Dr. Mikhail Kosiborod
Credit: Saint Luke’s Mid America Heart Institute

New data presented at the 2024 American College of Cardiology (ACC.24) Annual Scientific Sessions highlight the benefits of semaglutide in heart failure patients with preserved ejection fraction (HFpEF), especially those with diabetes and obesity. ing.¹

STEP HFpEF DM trial results presented by Mikhail Kosiborod, MD, reaffirm the beneficial effects of semaglutide 2.4 mg (Wegovy) on quality of life and physical symptoms associated with HFpEF seen in the original STEP HFpEF trial It is something to do.^{1, 2}

“Obesity forms a ‘common ground’ that can lead to the development of heart failure with preserved ejection fraction and type 2 diabetes, and patients with both diseases suffer a particularly high symptom burden. However, there are few treatment options available,” he said. Mikhail Kosiborod is a principal investigator and cardiologist at St. Luke’s Mid-America Heart Institute in Kansas City, USA.³

The original STEP HFpEF trial, presented at ESC Congress 2023, was a randomized, double-blind, placebo-controlled trial conducted at 96 sites across Asia, Europe, and the Americas. In a trial comparing the effects of semaglutide 2.4 mg and placebo therapy on symptoms and functional status in adults with obesity and HFpEF, 266 and 263 of 529 participants were randomized to the semaglutide 2.4 mg group and the placebo group, respectively. assigned. The median age of the entire study cohort was 69 years, median weight 105.1 kg, median BMI 37 kg/m2, and 66% had a BMI ≥35 kg/m2.²

The original trial was designed with two primary endpoints defined as change from baseline in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and change in body weight. Primary outcome analysis revealed mean change in KCCQ-CSS to be 16.6 points with semaglutide 2.4 mg and 8.7 points with placebo (estimated treatment difference) [ETD], 7.8 points. 95% confidence interval [CI]4.8 to 10.9. P < .001). When assessing weight loss, results suggested that the mean percentage change in body weight was -13.3% with semaglutide 2.4 mg and -2.6% with placebo (ETD, -10.7 percentage points; 95% CI, -11.9 ~ -9.4; P < .001).²

In STEP HFpEF DM, researchers randomly assigned 616 participants in a 1:1 ratio to semaglutide 2.4 mg or placebo therapy for 52 weeks. To participate, patients were required to have HFpEF, BMI greater than 30 kg/m2, and type 2 diabetes. Overall, 310 patients were randomized to semaglutide and 306 to placebo.¹

Similar to the original STEP HFpEF trial, STEP HFpEF DM had two primary endpoints: change from baseline in KCCQ-CSS and change in body weight. The STEP HFpEF DM also includes multiple secondary confirmatory endpoints, including change in 6-minute walk distance, a hierarchical composite endpoint of death, heart failure events, and KCCQ-CSS and 6-minute walk distance change. Contains change variance. Changes in C-reactive protein (CRP) levels.¹

Analysis showed mean change from baseline KCCQ-CSS was 13.7 points for semaglutide 2.4 mg and 6.4 points for placebo (ETD, 7.3 points; 95% CI, 4.1 to 10.4; P < .001). Assessment of weight change showed that the mean change from baseline in weight was -9.8% with semaglutide therapy and -3.4% with placebo therapy (ETD, -6.4 percentage points; 95% CI, -7.6 from -5.2; P < .001). The results of the secondary endpoint analysis showed that semaglutide 2.4 mg was advantageous in terms of changes in 6-minute walking distance (estimated between-group difference, 14.3 meters; 95% CI, 3.7 to 24.9; 95% CI, 3.7 to 24.9, 95% CI, 3.7-24.9). P=.008), hierarchical composite endpoint (win rate, 1.58; 95% CI, 1.29 to 1.94; P < .001), change in CRP levels (estimated treatment rate, 0.67; 95% CI, 0.55 to 0.80; P < .001) superior to placebo therapy.¹

“Today’s results, especially when combined with those from the STEP-HFpEF trial, open a new chapter in targeting obesity as a new and effective treatment strategy in patients with obesity-associated HFpEF, with or without diabetes. ” Kosiborod added.³

References:

1. Kosiborod MN, Petrie MC, Borlaug BA, et al. Semaglutide in patients with obesity-related heart failure and type 2 diabetes. N English J Medicine Published online on April 6, 2024. doi: 10.1056/NEJMoa2313917
2. Campbell P. Semaglutide 2.4 mg has shown efficacy as a treatment for heart failure associated with obesity. HCP live. August 24, 2023. Accessed April 6, 2024. https://www.hcplive.com/view/semaglutide-2-4-mg-shows-benefit-as-treatment-for-heart-failure-with-obesity.
3. St. Luke’s Health System. Semaglutide 2.4 mg has been shown to significantly reduce heart failure-related symptoms and physical limitations in patients with obesity-related heart failure and type 2 diabetes with preserved ejection fraction. St. Luke’s Health System. August 25, 2023. Accessed April 6, 2024. https://www.saintlukeskc.org/about/news/semaglutide-24-mg-demonstrates-large-reductions-heart-failure-popular-symptoms-and.