Semaglutide and related medications have recently been used to treat diabetes and obesity. Currently, other effects beyond weight loss are also being discussed. However, professional associations and regulatory authorities are advising caution. With regard to the treatment of heart failure, cardiology associations have pointed out that the data available to date for this indication is insufficient.
‘Thanks to our innovative study design, we have now worked with our colleagues at Harvard Medical School to create a solid database for the treatment of heart failure with these weight-loss injections,’ says Prof. Heribert Schunkert, Director of the Clinic for Cardiovascular Diseases at the TUM German Heart Centre. ‘In patients with heart failure and preserved pump function, semaglutide and tirzepatide have shown a clear protective effect that supports their use. Based on the analysis of approximately 100,000 patients, this provides a reliable basis for the first time, enabling a reassessment for an extension of the approval.’
The form of heart failure examined is referred to as ‘heart failure with preserved ejection fraction’. In these patients, the heart's pumping power is still intact. However, the heart muscle is stiffened, so that it cannot fill properly with blood. In technical jargon, this is referred to as ‘heart failure with preserved ejection fraction’, or HFpEF for short, which affects over 30 million people worldwide. To date, there are only a few effective treatment options for this form of the disease.
Database study provides solid evidence for use in heart failure
The study, published in the journal JAMA, examines the effects of the drugs semaglutide, trade name Ozempic, and tirzepatide, known as Mounjaro, on patients with this specific form of heart failure. The target group was patients with obesity and diabetes, which are common comorbidities of HFpEF. The researchers evaluated three US insurance databases for this group. These data were used to create computer models that, in a first step, confirmed the results of previous studies on the use of obesity drugs in patients with heart failure and other conditions such as obesity or diabetes. In a second step, the researchers used their models to make statements about the effectiveness in patients who were excluded from the clinical studies and to perform analyses that examined other endpoints such as hospitalisations and mortality due to heart failure.
In the study, treatment with both drugs was associated with a more than 40 per cent lower risk of being hospitalised or dying from heart failure – compared to another diabetes drug that had no effect on heart failure in previous studies.
"Currently, there are only a few drugs that can effectively treat HFpEF. At the same time, more and more of these patients are overweight and diabetic – factors that further exacerbate heart failure. In Germany, the disease is the number one reason for hospitalisations and thus places an enormous burden on the healthcare system. We were able to show that the drugs studied are highly effective, which significantly expands treatment options for patients and could prevent many hospital admissions," says Dr Nils Krüger, assistant physician at the TUM German Heart Centre and first author of the study.
Data-driven approaches for the approval of new medicines
The study used data from patients on a scale that was on average 19 times higher than in traditional clinical trials. This made it possible to map real-world care conditions in a more differentiated manner and to show that the results of the approval studies on so-called weight-loss injections are transferable to the broad patient population. ‘Such data-driven approaches are the future – together with traditional studies, they can ensure that findings from basic research are incorporated into patient care more quickly,’ explains Prof. Schunkert.
From the researchers' point of view, such analyses are also becoming increasingly relevant for Germany. The Health Data Use Act stipulates that anonymised health insurance data will in future be made systematically available for such research projects, while at the same time ensuring strict protection of sensitive personal data. ‘We use these large data sets to investigate the efficacy and safety of drugs in clinical practice,’ says Dr Krüger.
Original publication:
Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction. Krüger et al JAMA. doi: 10.1001/jama.2025.14092
Source: Press release TU Munich
