Acute pancreatitis due to different semaglutide regimens: An updated meta-analysis.

OBJECTIVES: Some concerns persist regarding the safety of semaglutide. The objective of this updated meta-analysis is to assess the risk of acute pancreatitis with the use of semaglutide, assessing the results according to the different administration regimens. METHODS: We performed an updated meta-analysis of randomised, placebo-controlled studies of semaglutide therapy that report acute pancreatitis. This meta-analysis was performed in line with PRISMA guidelines. A global and stratified analysis according to the therapeutic scheme used was performed using the fixed-effects model. RESULTS: Twenty-one eligible trials of semaglutide, including 34,721 patients, were identified and considered eligible for the analyses. Globally, semaglutide therapy was not associated with an increased risk of acute pancreatitis (OR 0.7; 95% CI 0.5-1.2, I2 0%). When we analysed the studies according to the different schemes used, the results were similar (group with oral semaglutide: OR 0.40; 95% CI 0.10-1.60, I2 0%; group with low subcutaneous doses of semaglutide: OR 0.80; 95% CI 0.40-1.90, I2 0%; group with high subcutaneous doses of semaglutide: OR 0.70; 95% CI 0.50-1.20, I2 0%; interaction p-value=0.689). CONCLUSION: This updated meta-analysis demonstrates that the use of semaglutide is not associated with an increased risk of acute pancreatitis compared to placebo. In the stratified analysis, the results were similar with the different semaglutide regimens analysed.

Effect of semaglutide on weight loss and glycaemic control in patients with Prader-Willi Syndrome and type 2 diabetes.

Prader-Willi Syndrome (PWS) is the most common genetic cause of obesity, occurring in approximately 1 in 15,000 newborns. It results from the lack of expression of genes on the paternal allele of the chromosomal region 15q-11q13 (65-75% due to type 1 or type 2 deletion). Individuals with PWS experience associated symptoms such as hypotonia, hyperphagia, and early-onset obesity (before 5 years of age). Around 20% of adults with PWS also develop type 2 diabetes. Previous studies have shown the beneficial effects of GLP1-RA medications, such as exenatide and liraglutide, in treating type 2 diabetes in PWS. However, there is limited information available on the use of semaglutide in PWS. This study aimed to evaluate the effects of semaglutide on weight loss and glycaemic control in four patients with PWS and type 2 diabetes associated with obesity. The patients were started on weekly subcutaneous progressive doses of semaglutide.

[Translated article] Glucagon-Like Peptide-1 Agonists for Treating Obesity in Patients With Immune-Mediated Skin Diseases / Agonistas del receptor de GLP-1 para el tratamiento de la obesidad en pacientes con dermatosis inmunomediadas

Psoriasis and hidradenitis suppurativa are often associated with obesity. Because chronic low-grade inflammation underlies these 2 diseases, they can progress to more severe forms in patients with obesity if weight-reduction measures are not taken. This review covers pharmacologic alternatives for treating obesity, with emphasis on the benefits associated with the novel use of glucagon-like peptide-1 (GLP-1) agonists that act on satiety receptors. These drugs have led to greater weight loss in clinical trials and real-world settings than orlistat, which until recently was the only drug approved for treating obesity in the European Union. Although experience with GLP-1 agonists in patients with obesity and inflammatory skin diseases is currently scarce, the promising results reported suggest they may offer a useful tool for managing obesity (AU)

La psoriasis (PsO) y la hidradenitis supurativa (HS) se asocian frecuentemente con la obesidad. La inflamación crónica de bajo grado subyace a estas condiciones, por lo que si no se adoptan medidas para reducir el peso del paciente con obesidad y PsO o HS, estas podrían evolucionar hacia formas más graves. Este trabajo revisa las opciones farmacológicas para tratar la obesidad, profundizando en los beneficios asociados al uso novedoso de agonistas del receptor de GLP-1 (arGLP-1), que actúan sobre los centros de la saciedad. Los resultados de ensayos y vida real demuestran que esta medicación consigue mayores pérdidas de peso que orlistat, hasta recientemente el único fármaco específico para la obesidad comercializado en la Unión Europea. Aunque la experiencia con arGLP-1 en pacientes con obesidad y dermatosis inflamatorias es escasa, los resultados son alentadores, por lo que podrían constituir una herramienta útil para el manejo de su obesidad (AU)

