Ensayos clínicos de exenatida y su rol en el tratamiento de la diabetes tipo 2 / Exenatide trials for the treatment of type 2 diabetes

La diabetes mellitus tipo 2 es una enfermedad metabólica crónica, frecuente y progresiva, responsable del 90% de los casos de diabetes a nivel mundial. Aproximadamente el 60% de los individuos que padecen este desorden no alcanzan niveles óptimos de hemoglobina glicosilada, a pesar de la disponibilidad de numerosas alternativas terapéuticas. Los dos objetivos más importantes a cumplir en el manejo actual de la diabetes tipo 2 son la capacidad de los agentes antidiabéticos de exhibir eficacia prolongada y la capacidad de preservar la función de las células beta pancreáticas. El efecto incretina se encuentra reducido en pacientes con diabetes tipo 2. Exenatida pertenece a un nuevo grupo de drogas antidiabéticas que mejoran el control de la glucemia en estos pacientes a través de mecanismos fisiológicos glucorregulatorios que mejoran el efecto incretina. Los ensayos clínicos fase III con exenatida demostraron una reducción media de aproximadamente el 1% en los valores de hemoglobina glicosilada. Los datos a largo plazo de estudios de extensión no controlados indican una mejoría sostenida en los niveles de hemoglobina glicosilada y una reducción progresiva del peso luego de 3 años de tratamiento con esta droga. La droga es generalmente bien tolerada y los efectos adversos más frecuentes son los gastrointestinales, con una intensidad leve a moderada. El objetivo de esta revisión es analizar la evidencia publicada hasta la fecha sobre la eficacia y tolerabilidad del tratamiento con exenatida y su rol en el tratamiento de la diabetes tipo 2.

Type 2 diabetes mellitus is a common, chronic and progressive metabolic disorder, which accounts for 90% of diabetes cases worldwide. Approximately 60% of individuals with the disease do not achieve target glycosylated hemoglobin levels, despite the availability of many antidiabetic agents. The two most important needs in the present management of diabetes are the ability of antidiabetic agents to exhibit prolonged efficacy in reducing hyperglycemia and to preserve beta-cell function. The incretin effect appears to be reduced in patients with type 2 diabetes. Exenatide is the first in a novel class of antidiabetic drugs that improves glycemic control in patients with type 2 diabetes through several physiological glucoregulatory mechanisms which improve the incretin effect. Overall, mean glycosylated hemoglobin (HbA1c) reductions achieved in the exenatide phase III clinical trials were in the order of 1%. Long-term data from the uncontrolled open-label extension studies indicate that adjunctive exenatide therapy leads to sustained improvements in HbA1c and progressive weight loss for at least 3 years. The drug is generally well tolerated. The most common adverse events were gastrointestinal in nature and mild to moderate in severity. The objective of this review is to discuss the available published evidence on exenatide therapeutic efficacy and tolerability, and the role of this new drug in the treatment of type 2 diabetes.

Exenatide and acute pancreatitis.

For a female, type 2 diabetic patient, with 4 years duration of diabetes, Exenatide (Byetta) was prescribed as glycaemic control was not satisfactory along with Glimepiride and Metformin. She had gastrointestinal disturbances, since the first day of the injection. From the eighth day she developed signs of acute pancreatitis which was confirmed with CT-Scan and biochemical investigations. Byetta was withdrawn, the patient was treated for acute pancreatitis and the symptoms subsided.

Tolerability, adverse events and compliance to glatiramer acetate in 28 patients with multiple sclerosis using the drug continuously for at least six months

AIM: To assess tolerability, adverse events and compliance to treatment with glatiramer acetate in multiple sclerosis. METHOD: Review of patient records and individual interviews. RESULTS: 30 individuals residing in the coastal region of the State of São Paulo who had been in use of glatiramer acetate for at least 6 months were identified. From this group, 28 individuals came to regular consultations and were individually assessed, their complaints being noted down in confidential records. Ten patients reported systemic reactions to the drug. Four of them stopped the medication due to such reactions. Eight patients reported local reactions to the injections. Compliance with injections was achieved, although three patients reported forgetting the injection on a few days. CONCLUSION: We noticed a higher level of systemic adverse events in our patients than in reports in the literature.

OBJETIVO: Avaliar tolerância, eventos adversos e aderência ao tratamento com acetato de glatiramer em esclerose múltipla. MÉTODO:Revisão de prontuários de pacientes e entrevistas individuais. RESULTADOS: 30 indivíduos residentes na região do litoral do Estado de São Paulo, que fizeram tratamento com acetato de glatirâmer por pelo menos 6 meses foram identificados. Deste grupo, 28 indivíduos compareceram a consultas regulares e foram avaliados individualmente, sendo suas queixas anotadas em prontuário confidencial. Dez pacientes relataram reações sistêmicas à droga. Quatro deles suspenderam o tratamento devido às reações. Oito pacientes relataram reação local às injeções. Aderência às injeções foi obtida, embora três pacientes admitam ter esquecido a injeção alguns poucos dias. CONCLUSÃO: Observamos um índice maior de reações sistêmicas em nossos pacientes do que o relatado na literatura.