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Controlled-Release Oxycodone Helps Resolve Sleep Problem in Patients with Diabetic Neuropathy: Presented at AAPM

By Jill Stein
Special to DG News

NEW ORLEANS, LA -- February 21, 2003 -- Treatment with controlled-release (CR) oxycodone provides good analgesic efficacy and improves sleep quality in patients with painful diabetic neuropathy (DN), investigators announced here on February 20^th at the 19^th Annual Meeting of the American Academy of Pain Medicine.

Dr. Edward Liao, with Purdue Pharma LP in Stamford, Connecticut, United States, presented data on 159 patients who participated in a randomised, double-blind, parallel, six-week study. All subjects had chronic moderate to severe painful distal diabetic polyneuropathy documented by neurological examination.

Subjects started therapy with oxycodone CR 10 mg every 12 hours or matching placebo followed by blinded-dose titration until patients reported adequate pain relief or intolerable side effects or a maximum dose of 60 mg every 12 hours had been reached.

The oxycodone CR and placebo groups were similar with respect to baseline age, gender, screening haemoglobin A1c levels, and the use of opioid analgesics, prior or concomitant medications such as non-opioid analgesics and adjuvant pain medications, and diabetes medications. Baseline neurological characteristics were also similar in the two groups.

Results showed oxycodone CR provided significantly better analgesia than placebo (p=0.002).

At baseline and on days 14, 28, and 42, the researchers used an item from the Brief Pain Inventory (BPI) to evaluate pain interference with sleep. A score of 0 meant that pain did not interfere with sleep and a score of 10 indicated that pain interfered completely with sleep. Quality of sleep was assessed by patients' daily journals. A score of 0 indicated poor sleep quality, and a score of 10 denoted excellent sleep.

Post-baseline mean BPI score was 3.6 in the oxycodone group and 5.3 in the placebo group. Change from baseline was -3.3 and -1.5 respectively (p< 0.001).

Post-baseline mean score for the quality of sleep was 6.1 in the oxycodone group and 5.4 in the placebo group. Change from baseline was 1.2 and 0.5 respectively (p<0.024).

Adverse events were typical for opioids and were seen more often with oxycodone CR than placebo. None of the serious adverse events was thought related to oxycodone CR, the researchers said.

More than 14 million adults in the US have diabetes. Estimates of the prevalence of painful DM range from 20 to 24 percent.

The study was supported by Purdue Pharma LP.


[Study title: Improvement of Sleep in Diabetics with Neuropathic Pain Treated With Controlled-Release Oxycodone]

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