Agonistas del receptor de GLP-1 para el tratamiento de la obesidad en pacientes con dermatosis inmunomediadas / Glucagon-Like Peptide-1 Agonists for Treating Obesity in Patients With Immune-Mediated Skin Diseases

La psoriasis (PsO) y la hidradenitis supurativa (HS) se asocian frecuentemente con la obesidad. La inflamación crónica de bajo grado subyace a estas condiciones, por lo que si no se adoptan medidas para reducir el peso del paciente con obesidad y PsO o HS, estas podrían evolucionar hacia formas más graves. Este trabajo revisa las opciones farmacológicas para tratar la obesidad, profundizando en los beneficios asociados al uso novedoso de agonistas del receptor de GLP-1 (arGLP-1), que actúan sobre los centros de la saciedad. Los resultados de ensayos y vida real demuestran que esta medicación consigue mayores pérdidas de peso que orlistat, hasta recientemente el único fármaco específico para la obesidad comercializado en la Unión Europea. Aunque la experiencia con arGLP-1 en pacientes con obesidad y dermatosis inflamatorias es escasa, los resultados son alentadores, por lo que podrían constituir una herramienta útil para el manejo de su obesidad (AU)

Psoriasis and hidradenitis suppurativa are often associated with obesity. Because chronic low-grade inflammation underlies these 2 diseases, they can progress to more severe forms in patients with obesity if weight-reduction measures are not taken. This review covers pharmacologic alternatives for treating obesity, with emphasis on the benefits associated with the novel use of glucagon-like peptide-1 (GLP-1) agonists that act on satiety receptors. These drugs have led to greater weight loss in clinical trials and real-world settings than orlistat, which until recently was the only drug approved for treating obesity in the European Union. Although experience with GLP-1 agonists in patients with obesity and inflammatory skin diseases is currently scarce, the promising results reported suggest they may offer a useful tool for managing obesity (AU)

Glucagon-Like Peptide-1 Agonists for Treating Obesity in Patients With Immune-Mediated Skin Diseases. / Agonistas del receptor de GLP-1 para el tratamiento de la obesidad en pacientes con dermatosis inmunomediadas.

Psoriasis and hidradenitis suppurativa are often associated with obesity. Because chronic low-grade inflammation underlies these 2 diseases, they can progress to more severe forms in patients with obesity if weight-reduction measures are not taken. This review covers pharmacologic alternatives for treating obesity, with emphasis on the benefits associated with the novel use of glucagon-like peptide-1 (GLP-1) agonists that act on satiety receptors. These drugs have led to greater weight loss in clinical trials and real-world settings than orlistat, which until recently was the only drug approved for treating obesity in the European Union. Although experience with GLP-1 agonists in patients with obesity and inflammatory skin diseases is currently scarce, the promising results reported suggest they may offer a useful tool for managing obesity.

[Translated article] Glucagon-Like Peptide-1 Agonists for Treating Obesity in Patients With Immune-Mediated Skin Diseases.

Psoriasis and hidradenitis suppurativa are often associated with obesity. Because chronic low-grade inflammation underlies these 2 diseases, they can progress to more severe forms in patients with obesity if weight-reduction measures are not taken. This review covers pharmacologic alternatives for treating obesity, with emphasis on the benefits associated with the novel use of glucagon-like peptide-1 (GLP-1) agonists that act on satiety receptors. These drugs have led to greater weight loss in clinical trials and real-world settings than orlistat, which until recently was the only drug approved for treating obesity in the European Union. Although experience with GLP-1 agonists in patients with obesity and inflammatory skin diseases is currently scarce, the promising results reported suggest they may offer a useful tool for managing obesity.

Glucagon-like peptide 1(GLP-1) receptor agonists in the management of the patient with type 2diabetes mellitus and chronic kidney disease: an approach for the nephrologist.

