Low doses of transdermal buprenorphine in opioid-naive patients with cancer pain: a 4-week, nonrandomized, open-label, uncontrolled observational study.

OBJECTIVE: The aim of this study was to evaluate the effect and tolerability of low doses of transdermal (TD) buprenorphine patches in opioid-naive patients with cancer pain. METHODS: This was a nonrandomized, open-label, uncontrolled study in consecutive opioid-naive patients with advanced cancer and moderate pain. TD buprenorphine was initiated at a dose of 17.5 microg/h (0.4 mg/d), with patch changes every 3 days. Doses were then adjusted according to the clinical response. Pain intensity, opioid-related adverse effects, TD buprenorphine doses, and quality of life were monitored over 4 weeks. The time to dose stabilization and indexes of dose escalation were also calculated. RESULTS: Thirty-nine consecutive patients completed all 4 weeks of the study. Low doses of TD buprenorphine were well tolerated and effective in these opioid-naive patients with cancer pain. Pain control was achieved within a mean of 1.5 days after the start of TD buprenorphine therapy. The mean TD buprenorphine dose was significantly increased from baseline beginning at 2 weeks after the start of therapy and had doubled by 4 weeks (P < 0.05). Pain intensity was significantly decreased from baseline beginning at 1 week and continuing through the remaining weekly evaluations (P < 0.05). The mean buprenorphine escalation index, calculated as a percentage and in milligrams, was 41.2% and 0.2 mg, respectively. Quality of life improved significantly over the study period (P = 0.007). There were no significant changes in opioid-related symptoms between weekly evaluations. CONCLUSION: Observations from this study suggest that randomized, controlled, double-blind studies of TD buprenorphine 17.5 microg/h in opioid-naive patients with cancer pain may be warranted