glucose cotransporter 2 (SGLT-2) inhibitors are drugs used to treat people with type 2 diabetes mellitus (T2D). Many studies have found that these medications are beneficial for people with heart failure, regardless of diabetes status. However, there is a lack of information regarding how SGLT-2 inhibitors may help people with chronic kidney disease. Our study is a systematic review and meta-analysis of all available evidence. We have performed a thorough literature search for relevant clinical trials, and we will combine their results in a single measure of effect for each outcome. Assessing the benefits of these drugs would help establish a new therapeutic role for this type of drug"
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      string(6) "Carlos"
      ["p_pers_l_name"]=>
      string(12) "Reyes-Farias"
      ["p_pers_degree"]=>
      string(15) "Medical Student"
      ["p_pers_pr_affil"]=>
      string(20) "Universidad de Piura"
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      string(6) "Franco"
      ["p_pers_l_name"]=>
      string(6) "Romani"
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      string(7) "MD, MSc"
      ["p_pers_pr_affil"]=>
      string(20) "Universidad de Piura"
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    ["label"]=>
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      string(195) "NCT01032629 - A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus"
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      string(188) "NCT01989754 - A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus"
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  ["property_scientific_abstract"]=>
  string(2215) "Background: Previous systematic reviews have demonstrated the efficacy of SGLT-2 inhibitors in reducing the risk of cardiovascular events and progression of renal outcomes. Nevertheless, most of these studies only included data from patients with T2D; therefore, they did not assess whether the effect is consistent regardless of the presence of T2D. Only one systematic review included data from both diabetic and non-diabetic patients. However, whether SGLT-2 inhibitors are efficacious in patients with CKD in the subgroups of patients with or without T2D was not analyzed.

Objective: To evaluate the therapeutic effect of SGLT-2 inhibitors compared to placebo or standard therapy on cardiovascular and renal outcomes in patients with chronic kidney disease with and without T2D.

Study Design: Systemic Review and Meta-analysis

Participants: RCTs of SGLT-2 inhibitors in patients with Chronic Kidney Disease

Outcomes:

- Primary cardiovascular outcome (composite):  Hospitalization due to heart failure or cardiovascular death

- Primary renal outcome (composite): 40% reduction in eGFR, kidney failure, or kidney-related death

- Secondary outcomes: All-cause mortality, Non-fatal acute myocardial infarction, Non-fatal stroke or cardiovascular death.

Statistical Analysis: For qualitative variables, the frequency and percentage will be reported; for quantitative variables, the mean and the standard deviation will be used instead. Time-to-event outcomes will be summarized by using the reported effect sizes and their corresponding 95% confidence intervals (CI) of each study. We will fit the random effects model with the restricted maximum likelihood estimation and the 95% confidence intervals will be calculated using the method developed by Hartung-Knapp which accounts for the uncertainty in the estimate of tau-squared (heterogeneity). We will perform a subgroup analysis to assess any difference in effect in patients with T2D to those without T2D. Therefore, we will assess the interaction between these two groups with a Wald-type test. We will also calculate the difference between effect sizes and their corresponding 95% confidence intervals."
  ["project_brief_bg"]=>
  string(1505) "Sodium-glucose cotransporter 2 (SGLT-2) inhibitors are used to treat people with type 2 diabetes mellitus (T2D)

Previous systematic reviews have demonstrated the efficacy of SGLT-2 inhibitors in reducing the risk of cardiovascular events and progression of renal outcomes. Nevertheless, most of these studies only included data from patients with T2D; therefore, they did not assess whether the effect is consistent regardless of the presence of T2D. Only one systematic review included data from both diabetic and non-diabetic patients.

The importance of this research lies in the fact that CKD is one of the most prevalent diseases in the world, so the verification of the efficacy of new therapeutic agents, such as SGLT-2 inhibitors, will help to incorporate alternatives for the management of this pathology, both in patients with DM2 and without DM2.

Finding a positive effect in patients without DM2 will strengthen previous evidence that SGLT-2 inhibitors work through mechanisms that go beyond glycemic control; as its beneficial effect on the kidney. This effect could potentially slow down the progression of CKD, reverse a certain degree of tissue damage and prevent the systemic complications generated by this pathology.

Therefore, this systematic review will help the scientific community, since it will give rise to research for the development of new active principles of the same pharmacological family, with an effect more directed to these other mechanisms."
  ["project_specific_aims"]=>
  string(647) "Objective: To evaluate the therapeutic effect of SGLT-2 inhibitors compared to placebo or standard therapy on cardiovascular and renal outcomes in patients with chronic kidney disease with and without T2D.

Hypotheses:

- SGLT-2 inhibitors have a beneficial therapeutic effect on cardiovascular outcomes in patients with chronic kidney disease with or without type 2 diabetes mellitus, compared to standard treatment or placebo.