Diabetic kidney disease, a common complication in patients with type 2 diabetes mellitus, is associated with a markedly increased morbidity and mortality, especially of cardiovascular origin, and faster progression to end-stage renal disease. To date, reducing cardiovascular and renal risk in this population was based on strict control of cardiovascular risk factors and the renin-angiotensin system blockade. More recently, sodium-glucose cotransporter type 2 inhibitors have demonstrated to offer cardiovascular and renal protection, but the residual risk remains high and their antihyperglycemic efficacy is limited in moderate-severe CKD. Therefore, drugs with a potent antihyperglycemic effect, independent of the glomerular filtration rate, with a low risk of hypoglycemia, that reduce weight in overweight/obese patients and that provide cardiovascular and renal protection, such as GLP-1 receptor agonists, are needed. However, these drugs require subcutaneous administration, which may limit their early use. The recent availability of oral semaglutide may facilitate the early introduction of this family with proven cardiovascular and renal benefits and excellent safety profile. In this review the family is analyzed as well as their cardiovascular and renal effects.

Agonistas del receptor de péptido similar al glucagón tipo 1 (GLP-1) en el manejo del paciente con diabetes mellitus tipo 2. Una aproximación para el nefrólogo / Glucagon-like peptide 1(GLP-1) receptor agonists in the management of the patient with type 2diabetes mellitus and chronic kidney disease: An approach for the nephrologist

La enfermedad renal diabética, frecuente en pacientes con diabetes mellitus tipo 2, se asocia con un marcado incremento de la morbimortalidad, especialmente cardiovascular, y de progresión a enfermedad renal crónica terminal. Hasta la fecha la reducción del riesgo cardiovascular y renal en esta población se ha basado en el control estricto de los factores de riesgo cardiovascular y en el uso de inhibidores del sistema renina-angiotensina. Mas recientemente los inhibidores del cotransportador sodio-glucosa tipo 2 han demostrado ofrecer protección cardiovascular y renal, pero el riesgo residual sigue siendo alto y su eficacia antihiperglucemiante es limitada en ERC moderada-severa. Por ello se precisan fármacos con un potente efecto antihiperglucemiante, independiente del filtrado glomerular, con bajo riesgo de hipoglicemia, que reduzcan el peso en pacientes con sobrepeso/obesidad y que proporcionen una protección cardiovascular y renal, como los agonistas del receptor de GLP-1. Sin embargo, estos fármacos precisan de su administración subcutánea, lo que puede limitar su uso temprano. La reciente disponibilidad de semaglutida oral puede ayudar a la introducción precoz de esta familia con beneficios cardiovasculares y renales probados y excelente perfil de seguridad. En esta revisión se describe la familia y sus efectos cardiovasculares y renales. (AU)

Diabetic kidney disease, a common complication in patients with type 2 diabetes mellitus, is associated with a markedly increased morbidity and mortality, especially of cardiovascular origin, and faster progression to end-stage renal disease. To date, reducing cardiovascular and renal risk in this population was based on strict control of cardiovascular risk factors and the renin–angiotensin system blockade. More recently, sodium-glucose cotransporter type 2 inhibitors have demonstrated to offer cardiovascular and renal protection, but the residual risk remains high and their antihyperglycemic efficacy is limited in moderate-severe CKD. Therefore, drugs with a potent antihyperglycemic effect, independent of the glomerular filtration rate, with a low risk of hypoglycemia, that reduce weight in overweight/obese patients and that provide cardiovascular and renal protection, such as GLP-1 receptor agonists, are needed. However, these drugs require subcutaneous administration, which may limit their early use. The recent availability of oral semaglutide may facilitate the early introduction of this family with proven cardiovascular and renal benefits and excellent safety profile. In this review the family is analyzed as well as their cardiovascular and renal effects. (AU)

Efecto de semaglutida sobre los biomarcadores de la enfermedad del hígado graso en pacientes con diabetes y obesidad / Effect of semaglutide on fatty liver disease biomarkers in patients with diabetes and obesity

