Cardiology Year in Review: 2024

Published on: December 26, 2024

This listicle highlights 5 major approvals and 5 trial updates in cardiovascular care from 2024.

The past year has been a defining one for cardiology, marked by groundbreaking approvals and pivotal clinical trial announcements that are set to shape the future of cardiovascular care. The cardiology community has been abuzz with significant developments, from novel therapies with the potential to transform patient outcomes to key trial results that could redefine clinical practice.

In this article, we are highlighting the 10 most impactful pieces of cardiology news from 2024, divided into 5 major US Food and Drug Administration (FDA) approvals and 5 key clinical trial announcements, all sourced from HCPLive Cardiology coverage. These updates reflect the latest advancements in cardiovascular medicine and demonstrate how new treatments and data are poised to influence clinical decision-making. For more in-depth coverage, we’ve included related articles and insights to provide further context on each of these transformative stories.

Top 5 Cardiology Trial News and Updates

SUMMIT Trial Proves Tirzepatide's Benefit in HFpEF with Obesity

On November 16, 2024, results from the SUMMIT trial were presented at the AHA Scientific Sessions 2024, highlighting the benefits of tirzepatide in patients with obesity and heart failure with preserved ejection fraction (HFpEF). The trial demonstrated that tirzepatide reduced the risk of heart failure hospitalization or cardiovascular death by 38%, while also contributing to a 12-21% reduction in body weight.

SUMMIT enrolled 731 patients and revealed a significant 46% relative reduction in the risk of worsening heart failure events with tirzepatide (HR, 0.54; P = 0.026). The KCCQ-CSS also showed favorable results for tirzepatide (mean change of 19.5 vs. 12.7 in the placebo group; P < 0.001).

Although there was a slightly higher rate of cardiovascular death in the tirzepatide group (2.2% vs. 1.4%), the overall safety profile showed higher adverse event discontinuations in the tirzepatide group (6.3% vs. 1.4% in placebo). Eli Lilly has submitted tirzepatide for approval to treat HFpEF and obesity with both the US FDA and the European Medicines Agency.

FINEARTS-HF: Finerenone Could Find Role as Second Pillar in HFmrEF/HFpEF

On August 5, 2024, Bayer announced that the FINEARTS-HF trial, a phase 3 study, met its primary endpoint, showing finerenone's efficacy in heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF). Presented at the ESC Congress 2024, the results suggest that finerenone could become a second pillar in guideline-directed medical therapy for HFmrEF/HFpEF, alongside SGLT2 inhibitors.

The trial, which involved 6016 patients with heart failure and an LVEF of 40% or greater, demonstrated that finerenone significantly reduced the rate of primary outcome events, including cardiovascular death and heart failure hospitalizations, by 16% compared to placebo (RR, 0.84; P = 0.007). Notably, there was an 18% reduction in heart failure hospitalizations (RR, 0.82; P = 0.006), while cardiovascular mortality showed a non-significant 7% reduction (HR, 0.93).

FLOW Trial Fortifies Semaglutide's Role in Chronic Kidney Disease and Type 2 Diabetes

The FLOW trial reflects the growing recognition of cardiovascular-kidney-metabolic disease. In the FLOW trial, semaglutide 1.0 mg (Ozempic) demonstrated a 24% reduction in major kidney disease events and a 21% reduction in kidney-specific outcomes among patients with type 2 diabetes and chronic kidney disease. This landmark trial also showed that semaglutide slowed the decline in eGFR and reduced cardiovascular death by 29% compared to placebo.

The trial, which included 3,553 patients, was halted early due to overwhelming efficacy. Safety data indicated fewer adverse events in the semaglutide group compared to placebo (49.6% vs 53.8%).

Muvalaplin, an Oral Lp(a)-Lowering Agent, Shows Promise in Phase 2 KRAKEN Trial

New phase 2 research presented at the AHA Annual Scientific Sessions 2024 demonstrates the potential of muvalaplin, a once-daily oral treatment, to significantly reduce lipoprotein (a) [Lp(a)] levels in adults with elevated Lp(a) and high cardiovascular risk.

In the 12-week KRAKEN trial, muvalaplin reduced Lp(a) by up to 85% at the highest dose (240 mg/day). The study enrolled 233 patients with elevated Lp(a) and atherosclerotic cardiovascular disease, diabetes, or familial hypercholesterolemia.

Muvalaplin, billed the first oral agent targeting Lp(a) by disrupting its formation, showed placebo-adjusted reductions of 47.6% to 85.8% across doses using the intact Lp(a) assay. Secondary outcomes, including changes in apolipoprotein B and high-sensitivity C-reactive protein (hsCRP), were also analyzed, with no safety concerns observed. This oral approach contrasts with injectable therapies in development, such as Eli Lilly's own injectable agent lepodisiran.

