Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial
Randomized controlled trial published in Lancet (London, England) (2009)
Abstract
BACKGROUND: Rosiglitazone is an insulin sensitiser used in combination with metformin, a sulfonylurea, or both, for lowering blood glucose in people with type 2 diabetes. We assessed cardiovascular outcomes after addition of rosiglitazone to either metformin or sulfonylurea compared with the combination of the two over 5-7 years of follow-up. We also assessed comparative safety. METHODS: In a multicentre, open-label trial, 4447 patients with type 2 diabetes on metformin or sulfonylurea monotherapy with mean haemoglobin A(1c) (HbA(1c)) of 7.9% were randomly assigned to addition of rosiglitazone (n=2220) or to a combination of metformin and sulfonylurea (active control group, n=2227). The primary endpoint was cardiovascular hospitalisation or cardiovascular death, with a hazard ratio (HR) non-inferiority margin of 1.20. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00379769. FINDINGS: 321 people in the rosiglitazone group and 323 in the active control group experienced the primary outcome during a mean 5.5-year follow-up, meeting the criterion of non-inferiority (HR 0.99, 95% CI 0.85-1.16). HR was 0.84 (0.59-1.18) for cardiovascular death, 1.14 (0.80-1.63) for myocardial infarction, and 0.72 (0.49-1.06) for stroke. Heart failure causing admission to hospital or death occurred in 61 people in the rosiglitazone group and 29 in the active control group (HR 2.10, 1.35-3.27, risk difference per 1000 person-years 2.6, 1.1-4.1). Upper and distal lower limb fracture rates were increased mainly in women randomly assigned to rosiglitazone. Mean HbA(1c) was lower in the rosiglitazone group than in the control group at 5 years. INTERPRETATION: Addition of rosiglitazone to glucose-lowering therapy in people with type 2 diabetes is confirmed to increase the risk of heart failure and of some fractures, mainly in women. Although the data are inconclusive about any possible effect on myocardial infarction, rosiglitazone does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs. FUNDING: GlaxoSmithKline plc, UK.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Resumen
Rosiglitazone is an insulin sensitiser used in combination with metformin, a sulfonylurea, or both, for lowering blood glucose in people with type 2 diabetes.
Por qué esto importa para la hirudoterapia
Este ensayo multicéntrico, aleatorizado y abierto evaluó los desenlaces cardiovasculares en 4.447 pacientes con diabetes tipo 2 aleatorizados a la adición de rosiglitazona frente a la combinación de metformina-sulfonilurea durante un seguimiento medio de 5,5 años. La rosiglitazona cumplió el criterio de no inferioridad para el criterio de valoración principal de hospitalización cardiovascular o muerte cardiovascular (HR 0,99; IC 95% 0,85–1,16), pero aumentó significativamente el riesgo de hospitalización o muerte por insuficiencia cardíaca (HR 2,10; IC 95% 1,35–3,27) y las tasas de fractura de miembros superiores y de la porción distal de los miembros inferiores, principalmente en mujeres. Este artículo versa sobre la seguridad de las tiazolidinedionas y la estrategia de reducción de la glucosa en el manejo de la diabetes. No guarda conexión alguna con las sanguijuelas, la hirudoterapia o el secretoma de la sanguijuela, y no existe una relevancia defendible respecto al ámbito de la ASH.
Citación
Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial
Home PD et al. · Lancet (London, England), 2009
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026