Semaglutide Improves Functional Status, Body Weight in Patients with HFpEF, Obesity, T2D: Daily Dose

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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

Last week, we reported on findings from a study presented at the American College of Cardiology’s 73rd Annual Scientific Session, held April 6-8, 2024, in Atlanta, Georgia.

The study

Researchers conducted the STEP HFpEF DM trial in which they randomly assigned 616 adults with heart failure with preserved ejection fraction (HFpEF), body mass index (BMI) of 30 kg/m² or greater, and type 2 diabetes (T2D) in a 1:1 ratio to receive once-weekly subcutaneous semaglutide 2.4 mg or placebo for 52 weeks.

Like STEP HFpEF, STEP HFpEF DM defined coprimary endpoints: change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS) and change in body weight. The researchers also defined the same multiple confirmatory secondary end points, including change in 6-minute walk distance (6MWD); a hierarchical composite end point that included death, HF events, and differences in the change in the KCCQ-CSS and 6MWD; and the change in level of C-reactive protein (CRP).

The findings

Investigators reported a mean change from baseline KCCQ-CSS of 13.7 points with semaglutide 2.4 mg and 6.4 points with placebo (estimated treatment difference [ETD], 7.3 points; 95% CI, 4.1 to 10.4; P < .001). Changes in body weight from baseline also favored the study drug at −9.8% with semaglutide and −3.4% with placebo therapy (ETD, −6.4 percentage points; 95% CI, −7.6 to −5.2; P < .001). Results for the secondary confirmatory endpoints also showed superiority over placebo for semaglutide 2.4 mg:

• change in 6MWD: estimated between-group difference, 14.3 meters; 95% CI, 3.7 to 24.9; P =.008

• hierarchical composite endpoint: win ratio, 1.58; 95% CI, 1.29 to 1.94; P < .001

• change in CRP level: estimated treatment ratio, 0.67; 95% CI, 0.55 to 0.80; P < .001

Authors' comment

"Today’s results, especially when combined with those from the STEP-HFpEF trial, open a new chapter of targeting obesity as a new and effective treatment strategy in patients with obesity-related HFpEF, both with and without diabetes."

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