Certara, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, announced that its model-based meta-analysis comparing tramadol with tapentadol for the treatment of chronic non-malignant pain has been published in the journal Pain and Therapy. This study provides an indirect comparison of the efficacy and tolerability profiles of the two medications.

“Our model-based meta analysis demonstrated that the benefit-risk profiles of tramadol 300 mg once daily and tapentadol 100-250 mg twice daily were approximately equal,” said lead author and senior pharmacometrician at Certara, Francois Mercier.

Model-based meta-analyses are commonly used to study time dynamics of an endpoint. Usually these models take a non-linear form to fit longitudinal data, and to study the dose-response relationship, either at the group level or by combining aggregated data with individual level data.

For this study, data were analysed from 45 phase II and phase III studies, representing a total of 81 treatment arms, and approximately 13,000 patients. After the initial selection of raw data from the literature, a critical data wrangling step was performed to transform heterogeneous and discordant information into clinically meaningful and comparable data.

Meta-analyses were used here to study pain intensity over time and across doses, as well as adverse event and drop-out frequency, amongst subjects experiencing chronic non-malignant pain, who were being treated with tramadol or tapentadol. The most commonly reported adverse events were constipation, nausea, vomiting, dizziness, and drowsiness. Subjects stopped taking the medication either due to an adverse event or lack of drug efficacy.

This project was sponsored by Mundipharma Research.

Certara is dedicated to improving human health by delivering a broad spectrum of software products and consulting services, spanning molecular discovery to clinical development, with special focus on supporting translational approaches to drug development.