Objetivo El objetivo de este trabajo es evaluar el efecto de la semaglutida subcutánea sobre los biomarcadores de la enfermedad metabólica hepática (MAFLD), a saber, el índice de esteatosis hepática (HSI) y el índice de fibrosis-4 (FIB-4), a las 24semanas en pacientes ambulatorios atendidos en los servicios de Medicina Interna. Métodos En este estudio se analizaron pacientes de un registro de cohortes en curso, multicéntrico, prospectivo, pre-post y no controlado que inscribe a pacientes únicos y consecutivos con diabetes tipo2 tratados con semaglutida subcutánea. La esteatosis/fibrosis se determinó mediante HSI (<30 descartada, >36 esteatosis) y FIB-4 (<1,3 descartada, >2,67 fibrosis), respectivamente. Resultados La muestra incluyó 213 pacientes (46,9% mujeres) con una mediana de edad de 64 (±19) años. El índice de masa corporal y el peso basales medios fueron de 36,1 (±8,4) kg/m2 y 98 (±26,9) kg, respectivamente. El 99,9% presentaba valores de HSI indicativos de esteatosis, con un HSI medio de 47,9 (±8,2). Además, el 10,8% presentaba fibrosis (FIB-4 >2,67) y el 42,72% tenía valores en rangos intermedios (FIB-4 1,3-2,67). A las 24 semanas se produjo una reducción significativa del HSI (−2,36 [IC95%: 1,83-2,9], p<0,00001) y del FIB-4 (−0,075 [IC95%: 0,015-0,14], p<0,016), relacionada principalmente con descensos del peso corporal, de los niveles de triglicéridos, de la resistencia a la insulina (estimada mediante el índice triglicéridos-glucosa) y de las enzimas hepáticas. Conclusiones Estos resultados muestran que la semaglutida subcutánea tuvo un efecto beneficioso sobre la esteatosis hepática que fue más allá del control de la glucosa. Sus efectos estaban relacionados principalmente con la pérdida de peso, la disminución de los biomarcadores y la mejora de la sensibilidad a la insulina. Para muchos pacientes, la detección precoz es esencial para mejorar los resultados de la MAFLD y puede permitir seleccionar las opciones terapéuticas más eficaces (AU)

Aim This work aims to assess the effect of weekly subcutaneous semaglutide on biomarkers of metabolic-associated fatty liver disease (MAFLD), namely the hepatic steatosis index (HSI) and the fibrosis-4 (FIB-4) index, at 24weeks in outpatients attended to in internal medicine departments. Methods This study analyzed patients in an ongoing, multicenter, prospective, pre-post, uncontrolled cohort registry that enrolls unique, consecutive patients with type2 diabetes treated with weekly subcutaneous semaglutide. Steatosis/fibrosis were determined by HSI (<30 ruled out, >36 steatosis) and FIB-4 (<1.3 ruled out, >2.67 fibrosis), respectively. Results The sample included 213 patients (46.9% women) with a median age of 64 (±19) years. The median baseline body mass index and weight were 36.1 (±8.4) kg/m2 and 98 (±26.9) kg, respectively. A total of 99.9% had HSI values indicating steatosis, with a mean HSI of 47.9 (±8.2). Additionally, 10.8% had fibrosis (FIB-4 >2.67) and 42.72% had values in intermediate ranges (FIB-4 1.3-2.67). At 24weeks, there was a significant reduction in HSI (−2.36 (95%CI: 1.83-2.9), p<0.00001) and FIB-4 (−0.075 (95%CI: 0.015-0.14), p<0.016), mainly related to declines in body weight, triglyceride levels, insulin resistance (estimated by the triglyceride-glucose index), and liver enzymes. Conclusion These results show that weekly subcutaneous semaglutide had a beneficial effect on liver steatosis that went beyond glucose control. Its effects were mainly related to weight loss, a decline in biomarkers, and improvements in insulin sensitivity. For many patients, early detection is essential for improving MAFLD outcomes and may allow for selecting the most efficient treatment options (AU)

La semaglutida en el tratamiento de las personas con diabesidad / Semaglutide in the Treatment of Diabesity Individuals

