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  string(119) "GLP-1RAs and SGLT-2is reduce cardiovascular events in women with type 2 diabetes. A systematic review and meta-analysis"
  ["project_narrative_summary"]=>
  string(655) "Men with no diabetes are at higher risk for developing heart disease compared to women; however, differences diminish in individuals with diabetes. GLP-1RAs and SGLT-2is improve diabetes control, lead to weight loss, and decrease the risk for developing heart disease. While diabetes guidelines recommend GLP-1RA or SGLT-2i once metformin fails, sulfonylureas remain the most common secondary agent prescribed.
We plan to perform a meta-analysis to explore if GLP-1RAs and SGLT-2i reduce the incidence of heart disease in women with type 2 diabetes. If the trial show that those medications are beneficial, this would help reduce health disparities." ["project_learn_source"]=> string(5) "other" ["project_learn_source_exp"]=> string(0) "" ["project_key_personnel"]=> bool(false) ["project_ext_grants"]=> array(2) { ["value"]=> string(68) "No external grants or funds are being used to support this research." ["label"]=> string(68) "No external grants or funds are being used to support this research." } ["project_funding_source"]=> string(0) "" ["project_assoc_trials"]=> array(2) { [0]=> object(WP_Post)#4671 (24) { ["ID"]=> int(1806) ["post_author"]=> string(4) "1363" ["post_date"]=> string(19) "2023-08-05 04:45:19" ["post_date_gmt"]=> string(19) "2023-08-05 04:45:19" ["post_content"]=> string(0) "" ["post_title"]=> 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" ["post_excerpt"]=> string(0) "" ["post_status"]=> string(7) "publish" ["comment_status"]=> string(4) "open" ["ping_status"]=> string(4) "open" ["post_password"]=> string(0) "" ["post_name"]=> string(189) "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" ["to_ping"]=> string(0) "" ["pinged"]=> string(0) "" ["post_modified"]=> string(19) "2023-09-11 15:43:36" ["post_modified_gmt"]=> string(19) "2023-09-11 19:43:36" ["post_content_filtered"]=> string(0) "" ["post_parent"]=> int(0) ["guid"]=> string(238) "https://dev-yoda.pantheonsite.io/clinical-trial/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/" ["menu_order"]=> int(0) ["post_type"]=> string(14) "clinical_trial" ["post_mime_type"]=> string(0) "" ["comment_count"]=> string(1) "0" ["filter"]=> string(3) "raw" } [1]=> object(WP_Post)#4672 (24) { ["ID"]=> int(1808) ["post_author"]=> string(4) "1363" ["post_date"]=> string(19) "2019-08-12 15:10:00" ["post_date_gmt"]=> string(19) "2019-08-12 15:10:00" ["post_content"]=> string(0) "" ["post_title"]=> 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" ["post_excerpt"]=> string(0) "" ["post_status"]=> string(7) "publish" ["comment_status"]=> string(4) "open" ["ping_status"]=> string(4) "open" ["post_password"]=> string(0) "" ["post_name"]=> string(182) "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" ["to_ping"]=> string(0) "" ["pinged"]=> string(0) "" ["post_modified"]=> string(19) "2023-09-11 15:45:40" ["post_modified_gmt"]=> string(19) "2023-09-11 19:45:40" ["post_content_filtered"]=> string(0) "" ["post_parent"]=> int(0) ["guid"]=> string(231) "https://dev-yoda.pantheonsite.io/clinical-trial/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/" ["menu_order"]=> int(0) ["post_type"]=> string(14) "clinical_trial" ["post_mime_type"]=> string(0) "" ["comment_count"]=> string(1) "0" ["filter"]=> string(3) "raw" } } ["project_date_type"]=> string(8) "Full CSR" ["property_scientific_abstract"]=> string(1620) "Background: Women may develop cardiovascular disease later in age compared to men. This has led to the misperception that women are protected against cardiovascular disease. Thus, controlling risk factors in women may be delayed.
Objective: To explore if glucagon-like peptide-1 receptor agonist (GLP-1RA) and sodium glucose co-transporter-2 inhibitor (SGLT-2i) reduce cardiovascular events in women with type 2 diabetes.
Study Design: A meta-analysis of the cardiovascular outcome trials (CVOT). Since the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) updated their recommendations for individuals with type 2 diabetes and cardiovascular disease based on the CVOT showing cardiovascular benefit, our analysis will include trials that had a statistically significant either primary or secondary outcome. We will then extract the incidence of Major Adverse Cardiovascular Events (MACE) in women from those trials. If the results are not reported as absolute numbers of women, the data will be requested.
Participants: Women with type 2 diabetes and increased cardiovascular risk.
Main Outcome Measures: The incidence of MACE in women with type 2 diabetes.
