Instituto Mexicano del Seguro Social — Biomedical Watch V2

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Traitements

4

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Dapagliflozin 10 MG Oral TabletThe primary risk factor for coronary artery disease is atherosclerosis, with inflammation playing a crucial role in the development and progression of this condition. It has now been proven that inflammation is key in the development of complications after an acute myocardial infarction. These complications can be immediate and mechanical, such as ventricular wall rupture and ventricular arrhythmia, or long-term, presenting as major cardiovascular events like heart failure. During acute myocardial infarction (AMI), circulating high-sensitivity CRP levels increase approximately 6 hours after the onset of ischemia. CRP levels measured between 24 and 72 hours after symptom onset are a significant prognostic marker for one-year outcomes. Higher high-sensitivity CRP levels at the time of AMI are linked to more severe coronary atherosclerotic lesions seen on angiography and lower LVEF one month after the event. A serum high-sensitivity CRP concentration greater than 10 mg/L after an AMI indicates inflammation, reflecting myocardial necrosis, plaque rupture, and acute thrombosis. In patients with AMI, persistent or increasing CRP levels are strongly associated with a higher risk of all-cause and non-cardiovascular death, especially when inflammation (CRP \> 2.0 mg/L) continues for a year. Aside from reperfusion therapy, very few pharmacological approaches have been used to reduce inflammation after AMI. One such approach was the use of colchicine in the COVERT-MI randomized, double-blind, multicenter trial. This trial compared five days of oral colchicine with a placebo and found no difference in infarct size between the groups at five days or three months, as measured by cardiac magnetic resonance imaging. SGLT-2 inhibitors are drugs that have revolutionized the management of cardiovascular diseases, offering proven benefits for patients with heart failure and notable nephroprotective effects. However, their use after acute myocardial infarction has not yet been sufficiently established, as the only two published clinical trials so far failed to meet their primary goal of reducing hospitalizations for heart failure. Additionally, evidence of their use in post-AMI inflammation exists only in experimental studies. In experimental studies, SGLT2 global-knockout (KO) mice were used to demonstrate that dapagliflozin significantly influences cardiac fibrosis and inflammation, and markedly alters the gene expression profiles of macrophages and fibroblasts. Moreover, dapagliflozin directly inhibited macrophage-mediated inflammation, thereby suppressing cardiac fibroblast activation. Similarly, only experimental studies have shown that semaglutide decreases elevated levels of TNF-α, IL-6, ROS, and MDA in the serum and cardiac tissues of obese mice. By lowering the expression of Cxcl2, S100a8, and S100a9 in neutrophils, semaglutide may help reduce cardiac inflammation and oxidative stress. Therefore, the objective of this study is to compare the effects of dapagliflozin and semaglutide on inflammatory markers (hs-CRP and IL-6) in patients with acute ST-segment elevation myocardial infarction.	Maladie coronarienne	Phase 3	Neuroprotection + Ralentissement de la progression + Immunomodulation	Mexico	À vérifier
Semaglutide (Rybelsus®)Duchenne Muscular Dystrophy (DMD) is a rare, genetic disease that leads to muscle weakness, breathing difficulties, heart disease, and early death. Approximately half of individuals with DMD have elevated body mass indices (BMIs) in the overweight or obesity range. High BMI is due to a combination of factors including limited mobility and steroid medications, which are used to treat DMD. There are new medications, glucagon-like peptide-1 receptor agonists (GLP-1 RAs) that promote weight loss in the general population. GLP-1 RAs are approved for weight loss in children and adults and have beneficial effects on the heart. There is a concern that these medications could have unwanted side effects in individuals with DMD, specifically decreasing their muscle mass. While it is important to consider the use weight-loss medications in DMD, the investigators want to ensure that they are safe and well-tolerated. Therefore, this study will systematically evaluate whether the use of GLP-1 RAs in adolescents and young adults with DMD affects muscle mass. The overall goal of this study is to assess the safety and tolerability of GLP1-RAs in individuals with both DMD and obesity. The primary focus will be on muscle health, but the study will also evaluate activity levels, mood, gastrointestinal symptoms, and quality of life. Secondary goals will be to understand the impact of GLP1-RAs on weight, fat mass, glucose and insulin levels, and heart and lung function in individuals with DMD. The investigators hypothesize that GLP1-RAs will be well-tolerated and will decrease fat mass, without a large decrease in muscle mass. Participants will: * Take oral semaglutide or a placebo every day for 24 weeks (randomized controlled trial) * Then take oral semaglutide every day for 40 weeks (open label extension) * Complete in-person study visits at 3 timepoints * Study visits may include: an MRI of the body to evaluate muscle and fat tissue, laboratory testing, a mixed meal tolerance test, questionnaires, an MRI of the heart, pulmonary function tests, and additional measures * Calls with the study team between visits (monthly or every other month)	Maladie coronarienne, Myopathies	Phase 3	Traitement symptomatique	Mexico	À vérifier
