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.


CONCLUSIONS
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.
Mercadante
Sebastiano
S
Porzio
Gianpiero
G
Ferrera
Patrizia
P
Aielli
Federica
F
Verna
Lucilla
L
Tirelli
Walter
W
Villari
Patrizia
P
Casuccio
Alessandra
A
D000279:Administration, Cutaneous; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D002047:Buprenorphine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D010147:Pain Measurement; D010148:Intractable Pain / Q000188:drug therapy* / Q000209:etiology; D011788:Quality of Life
D000701:Analgesics, Opioid; D002047:Buprenorphine