BALTIMORE, Md.—Treatment with tapentadol extended-release (ER) may result in better long-term compliance and more enduring pain relief than oxycodone controlled-release (CR) in patients with moderate-to-severe chronic low back or osteoarthritis pain.
In a post-hoc analysis of a phase III randomized, open-label, 1-year safety study, tapentadol ER 100-250 mg bid (n=894), an investigational therapy, demonstrated similar pain relief to oxycodone HCl CR 20-50 mg bid (n=223) and had lower incidences of treatment-emergent adverse events (TEAEs), David M. Biondi, DO, of Ortho-McNeil Janssen Scientific Affairs, Raritan, NJ, and colleagues reported.
Kaplan-Meier plots estimated distributions of times to first onset and probabilities of discontinuations due to constipation, nausea, and vomiting by days 10 and 30; i.e., within the first 4 weeks of treatment, when gastrointestinal TEAEs were more frequent. Patients treated with tapentadol ER had lower incidences of discontinuation due to any TEAE than those on oxycodone CR (22.1% vs 36.8%; P<0.0001). This was attributed to lower incidences of patients discontinuing due to gastrointestinal TEAEs; 8.6% for tapentadol ER vs 21.5% for oxycodone CR (P<0.0001). Earlier first onsets of constipation, nausea, and vomiting and subsequent time to discontinuation was significantly higher in those receiving oxycodone CR than tapentadol ER (all P≤0.0001).
For patients in the oxycodone CR group, the probability of discontinuation at day 10 for constipation was 8.7 times higher than for those in the tapentadol ER group; it was 5.6 times higher for nausea and 5.2 times higher for vomiting. By day 30, these rates were 6.2 times higher for constipation, 3.6 times higher for nausea, and 3.7 times higher for vomiting in those receiving oxycodone CR vs tapentadol ER.
Compared with oxycodone CR, tapentadol ER was associated with better gastrointestinal tolerability, fewer discontinuations due to gastrointestinal TEAEs, and longer times to first onset of and discontinuation due to constipation, nausea, and vomiting, the investigators told those attending The American Pain Society’s 29th Annual Meeting.