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      Managing severe cancer pain: the role of transdermal buprenorphine: a systematic review

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          Pain is a frequent and important symptom in cancer patients. Among the available strong opioids, transdermal buprenorphine has been licensed in Europe since 2002, and results from a few clinical studies suggest that it may be a good alternative to the other oral or transdermal opioids. To assess the best available evidence on its efficacy and safety, we carried out a systematic literature review with the aim of pooling relevant studies. We identified 19 eligible papers describing 12 clinical studies (6 randomized controlled trials and 6 observational prospective studies), including a total of about 5000 cancer patients. Given the poor quality of reports and the heterogeneity of methods and outcomes, pooling was not feasible as the type of data was not appropriate for combining the results statistically. A meta-analysis based on individual data is ongoing in the context of the Cochrane Collaboration. In conclusion, although the narrative appraisal of each study suggests a positive risk benefit profile, well designed and statistically powered controlled clinical trials are needed to confirm this preliminary evidence.

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          Most cited references 8

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          Efficacy and safety of transdermal buprenorphine: a randomized, placebo-controlled trial in 289 patients with severe cancer pain.

          Strong opioids are recommended for treating severe cancer pain in the advanced stages of the disease. Few data are available concerning the efficacy of buprenorphine in cancer pain. We compared transdermal buprenorphine 70 microg/h (BUP TDS) to placebo in an enriched design study. Opioid-tolerant patients with cancer pain requiring strong opioids in the dose range of 90-150 mg/d oral morphine equivalents entered a two-week run-in phase, during which they were converted to BUP TDS. Patients who could be stabilized on BUP TDS were randomized to BUP TDS or placebo patch for a two-week maintenance phase. Rescue medication (buprenorphine sublingual tablets 0.2mg) was allowed as required. Response was defined as a mean pain intensity of <5 (0-10 scale) and a mean daily buprenorphine sublingual tablet intake of < or =2 tablets during the maintenance phase. Of 289 patients who entered the run-in phase, 100 discontinued treatment due to lack of efficacy or adverse events; 189 patients continued treatment in the maintenance phase (94 BUP TDS, 95 placebo), of whom 31 discontinued treatment (7 BUP TDS, 24 placebo). A significant difference in the number of treatment responders was observed: 70 BUP TDS (74.5%, 65.7-83.3) vs. 47 placebo (50%, 39.9-60.1) (P=0.0003). This result was supported by a lower daily pain intensity, lower intake of buprenorphine sublingual tablets and fewer dropouts in the BUP TDS group. The incidence of adverse events was slightly higher for BUP TDS. In conclusion, BUP TDS 70 microg/h is an efficacious and safe treatment for patients with severe cancer pain.
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            Buprenorphine in long-term control of chronic pain in cancer patients.

            The aim of this randomized open-label prospective study was to evaluate the analgesic activity of buprenorphine in a transdermal formulation for cancer chronic pain control versus sustained-release morphine, in all cases combined with oral tramadol. A transdermal system with 35 microg/h buprenorphine was applied to the first group of patients (BT); the second group received 60 mg/day of sustained-release morphine (MT). In both groups oral tramadol was administered to a maximum of 200 mg daily, in case of need. The administration of transdermal buprenorphine versus morphine resulted in significant differences in the physical pain (P = 0.01), mental health (P = 0.03) and vitality (P = 0.001). These data indicated that the BT group showed an improvement of pain and a positive effect on the quality life.
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              Buprenorphine : characteristics of binding sites in the rat central nervous system.


                Author and article information

                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                15 September 2009
                : 5
                : 707-718
                [1 ] Center for the Evaluation and Research on Pain (CERP), Istituto di Ricerche Farmacologiche “Mario Negri”, Milan, Italy
                [2 ] Istituto di Statistica Medica e Biometria “GA Maccacaro”, Università degli studi di Milano, Milan, Italy
                [3 ] Italian Cochrane Center, Istituto di Ricerche Farmacologiche “Mario Negri”, Milan, Italy
                Author notes
                Correspondence: Giovanni Apolone, Center for the Evaluation and Research on Pain (CERP), Istituto di Ricerche Farmacologiche “Mario Negri”, Via La Masa 19, 20156 Milan Italy, Tel +39 02 39014-515, Fax +39 02 33200-231, Email apolone@ 123456marionegri.it
                © 2009 Deandrea et al, publisher and licensee Dove Medical Press Ltd.

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.



                systematic review, transdermal buprenorphine, cancer pain


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