Introducción
The recent ACHIEVE-4 trial evaluated orforglipron (Foundayo), an oral GLP-1 receptor agonist, demonstrating cardiovascular safety though its heart benefits remain unestablished.
Resultados del ensayo
In adults with type 2 diabetes and obesity or overweight who were on existing glucose-lowering therapies, orforglipron showed non-inferiority compared to insulin glargine regarding major adverse cardiovascular events (MACE) over a median follow-up of two years (4.2% vs 5.0%; HR 0.84, 95% CI 0.59-1.20, P<0.0001).
Improvements in glycemic control and body weight were maintained over 104 weeks. Patients also experienced a significant reduction in albuminuria after 52 weeks and a slower decline in kidney function compared to those treated with insulin glargine. However, gastrointestinal side effects were notably higher with orforglipron (62.1% frente a 14.2%) and were the most common reason for dropping out of the treatment.
Presentación de los resultados
Dr. Klara Klein from the University of North Carolina presented these findings during a diabetes conference in Milan, with the results published simultaneously in The Lancet. The study indicates that orforglipron might serve as a convenient once-daily oral treatment option with a safety profile consistent with earlier studies for glycemic control and weight management.
Características del fármaco
Orforglipron is distinguished from the better-known peptide GLP-1 medications such as semaglutide, as its non-peptide formulation simplifies manufacturing and offers greater convenience in its administration, with no restrictions regarding timing.
Próximos pasos y estudios futuros
While the ACHIEVE-4 trial confirmed the safety profile of orforglipron and showed relevant improvements in blood sugar control, it was not powered to demonstrate cardiovascular superiority. Future studies, including the ongoing ATTAIN-Outcomes trial, are anticipated to provide clarity on the cardiovascular benefits of orforglipron in populations with pre-existing conditions. Additionally, orforglipron is being investigated for various other conditions, including obstructive sleep apnea and hypertension.
Detalles del ensayo ACHIEVE-4
Conducted across 16 countries, the ACHIEVE-4 trial randomized 2,749 adults with type 2 diabetes and a BMI of 25 or more. The cohort had a significant prevalence of established cardiovascular disease and chronic kidney disease.
The study’s cardiovascular endpoints included death, myocardial infarction, stroke, and unstable angina hospitalizations. Secondary endpoints indicated that hypoglycemia rates were lower with orforglipron compared to insulin glargine.
Despite its findings, the open-label design of ACHIEVE-4 presents limitations, necessitating further investigation to confirm the effectiveness of orforglipron.
Disclaimer
Este contenido es meramente informativo y no debe utilizarse como sustituto del consejo o tratamiento médico profesional. Consulte a su médico para obtener recomendaciones específicas sobre su salud.
Fuente: https://www.medpagetoday.com/meetingcoverage/easd/123204
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