Semaglutide (Rybelsus®)Duchenne Muscular Dystrophy (DMD) is a rare, genetic disease that leads to muscle weakness, breathing difficulties, heart disease, and early death. Approximately half of individuals with DMD have elevated body mass indices (BMIs) in the overweight or obesity range. High BMI is due to a combination of factors including limited mobility and steroid medications, which are used to treat DMD. There are new medications, glucagon-like peptide-1 receptor agonists (GLP-1 RAs) that promote weight loss in the general population. GLP-1 RAs are approved for weight loss in children and adults and have beneficial effects on the heart. There is a concern that these medications could have unwanted side effects in individuals with DMD, specifically decreasing their muscle mass. While it is important to consider the use weight-loss medications in DMD, the investigators want to ensure that they are safe and well-tolerated. Therefore, this study will systematically evaluate whether the use of GLP-1 RAs in adolescents and young adults with DMD affects muscle mass. The overall goal of this study is to assess the safety and tolerability of GLP1-RAs in individuals with both DMD and obesity. The primary focus will be on muscle health, but the study will also evaluate activity levels, mood, gastrointestinal symptoms, and quality of life. Secondary goals will be to understand the impact of GLP1-RAs on weight, fat mass, glucose and insulin levels, and heart and lung function in individuals with DMD. The investigators hypothesize that GLP1-RAs will be well-tolerated and will decrease fat mass, without a large decrease in muscle mass. Participants will: * Take oral semaglutide or a placebo every day for 24 weeks (randomized controlled trial) * Then take oral semaglutide every day for 40 weeks (open label extension) * Complete in-person study visits at 3 timepoints * Study visits may include: an MRI of the body to evaluate muscle and fat tissue, laboratory testing, a mixed meal tolerance test, questionnaires, an MRI of the heart, pulmonary function tests, and additional measures * Calls with the study team between visits (monthly or every other month)	Myopathies	Phase 1/2	Traitement symptomatique	United States	À vérifier
Dapagliflozin 10 MG Oral TabletThe primary risk factor for coronary artery disease is atherosclerosis, with inflammation playing a crucial role in the development and progression of this condition. It has now been proven that inflammation is key in the development of complications after an acute myocardial infarction. These complications can be immediate and mechanical, such as ventricular wall rupture and ventricular arrhythmia, or long-term, presenting as major cardiovascular events like heart failure. During acute myocardial infarction (AMI), circulating high-sensitivity CRP levels increase approximately 6 hours after the onset of ischemia. CRP levels measured between 24 and 72 hours after symptom onset are a significant prognostic marker for one-year outcomes. Higher high-sensitivity CRP levels at the time of AMI are linked to more severe coronary atherosclerotic lesions seen on angiography and lower LVEF one month after the event. A serum high-sensitivity CRP concentration greater than 10 mg/L after an AMI indicates inflammation, reflecting myocardial necrosis, plaque rupture, and acute thrombosis. In patients with AMI, persistent or increasing CRP levels are strongly associated with a higher risk of all-cause and non-cardiovascular death, especially when inflammation (CRP \> 2.0 mg/L) continues for a year. Aside from reperfusion therapy, very few pharmacological approaches have been used to reduce inflammation after AMI. One such approach was the use of colchicine in the COVERT-MI randomized, double-blind, multicenter trial. This trial compared five days of oral colchicine with a placebo and found no difference in infarct size between the groups at five days or three months, as measured by cardiac magnetic resonance imaging. SGLT-2 inhibitors are drugs that have revolutionized the management of cardiovascular diseases, offering proven benefits for patients with heart failure and notable nephroprotective effects. However, their use after acute myocardial infarction has not yet been sufficiently established, as the only two published clinical trials so far failed to meet their primary goal of reducing hospitalizations for heart failure. Additionally, evidence of their use in post-AMI inflammation exists only in experimental studies. In experimental studies, SGLT2 global-knockout (KO) mice were used to demonstrate that dapagliflozin significantly influences cardiac fibrosis and inflammation, and markedly alters the gene expression profiles of macrophages and fibroblasts. Moreover, dapagliflozin directly inhibited macrophage-mediated inflammation, thereby suppressing cardiac fibroblast activation. Similarly, only experimental studies have shown that semaglutide decreases elevated levels of TNF-α, IL-6, ROS, and MDA in the serum and cardiac tissues of obese mice. By lowering the expression of Cxcl2, S100a8, and S100a9 in neutrophils, semaglutide may help reduce cardiac inflammation and oxidative stress. Therefore, the objective of this study is to compare the effects of dapagliflozin and semaglutide on inflammatory markers (hs-CRP and IL-6) in patients with acute ST-segment elevation myocardial infarction.	Maladie coronarienne	Phase 3	Neuroprotection + Ralentissement de la progression + Immunomodulation	Mexico	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
Dapagliflozin 10 MG Oral Tablet	Maladie coronarienne	Phase 3	NCT07295223	Effect of Glp-1 and Antidiabetic sgLT2 Agents for myoCardial infarcTion and Ultrasensitive Inflammatory Surveillance (GALACTUS Trial)	COMPLETED
Semaglutide (Rybelsus®)	Myopathies	Phase 1/2	NCT07642635	Glucagon-Like Peptide-1 Receptor Agonists to Attenuate Metabolic Risk in Individuals With Duchenne Muscular Dystrophy	NOT_YET_RECRUITING

Publications

0

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.