by Ruggiero Corcella
The results of a study on 529 patients were presented at the Congress of the European Society of Cardiology. The medicine proved effective in containing symptoms related to heart failure and in reducing the weight of participants by 13 percent
Semaglutide, the anti-diabetes drug at the center of a dangerous trend (launched a few months ago on social networks by Hollywood stars and personalities such as Elon Musk which has also caused a shortage of the drug throughout Italy to the detriment of diabetic patients) on its use for weight loss (but with even heavy side effects), would have positive effects in reducing the symptoms of heart failure (or heart failure). These are the results of the STEP-HFpEF study, presented at the Congress of the European society of cardiology underway in Amsterdam e published in the New England Journal of Medicine.
What is heart failure
The scientific work (co-designed by academic members of the Steering Committee and Danish drug multinational Novo Nordisk, a major antidiabetic drug maker, which also sponsored it) also reported improved exercise capacity and increased weight loss. compared to placebo in patients with heart failure with preserved ejection fraction (HFpEF) and obesity. Heart failure (i.e. deterioration of heart function that prevents proper blood supply to the body) with preserved ejection fraction (i.e. the heart’s pumping ability) (≥50%, HFpEF) is a disease with a high prevalence.
However, HFpEF still has no effective medical therapy, as no drug has been able to improve its survival. HFpEF is a syndrome which in its classic form is associated with multiple risk factors and numerous concomitant pathologies (comorbidities). These risk factors and comorbidities represent one of the elements of extreme heterogeneity that characterizes HFpEF. The pathophysiological mechanisms themselves, in addition to the clinical presentation, are multiple. All these peculiar aspects largely explain the diagnostic difficulty and the failure of an all-inclusive therapeutic strategy in patients with HFpEF.
debilitating symptoms
About half of patients with heart failure have the preserved ejection fraction form. Most patients with HFpEF are overweight or frankly obese. Accumulating evidence suggests that obesity and excess fat are not mere comorbidities, but may play a central role in the development and progression of HFpEF. Patients with obesity-related HFpEF have a particularly high burden of debilitating symptoms (dyspnoea, exercise intolerance, edema) and physical limitations, which overall translate into a poor quality of life.
What is semaglutide
Semaglutide is a potent glucagon-like peptide-1 receptor agonist that has been shown to produce substantial weight loss in overweight and obese people. The STEP-HFpEF study tested the hypothesis that in patients with HFpEF and obesity, treatment with semaglutide could significantly improve symptoms, physical limitations and exercise capacity, as well as produce weight loss.
I study
STEP-HFpEF was a Phase II (therefore requiring confirmation in a Phase 3 study) randomised, double-blind, placebo-controlled clinical study conducted at 96 sites in 13 countries in Asia, Europe, North America and South America. The study involved 529 patients. The mean age was 69 years and 56.1% were women. Two main endpoints have been set: change in symptoms and physical limitations related to heart failure after 52 weeks; body weight. Both objectives have been achieved. As regards weight, in particular, a decrease of 13.3% was recorded with semaglutide compared to 2.6% obtained with placebo. Even the so-called secondary endpoints showed improvements in complementary indicators of quality of life, functional capacity and biochemistry.
The impact on clinical practice
Principal investigator, Mikhail Kosiborod of Saint Luke’s Mid America Heart Institute in Kansas City, said: In patients with HFpEF and obesity, treatment with semaglutide 2.4 mg produced major improvements in symptoms, physical limitations and exercise capacity. , reduced inflammation and resulted in more weight loss and fewer serious adverse events than placebo. To our knowledge, this is the first study of a pharmacological agent specifically targeting obesity as a treatment strategy for HFpEF, and the magnitude of observed benefit is the largest seen with any drug therapy in HFpEF.
This result will probably have a significant impact on clinical practice, especially due to the scarcity of effective therapies in this group of vulnerable patients. We believe these findings should also change the nature of the discussion about the role of obesity in HFpEF, as the STEP-HFpEF findings clearly indicate that obesity is not simply a comorbidity in patients with HFpEF, but a root cause and a target for therapeutic intervention, he concluded.
August 26, 2023 (change August 26, 2023 | 16:38)
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