Certara, a provider of software and scientific consulting services to improve productivity and decision-making from drug discovery and development, has announced that its model-based meta-analysis comparing tramadol with tapentadol for the treatment of chronic nonmalignant 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. The resulting peer-reviewed paper is now available online.
Model-based meta-analyses are commonly used to study time dynamics of an endpoint. Often 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 was 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 step in the process was to transform the data 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 nonmalignant 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.
‘Our model-based meta-analysis demonstrated that the benefit-risk profiles of tramadol 300mg once daily and tapentadol 100-250mg twice daily were approximately equal,’ said lead author and senior pharmacometrician at Certara, Francois Mercier.