Restricted mean survival time for the analysis of cardiovascular outcome trials assessing non-inferiority: Case studies from antihyperglycemic drug development.
Am Heart J
; 215: 178-186, 2019 09.
Article
em En
| MEDLINE
| ID: mdl-31349109
Cardiovascular outcome trials (CVOTs) have been employed in multiple therapeutic areas to explore whether a noncardiovascular drug increases the risk for cardiovascular events. These studies are now a central part of drug development programs for antihyperglycemic drugs. These programs are expected to demonstrate that new antihyperglycemic drugs for patients with Type 2 diabetes do not have unacceptable cardiovascular risk. The hazard ratio, which is usually provided as evidence that patients receiving the investigational treatment are not at statistically significantly greater cardiovascular risk than patients on the control treatment, can be difficult to interpret for various reasons. Therefore, an alternative approach known as the Restricted Mean Survival Time (RMST) or τ-year mean survival time is presented, and its ability to overcome interpretation challenges with the hazard ratio discussed. The RMST approach is applied to five completed CVOTs and is compared with the corresponding hazard ratios. Additionally, detailed considerations are given on how to design a non-inferiority CVOT using the RMST approach. The RMST methodology is shown to be a practical alternative to the hazard ratio methodology for designing a non-inferiority CVOT.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Doenças Cardiovasculares
/
Diabetes Mellitus Tipo 2
/
Desenvolvimento de Medicamentos
/
Hipoglicemiantes
Tipo de estudo:
Etiology_studies
/
Prognostic_studies
Limite:
Humans
Idioma:
En
Revista:
Am Heart J
Ano de publicação:
2019
Tipo de documento:
Article