Statistical Analysis: Analyses will be performed using the Review Manager Software. A random effects model will be used. Dichotomous data will be summarized as relative risk with 95% confidence interval. The number needed to treat will be calculated for statistically significant outcomes. A sensitivity and subgroup analysis will be performed based in the class of diabetes medications." ["project_brief_bg"]=> string(1129) "While the absolute rates of cardiovascular disease are higher in men compared to women in the absence of diabetes, these differences between both genders would diminish in individuals with diagnosed type 2 diabetes.5,7,8 Although cardiovascular death continues to be the leading cause of death in both men and women, health disparities exist.9 Women are usually underdiagnosed and would have a delay in diagnosis of cardiovascular disease.4 While the ADA and EASD algorithm for the management of type 2 diabetes and established cardiovascular disease recommend adding either GLP-1RA or SGLT-2i when metformin fails, sulfonylureas remain the most common secondary agent prescribed.10 GLP-1RAs and SGLT-2is are potent diabetes medications that reduce hemoglobin A1c, lead to weight loss, and show cardiovascular benefit.11 We aim to explore if the ADA and EASD recommendation can be applied to women like the general population. If those medications are associated with cardiovascular benefit in women, this would help reduce health disparities relates to preventable differences in the burden of disease between population groups." ["project_specific_aims"]=> string(271) "Aim: To explore if GLP-1RAs and SGLT-2i reduce cardiovascular events in women with type 2 diabetes.
Hypothesis: GLP-1RAs and SGLT-2is will show a statistically significant lower incidence of MACE in women with type 2 diabetes and established cardiovascular disease." ["project_study_design"]=> string(0) "" ["project_study_design_exp"]=> string(0) "" ["project_purposes"]=> array(3) { [0]=> array(2) { ["value"]=> string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations" ["label"]=> string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations" } [1]=> array(2) { ["value"]=> string(32) "Summary-level data meta-analysis" ["label"]=> string(32) "Summary-level data meta-analysis" } [2]=> array(2) { ["value"]=> string(69) "Meta-analysis using data from the YODA Project and other data sources" ["label"]=> string(69) "Meta-analysis using data from the YODA Project and other data sources" } } ["project_purposes_exp"]=> string(0) "" ["project_software_used"]=> array(2) { ["value"]=> string(86) "not_analyzing_participant_level_data__plan_to_use_another_secure_data_sharing_platform" ["label"]=> string(92) "I am not analyzing participant-level data / plan to use another secure data sharing platform" } ["project_software_used_exp"]=> string(200) "I am requesting the absolute number of women who developed MACE outcome in canagliflozin group and in the placebo group. This data is presented in figure 4 in the published article NEJM 2017; 377: 652" ["project_research_methods"]=> string(1070) "Data required:
? Data from CANVAS12 and CANVAS-R12 will be requested since it is not reported as absolute numbers. Will need the absolute number of women who developed MACE in the canagliflozin group and in the placebo group. This data is presented in Figure 4 in the published article NEJM 2017; 377: 652. No participant-level data is needed.
? Data from other CVOT will be extracted as the absolute number of women who developed MACE in the diabetes medications group versus placebo.
? After obtaining the data from the CANVAS Program, all data from the CVOT will be pooled together.
Inclusion criteria:
? Randomized controlled trial that explore a diabetes medication (GLP-1RA or SGLT-2i) to placebo in individuals with type 2 diabetes.
? The primary outcome of the trial investigating the incidence of MACE (defined as cardiovascular death, myocardial infarction, or stroke).
? CVOT with a statistically significant either primary or secondary outcome.
Exclusion criteria:
? Trials investigating type 1 diabetes." ["project_main_outcome_measure"]=> string(224) "Incidence of MACE in women in the diabetes medication group (GLP-1RA or SGLT-2i) compared to placebo.
This will be dichotomous data. Results from the CANVAS Program will be added to other cardiovascular outcome trials." ["project_main_predictor_indep"]=> string(2) "NA" ["project_other_variables_interest"]=> string(2) "NA" ["project_stat_analysis_plan"]=> string(455) "Analyses will be performed using the Review Manager Software. A random effects model will be used. Dichotomous data will be summarized as relative risk with 95% confidence interval. The number needed to treat will be calculated for statistically significant outcomes. A sensitivity and subgroup analysis will be performed based in the class of diabetes medications.
Data will be collected from the trials. No participant-level data will be analyzed." ["project_timeline"]=> string(296) "January 2019: Submit an abstract for consideration at the American Diabetes Association Scientific Meeting.
December 2019 ? January 2020: Drafting the manuscript for consideration for publications.
January 2020 ? February 2020: Submit the manuscript for consideration for publication." ["project_dissemination_plan"]=> string(245) "? If accepted at the American Diabetes Association Scientific Meeting, it will be potentially presented to a diversity group of general practitioners, endocrinologist, and cardiologist.
? Publications plan: Diabetes Obesity and Metabolism." ["project_bibliography"]=> string(2491) "

