TOPLINE:

About 60% of adults in the US (representing roughly 148 million) met FDA-approved indications for at least one novel cardiovascular-kidney-metabolic (CKM) therapy, most often GLP-1 receptor agonists for weight management; many adults were eligible for more than one drug class.

METHODOLOGY:

• Researchers analyzed national, community-based, and health system data to estimate the proportion of US adults who met current FDA-approved indications for novel CKM therapies.
• They drew data from a nationally representative US survey (weighted to represent 245 million adults), five pooled community-based longitudinal cohort studies (n = 30,929 adults), and two large ambulatory healthcare system cohorts (n = 447,199 adults). Mean ages of the participants ranged from 46 years to 63 years, and women comprised 52%-61% of the samples.
• The analysis assessed three medication classes: GLP-1 receptor agonists, SGLT2 inhibitors, and nonsteroidal mineralocorticoid receptor antagonists.
• Researchers determined eligibility for each medication class using FDA-approved indications based on clinical characteristics such as BMI, type 2 diabetes status, cardiovascular disease, chronic kidney disease, or heart failure.
• In exploratory analyses, they examined cardiovascular outcomes and all-cause mortality in selected cohorts, with follow-up extending up to 15 years.

TAKEAWAY:

• Researchers found that 60% of adults, representing 147.9 million US adults, in the nationally representative sample met indications for at least one CKM medication; the corresponding proportions were 61% in the community-based cohorts and 42%-46% in the ambulatory cohorts.
• Eligibility was most common for GLP-1 receptor agonists (56% in the national sample), mainly driven by indications for weight management. Eligibility was 24% for SGLT2 inhibitors in the national sample and 1%-5% for nonsteroidal mineralocorticoid receptor antagonists across samples.
• Overall, 12%-17% of adults qualified for both GLP-1 drugs and SGLT2 inhibitors, and 1%-5% qualified for all three classes of drugs.
• Among those eligible for GLP-1 drugs, rates of all-cause mortality were highest among those with type 2 diabetes and cardiovascular disease, reaching 29.4-39.3 per 1000 person-years across cohorts.

IN PRACTICE:

“[The study] data highlight the large potential treatment-eligible population for CKM therapies and the substantial theoretical gains in CKM-related population health with widespread uptake of these therapies. Studies to systematically address barriers to equitable access for these therapies are urgently needed,” the researchers wrote.

SOURCE:

This study was led by Louisa A. Mounsey, MD, of Beth Israel Deaconess Medical Center in Boston. It was published online on January 28 in JAMA Cardiology.

LIMITATIONS:

Eligibility varied across samples because conditions such as chronic kidney disease were captured differently. FDA indication did not always mean a patient should get the drug, and the study could not account for individual contraindications. Baseline data came before these drugs were widely used, and the ambulatory data came from one region, so the study showed potential eligibility rather than real-world use and may not be generalized widely.

DISCLOSURES:

Several authors reported receiving grants and support from multiple sources including the National Institutes of Health; the National Heart, Lung, and Blood Institute; and Patient-Centered Outcomes Research Institute. Multiple authors reported other financial ties such as receiving personal fees, speaker consultancy fees, and/or advisory board service with various pharmaceutical and healthcare companies including AstraZeneca, Novo Nordisk, and Bayer.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.