(P-288) Novel Glucose-lowering Agents and Cardiorenal Benefits: Absence of Racial/ethnic Diversity in Clinical Trials

Location: Poster Gallery-Health Economics/Outcomes Research

Presenting Author(s)

HT

Huilin Tang

University of Florida Department of Pharmaceutical Outcomes and Policy
Gainesville, Florida, United States

Co-Author(s)

SK

Stephen Kimmel

Department of Epidemiology, College of Public Health and Health Professions and College of Medicine, University of Florida, Florida, United States
Inmaculada Hernandez, PharmD, PhD

Assistant Professor
Department of Pharmacy and Therapeutics, University of Pittsburgh, United States
JM

Jared W Magnani

Division of Cardiology, Department of Medicine, University of Pittsburgh School of Medicine, Pennsylvania, United States
MB

Maria M Brooks

Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pennsylvania, United States
Almut G. Winterstein, PhD

Department of Pharmaceutical Outcomes and Policy and Center for Drug Evaluation and Safety, College of Pharmacy, University of Florida, Florida, United States
JG

Jingchuan Guo, MD, PhD

Assistant Professor
Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida
Gainesville, Florida, United States

Background: Evidence from clinical trials demonstrates distinctive cardiovascular and renal benefits of SGLT2 inhibitors and GLP-1RAs among patients with type 2 diabetes. These trials were foremost comprised on non-Hispanic individuals of White race. Generalizability to individuals of other racial and ethnic categories remains unknown.

Objectives: To assess the effects of novel glucose-lowering agents (DPP-4 inhibitors, GLP-1RAs, and SGLT2 inhibitors) on cardiovascular and renal outcomes in individuals identified as Black race with or without type 2 diabetes.

Methods: We systematically searched Pubmed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) up to December 2020 to include outcomes trials reporting the respective outcomes stratified by race and ethnicity. We extracted the data from subgroups specifically identified as comprised of individuals of Black race. We calculated the pooled OR and 95% CI with a random-effects model. We conducted trial sequential analysis (TSA) to calculate the required information size for detecting a 15% relative risk reduction in cardiovascular or renal outcomes.

Results: We identified 18 trials (5 with DPP-4 inhibitors, 7 with GLP-1RAs, and 6 with SGLT2 inhibitors) involving 6,670 Black patients (4.7% of the total trial participants) were included. The results showed that these novel glucose-lowering drugs were not associated with a risk reduction in major adverse cardiovascular events among Black study participants (DPP-4 inhibitors: OR 0.95, 95% CI 0.70–1.28; GLP-1RAs: OR 1.04, 95% CI 0.69–1.56; SGLT2 inhibitors: OR 0.96, 95% CI 0.57–1.62). SGLT2 inhibitors were not associated with a risk reduction either for the composite endpoint of heart failure hospitalization or cardiovascular death (OR 0.62; 95% CI 0.38–1.01) or the composite renal outcome (OR 0.71; 95% CI 0.44–1.15). Our TSA suggested that the required information size for detecting a 15% relative treatment effect, n ≥ 17,299, was not reached for any of these outcomes; thus, the current evidence is insufficient.

Conclusions: Too few Black patients have been included in randomized trials to quantify the effects of GLP-1RAs and SGLT2 inhibitors on cardiorenal outcomes in these patients. Rigorous observational studies to assess real-world heterogeneities in treatment response are warranted.