Introducción: La semaglutida es un fármaco que contribuye a la liberación de insulina por el páncreas y a la supresión del apetito por lo que lo convierte en un importante candidato para ser usado en el tratamiento de la diabesidad. Objetivo: Describir el efecto de la semaglutida en el tratamiento de las personas con diabesidad. Métodos: Se revisó la literatura publicada en el período comprendido de enero-febrero de 2021. Las palabras clave utilizadas fueron obesidad; diabetes mellitus; diabesidad; semaglutida; análogo del péptido similar al glucagón tipo 1. Se utilizaron como motores de búsqueda las bases de datos de Google Académico, PubMed y SciELO. Se evaluaron diferentes trabajos de revisión, investigación y páginas web que tenían menos de 10 años de publicados en idioma español, portugués o inglés, y que por el título trataban el tema de estudio. Fueron excluidos los artículos que no abordaron la relación entre diabetes y obesidad, así como el tratamiento con análogos del péptido similar al glucagón tipo 1. Esto permitió la consulta de 84 artículos, de los cuales 59 fueron referenciados. Conclusiones: El empleo de semaglutida favorece una mejor evolución en paciente con diabesidad, como complemento de una dieta y una actividad física adecuada. Al optimizar el control glucémico, contribuir a la pérdida de peso y a la mejoraría de ciertas comorbilidades, entre ellas la salud cardiovascular(AU)

Introduction: Semaglutide is a drug that contributes to the release of insulin from the pancreas and suppresses appetite, which makes it an important candidate for treating diabesity. Objective: To describe the role of semaglutide in the treatment of diabesity individuals. Methods: The necessary information to write this article was obtained in the 2022 two-month period January-February. The keywords used were obesity; Mellitus diabetes; diabesity; semaglutide; type 1 glucagon-like peptide analogue. The search engines corresponding to the Google Scholar, PubMed and SciElO databases were used. Different review, research and web pages were evaluated, which in general were published no more than 10 years ago, in Spanish, Portuguese or English and which dealt with the subject of study by title. Articles that did not address the relationship between diabetes and obesity, as well as treatment with glucagon-like peptide 1 analogues, were excluded. This allowed the consultation of 84 articles, 59 of them were referenced. Conclusions: The use of semaglutide, as a complement to a diet and physical activity appropriate to the needs of patients with diabesity, brought about several effects that favor better evolution of this health problem, by optimizing glycemic control, contributing to the loss of weight and the improvement of certain comorbidities, including cardiovascular health(AU)

Effect of semaglutide on fatty liver disease biomarkers in patients with diabetes and obesity.

AIM: This work aims to assess the effect of weekly subcutaneous semaglutide on biomarkers of metabolic-associated fatty liver disease (MAFLD), namely the hepatic steatosis index (HSI) and the fibrosis-4 (FIB-4) index, at 24 weeks in outpatients attended to in internal medicine departments. METHODS: This study analyzed patients in an ongoing, multicenter, prospective, pre-post, uncontrolled cohort registry that enrolls unique, consecutive patients with type 2 diabetes treated with weekly subcutaneous semaglutide. Steatosis/fibrosis were determined by HSI (<30 ruled out, >36 steatosis) and FIB-4 (<1.3 ruled out, >2.67 fibrosis), respectively. RESULTS: The sample included 213 patients (46.9% women) with a median age of 64 (19) years. The median baseline body mass index and weight were 36.1 (8.4) kg/m2 and 98 (26.9) kg, respectively. A total of 99.9% had HSI values indicating steatosis, with a mean HSI of 47.9 (8.2). Additionally, 10.8% had fibrosis (FIB-4 > 2.67) and 42.72% had values in intermediate ranges (FIB-4 1.3-2.67). At 24 weeks, there was a significant reduction in HSI (-2.36 (95%CI 1.83-2.9) p < 0.00001) and FIB-4 (-0.075 (95%CI 0.015-0.14) p < 0.016), mainly related to declines in body weight, triglyceride levels, insulin resistance (estimated by the triglyceride-glucose index), and liver enzymes. CONCLUSION: These results show that weekly subcutaneous semaglutide had a beneficial effect on liver steatosis that went beyond glucose control. Its effects were mainly related to weight loss, a decline in biomarkers, and improvements in insulin sensitivity. For many patients, early detection is essential for improving MAFLD outcomes and may allow for selecting the most efficient treatment options.