- SGLT-2 inhibitors have a beneficial therapeutic effect on renal outcomes in patients with chronic kidney disease with or without type 2 diabetes mellitus, compared to standard treatment or placebo."
  ["project_study_design"]=>
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    ["value"]=>
    string(7) "meta_an"
    ["label"]=>
    string(52) "Meta-analysis (analysis of multiple trials together)"
  }
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  ["project_purposes"]=>
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  }
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  }
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  ["project_research_methods"]=>
  string(244) "- Participants: Studies including adults (18 years or older) with chronic kidney disease with or without diabetes mellitus type 2. Studies might have different definitions of CKD and they will be included regardless of their definition (an eGFR"
  ["project_main_outcome_measure"]=>
  string(938) "Domain: Cardiovascular efficacy

Specific measurement: Hospitalization due to heart failure or cardiovascular death

Specific Metric: Time to event

Method of Aggregation: Hazard ratio

Time-point(s): not applicable

Domain: Renal efficacy

Specific measurement: 40% reduction in eGFR, kidney failure, or kidney-related death

Specific Metric: Time to event

Method of Aggregation: Hazard ratio

Time-point(s): not applicable

Domain: Mortality

Specific measurement: All-cause mortality

Specific Metric: Time to event

Method of Aggregation: Hazard ratio

Time-point(s): not applicable

Domain: Cardiovascular efficacy

Specific measurement: Non-fatal acute myocardial infarction, Non-fatal stroke or cardiovascular death.

Specific Metric: Time to event

Method of Aggregation: Hazard ratio

Time-point(s): not applicable"
  ["project_main_predictor_indep"]=>
  string(1073) "Treatment with an SGLT-2 inhibitor or Placebo, plus standard therapy.

Interventions: SGLT-2 inhibitor alone or SGLT-2 inhibitor plus standard therapy. SGLT-2 inhibitors considered will be dapagliflozin, canagliflozin, empagliflozin, sotagliflozin, tofogliflozin, luseogliflozin, ipragliflozin, ertugliflozin y remogliflozin. Standard therapy can include drugs the following drugs: metformin, sulfonylureas, Glucagon-like peptide-1 (GLP-1) analogs, dipeptidyl peptidase-4 (DPP-4) inhibitor, angiotensin-converting-enzyme inhibitors (ACE inhibitors), angiotensin II receptor blockers (ARBs), statins, and any other treatment for other comorbidities.  

Comparators: Placebo plus standard therapy or Placebo alone or Standard therapy alone. Standard therapy can include drugs the following drugs: metformin, sulfonylureas, Glucagon-like peptide-1 (GLP-1) analogs, dipeptidyl peptidase-4 (DPP-4) inhibitor, angiotensin-converting-enzyme inhibitors (ACE inhibitors), angiotensin II receptor blockers (ARBs), statins, and any other treatment for other comorbidities."
  ["project_other_variables_interest"]=>
  string(43) "- Chronic Kidney Disease defined as an eGFR"
  ["project_stat_analysis_plan"]=>
  string(2045) "Patient baseline characteristics will be summarized according to the type of the variable. For qualitative variables, the frequency and percentage will be reported; for quantitative variables, the mean and the standard deviation will be used instead.

Time-to-event cardiovascular and renal outcomes will be presented as cumulative incidence (events/total participants) and incidence rate (events/1000 person-years).

Time-to-event outcomes will be summarized by using the reported effect sizes and their corresponding 95% confidence intervals (CI) of each study.

We will fit the random effects model with the restricted maximum likelihood estimation and the 95% confidence intervals will be calculated using the method developed by Hartung-Knapp which accounts for the uncertainty in the estimate of tau-squared (heterogeneity).[17]

Heterogeneity will be calculated using tau-squared. The I-squared statistics will also be calculated as it estimates how much of the total variability in the effect sizes can be attributed to heterogeneity among the true effects. The 95% confidence intervals of tau-squared and I-squared will be calculated. Additionally, 95% prediction intervals will be determined.[18] Publication bias will be explored using contour enhanced funnel plots for outcomes reported in at least 10 studies.[19]

We will perform a subgroup analysis to assess any difference in effect in patients with T2D to those without T2D. Therefore, we will assess the interaction between these two groups with a Wald-type test. We will also calculate the difference between effect sizes and their corresponding 95% confidence intervals.[20]

To assess the risk of bias in clinical trial, two authors will use the Risk of Bias 2 tool (Rob2); a new version of Cochrane Collaboration tool from the Chapter 8 of Cochrane Handbook for Systematic Reviews of Interventions.[14] The tool evaluates the risk of bias on an outcome level, and we will use the main cardiovascular and renal outcome for our assessment."
  ["project_timeline"]=>
  string(314) "Target Analysis Start Date:

08/27/2022

Estimated Analysis Completion Date:

10/15/2022

Manuscript Draft - Final Version Date:

11/16/2022

Manuscript First Submission Date:

11/30/2022

Data report for YODA Project Date (estimated):

12/01/2022 - 01/01/2023"
  ["project_dissemination_plan"]=>
  string(202) "We intend to submit an article with our findings in late-2022. The target audience is nephrologists and cardiologists.

