{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,10,3]],"date-time":"2023-10-03T07:45:55Z","timestamp":1696319155336},"reference-count":18,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2016,4,15]],"date-time":"2016-04-15T00:00:00Z","timestamp":1460678400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Janssen Pharmaceutical K.K. of Johnson & Johnson in Japan"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pain Practice"],"published-print":{"date-parts":[[2017,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>The purpose of this study was to discuss the safety, treatment profile, and clinical effectiveness of 12\u2010month treatment with fentanyl patch (<jats:styled-content style=\"fixed-case\">FP<\/jats:styled-content>), a strong opioid, in medical practice in Japan under the risk minimization action plan (<jats:styled-content style=\"fixed-case\">RMAP<\/jats:styled-content>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with moderate\u2010to\u2010severe chronic noncancer pain who had switched to <jats:styled-content style=\"fixed-case\">FP<\/jats:styled-content> from another opioid were registered to take this survey to assess adverse drug reactions (<jats:styled-content style=\"fixed-case\">ADR<\/jats:styled-content>s), therapeutic effect, and pain intensity for up to 12 months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 517 patients were enrolled, and 499 patients (male, 50.9%; mean [<jats:styled-content style=\"fixed-case\">SD<\/jats:styled-content>] age, 63.0 [15.4] years) were included in the safety population. During the 12\u2010month observation period, an <jats:styled-content style=\"fixed-case\">ADR<\/jats:styled-content> occurred in 262 patients (52.5%); most frequent <jats:styled-content style=\"fixed-case\">ADR<\/jats:styled-content>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 (<jats:styled-content style=\"fixed-case\">VAS<\/jats:styled-content>) scores for pain severity decreased by 22.3 (26.9) mm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Our results identified a reasonable risk\u2013benefit profile for the management of moderate\u2010to\u2010severe chronic noncancer pain in patients previously treated with opioids under long\u2010term treatment with <jats:styled-content style=\"fixed-case\">FP<\/jats:styled-content> under the <jats:styled-content style=\"fixed-case\">RMAP<\/jats:styled-content>. Respiratory depression, drug dependency, and drug withdrawal were rarely observed even under the <jats:styled-content style=\"fixed-case\">RMAP<\/jats:styled-content> in Japan.<\/jats:p><\/jats:sec>","DOI":"10.1111\/papr.12454","type":"journal-article","created":{"date-parts":[[2016,4,15]],"date-time":"2016-04-15T05:03:28Z","timestamp":1460696608000},"page":"239-248","source":"Crossref","is-referenced-by-count":3,"title":["Use of Fentanyl Patch for Treatment of Moderate\u2010to\u2010severe Chronic Noncancer Pain: Postmarketing Surveillance of Medical Practice in Japan Using a Risk Minimization Action Plan"],"prefix":"10.1111","volume":"17","author":[{"given":"Koji","family":"Kawai","sequence":"first","affiliation":[{"name":"Medical Affairs Division Janssen Pharmaceutical K.K. Tokyo Japan"},{"name":"Ishinomaki Branch Sendai Pain Clinic Center Medical Corporation Kanteikai Sendai Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazutake","family":"Yoshizawa","sequence":"additional","affiliation":[{"name":"Medical Affairs Division Janssen Pharmaceutical K.K. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Motoko","family":"Fujie","sequence":"additional","affiliation":[{"name":"Japan Safety &amp; Surveillance Division Janssen Pharmaceutical K.K. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hisanori","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Medical Affairs Division Janssen Pharmaceutical K.K. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshimasa","family":"Ogawa","sequence":"additional","affiliation":[{"name":"Japan Safety &amp; Surveillance Division Janssen Pharmaceutical K.K. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tsutomu","family":"Yajima","sequence":"additional","affiliation":[{"name":"Biostatistics Department Quantitative Science Division Janssen Pharmaceutical K.K. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,4,15]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"crossref","first-page":"E1","DOI":"10.36076\/ppj.2014\/17\/E1","article-title":"Opioids in chronic non\u2010cancer pain: have we reached a boiling point yet?","volume":"17","author":"Manchikanti L","year":"2014","journal-title":"Pain Physician."},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.5055\/jom.2011.0066"},{"key":"e_1_2_7_4_1","first-page":"1","article-title":"Opioid guidelines in the management of chronic non\u2010cancer pain","volume":"9","author":"Trescot AM","year":"2006","journal-title":"Pain Physician."},{"key":"e_1_2_7_5_1","first-page":"S5","article-title":"Opioids in the management of chronic non\u2010cancer pain: an update of American Society of the Interventional Pain Physicians' (ASIPP) guidelines","volume":"11","author":"Trescot AM","year":"2008","journal-title":"Pain Physician."},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpain.2008.10.008"},{"key":"e_1_2_7_7_1","first-page":"137","article-title":"Survey on the actual situation of chemotherapy\u2010based treatment for chronic pain\u2014comparison among Japan, the United States, and Germany","volume":"28","author":"Saito Y","year":"2010","journal-title":"Pharma Medica."},{"key":"e_1_2_7_8_1","first-page":"303","article-title":"Fentanyl transdermal matrix patch (Durotep\u00ae patch)","volume":"35","author":"Hori N","year":"2014","journal-title":"Pain Clin."},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2006.02758.x"},{"key":"e_1_2_7_10_1","unstructured":"FDA Guidance for industry development and use of risk minimization action plans 2005.http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM071616.pdf. (accessed June 15 2015)"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejpain.2005.06.009"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar1782"},{"key":"e_1_2_7_13_1","first-page":"157","article-title":"Clinical trial of Durotep\u00ae MT patch in patients with chronic non\u2010cancer pain: 4\u2010week and long\u2010term (52\u2010week) applications","volume":"59","author":"Miyazaki H","year":"2010","journal-title":"J New Remedies Clin."},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.21884"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2015.1091975"},{"key":"e_1_2_7_16_1","first-page":"181","article-title":"Clinical trial of Durotep\u00ae MT patch in patients with chronic non\u2010cancer pain: a multicenter open\u2010label uncontrolled trial","volume":"59","author":"Miyazaki H","year":"2010","journal-title":"J New Remedies Clin."},{"key":"e_1_2_7_17_1","volume-title":"Japan Society of Pain Clinicians\u2014Guidelines for Prescribing Opioid Analgesics for Chronic Non\u2010Cancer Pain","author":"The Committee for the Guidelines for Prescribing Opioid Analgesics for Chronic Non\u2010cancer Pain of JSPC","year":"2012"},{"key":"e_1_2_7_18_1","volume-title":"MT Patch [Package Insert]","author":"Durotep\u00ae","year":"2013"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.berh.2005.03.003"}],"container-title":["Pain Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fpapr.12454","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fpapr.12454","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/papr.12454","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,2]],"date-time":"2023-10-02T06:24:39Z","timestamp":1696227879000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/papr.12454"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,4,15]]},"references-count":18,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2017,2]]}},"alternative-id":["10.1111\/papr.12454"],"URL":"https:\/\/doi.org\/10.1111\/papr.12454","archive":["Portico"],"relation":{},"ISSN":["1530-7085","1533-2500"],"issn-type":[{"value":"1530-7085","type":"print"},{"value":"1533-2500","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,4,15]]}}}