Clinical trial

Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07188545

Active, not recruitingNot applicableObservational

What this study is about

Complex pathophysiological interactions among obesity, metabolic risk factors, chronic kidney disease (CKD), and the cardiovascular system lead to poor cardiovascular-kidney-metabolic health (CKMH), which is a major determinant of premature morbidity and mortality. Poor CKMH may lead to cardiovascular-kidney-metabolic syndrome (CKMS) - the five-stage framework introduced by The American Heart Association (AHA) which accounts for the critical overlap between cardiorenal syndrome and cardiometabolic disease. Evidence from randomized controlled trials shows glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose co-transporter-2 inhibitors (SGLT2is) may improve CKMH in individuals with Type 2 Diabetes (T2D) and/ or obesity. However, there is modest evidence suggesting differential effectiveness of GLP-1RA and SGLT2i drugs between males and females. The extent of these sex-based differences is currently unknown. In part, this may be due to underrepresentation of females in clinical trials. Exploring sex-based differences in GLP-1RA and SGLT2i treatment on CKMH outcomes is important to inform CKMS treatment and equity in CKMH. Robust secondary data sources present the opportunity to elucidate sex heterogeneity in GLP-1RA and SGLT2i treatment on CKMH outcomes. Using a target-trial emulation design, this study aims to observe differences in long-term CKMH outcomes between patients treated by GLP-1RA and SGLT2i medications versus those treated with active comparator medications, and whether there is an observed interaction between sex and treatment.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionCardiovascular Kidney Metabolic Syndrome

Full registry criteria

Inclusion Criteria: * Stage 1 or 2 CKMS at baseline * At least one prescription for an intervention or comparator medication after CKMS diagnosis * At least 180 days of continuous enrollment prior to the first prescription for any medication of interest (index date) * Age 18+ at index date Exclusion Criteria: * Stage 3 or 4 CKMS at baseline * Medications of interest during baseline period * Any history of type I diabetes * Cancer at baseline * Renal replacement therapy at baseline * End stage renal disease at baseline * Solid organ transplant at baseline * Missing sex

Treatments and study arms

Intervention

Drug

GLP-1RA and/or SGLT2i adult users with ≥1 prescription for the intervention GLP-1RA or SGLT2i medications (including combination drugs or mixed therapies with comparator medications). GLP-1RAs include: Exenatide, Liraglutide, Semaglutide, Dulaglutide, Lixisenatide, Albiglutide, Tirzepatide. SGLT2is include: Canagliflozin, Dapagliflozin, Bexagliflozin, Empagliflozin, Ertugliflozin, Sotagliflozin.

Active Comparator

Drug

DPP4i or Oral Obesity Agent adult users with ≥1 prescription for the comparator DPP4i or Oral Obesity Agent medications AND no intervention GLP-1RA or SGLT2i prescriptions in first 30 days of follow up. DPP4is include: Alogliptin, Saxagliptin, Linagliptin, Sitagliptin. Oral Obesity Agents include: Orlistat, Naltrexone-bupropion, Phentermine-topiramate, Phentermine, Diethylpropion, Bupropion (off-label), Topiramate (off-label)

Primary outcomes

3-Point major adverse cardiovascular event (3P-MACE)Up to 5 years

Any of the following events: * Nonfatal myocardial infarction * Nonfatal stroke * Death within 14 days of myocardial infarction, ischemic stroke, heart failure, acute coronary syndrome, coronary artery bypass grafting, or percutaneous coronary intervention

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Ohio State University🇺🇸 Columbus, Ohio, United States

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