Cardiology Month in Review: June 2025

June 2025 delivered a mix of progress and recalibration in cardiology, with new approvals, pivotal trial results, and data that could reshape practice in high-risk populations.

In an environment where access and implementation remain as challenging as innovation, the FDA’s approval of a first-in-class triple combination pill for hypertension and new movement on pulmonary arterial hypertension with sotatercept underscore the regulatory momentum. At the same time, landmark studies presented at major conferences—including ADA, ERA, and Heart in Diabetes—revealed both promising advancements and sobering limitations in cardiometabolic care. Below is a roundup of the key regulatory and pipeline developments in cardiovascular health from June.

Regulatory and Pipeline Updates in Cardiology

Phase 3 Trial Results Announced for Sotatercept-csrk in Pulmonary Arterial Hypertension

On June 23, 2025, Merck announced positive topline results from the Phase 3 HYPERION trial, showing sotatercept-csrk (WINREVAIR) significantly reduced time to clinical worsening in newly diagnosed PAH patients at intermediate or high risk. Based on a composite primary endpoint, the trial met its goal, with additional benefits seen in walking distance, NT-proBNP levels, and functional class. According to Merck, these findings extend sotatercept’s evidence base to earlier-stage patients, building on prior success in advanced PAH. On July 02, 2025, Merck announced the FDA’s acceptance of their BLA for a label expansion, which was granted Priority Review.

FDA Approves Triple Combination Drug GMRx2 (Widaplik) for Hypertension Treatment

On June 9, 2025, the FDA approved GMRx2 (Widaplik), the first single-pill triple combination therapy—telmisartan, amlodipine, and indapamide—approved for initial treatment of hypertension in adults likely needing multiple drugs. Based on positive results from 2 phase 3 trials and the VERONICA study, Widaplik demonstrated superior blood pressure control and good tolerability. According to George Medicines, the pill's design aligns with global guidelines recommending early use of combination therapy. A US launch is expected in Q4 2025.

Conference Updates in Cardiometabolic Health

American Diabetes Association

STRIDE: Semaglutide Reduces Progression of PAD by 54% in Type 2 Diabetes

On June 21, 2025, new subanalysis data from the STRIDE trial presented at ADA 2025 showed semaglutide 1.0 mg (Ozempic) significantly improved walking ability, quality of life, and reduced disease progression risk by 54% in patients with type 2 diabetes and peripheral artery disease (PAD). Based on a 52-week study of 792 participants, benefits were consistent regardless of HbA1c, diabetes duration, BMI, or SGLT2 inhibitor use.

European Renal Association 2025

ACHIEVE: Spironolactone Fails to Reduce Cardiovascular Risk in Dialysis Patients

On June 6, 2025, results from the ACHIEVE trial presented at ERA 2025 showed that spironolactone did not significantly reduce cardiovascular death or heart failure hospitalization in dialysis patients. Based on data from over 2,500 participants, the primary outcome occurred in 20.5% of the spironolactone group vs. 21.6% in the placebo group (HR 0.92; P = .35). According to investigators, the findings challenge earlier studies suggesting large cardioprotective benefits. Additionally, spironolactone was associated with a higher rate of severe hyperkalemia, occurring in 6.6% of patients.

CONFIDENCE: SGLT2i and Finerenone Effective, Safe to Initiate Simultaneously in CKD

On June 5, 2025, results from the CONFIDENCE trial showed that simultaneous initiation of finerenone (Kerendia) and empagliflozin (Jardiance) was well-tolerated and led to a 52% reduction in urinary albumin-to-creatinine ratio (UACR), significantly outperforming either therapy alone in patients with CKD and type 2 diabetes. Based on data from 800 patients, combination therapy reduced UACR 29% more than finerenone alone and 32% more than empagliflozin alone. According to investigators, this supports early combination use to enhance kidney and cardiovascular protection.

Related: Kidney Compass: CONFIDENCE Trial at ERA 2025, with Rajiv Agarwal, MD, MS

Heart in Diabetes

Confronting Cardiology's Data Accessibility Problem, with Robert Califf, MD

At the 9th Annual Heart in Diabetes Conference, Robert Califf, MD, instructor in medicine at Duke University School of Medicine and former commissioner of the US FDA, presented his perspective on the ongoing difficulties in implementation of digital technologies and preventative measures for cardiovascular diseases and diabetes. In our interview, Califf discusses the difficulty patients face in accessing healthcare information despite rapid technology and treatment advancements.

Don’t Miss a Beat: CONFIDENCE Trial and Combination T2D, CKD Therapy at Heart in Diabetes 2025

In this episode of Don’t Miss a Beat, hosts Muthiah Vaduganathan, MD, MPH, and Steve Greene, MD, review key findings and clinical implications of data from the CONFIDENCE trial. Recorded on-site at the 9th Annual Heart in Diabetes Conference, the episode breaks down the potential of combination initial therapy with finerenone plus empagliflozin in patients with both CKD and type 2 diabetes. Of note, Vaduganathan served as an investigator in the CONFIDENCE trial.