Tolerability of tapentadol immediate release (IR) versus oxycodone IR in elderly patients with low back pain or osteoarthritis pain of the hip or knee

Abstract

In a double-blind, phase 3, 90-day safety study in adults (randomized 4:1; safety population, n=849) with moderate-to-severe low back or osteoarthritis pain, tapentadol IR (50 or 100mg q4-6h) was associated with better gastrointestinal tolerability than oxycodone HCl IR (10 or 15mg q4-6h), while providing similar pain relief (ClinicalTrials.gov Identifier: NCT00364546). This post-hoc analysis evaluated the tolerability of tapentadol IR (n=158) versus oxycodone IR (n=45) among elderly patients (≥65 years of age). Times to onset of constipation, nausea, and vomiting were estimated with Kaplan-Meier plots (treatment differences compared using the log-rank test); percentages of treatment days with these TEAEs were calculated (treatment differences compared using the Wilcoxon test). Among elderly patients, incidences of TEAEs were 77.2% and 88.9% for the tapentadol IR and oxycodone IR groups, respectively; incidences of gastrointestinal TEAEs were 46.8% and 68.9%. Among elderly patients, incidences of constipation (19.0% vs 35.6%) and the composite of nausea or vomiting (30.4% vs 51.1%) were significantly lower with tapentadol IR versus oxycodone IR (all P<0.05), and initial onsets of nausea and constipation occurred significantly earlier with oxycodone IR versus tapentadol IR (P≤0.0312 for both). Elderly patients experienced constipation for a greater percentage of treatment days with oxycodone IR versus tapentadol IR (P=0.0203), and a higher percentage of oxycodone IR- (22.2%) than tapentadol IR-treated patients (12.0%) began using laxatives and/or stool softeners during treatment. For tapentadol IR- and oxycodone IR-treated elderly patients, respectively, incidences of study discontinuation due to TEAEs were 31.6% and 37.8% and due to gastrointestinal TEAEs were 15.8% and 24.4%. Tapentadol IR may be a better treatment option for elderly patients with moderate-to-severe low back or osteoarthritis pain because it was associated with lower incidences of and rates of discontinuation due to gastrointestinal TEAEs than oxycodone IR. (OMJSA L.L.C. and Grünenthal GmbH supported this study.)