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Tag: composite measures|low back pain|manag|meta analysis|mody|multicenter|osteoarthritis knee pain|sf 36

Composite measure to assess efficacy/gastrointestinal tolerability of tapentadol ER versus oxycodone CR for chronic pain: Pooled analysis of randomized studies.

By wp_zaman

Composite measure to assess efficacy/gastrointestinal tolerability of tapentadol ER versus oxycodone CR for chronic pain: Pooled analysis of randomized studies.

J Opioid Manag. 2013 January-February;9(1):51-61

Authors: Merchant S, Provenzano D, Mody S, Ho KF, Etropolski M

Abstract
Objective: To evaluate a composite measure for chronic pain that balances pain relief with tolerability. Design: Post hoc meta-analysis of three randomized, multicenter, double-blind studies. Participants: Subjects with moderate-to-severe chronic osteoarthritis knee pain or low back pain who had been randomized to receive active treatment with tapentadol extended release (ER; n = 978) or oxycodone controlled release (CR; n = 999). Twenty-two subjects were excluded, mainly because they did not receive treatment. Main outcome measures: We defined the composite measure as ≥30 percent pain relief without nausea/vomiting/constipation and without discontinuations (≥30 percent PRT [pain relief/tolerability]). We also considered ≥50 percent PRT as well as ≥30 percent and ≥50 percent pain relief without any adverse events of any type. To further evaluate ≥30 percent PRT, we studied its relationship with four patient-reported outcomes: EQ-5D, Physical and Mental Component Summaries of SF-36, Patient Global Impression of Change, and Patient Assessment of Constipation Symptoms. Results: At week 12, tapentadol ER recipients were more likely to have ≥30 percent PRT than oxycodone CR recipients (OR, 3.15; 95% CI, 2.47, 4.00; p < 0.001). Significant differences were also observed with the other three composite measures (p < 0.001). At week 12, subjects with ≥30 percent PRT had more favorable changes in all patient-reported outcomes than those without and were more likely to have threshold changes in EQ-5D and SF-36 (all p < 0.001). Conclusions: Tapentadol ER was associated with significantly better composite outcomes than oxycodone CR. Because both pain relief and gastrointestinal tolerability appeared to be related to outcomes, the composite measure may represent a useful tool for comparing opioids that merits further evaluation.

PMID: 23709304 [PubMed – as supplied by publisher]