What proportion of US adults meet FDA-approved indications for novel cardiovascular-kidney-metabolic (CKM) therapy classes?
A massive proportion of the US adult population (up to 61%) is eligible for novel CKM therapies, highlighting an urgent need for broad implementation strategies.
ImportanceThe prevalence of obesity and cardiovascular-kidney-metabolic (CKM) syndrome continues to rise. Indications for novel CKM therapies, including glucagonlike peptide 1 receptor agonists (GLP-1RAs), sodium-glucose cotransporter-2 inhibitors (SGLT2is), and nonsteroidal mineralocorticoid antagonists (nsMRAs) continue to expand, yet the proportion of adults meeting expanded indications, including for multiple medications remains unclear.ObjectiveTo examine proportion of adults meeting US Food and Drug Administration (FDA)–approved indications for GLP1-RAs, SGLT2is, and nsMRAs across national survey, community-based, and ambulatory health care samples.Design, Setting, and ParticipantsThis study used a representative cross-sectional survey of US adults (National Health and Nutrition Examination Survey NHANES, weighted 245 million; mean SD age, 47 18 years; 126.8 million 52% female), 5 pooled community-based cohort studies (the Framingham Heart Study, the Multi-Ethnic Study of Atherosclerosis, the Prevention of Renal and Vascular Endstage Disease Study, the Atherosclerosis Risk in Communities Study, and the Cardiovascular Health Study; n = 30 929; mean SD age, 63 14 years; 16 749 54% female), and 2 ambulatory health care samples (the Beth Israel Deaconess Medical Center cohort BIDMC, n = 84 714; mean SD age, 46 17 years; 51 113 60% female] and the Mass General Brigham cohort MGB, n = 362 485; mean SD age, 48 17 years; 227 206 61% female). Data were analyzed from November 2024 to November 2025.ExposuresFDA-approved indications for GLP-1RAs, SGLT2is, and nsMRAs.Main Outcomes and MeasuresMedication class eligibility within each study sample.ResultsThe proportion of individuals who met current FDA-approved indications for 1 or more CKM medication was 60% in NHANES (representing 148 million US adults), 61% in the pooled cohorts, 42% in the BIDMC ambulatory cohort, and 46% in the MGB ambulatory cohort. Eligibility for GLP-1RA therapy was most common, with 56% (representing 137.1 million US adults) in NHANES, 49% in the pooled cohorts, 41% in the BIDMC cohort, and 46% in the MGB cohort. This was followed by SGLT2i therapy (24% 57.9 million in NHANES, 33% in the pooled cohorts, 14% for both BIDMC and MGB) and nsMRA (5% 11.7 million in NHANES, 5% in the pooled cohorts, and 1% to 2% in ambulatory samples). Overlapping eligibility for multiple classes was common, with 12% to 17% for GLP1-RA and SGLT2i therapies and 1% to 5% for all 3 classes (an estimated 11.7 million US adults in NHANES).Conclusions and RelevanceThis study found that up to 61% of adults met FDA-approved indications for at least 1 of 3 novel CKM therapy classes. This represents an estimated 148 million US adults, including 11.7 million US adults with potential FDA indications for triple therapy, highlighting the urgent need to optimize implementation and utilization of CKM syndrome therapies.
“This is a very large and interesting study. It found that an enormous number of Americans (about 150 million) would meet the FDA indications for one of the newer diabetes or kidney drugs. In prior randomized clinical trials, these same drugs have been shown to have important cardiovascular benefits, such as reducing the risks of heart and kidney failure, or heart attacks and strokes. Therefore, these new drugs are ones that cardiologists must become more familiar with prescribing.”
Mounsey et al. (2026) studied this question.