PALISADE: Plozasiran Offers Hope for Treating Familial Chylomicronemia Syndrome

New phase 3 data from the PALISADE trial presented at the ESC Congress 2024 highlights the potential of plozasiran, a small interfering RNA therapy, in treating familial chylomicronemia syndrome (FCS). The trial demonstrated significant reductions in triglyceride levels and a lower incidence of acute pancreatitis in patients receiving plozasiran compared to placebo. At 10 months, the 25 mg and 50 mg doses of plozasiran reduced triglycerides by 80% and 78%, respectively, compared to a 17% reduction with placebo (P <.001). The therapy also lowered the risk of acute pancreatitis by 83% (Odds Ratio, 0.17; P = .03).

In a release published at the time of the ESC Congress presentation, Arrowhead Pharmaceuticals noted plans to file a New Drug Application with the FDA by the end of 2024.

Top 5 Cardiology FDA Approvals and Decisions

Semaglutide Receives FDA Label Expansion to Include Cardiovascular Risk Reduction

On March 8, 2024, the FDA approved an expanded label indication for semaglutide 2.4 mg (Wegovy) to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and obesity or overweight. This approval marks the first time a weight loss medication has been approved for cardiovascular risk reduction in this patient population.

The approval is based on data from the SELECT trial, a 17,604-patient study that demonstrated a 20% relative reduction in the risk of the primary cardiovascular events (HR, 0.80; P <.001) in patients receiving semaglutide compared to placebo. Additionally, semaglutide was associated with a mean body weight reduction of 9.39% versus 0.88% for placebo. Further analysis also suggested trends towards benefits in reducing cardiovascular death, heart failure hospitalization, and all-cause mortality.

FDA Approves Aprocitentan for Treatment-Resistant Hypertension

On March 20, 2024, Idorsia Ltd. announced the FDA approved aprocitentan (Tryvio) for treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. The approval marked the first for an oral antihypertensive agent with a new mechanism of action in more than 30 years and was based on data from the phase 3 PRECISION trial

The decision comes more than a year after initial filing of the New Drug Application in December 2022 and just more than 6 months after Idorsia reacquired the worldwide rights to the oral, dual endothelin receptor antagonist back from with Johnson & Johnson's Janssen Biotech unit in September 2023.

Bempedoic Acid Wins FDA Approval for Reducing Cardiovascular Risk in Primary, Secondary Prevention

On March 22, 2024, Esperion announced the FDA approved label expansions for bempedoic acid (Nexletol) and bempedoic acid with ezetimibe (Nexlizet) to include primary and secondary prevention of cardiovascular risk.

According to Esperion, the FDA’s decision makes bempedoic acid the first LDL-lowering non-statin agent to receive a primary prevention indication. Based on data from the CLEAR Outcomes trial, the new indications expand the agent's potential patient population to approximately 70 million in the US.

Olezarsen Earns First-Ever FDA Approval for Familial Chylomicronemia Syndrome

On December 19, 2024, the FDA approved olezarsen (TRYNGOLZA), an RNA-targeted treatment from Ionis Pharmaceuticals, for use as an adjunct to diet in reducing triglycerides in adults with familial chylomicronemia syndrome (FCS). This approval marks the first FDA-approved therapy for FCS, addressing a significant unmet need in managing this rare genetic disorder characterized by severely elevated triglycerides and a high risk of acute pancreatitis.

The approval was supported by data from the Phase 3 BALANCE trial, which demonstrated significant reductions in fasting triglyceride levels, with the 80 mg dose achieving a 42.5% reduction at 6 months (P = .0084) and a 57% reduction at 12 months. Additionally, olezarsen showed a 73.7% reduction in apolipoprotein C-III levels and a notable decrease in acute pancreatitis events. The trial involved 66 patients, with olezarsen showing a rate ratio of 0.12 for acute pancreatitis compared to placebo. Ionis also announced ongoing trials for severe hypertriglyceridemia, with results expected in 2025.

FDA Approves Acoramidis (Attruby) for ATTR-CM

On November 22, 2024, the FDA approved acoramidis (Attruby), an orally administered stabilizer of transthyretin (TTR), for the treatment of adults with transthyretin amyloid cardiomyopathy (ATTR-CM). This approval marks acoramidis as the first and only treatment with a label specifying near-complete TTR stabilization.

The approval follows data from the phase 3 ATTRibute-CM trial, a double-blind, placebo-controlled study with 632 patients, which showed significant reductions in all-cause mortality and cardiovascular-related hospitalizations. The trial demonstrated that acoramidis reduced composite all-cause mortality and recurrent cardiovascular-related hospitalization by 42% compared to placebo at 30 months. Additionally, acoramidis showed a 50% reduction in the cumulative frequency of cardiovascular-related hospitalizations.