The efficacy of low-dose transdermal fentanyl in opioid-naive cancer patients with moderate-to-severe pain
The Korean Journal of Internal Medicine
; : 88-95, 2015.
Article
in En
| WPRIM
| ID: wpr-106130
Responsible library:
WPRO
ABSTRACT
BACKGROUND/AIMS: Little is known about the efficacy of low-dose transdermal fentanyl (TDF) patches in opioid-naive patients with moderate-to-severe cancer pain. METHODS: This study had an open-label, prospective design, and was conducted between April 2007 and February 2009 in seven tertiary cancer hospitals; 98 patients were enrolled. TDF was started using a low-dose formulation (12.5 microg/hr), and the dose was adjusted according to the clinical situation of individual patients. Pain intensity, the TDF doses used, and adverse events (AEs) were monitored over 4 weeks. Data were analyzed using the intent-to-treat and per-protocol principles. RESULTS: Of the 98 patients enrolled, 64 (65%) completed the study. The median pain intensity decreased from 6.0 to 3.0 (p < 0.001) at the follow-up visit. The efficacy of low-dose TDF on pain relief was consistent across groups separated according to gender (p < 0.001), age (p < 0.001), metastasis (p < 0.001), previous treatment (p < 0.001), and baseline pain intensity (p < 0.001). The decrease in pain intensity was significantly greater in the severe group compared with the moderate group (mean +/- SD, 5.10 +/- 2.48 vs. 2.48 +/- 1.56; p < 0.001). TDF dose (27.8 microg/hr vs. 24.8 microg/hr, p = 0.423) and the mean treatment time (7.5 days vs. 7.9 days, p = 0.740) required for pain control were not different between the two pain-intensity groups. Patients had AEs of only mild or moderate intensity; among these, nausea (38%) was the most common, followed by vomiting (22%) and somnolence (22%). CONCLUSIONS: Low-dose TDF was an effective treatment for patients with cancer pain of moderate-to-severe intensity. Further randomized trials assessing the efficacy of TDF for severe pain and/or optimal starting doses are warranted.
Key words
Full text:
1
Index:
WPRIM
Main subject:
Pain
/
Time Factors
/
Severity of Illness Index
/
Administration, Cutaneous
/
Pain Measurement
/
Fentanyl
/
Prospective Studies
/
Treatment Outcome
/
Intention to Treat Analysis
/
Republic of Korea
Type of study:
Clinical_trials
/
Guideline
/
Observational_studies
Limits:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
/
Male
Country/Region as subject:
Asia
Language:
En
Journal:
The Korean Journal of Internal Medicine
Year:
2015
Type:
Article