1. Davies MJ, D’Alessio DA, Fradkin J, et al. Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2018;61(12):2461-2498.
2. Davies MJ, D’Alessio DA, Fradkin J, et al. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes care. 2018;41(12):2669-2701.
3. Cefalu WT, Kaul S, Gerstein HC, et al. Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From a Diabetes Care Editors’ Expert Forum. Diabetes care. 2018;41(1):14-31.
4. Mehta PK, Bess C, Elias-Smale S, et al. Gender in cardiovascular medicine: chest pain and coronary artery disease. European heart journal. 2019.
5. Huebschmann AG, Huxley RR, Kohrt WM, Zeitler P, Regensteiner JG, Reusch JEB. Sex differences in the burden of type 2 diabetes and cardiovascular risk across the life course. Diabetologia. 2019;62(10):1761-1772.
6. Kautzky-Willer A, Harreiter J, Pacini G. Sex and Gender Differences in Risk, Pathophysiology and Complications of Type 2 Diabetes Mellitus. Endocrine reviews. 2016;37(3):278-316.
7. Maas AH, Appelman YE. Gender differences in coronary heart disease. Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation. 2010;18(12):598-602.
8. Regitz-Zagrosek V, Kararigas G. Mechanistic Pathways of Sex Differences in Cardiovascular Disease. Physiological reviews. 2017;97(1):1-37.
9. Whyte MB, Hinton W, McGovern A, et al. Disparities in glycaemic control, monitoring, and treatment of type 2 diabetes in England: A retrospective cohort analysis. PLoS medicine. 2019;16(10):e1002942.
10. Montvida O, Shaw J, Atherton JJ, Stringer F, Paul SK. Long-term Trends in Antidiabetes Drug Usage in the U.S.: Real-world Evidence in Patients Newly Diagnosed With Type 2 Diabetes. Diabetes care. 2018;41(1):69-78.
11. American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019. Diabetes care. 2019;42(Suppl 1):S90-s102.
12. Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. The New England journal of medicine. 2017;377(7):644-657.

