Tapentadol extended release (ER) versus oxycodone controlled release (CR) for management of chronic low back or osteoarthritis pain: influence of prior opioid experience on study discontinuations due to constipation, nausea, or vomiting

Abstract

In a phase 3, randomized, open-label, 1-year safety study in patients with moderate-to-severe chronic low back or osteoarthritis pain, tapentadol ER (100-250mg bid; n=894) demonstrated similar pain relief to oxycodone HCl CR (20-50mg bid; n=223), with lower incidences of gastrointestinal treatment-emergent adverse events (TEAEs; ClinicalTrials.gov:NCT00361504). This post-hoc data analysis evaluated study discontinuations due to any TEAE and due to constipation, nausea, or vomiting for patients stratified by prior opioid experience (defined as use of opioid medications ≤3 months before screening).