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Controlled-release oxycodone for pain in diabetic neuropathy: a randomized controlled trial
Joseph S Gimbel1, Patricia Richards, Russell K Portenoy
1Arizona Research Center, LLC, Phoenix, USA.
Neurology
|March 26, 2003
Summary
Controlled-release oxycodone effectively reduced moderate to severe pain in diabetic neuropathy patients over six weeks. Adverse events were consistent with typical opioid side effects, indicating a potential treatment option.
Area of Science:
- Neurology
- Pain Management
- Pharmacology
Background:
- Diabetic neuropathy often causes moderate to severe pain.
- Opioid treatment's role in diabetic neuropathy is limited due to pain response concerns.
Purpose of the Study:
- To evaluate the efficacy and safety of controlled-release (CR) oxycodone.
- To assess CR oxycodone for managing moderate to severe pain from diabetic neuropathy.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled study.
- 159 subjects with diabetic neuropathy pain received CR oxycodone or placebo for up to 6 weeks.
- Dose titration allowed up to 60 mg CR oxycodone every 12 hours.
Main Results:
- CR oxycodone demonstrated significantly greater analgesia than placebo (p=0.002).
- Average daily pain intensity was lower in the CR oxycodone group (4.1) versus placebo (5.3) from days 28-42.
- Adverse events were reported in 96% of CR oxycodone recipients versus 68% of placebo recipients.
Conclusions:
- CR oxycodone proved effective for moderate to severe diabetic neuropathy pain in a 6-week trial.
- Observed adverse events were characteristic of opioid-related side effects.