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Catch up with groundbreaking FDA decisions, exciting new GLP-1 news, and more.
Cardiology has expanded exponentially in October 2025, between critical new research on GLP-1 receptor agonists and key new approvals from the US Food and Drug Administration (FDA). Topline results from trials like Bax24 and iMODERN have opened potential new avenues for both investigation and, potentially, treatment of various cardiovascular diseases.
The FDA’s approval of oral semaglutide 7 mg and 14 mg is groundbreaking, as it marks the first official GLP-1 receptor agonist on the market. Additionally, its approval is specifically noted for cardiovascular risk reduction, expounding on the recent SELECT data showing possible cardiovascular protective effects irrespective of adiposity and weight loss. Results EPIC-Norfolk have also made a splash in the industry, providing clinicians with an accessible, affordable, and standardized assay to measure LDL cholesterol, high-sensitivity C-reactive protein (hsCRP), and Lp(a).
Given the onslaught of regulatory and investigative updates, the editorial team at HCPLive has collected 8 of the most important headlines from this past month. Check them out below.
On October 27, the FDA announced an updated indication for Merck’s activin signaling inhibitor sotatercept-csrk. The phase 3 ZENITH study, examining the efficacy of sotatercept-csrk with background therapy, indicated a significant reduction in major morbidity and mortality outcomes in patients with pulmonary arterial hypertension (PAH). Investigators also found lower rates of lung transplantation and hospitalization for worsening PAH.
On October 17, Novo Nordisk announced the FDA’s approval of their investigative oral GLP-1 receptor agonist semaglutide 7 mg and 14 mg for cardiovascular risk reduction in patients with type 2 diabetes (T2D). Based on data from the SOUL trial, which highlighted a 14% relative reduction in major adverse cardiovascular events (MACES) at 4 years, this approval opens the way to future oral GLP-1 indications, easing treatment burden for patients and making the medication more accessible.
Presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 conference, the iMODERN study highlights the equivalent efficacy of immediate instantaneous wave-free ratio-guided percutaneous coronary intervention (PCI) and deferred cardiac stress magnetic resonance imaging-guided PCI of nonculprit lesions in patients with ST-segment elevation myocardial infarction (STEMI). This trial opens the way for clinicians to provide complete STEMI therapy in one sitting without compromising long-term outcomes.
This groundbreaking trial has indicated a potential cardioprotective effect of the popular GLP-1 receptor agonist semaglutide, based on a reduction of MACE in patients with atherosclerotic cardiovascular disease. The SELECT trial may pave the way for GLP-1s to move fully into cardiology, having shown benefits independent of baseline adiposity and weight loss.
Baxdrostat, a potential first-in-class, highly potent and selective small molecule from parent company AstraZeneca, has shown its efficacy in reducing ambulatory 24-hour average systolic blood pressure (SBP) in patients with treatment-resistant hypertension. The drug also demonstrated efficacy throughout a 24-hour study period, including early morning, at which time patients with hypertension are at greater cardiovascular risk.
According to results from the EPIC-Norfolk study, a single measurement of LDL cholesterol, hsCRP, and Lp(a) among initially healthy patients can predict incident MACE. This UK study also replicates existing data from recent American evidence, reinforcing the efficacy of these standardized, inexpensive, and readily available assays in measuring potentially severe disease outcomes.
A secondary analysis of the phase 3 SUMMIT trial has indicated no significant difference by sex in the effects of tirzepatide in patients with obesity-related heart failure with preserved ejection fraction (HFpEF). Barry Borlaug, MD, associate professor of medicine at Mayo Clinic, sat down with the editorial team at HCPLive during the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025 to discuss these findings, as well as to emphasize the importance of extrapolating this analysis to other medications in other conditions.
12-month data from an open-label extension of the HELIOS-B trial have shown significant clinical benefits from vutrisiran compared to placebo in patients with transthyretin amyloidosis with cardiomyopathy. Ronald Witteles, MD, co-director of the Stanford Amyloid Center and the Stanford Multidisciplinary Sarcoidosis Program at the Stanford University School of Medicine, sat down with the HCPLive editorial team at the HFSA Annual Scientific Meeting 2025 to explain these data and how it emphasizes the need for early and aggressive treatment.