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Use of Fentanyl Patch for Treatment of Moderate‐to‐severe Chronic Noncancer Pain: Postmarketing Surveillance of Medical Practice in Japan Using a Risk Minimization Action Plan
Author(s) -
Kawai Koji,
Yoshizawa Kazutake,
Fujie Motoko,
Kobayashi Hisanori,
Ogawa Yoshimasa,
Yajima Tsutomu
Publication year - 2017
Publication title -
pain practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.899
H-Index - 58
eISSN - 1533-2500
pISSN - 1530-7085
DOI - 10.1111/papr.12454
Subject(s) - medicine , somnolence , nausea , depression (economics) , vomiting , population , adverse effect , fentanyl , opioid , visual analogue scale , anesthesia , chronic pain , physical therapy , receptor , environmental health , economics , macroeconomics
Objective The purpose of this study was to discuss the safety, treatment profile, and clinical effectiveness of 12‐month treatment with fentanyl patch ( FP ), a strong opioid, in medical practice in Japan under the risk minimization action plan ( RMAP ). Methods Patients with moderate‐to‐severe chronic noncancer pain who had switched to FP from another opioid were registered to take this survey to assess adverse drug reactions ( ADR s), therapeutic effect, and pain intensity for up to 12 months. Results A total of 517 patients were enrolled, and 499 patients (male, 50.9%; mean [ SD ] age, 63.0 [15.4] years) were included in the safety population. During the 12‐month observation period, an ADR occurred in 262 patients (52.5%); most frequent ADR s included nausea (24.2%), somnolence (22.4%), constipation (18.2%), vomiting (9%), and dizziness (4.6%). The prespecified priority survey items, including respiratory depression, drug dependence, and drug withdrawal syndrome, occurred in 2 (both nonserious), 3 (all serious), and 9 (all serious) patients, respectively. In 418 patients from the efficacy population, the response rate was 77.3%, the rate of achievement of the therapeutic goal was 64.5%, and the visual analog scale ( VAS ) scores for pain severity decreased by 22.3 (26.9) mm. Conclusion Our results identified a reasonable risk–benefit profile for the management of moderate‐to‐severe chronic noncancer pain in patients previously treated with opioids under long‐term treatment with FP under the RMAP . Respiratory depression, drug dependency, and drug withdrawal were rarely observed even under the RMAP in Japan.