loading page

THE RESTRICTED MEAN SURVIVAL TIME AS A TOOL FOR RANKING COMPARATIVE OUTCOMES IN A NARRATIVE REVIEW THAT EVALUATES A NETWORK OF RANDOMISED TRIALS: AN EXAMPLE BASED ON PCSK9 INHIBITORS
  • +2
  • Andrea MessoriOrcid,
  • Laura Bartoli,
  • Marco ChiumenteOrcid,
  • Daniele Mengato,
  • Sabrina Trippoli
Andrea Messori
Orcid
Tuscany Region
Author Profile
Laura Bartoli
Tuscany Region
Author Profile
Marco Chiumente
Orcid
Italian Society for Clinical Pharmacy and Therapeutics, Milan, Italy
Author Profile
Daniele Mengato
Italian Society for Clinical Pharmacy and Therapeutics, Milan, Italy
Author Profile
Sabrina Trippoli
Tuscany Region
Author Profile

Abstract

Evolocumab and alirocumab have been approved based on a randomised trial. We analysed the outcomes reported in the two trials to develop an original framework of comparative assessment that uses the restricted mean survival time (RMST). The objective was to show that, in the context of a narrative review, the RMST can be an efficient though simple tool to make indirect comparisons. For each cohort of patients (13,784 patients given evolocumab, 9,462 given alirocumab, 23,242 controls; results expressed in months of event-free survival), we determined the values of RMST with 95% confidence intervals [CI] (evolocumab: 33.48, 95%CI: 33.45 to 33.50; alirocumab: 33.89, 95%CI: 36.86 to 33.92). These results, along with those of the control groups, were analysed and interpreted narratively. A univariate statistics was conducted; no network meta-analysis was done. The experience presented herein indicates that a framework of evidence assessment focused on RMST is a worthwhile option.