Shigeki Yamaguchi1, Eiji Uchida2, Takaaki Terahara3, Koji Okawa3, Fumitaka Hashimoto4, Yusuke Tanaka3. 1. Department of Anesthesia and Pain Medicine, Dokkyo Medical University School of Medicine, Tochigi, Japan. 2. Showa University, Tokyo, Japan. 3. Hisamitsu Pharmaceutical Co., Inc., 2-4-1, Marunouchi, Chiyoda-ku, Tokyo, 100-6330, Japan. 4. Hisamitsu Pharmaceutical Co., Inc., 2-4-1, Marunouchi, Chiyoda-ku, Tokyo, 100-6330, Japan. Fumitaka_Hashimoto@hisamitsu.co.jp.
Abstract
BACKGROUND AND OBJECTIVE: The use of transdermal fentanyl for opioid-naïve patients is restricted, however, transdermal fentanyl is a useful opioid analgesic for patients in whom oral administration is difficult or for those with renal failure. In this study, the efficacy and safety of fentanyl citrate patches was evaluated in opioid-naïve patients suffering from cancer pain. METHODS: An open-label uncontrolled study was conducted in opioid-naïve patients with cancer pain unable to be controlled by non-opioid analgesics. Fentanyl citrate patches starting at a low dose (0.5 mg/patch, corresponding to 6.25 μg/h fentanyl delivered) were applied once/day for up to 14 days. The analgesic effect was assessed every day from the visual analogue scale pain score and the number of doses of rescue medication. When improvement of the analgesic effect was "significant" or "moderate" at a certain dose for three consecutive days, the patient was classified as a "responder" and was considered to have "completed" the study. RESULTS: A fentanyl citrate patch was administered to 208 of 209 enrolled patients. In the full-analysis set, 87.0% of the patients were "responders" (95% confidence interval 81.7-91.3%). In 148 patients, the optimum dose was low (0.5 mg in 99, and 1 mg in 49), with patients finishing the study on days 4-8. Following dose escalation to 4 mg, respiratory depression occurred in one patient; however, this was considered a mild adverse event. CONCLUSION: A low-dose fentanyl citrate patch was effective in the management of cancer pain in opioid-naïve patients and was well tolerated. STUDY REGISTRATION: JPRN-JapicCTI-173717.
BACKGROUND AND OBJECTIVE: The use of transdermal fentanyl for opioid-naïve patients is restricted, however, transdermal fentanyl is a useful opioid analgesic for patients in whom oral administration is difficult or for those with renal failure. In this study, the efficacy and safety of fentanyl citrate patches was evaluated in opioid-naïve patients suffering from cancer pain. METHODS: An open-label uncontrolled study was conducted in opioid-naïve patients with cancer pain unable to be controlled by non-opioid analgesics. Fentanyl citrate patches starting at a low dose (0.5 mg/patch, corresponding to 6.25 μg/h fentanyl delivered) were applied once/day for up to 14 days. The analgesic effect was assessed every day from the visual analogue scale pain score and the number of doses of rescue medication. When improvement of the analgesic effect was "significant" or "moderate" at a certain dose for three consecutive days, the patient was classified as a "responder" and was considered to have "completed" the study. RESULTS: A fentanyl citrate patch was administered to 208 of 209 enrolled patients. In the full-analysis set, 87.0% of the patients were "responders" (95% confidence interval 81.7-91.3%). In 148 patients, the optimum dose was low (0.5 mg in 99, and 1 mg in 49), with patients finishing the study on days 4-8. Following dose escalation to 4 mg, respiratory depression occurred in one patient; however, this was considered a mild adverse event. CONCLUSION: A low-dose fentanyl citrate patch was effective in the management of cancer pain in opioid-naïve patients and was well tolerated. STUDY REGISTRATION: JPRN-JapicCTI-173717.
Authors: Augusto Caraceni; Geoffrey Hanks; Stein Kaasa; Michael I Bennett; Cinzia Brunelli; Nathan Cherny; Ola Dale; Franco De Conno; Marie Fallon; Magdi Hanna; Dagny Faksvåg Haugen; Gitte Juhl; Samuel King; Pål Klepstad; Eivor A Laugsand; Marco Maltoni; Sebastiano Mercadante; Maria Nabal; Alessandra Pigni; Lukas Radbruch; Colette Reid; Per Sjogren; Patrick C Stone; Davide Tassinari; Giovambattista Zeppetella Journal: Lancet Oncol Date: 2012-02 Impact factor: 41.316
Authors: Jung Hun Kang; 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 Journal: Korean J Intern Med Date: 2014-12-30 Impact factor: 2.884