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Sustained safety and efficacy of once-daily hydromorphone extended-release (oros hydromorphone er) compared with twice-daily oxycodone controlled-release over 52 weeks in patients with moderate to severe chronic noncancer pain

Richarz U et al. – The majority of patients receiving OROS hydromorphone ER (88.3%) and oxycodone CR (88.5%) rated tolerability as good or very good at Week 52; few patients discontinued treatment because of an adverse event (1.6% vs. 0.4%, respectively). The effectiveness of OROS hydromorphone ER and oxycodone CR was maintained through 1 year.

Methods
  • An open–label, randomized, 24–week, parallel group, flexible–dose study demonstrated noninferiority of OROS hydromorphone ER vs. twice–daily oxycodone CR in patients with chronic noncancer pain.
  • In total, 112 patients were enrolled in a 28–week, open–label extension study; 60 patients received OROS hydromorphone ER and 52 received oxycodone CR.
  • The primary efficacy measure was the change from baseline to Weeks 38 and 52 in Brief Pain Inventory item “pain right now.”
  • Global assessments of efficacy, dosing convenience, and tolerability were secondary endpoints.
  • Mean change in “pain right now” from baseline to Week 38 was –3.0 (OROS hydromorphone ER) vs. –2.8 (oxycodone CR), and from baseline to Week 52 was –2.9 vs. –2.8; these changes were similar to the changes in the core phase (–2.1 vs. –2.1).

Results
  • Similar improvements were demonstrated for secondary assessments, including pain, pain interference, and quality of life.
  • At Week 52, global assessment of efficacy was rated as “very good” or “good” by the majority of patients (OROS hydromorphone ER, 91.7%; oxycodone CR, 86.5%).
  • More patients in the OROS hydromorphone ER group (35.0% vs. 21.2%) assessed mode of drug intake as “very convenient.”
[more...]

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