Tapentadol ER Demonstrates Better GI Tolerability When Compared with Oxycodone CR

AUSTIN, TXResults of a post-hoc analysis presented at the American Pain Society's 30th Annual Scientific Meeting demonstrated that tapentadol extended-release (ER) is associated with comparable analgesia and better gastrointestinal (GI) tolerability than oxycodone HCl controlled-release (CR).

David Biondi, DO, from Ortho-McNeil Janssen and colleagues evaluated the analgesic efficacy and GI tolerability of tapentadol ER (100–250mg twice daily) vs. oxycodone HCl CR  (20–50mg twice daily) in patients ≥75 years of age using pooled data from three similarly designed Phase 3, 15-week, randomized, double-blind, controlled-dose adjustment, placebo- and active-controlled studies of tapentadol ER for moderate-to-severe chronic osteoarthritis knee pain or low back pain (NCT00421928, NCT00486811, NCT00449176). Analgesic efficacy was determined by the change in pain intensity from baseline using an 11-point numerical rating scale. Between-group differences in the incidences of treatment-emergent adverse events (TEAE) and incidences of TEAEs leading to study discontinuation were evaluated using Fisher's exact test. The time to study discontinuation due to these TEAEs was estimated using Kaplan-Meier plots.

At Week 15, no significant between-treatment difference in the least-squares mean change in pain intensity from baseline was observed (tapentadol ER: -2.59 [0.27]; oxycodone CR: -2.13 [0.26]; P=0.2172). Overall, a significantly smaller percentage of patients who received tapentadol ER reported gastrointestinal TEAEs compared with oxycodone CR (51.4% vs. 71.8%; P=0.0119). Common opioid-related GI TEAEs were experienced for a lower mean percentage of study days with tapentadol ER vs. oxycodone CR, respectively: nausea, 10.2% vs. 20.2% (P=0.0621); vomiting 1.6% vs. 9.1% (P=0.0008); constipation, 12.0% vs. 24.8% (P=0.1144). Dr. Biondi also reports that the number of study discontinuations due to GI TEAEs was significantly lower among patients treated with tapentadol ER (16.7% vs. 42.3%; P=0.0007).

Treatment with tapentadol ER resulted in a delayed time to initial onset of nausea, vomiting, constipation, and nausea and/or vomiting when compared with oxycodone CR (P≤0.0388 for all comparisons). Time to study discontinuation due to nausea and/or vomiting occurred significantly later when comparing tapentadol ER to oxycodone CR (P≤0.0079 for all comparisons). Severity ratings of the common opioid-related GI TEAEs (nausea, vomiting, constipation, and nausea and/or vomiting) were generally lower with tapentadol ER versus oxycodone CR.

Study investigators concluded that tapentadol ER is as effective in relieving pain as oxycodone HCl CR, but offers a better GI side effect profile, including lower incidences of GI TEAEs and study discontinuation due to GI TEAEs, in patients ≥75 years of age.