The efficacy of low-dose transdermal fentanyl in opioid-naive cancer patients with moderate-to-severe pain.
10.3904/kjim.2015.30.1.88
- Author:
Jung Hun KANG
1
;
Sung Yong OH
;
Seo Young SONG
;
Hui Young LEE
;
Jung Han KIM
;
Kyoung Eun LEE
;
Hye Ran LEE
;
In Gyu HWANG
;
Se Hoon PARK
;
Won Seok KIM
;
Young Suk PARK
;
Keunchil PARK
Author Information
1. Department of Internal Medicine, Gyeongsang National University School of Medicine, Jinju, Korea.
- Publication Type:Original Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
- Keywords:
Transdermal patch;
Fentanyl;
Neoplasms;
Pain;
Opioids
- MeSH:
Administration, Cutaneous;
Adult;
Aged;
Aged, 80 and over;
Analgesics, Opioid/*administration & dosage/adverse effects;
Female;
Fentanyl/*administration & dosage/adverse effects;
Humans;
Intention to Treat Analysis;
Male;
Middle Aged;
Neoplasms/*complications;
Pain/diagnosis/*drug therapy/etiology;
Pain Measurement;
Prospective Studies;
Republic of Korea;
Severity of Illness Index;
Tertiary Care Centers;
Time Factors;
Transdermal Patch;
Treatment Outcome
- From:The Korean Journal of Internal Medicine
2015;30(1):88-95
- CountryRepublic of Korea
- Language:English
-
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.
