Tirzepatide lowered risk of worsening heart failure and CVD death for obese adults

Research highlights:

• In an international trial called SUMMIT, which enrolled 713 adults from nine countries, including the United States, participants with heart failure with preserved ejection fraction (HFpEF) and obesity who took tirzepatide for an average of two years experienced worsening of heart failure events. and reduced the combined risk of cardiovascular death. Improved health status and functional capacity compared to participants in the placebo group.
• This is the first trial to test the drug’s effect on HFpEF and major heart failure outcomes in obese patients.
• Tirzepatide is a long-acting agonist of the glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors and is useful in the treatment of patients with type 2 diabetes or chronic weight management in overweight patients. FDA approved for use. Or obesity.
• Note: This news release contains the latest data and statistics included in the full text and is being published simultaneously. New England Medical Journal.

Embargoed until Saturday, November 16, 2024, 8:59 AM CT/9:59 AM ET

CHICAGO, November 16, 2024 — The international SUMMIT trial tested adults with the following symptoms: Heart failure preserved ejection fraction Obese patients with HFpEF who took tirzepatide for up to three years had a reduced combined risk of worsening heart failure events and cardiovascular death compared to participants who took a placebo, according to new science published today. It is said that his health condition and physical function have improved. American Heart Association 2024 Scientific Sessions. The conference, to be held in Chicago from November 16-18, 2024, is a global hub for the latest in scientific advances, research, and evidence-based clinical practice in cardiovascular science.

Tirzepatide is a long-acting agonist of the glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors and type 2 for weight management in people with the following conditions: Approved by the U.S. Food and Drug Administration for the treatment of diabetes. Overweight or obese. Previous studies have shown a 12% to 21% weight loss in obese patients taking tirzepatide.

“Obesity contributes to worsening of symptoms” heart failure“And while tirzepatide causes significant weight loss, there is a lack of research on its effects on cardiovascular disease,” said Dr. said study lead author Milton Packer, MD, visiting professor at Imperial College. London. “This is the first trial to test the drug’s effect on major heart failure outcomes in patients with HFpEF and obesity.”

The international SUMMIT trial included 731 adults aged 40 and older who were diagnosed with HFpEF and obesity at health centers in nine countries, including the United States. All study participants had a measured ejection fraction ≧50%; all had ejection fraction measured. Have a body mass index (BMI) measurement of 30 kg/m or higher²diagnostic criteria for obesity.

In this double-blind study, participants were randomly assigned in approximately equal numbers to either tirzepatide or a placebo. (A double-blind study means that neither the patient nor the medical team knew which treatment group the patient was assigned to.) Participants received weekly injections of tirzepatide or a placebo; Doses were gradually increased from 2.5 mg to the highest possible dose. 15mg per week. All participants continued to take their regular medications, including medications for heart failure, while enrolled in the study.

Over a median follow-up of 2 years and a maximum of 3 years, researchers assessed health status and functional capacity, as well as rates of worsening heart failure events or death from cardiovascular disease. Specifically, we tracked the time to the first occurrence of cardiovascular death, heart failure worsening requiring hospitalization, or emergency heart failure visit requiring increased intravenous drug therapy or oral diuretics.

In addition, changes in participants’ health status and symptom burden were assessed using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS). The KCCQ-CSS is a 23-question patient questionnaire commonly used to assess heart failure patients’ symptoms, physical function, quality of life, and social functioning over the past 2 weeks.

6-minute walk test, the distance a participant can walk within a 6-minute time frame. KCCQ-CSS score. Blood high-sensitivity C-reactive protein levels were measured at enrollment and after 24 and 52 weeks.

The study found that participants in the tirzepatide group had a reduced combined risk of cardiovascular death and worsening heart failure events compared to participants in the placebo group.

Specifically, we obtained the following results:

• Cardiovascular death or worsening heart failure events occurred in 36 patients (9.9%) in the tirzepatide group and 56 (15.3%) in the placebo group, with a 38% risk reduction in patients taking tirzepatide.
• Worsening heart failure events occurred in 29 patients (8.0%) in the tirzepatide group compared to 52 patients (14.2%) in the placebo group, representing a 46% reduced risk for patients taking tirzepatide. It means that.
• There were a total of 15 deaths from cardiovascular disease in both groups, 11 without preceding worsening of heart failure, and two in the tirzepatide group after patients had not taken the drug for more than 15 months. Of all participants, 34 people died for any reason.
• After 1 year, KCCQ-CSS scores improved by an average of 6.9 points in the tirzepatide group compared to the placebo group, indicating that participants perceived greater improvements in health and function with tirzepatide.
• The average change in weight of participants was 11.9% greater in the tirzepatide group compared to the placebo group when measured after one year.
• Participants in the tirzepatide group improved an average of 18.3 meters further on the 6-minute walking distance test after one year compared to those in the placebo group.
• Participants in the tirzepatide group had less systemic inflammation, as shown by high-sensitivity C-reactive protein (hs-CRP) measurements. On average, the difference in percent change in the tirzepatide group was 32.9% when compared to placebo, indicating lower levels of inflammation. The hs-CRP blood test can detect low-level inflammation in the body and is focused on assessing the risk of heart disease and stroke.

“These results demonstrate that tirzepatide had a meaningful effect in people living with heart failure while maintaining ejection fraction and obesity,” Packer said. “Patients had improved health status and exercise tolerance, as well as a reduced combined risk of worsening heart failure events and death from cardiovascular disease. This suggests that drug therapy alters the clinical course of the disease in patients with HFpEF and obesity. This is the first test to demonstrate that it can be done.

Research background and details:

• From April 20, 2021 to June 30, 2023, 1,494 patients with heart failure and obesity were tested in the study at 129 health centers in nine countries. Health centers were located in the United States, Argentina, Brazil, China, India, Israel, Mexico, Russia, and Taiwan.
• 731 adults enrolled. Must be over 40 years old. The average age was 65.2 years. 53.8% were women. Average BMI is 38.3kg/m3².
• All participants had a measured ejection fraction ≥50% and were randomly assigned to receive either tirzepatide or placebo: 364 in the tirzepatide group and 367 in the placebo group.
• Median follow-up was 104 weeks, and 15 patients (2%) were lost to follow-up by the end of the study (4 in the tirzepatide group and 11 in the placebo group).
• Body weight, heart failure symptoms, major heart failure worsening events, changes in heart failure medications, and adverse events were monitored every 1 to 6 months during the study.
• Approximately 4% of patients in the tirzepatide group discontinued treatment due to gastrointestinal symptoms.

An important limitation of this study was that BMI was used as a measure of body size. People with HFpEF often have a higher than normal waist-to-height ratio, indicating excess visceral or abdominal fat, and a BMI of less than 30 kg/m2.²Does not meet diagnostic criteria for obesity. Further research is needed to further define the most accurate parameters for patients to benefit from treatment.

According to American Heart Association Heart Disease and Stroke Statistics for 2024heart failure affects an estimated 56 million people worldwide and significantly impacts their ability to perform daily activities. Ejection fraction is a metric often used to diagnose and track the severity of heart failure, specifically measuring how much blood the left ventricle pumps out with each contraction of the heart. A normal ejection fraction measurement is between 55% and 70%.

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