Potential journals include: PLOS One, Journal of Nephrology, and Nefrologia."
  ["project_bibliography"]=>
  string(4369) "
1. Palmer SC, Tendal B, Mustafa RA, Vandvik PO, Li S, Hao Q, et al. Sodium-glucose cotransporter protein-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists for type 2 diabetes: systematic review and network meta-analysis of randomised controlled trials. BMJ [Internet] 2021 [cited 2021 Apr 20];372. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7804890/

2. Kalra S. Sodium Glucose Co-Transporter-2 (SGLT2) Inhibitors: A Review of Their Basic and Clinical Pharmacology. Diabetes Ther 2014;5(2):355?66.

3. Rajasekeran H, Cherney DZ, Lovshin JA. Do effects of sodium-glucose cotransporter-2 inhibitors in patients with diabetes give insight into potential use in non-diabetic kidney disease? Curr Opin Nephrol Hypertens 2017;26(5):358?67.

4. Heerspink Hiddo J.L., Perkins Bruce A., Fitchett David H., Husain Mansoor, Cherney David Z. I. Sodium Glucose Cotransporter 2 Inhibitors in the Treatment of Diabetes Mellitus. Circulation 2016;134(10):752?72.

5. Heerspink HJL, Stefnsson BV, Correa-Rotter R, Chertow GM, Greene T, Hou F-F, et al. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med 2020;383(15):1436?46.

6. Anker SD, Butler J, Filippatos G, Khan MS, Marx N, Lam CSP, et al. Effect of Empagliflozin on Cardiovascular and Renal Outcomes in Patients With Heart Failure by Baseline Diabetes Status: Results From the EMPEROR-Reduced Trial. Circulation 2021;143(4):337?49.

7. Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Bonaca MP, et al. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet 2019;393(10166):31?9

8. Toyama T, Neuen BL, Jun M, Ohkuma T, Neal B, Jardine MJ, et al. Effect of SGLT2 inhibitors on cardiovascular, renal and safety outcomes in patients with type 2 diabetes mellitus and chronic kidney disease: A systematic review and meta-analysis. Diabetes, Obesity and Metabolism 2019;21(5):1237?50.

9. McGuire DK, Shih WJ, Cosentino F, Charbonnel B, Cherney DZI, Dagogo-Jack S, et al. Association of SGLT2 Inhibitors With Cardiovascular and Kidney Outcomes in Patients With Type 2 Diabetes. JAMA Cardiol 2021;6(2):1?11.

10. Salah HM, Al?Aref SJ, Khan MS, Al-Hawwas M, Vallurupalli S, Mehta JL, et al. Effect of sodium-glucose cotransporter 2 inhibitors on cardiovascular and kidney outcomes-Systematic review and meta-analysis of randomized placebo-controlled trials. Am Heart J 2021;232:10?22.

11. Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Systematic Reviews 2015;4(1):1.

12. Yale University Open Data Access (YODA) Project.org [Internet]. [cited 2021 May 23]; Available from: https://yoda.yale.edu/

13. Vivli – Center for Global Clinical Research Data [Internet]. [cited 2021 May 23]. Available from: https://vivli.org/

14. Higgins J, Savovi? J, Page M, Elbers R, Sterne J. Chapter 8: Assessing risk of bias in a randomized trial. In: Cochrane Handbook for Systematic Reviews of Interventions version 6.2 (updated February 2021). [Internet]. Cochrane; 2021. Available from: www.training.cochrane.org/handbook.

15. Sterne JAC, Savovi? J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019;366:l4898.

16. Risk of bias tools – Current version of RoB 2 [Internet]. [cited 2021 Apr 25];Available from: https://sites.google.com/site/riskofbiastool/welcome/rob-2-0-tool/curren…

17. Hartung J, Knapp G. A refined method for the meta-analysis of controlled clinical trials with binary outcome. Stat Med 2001;20(24):3875?89.

18. IntHout J, Ioannidis JPA, Rovers MM, Goeman JJ. Plea for routinely presenting prediction intervals in meta-analysis. BMJ Open 2016;6(7):e010247.

19. Sterne JAC, Sutton AJ, Ioannidis JPA, Terrin N, Jones DR, Lau J, et al. Recommendations for examining and interpreting funnel plot asymmetry in meta-analyses of randomised controlled trials. BMJ 2011;343:d4002.

20. Altman DG. Statistics Notes: Interaction revisited: the difference between two estimates. BMJ 2003;326(7382):219?219.
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