The drug tirzepatide (Mounjaro) indicated for the treatment of type 2 diabetes and obesity has shown that it is also effective in treating heart failure, as announced by the pharmaceutical company Lilly based on the results of the phase 3 SUMMIT clinical trial, which reveal that it significantly reduces the risk of heart failure events in adults with preserved ejection fraction heart failure (HFpEF) and obesity.
Additionally, treated patients experienced notable improvements in the symptoms and physical limitations associated with this disease. The results have been published in The New England Journal of Medicine and have been presented during the 2024 Scientific Sessions of the American Heart Association (AHA).
“Currently, no one doubts the unfavorable impact of obesity on heart failure with preserved ejection fraction, through the direct effect on the myocardium, affecting its relaxation and increasing chamber filling pressures, in addition to promoting inflammation. at a systemic and local level among other effects,” says Dr. Almudena Castro Conde, cardiologist and head of the Cardiac Rehabilitation Unit Section at the La Paz University Hospital in Madrid, in the press release. released by Lilly.
“SUMMIT gives us solid evidence of the benefit of tirzepatide in this profile of patients who until a few years ago lacked drugs that would improve their prognosis. At the same time, it is a call to action so that the medical community that treats these patients understands the close relationship between obesity and HFpEF and, therefore, its treatment is another pillar of our therapeutic arsenal,” adds the doctor.
An advance in the treatment of heart failure and obesity
Tirzepatide is a medicine approved in Europe for the treatment of overweight or obesity and at least one related disease in adults, which must be combined with a low-calorie diet and physical exercise. It is also indicated for people with type 2 diabetes who do not achieve adequate control of the disease with other treatments. This drug belongs to a new therapeutic class that simultaneously activates the GIP and GLP-1 hormone receptors and constitutes an innovative approach to treat complex conditions such as heart failure and obesity.
The SUMMIT clinical trial included 731 participants from around the world and evaluated the efficacy and safety of tirzepatide in patients with heart failure with preserved ejection fraction (HFpEF) and obesity, with or without type 2 diabetes. Participants were randomly assigned to receive tirzepatide at doses of 5, 10 or 15 mg, or a placebo. During the trial, both the reduction in heart failure events and improvements in symptoms and physical limitations were investigated, with follow-up reaching up to three years in some cases.
The study has met its two main objectives, showing that tirzepatide is able to reduce the risk of heart failure-related events by 38%, compared to placebo. A 56% decrease in the risk of hospitalization for this disease was also observed. Additionally, patients treated with tirzepatide experienced a significant improvement in their quality of life, which translated into an increase of almost 25 points on the KCCQ-CSS questionnaire, which assesses symptoms and physical limitations. In comparison, the placebo group only achieved a 15-point improvement.
“Data from the SUMMIT study suggest that tirzepatide could provide significant benefit for people with obesity and heart failure with preserved ejection fraction”
The benefits of tirzepatide were not limited to the primary endpoints of the trial. Thus, the treated patients walked approximately 30 meters further in the six-minute test, while those in the placebo group advanced only an additional 8 meters. The weight reduction was also relevant: an average of 15.7% compared to 2.2% in the placebo group. Another important fact is the 43.4% decrease in the levels of high-sensitivity C-reactive protein (hs-CRP), a marker of inflammation, while in the group that was administered placebo, a reduction of only 3.4% was achieved. 5%.
Regarding adverse effects, the most common included gastrointestinal discomfort such as diarrhea (18.4% vs. 6.3% with placebo), nausea (17% vs. 6.5%) and constipation (14.8% vs. 6% ). In general, the intensity of these events was mild to moderate, although in some cases they led to treatment discontinuation (23 patients in the tirzepatide group, versus 5 in the placebo group).
“Cardiometabolic diseases, such as heart failure and obesity, are closely related and often coexist. New approaches are needed to address the interrelated nature of these conditions. At Lilly, we want to better understand the fundamental causes of these diseases and how they relate to each other in order to better treat them,” said Dr. Miriam Rubio de Santos, medical director of Diabetes and Obesity at Lilly Spain.
The specialist adds that “data from the SUMMIT study suggest that tirzepatide could provide significant benefit for people with obesity and heart failure with preserved ejection fraction.” With these advances, tirzepatide promises to become a fundamental tool in the management of cardiometabolic diseases, improving both the health and quality of life of those facing these health problems.
Source: American Heart Association and Lilly
