Evaluación de Sitagliptina para el tratamiento de pacientes adultos con diabetes mellitus tipo 2: revisión sistemática de costo-efectividad / Evaluation of Sitagliptin for the treatment of adult patients with type 2 diabetes mellitus: a systematic review of cost-effectiveness

Introducción: La diabetes mellitus tipo 2 es un problema de salud pública mundial y es una de las principales causas de mortalidad en Ecuador. La Sitagliptina fue el primer fármaco potenciador del sistema de las incretinas comercializado localmente. Los países no tienen recursos ilimitados para atender las necesidades de salud de su población, por lo que deben adoptar las intervenciones sanitarias más adecuadas, considerando los costos que un país pueda asumir y sostener. Objetivo: Sintetizar los resultados de estudios de costo-efectividad de la sitagliptina para el tratamiento oral combinado de pacientes adultos con diabetes tipo 2 en comparación con sulfonilureas. Metodología: Se realizó una revisión sistemática sin metaanálisis basado en las recomendaciones PRISMA. Los términos de búsqueda se estructuraron en base a la estrategia PICO y la pesquisa se realizó en las bases de datos: Pubmed, Tripdatabase y Pubmed Central para artículos de evaluaciones de tecnologías sanitarias, evaluaciones económicas y guías de práctica clínica, y para las políticas de cobertura se utilizó HTAiVortal y Google avanzado. Resultados: Se seleccionaron 3 ensayos clínicos y 8 revisiones sistemáticas-metaanálisis, 2 estudios de cohorte, 3 políticas de cobertura y 1 estudio de costo-efectividad. Tres revisiones sistemáticas establecieron pocos efectos modestos en cuanto a los efectos hipoglicemiantes de sitagliptina en adultos y adultos mayores; con un bajo riesgo de hipoglicemia. Un metaanálisis de 25 ensayos clínicos reportó mayor riesgo cardiovascular en los pacientes tratados con sitagliptina. Una revisión sistemática con evaluación económica mostró que la sitagliptina con metformina fue una alternativa costo-efectiva versus añadir una sulfonilurea o roziglitazona. Conclusiones: Por el perfil de costo-efectividad podría considerarse a la sitagliptina como segundo fármaco para pacientes que no consiguen control glicémico con dosis máximas de metformina, o en donde su asociación a una sulfonilurea no sea factible (por riesgos de hipoglicemia o adultos mayores).

Introduction: Type 2 diabetes mellitus is a global public health problem, being one of the main causes of mortality in Ecuador. Sitagliptin was the first locally marketed incretin-enhancing drug. Countries do not have unlimited resources to meet the health needs of their population, so they must adopt the most appropriate health interventions, considering the costs that a country can assume and sustain. Objective: To synthesize the results of cost-effectiveness studies of sitagliptin for combined oral treatment of adult patients with type 2 diabetes, compared with sulfonylureas.Methodology: This is a systematic review study without meta-analysis, conducted on PRISMA recommendations. The in-formation search was structured under the PICO strategy and the searches were conducted in Pubmed, Tripdatabase and Pubmed Central for articles on health technology evaluations, economic evaluations and clinical practice guides and for coverage policies HTAiVortal and advanced Google were used.Results: 3 clinical trials and 8 systematic reviews-meta-analysis, 2 cohort studies, 3 coverage policies and 1 cost-effectiveness study were selected. Three systematic reviews establish few effects regarding the hypoglycemic effects of sitagliptin in adults and elderly, with a low risk of hypoglycemia. A meta-analysis of 25 clinical trials reported an increased cardiovascular risk in patients treated with sitagliptin. A systematic review with economic evaluation showed that sitagliptin with metformin was a cost-effective alternative, versus adding a sulfonylurea or roziglitazone.Conclusions: Due to its cost-effectiveness profile, sitagliptin could be considered as a second drug for patients who do not achieve glycemic control with maximum doses of metformin, or where its association with a sulfonylurea is not feasible (due to risks of hypoglycemia or elderly).

Efficacy and safety of sitagliptin added to metformin and insulin compared with voglibose in patients with newly diagnosed type 2 diabetes

OBJECTIVE: To assess the efficacy and safety of sitagliptin compared with voglibose added to combined metformin and insulin in patients with newly diagnosed type 2 diabetes (T2DM). METHODS: In this 12-week prospective, randomized, parallel trial, 70 newly diagnosed T2DM patients with glycosylated hemoglobin (HbA1c) ≥9% and/or fasting plasma glucose (FPG) ≥11.1 mmol/L were randomized (1:1) to receive sitagliptin 100 mg per day + metformin + insulin glargine or voglibose 0.2 mg three times daily + metformin + insulin glargine. Change in HbA1c at week 12 was the primary endpoint. RESULTS: The mean baseline HbA1c was 11.0% in the patients. The changes in HbA1c from baseline were -6.00% in the sitagliptin group and -3.58% in the voglibose group, and the between-group difference was -2.42% (95% CI -1.91 to -2.93, p=0.02). The differences in FPG and homeostatic model assessment of β-cell function (HOMA-β) and the change in body weight between groups from baseline were -2.95 mmol/L (p=0.04), 43.91 (p=0.01) and -2.23 kg (p=0.01), respectively. One patient (2.9%) in the sitagliptin group and three patients (8.6%) in the voglibose group exhibited hypoglycemia. CONCLUSIONS: Sitagliptin added to combined metformin and insulin therapy showed greater efficacy and good safety regarding hypoglycemia in patients with newly diagnosed T2DM compared with voglibose.