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- W2019819198 abstract "This post-hoc analysis evaluated analgesic efficacy and tolerability of tapentadol ER (100-250 mg bid) versus oxycodone HCl CR (20-50 mg bid) in patients ≥75 years of age (tapentadol ER, n=72; oxycodone CR, n=78) using pooled data from 3 similarly-designed 15-week, randomized, double-blind, placebo- and active-controlled, phase 3 studies of tapentadol ER for moderate-to-severe chronic osteoarthritis knee (NCT00421928, NCT00486811) or low back (NCT00449176) pain. Analgesic efficacy was determined by the change in pain intensity (11-point numerical rating scale). Times to initial onset of gastrointestinal TEAEs and time to study discontinuation due to these TEAEs were estimated using Kaplan-Meier plots. No significant between-treatment difference in the least-squares mean (SEM) change in pain intensity from baseline to Week 15 was observed (tapentadol ER, −3.66[0.44]; oxycodone CR, −4.02[0.54]; P=0.604). Significantly lower percentages of patients who received tapentadol ER versus oxycodone CR reported gastrointestinal TEAEs (51.4% vs 71.8%; P=0.0119) and study discontinuations due to gastrointestinal TEAEs (16.7% vs 42.3%; P=0.0007). Times to initial onsets of nausea, vomiting, and constipation and times to study discontinuation due to nausea and vomiting occurred later with tapentadol ER versus oxycodone CR (all P≤0.0388; time to discontinuation due to constipation, P=0.4685). Patients experienced the following common opioid-related gastrointestinal TEAEs for lower mean percentages of study days with tapentadol ER versus oxycodone CR, respectively: nausea, 10.2% versus 20.2%, P=0.0621; vomiting, 1.6% versus 9.1%, P=0.0008; constipation, 12.0% versus 24.8%, P=0.1144. Severity ratings of the common opioid-related gastrointestinal TEAEs (nausea, vomiting, constipation, and nausea and/or vomiting) were generally lower with tapentadol ER versus oxycodone CR. Tapentadol ER (100-250 mg bid) was associated with comparable analgesia and better gastrointestinal tolerability than oxycodone HCl CR (20-50 mg bid), including lower incidences of gastrointestinal TEAEs and study discontinuation due to gastrointestinal TEAEs, in patients ≥75 years of age. Ortho-McNeil Janssen Scientific Affairs, LLC, supported this analysis." @default.
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- W2019819198 date "2011-04-01" @default.
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- W2019819198 title "A post hoc pooled data analysis to evaluate the gastrointestinal tolerability profile of tapentadol extended release (ER) versus oxycodone controlled release (CR) in patients ≥75 years of age" @default.
- W2019819198 doi "https://doi.org/10.1016/j.jpain.2011.02.226" @default.
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