Cardiology Month in Review: February 2025

February brought pivotal developments in cardiology, signaling major shifts in treatment strategies and patient care. With new therapies advancing through regulatory approval and clinical trials, the field is rapidly evolving toward more targeted and transformative approaches for cardiovascular diseases.

New therapies targeting lipid management, heart failure, and rare diseases signaled a shift toward more personalized and effective cardiovascular care. Emerging trial data reinforced the expanding role of novel cardiometabolic therapies, while also highlighting ongoing research challenges. In particular, disparities in cardiovascular outcomes and barriers to patient enrollment in the United States raised concerns about equitable access and the generalizability of trial findings.

As cardiovascular medicine continues to evolve, these developments emphasize the importance of rigorous trial design and a patient-centered approach to treatment innovations.

Here’s a recap of what happened in cardiology in February:

Pipeline News

FDA Accepts Lerodalcibep BLA for LDL-C Reduction in High-Risk Patients

The US Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for lerodalcibep, assigning a PDUFA date of December 12, 2025. The BLA was supported by 5 global Phase 3 registrational studies in the LIBerate program, targeting reductions in LDL-C levels in patients with or at high risk for atherosclerotic cardiovascular disease (ASCVD) and primary hyperlipidemia.

Olpasiran Reduces Oxidized Phospholipids on ApoB in OCEAN(a)-DOSE Trial

Olpasiran achieved significant reduction in oxidized phospholipids associated with apoliprotein B (apoB), but demonstrated no effect on high-sensitivity interleukin 6 (IL-6) or C-reactive protein (CRP), in the Phase 2 OCEAN(a)-DOSE trial. A small interfering RNA inhibitor of lipoprotein (a) [Lp(a)], previous results showed increased olpasiran doses reduced circulating Lp(a) by ≥95% in a population with ASCVD.

Sotagliflozin Cuts MACE Risk By 23% in Patients with Type 2 Diabetes, CKD

Sotagliflozin, a dual sodium-glucose cotransporter (SGLT) 1/2 inhibitor, lowered the risk of major adverse cardiovascular events (MACE) in a population of appproximately 11,000 patients with type 2 diabetes and chronic kidney disease (CKD). A prespecified analysis of the SCORED trial, sotagliflozin reduced the rate of myocardial infarction, stroke, and cardiovascular death by nearly 23% versus placebo.

FDA Approves Chenodiol Tablets for Cerebrotendinous Xanthomatosis

The FDA approved chenodiol tablets (Ctexli) for treating adults with cerebrotendinous xanthomatosis (CTX), representing the first approved treatment for the rare genetic lipid storage disease. Awarded to Mirum Pharmaceuticals, chenodiol reduced bile alcohols with high statistical significance (P <0.0001) in the Phase 3 RESTORE study.

Finerenone Limits Outpatient Oral Diuretic Intensification in Heart Failure

Secondary analysis of the FINEARTS-HF trials showed finerenone could prevent outpatient worsening heart failure (HF) events requiring oral diuretic intensification in people with mildly reduced or preserved ejection fraction. Oral diuretic intensification was frequent among nearly 6000 participants with HF—finerenone, a nonsteroidal mineralocorticoid receptor antagonist (nsMRA), reduced these rates by approximately 11%.

Study Finds Icosapent Ethyl Can Reduce Cardiovascular Risk, Even in Well-Controlled LDL-C

Analysis of the landmark REDUCE-IT trial revealed further benefits of icosapent ethyl (Vascepa) for a population with well-controlled LDL-C. Icosapent ethyl was linked to a reduced rate of cardiovascular endpoints regardless of baseline LDL‐C levels, with those with LDL-C <55 mg/dL at baseline experiencing a statistically significant 34% reduction.

Public Health

Cardiovascular Hospitalizations Burden the US More than Denmark

Cardiovascular hospitalizations burdened the US more than Denmark in a cross-sectional analysis of 60 million US adults and 2 million Danish adults. Rates of myocardial infarction and heart failure-related hospitalizations were 1.5-fold higher for adults aged ≥65, with notable disparities by social risk factors, in the US, compared with Denmark.

Patient Enrollment Low in Cardiovascular Clinical Trials in the US

Cardiology clinical outcome trials in cardiology often require an expanded number of sites to match enrollment targets. A database search across major medical journals revealed nearly one-third of trials relied on more than 500 sites. Patient-per-site ratios were low, with the US reporting the most sites but enrolling significantly fewer patients than other countries.

Major ASCVD Trials Frequently Alter Endpoints From Initiation to Publication

Large atherosclerotic cardiovascular disease (ASCVD) randomized controlled trials (RCTs) in eminent medical journals often alter primary endpoints, particularly from trial initiation to publication. These discrepancies in contemporary ASCVD trials could influence the reported results and complicate trials with similar interventions or data collection for meta-analyses.