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2019-4093

Research Proposal

Project Title: GLP-1RAs and SGLT-2is reduce cardiovascular events in women with type 2 diabetes. A systematic review and meta-analysis

Scientific Abstract: Background: Women may develop cardiovascular disease later in age compared to men. This has led to the misperception that women are protected against cardiovascular disease. Thus, controlling risk factors in women may be delayed.
Objective: To explore if glucagon-like peptide-1 receptor agonist (GLP-1RA) and sodium glucose co-transporter-2 inhibitor (SGLT-2i) reduce cardiovascular events in women with type 2 diabetes.
Study Design: A meta-analysis of the cardiovascular outcome trials (CVOT). Since the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) updated their recommendations for individuals with type 2 diabetes and cardiovascular disease based on the CVOT showing cardiovascular benefit, our analysis will include trials that had a statistically significant either primary or secondary outcome. We will then extract the incidence of Major Adverse Cardiovascular Events (MACE) in women from those trials. If the results are not reported as absolute numbers of women, the data will be requested.
Participants: Women with type 2 diabetes and increased cardiovascular risk.
Main Outcome Measures: The incidence of MACE in women with type 2 diabetes.
Statistical Analysis: Analyses will be performed using the Review Manager Software. A random effects model will be used. Dichotomous data will be summarized as relative risk with 95% confidence interval. The number needed to treat will be calculated for statistically significant outcomes. A sensitivity and subgroup analysis will be performed based in the class of diabetes medications.

Brief Project Background and Statement of Project Significance: While the absolute rates of cardiovascular disease are higher in men compared to women in the absence of diabetes, these differences between both genders would diminish in individuals with diagnosed type 2 diabetes.5,7,8 Although cardiovascular death continues to be the leading cause of death in both men and women, health disparities exist.9 Women are usually underdiagnosed and would have a delay in diagnosis of cardiovascular disease.4 While the ADA and EASD algorithm for the management of type 2 diabetes and established cardiovascular disease recommend adding either GLP-1RA or SGLT-2i when metformin fails, sulfonylureas remain the most common secondary agent prescribed.10 GLP-1RAs and SGLT-2is are potent diabetes medications that reduce hemoglobin A1c, lead to weight loss, and show cardiovascular benefit.11 We aim to explore if the ADA and EASD recommendation can be applied to women like the general population. If those medications are associated with cardiovascular benefit in women, this would help reduce health disparities relates to preventable differences in the burden of disease between population groups.

Specific Aims of the Project: Aim: To explore if GLP-1RAs and SGLT-2i reduce cardiovascular events in women with type 2 diabetes.
Hypothesis: GLP-1RAs and SGLT-2is will show a statistically significant lower incidence of MACE in women with type 2 diabetes and established cardiovascular disease.

Study Design:

What is the purpose of the analysis being proposed? Please select all that apply.: New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations Summary-level data meta-analysis Meta-analysis using data from the YODA Project and other data sources

Software Used: I am not analyzing participant-level data / plan to use another secure data sharing platform

Data Source and Inclusion/Exclusion Criteria to be used to define the patient sample for your study: Data required:
? Data from CANVAS12 and CANVAS-R12 will be requested since it is not reported as absolute numbers. Will need the absolute number of women who developed MACE in the canagliflozin group and in the placebo group. This data is presented in Figure 4 in the published article NEJM 2017; 377: 652. No participant-level data is needed.
? Data from other CVOT will be extracted as the absolute number of women who developed MACE in the diabetes medications group versus placebo.
? After obtaining the data from the CANVAS Program, all data from the CVOT will be pooled together.
Inclusion criteria:
? Randomized controlled trial that explore a diabetes medication (GLP-1RA or SGLT-2i) to placebo in individuals with type 2 diabetes.
? The primary outcome of the trial investigating the incidence of MACE (defined as cardiovascular death, myocardial infarction, or stroke).
? CVOT with a statistically significant either primary or secondary outcome.
Exclusion criteria:
? Trials investigating type 1 diabetes.