Una visión actual del tratamiento farmacológico para la obesidad / A current vision of the pharmacological treatment for obesity

Fundamentos: La obesidad es una patología muy prevalente a nivel mundial. La prevención, modificación deestilo de vida, tratamiento nutricional, psicológico y tratamiento farmacológico son estrategias para combatiresta enfermedad. El objetivo de esta revisión es analizar las evidencias existentes sobre la eficacia de losfármacos en la reducción del peso corporal y otros parámetros antropométricos y metabólicos relacionados.Métodos: Se ha realizado una búsqueda en PubMed y ScienceDirect de los artículos publicados en los últimos10 años seleccionando ensayos clínicos con fármacos en hombres y mujeres adultos obesos.Resultados: La naltrexona-bupropión es la asociación de fármacos contra la obesidad que obtiene mejoresresultados en la reducción de los parámetros antropométricos y metabólicos (perfil lipídico y presión arterial),seguida de la liraglutida 3,0 mg y el orlistato; la semaglutida es el hipoglucemiente que reduce más estosparámetros. La mejora de la calidad de vida no es relevante y los efectos adversos muy similares entre losfármacos. En fármacos nuevos o en estudio no se observan mejores resultados.Conclusiones: Los fármacos indicados para la obesidad en nuestro entorno son eficaces y seguros, lasemaglutida puede ser otra opción para el tratamiento. Hace falta más evidencia para incluir nuevos fármacosentre los comercializados contra la obesidad. (AU)

Background: Obesity is a very prevalent disease worldwide. Prevention, lifestyle modification, nutritional,psychological and pharmacological treatment are strategies to combat this disease. The objective of this reviewis to analyze the existing evidence on the efficacy of drugs in reducing body weight and other relatedanthropometric and metabolic parameters.Methods: A search was made in PubMed and ScienceDirect of the last 10 years, selecting clinical trials withdrugs in obese adult men and women.Results: Naltrexone-bupropion is the anti-obesity drug association that obtains the best results in reducinganthropometric and metabolic parameters (lipid profile and blood pressure), followed by liraglutide 3.0 mg andorlistato; semaglutide is the hypoglycemic agent that reduces these parameters the most. The improvement inquality of life is not relevant and the adverse effects are very similar between the drugs. Better results are notobserved in new or in-study drugs.Conclusions: The drugs indicated for obesity in our country are effective and safe, and semaglutide can alsobe a good option for obesity treatment. More evidence is needed to include new drugs among those marketedagainst obesity. (AU)

Uso de semaglutida inyectable para indicación fuera de ficha técnica. Caso clínico / Use of injectable semaglutide for off-label indication. Clinical case

ANTECEDENTES: llega a nuestra farmacia una prescripción de semaglutida 1 mg inyectable como inicio de tratamiento. Preguntamos si es para diabetes y el paciente refiere que es para adelgazar. Está pautada por endocrinólogo. Nos explica que las primeras semanas debe ponerse 17 clics y luego ir aumentando.EVALUACIÓN: comprobamos en ficha técnica la indicación autorizada por la AEMPS: tratamiento de DM2, que no han sido controlados adecuadamente, como complemente a dieta y ejercicio en monoterapia o añadida a otros medicamentos para la diabetes. Revisamos en ficha técnica las dosis y nos aparecen en milígramos, nunca en clics. En el prospecto pide que no se cuenten los clics de la pluma.INTERVENCIÓN: desconocemos esta indicación y la medida de los clics no está contemplada en la ficha técnica. Pedimos al paciente que revise la pauta con el especialista y vuelva a la farmacia. En FC revisamos la bibliografía de la Aemps y la FDA y consultamos internet.RESULTADO/SEGUIMIENTO: el paciente vuelve con la hoja pautada del especialista y en ella están anotados los clics descritos así: Dosis semanal : -17 clicks = 0.25 mg ( hasta la cuarta semana)-34 clicks = 0.50 mg ( en función de la respuesta ) -51 clicks = 0.75 mg- Tope : 1 mg. Nosotros por nuestra parte observamos diferentes contenidos en redes sociales y en blogs de diversas descripciones sobre las dosis de semaglutida inyectable y su equivalente en clics. (AU)