Diabetes Risk Factors in People With HIV Receiving Pitavastatin Versus Placebo for Cardiovascular Disease Prevention
Year: 2024
Type: article
Abstract: BACKGROUND: REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) led to new guidelines for statin use among people with HIV (PWH) with low to moderate risk for atherosclerotic cardiovascular disease (ASCVD). Little is known about the natural history of diabetes mellitus (DM) or mechanisms contributing to statin effects on DM among this population. OBJECTIVE: To determine the contribution of known DM risk factors to excess risk for DM with pitavastatin in REPRIEVE. DESIGN: Phase 3, primary ASCVD prevention trial over a median of 5.6 years of follow-up. (ClinicalTrials.gov: NCT02344290). SETTING: Global, multicenter trial. PARTICIPANTS: 7731 PWH aged 40 to 75 years with low to moderate ASCVD risk (by the pooled cohort equations from the American College of Cardiology and American Heart Association) without DM at study entry. INTERVENTION: Random 1:1 assignment to pitavastatin, 4 mg daily, or placebo. MEASUREMENTS: New-onset DM was determined at each visit by clinical diagnosis requiring initiation of medication treatment for DM. The incidence of new-onset DM was assessed in relation to predefined demographic and metabolic risk factors, stratified by treatment group. Treatment effects of pitavastatin on progression to new DM in key subgroups were determined. RESULTS: < 0.005). LIMITATION: Pitavastatin was the only statin assessed; DM was assessed clinically. CONCLUSION: Metabolic risk factors, including prediabetes and obesity, contributed to new-onset DM in statin- and placebo-treated participants. A clinically significant effect of pitavastatin on DM was seen primarily among those with multiple risk factors for DM at entry. Strategies targeting key metabolic risk factors, like obesity and prediabetes, may help protect against DM among PWH. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute of the National Institutes of Health.
Source: Annals of Internal Medicine
Authors: Kathleen V. Fitch, Markella V. Zanni, Jennifer Manne-Goehler, Marissa R. Diggs, Arijeet K. Gattu, Judith S. Currier, Gerald S. Bloomfield, Chiu-Bin Hsiao, Samir K. Gupta, Judith A. Aberg, Carlos D. Malvestutto, Carl J. Fichtenbaum, Michael T. Lu, Pamela S. Douglas, Heather J. Ribaudo, Steven K. Grinspoon
Institutions: Harvard University, Massachusetts General Hospital, Brigham and Women's Hospital, University of California, Los Angeles, Duke University, Duke Medical Center, Drexel University, Icahn School of Medicine at Mount Sinai, The Ohio State University Wexner Medical Center, The Ohio State University, University of Cincinnati, Indiana University Indianapolis, Indiana University School of Medicine
Language: English
Subfield: Emergency Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: American Heart Association, Eli Lilly and Company, Pfizer, AstraZeneca, Gilead Sciences, Regeneron Pharmaceuticals, ViiV Healthcare, ACT Government, Kowa Company, Moderna, National Institutes of Health, National Institute on Aging, National Heart, Lung, and Blood Institute, National Institute of Mental Health, National Institute of Allergy and Infectious Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Center for Advancing Translational Sciences
Awards: G1049408530, G182863319, G2127051194, G2612708308, G285461174, G3382714297, G3810609436, G4553935269, G54768859, G6017004319, G6186512954, G6808556474, G6966333855, G857487509, G876475942, G890154010, G9000039438, G9000044041, G9000047228, G9000078893, G9000083608, G9000326527, AIDS Clinical Trial Group Laboratory Center
OpenAlex ID: W4403177478