Primary and Secondary Outcome Measure(s) and how they will be categorized/defined for your study: Incidence of MACE in women in the diabetes medication group (GLP-1RA or SGLT-2i) compared to placebo.
This will be dichotomous data. Results from the CANVAS Program will be added to other cardiovascular outcome trials.

Main Predictor/Independent Variable and how it will be categorized/defined for your study: NA

Other Variables of Interest that will be used in your analysis and how they will be categorized/defined for your study: NA

Statistical Analysis Plan: Analyses will be performed using the Review Manager Software. A random effects model will be used. Dichotomous data will be summarized as relative risk with 95% confidence interval. The number needed to treat will be calculated for statistically significant outcomes. A sensitivity and subgroup analysis will be performed based in the class of diabetes medications.
Data will be collected from the trials. No participant-level data will be analyzed.

Narrative Summary: Men with no diabetes are at higher risk for developing heart disease compared to women; however, differences diminish in individuals with diabetes. GLP-1RAs and SGLT-2is improve diabetes control, lead to weight loss, and decrease the risk for developing heart disease. While diabetes guidelines recommend GLP-1RA or SGLT-2i once metformin fails, sulfonylureas remain the most common secondary agent prescribed.
We plan to perform a meta-analysis to explore if GLP-1RAs and SGLT-2i reduce the incidence of heart disease in women with type 2 diabetes. If the trial show that those medications are beneficial, this would help reduce health disparities.

Project Timeline: January 2019: Submit an abstract for consideration at the American Diabetes Association Scientific Meeting.
December 2019 ? January 2020: Drafting the manuscript for consideration for publications.
January 2020 ? February 2020: Submit the manuscript for consideration for publication.

Dissemination Plan: ? If accepted at the American Diabetes Association Scientific Meeting, it will be potentially presented to a diversity group of general practitioners, endocrinologist, and cardiologist.
? Publications plan: Diabetes Obesity and Metabolism.

Bibliography:

1. Davies MJ, D’Alessio DA, Fradkin J, et al. Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2018;61(12):2461-2498.
2. Davies MJ, D’Alessio DA, Fradkin J, et al. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes care. 2018;41(12):2669-2701.
3. Cefalu WT, Kaul S, Gerstein HC, et al. Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From a Diabetes Care Editors’ Expert Forum. Diabetes care. 2018;41(1):14-31.
4. Mehta PK, Bess C, Elias-Smale S, et al. Gender in cardiovascular medicine: chest pain and coronary artery disease. European heart journal. 2019.
5. Huebschmann AG, Huxley RR, Kohrt WM, Zeitler P, Regensteiner JG, Reusch JEB. Sex differences in the burden of type 2 diabetes and cardiovascular risk across the life course. Diabetologia. 2019;62(10):1761-1772.
6. Kautzky-Willer A, Harreiter J, Pacini G. Sex and Gender Differences in Risk, Pathophysiology and Complications of Type 2 Diabetes Mellitus. Endocrine reviews. 2016;37(3):278-316.
7. Maas AH, Appelman YE. Gender differences in coronary heart disease. Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation. 2010;18(12):598-602.
8. Regitz-Zagrosek V, Kararigas G. Mechanistic Pathways of Sex Differences in Cardiovascular Disease. Physiological reviews. 2017;97(1):1-37.
9. Whyte MB, Hinton W, McGovern A, et al. Disparities in glycaemic control, monitoring, and treatment of type 2 diabetes in England: A retrospective cohort analysis. PLoS medicine. 2019;16(10):e1002942.
10. Montvida O, Shaw J, Atherton JJ, Stringer F, Paul SK. Long-term Trends in Antidiabetes Drug Usage in the U.S.: Real-world Evidence in Patients Newly Diagnosed With Type 2 Diabetes. Diabetes care. 2018;41(1):69-78.
11. American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019. Diabetes care. 2019;42(Suppl 1):S90-s102.
12. Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. The New England journal of medicine. 2017;377(7):644-657.