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Transdermal buprenorphine (Transtec ® ) in clinical practice: an introduction to three short communications

2012; Future Medicine; Volume: 2; Issue: 2 Linguagem: Inglês

10.2217/pmt.11.90

1758-1877

Marek Hakl, Dana Vondráčková, Nevenka Krčevski Škvarč,

Pain Mechanisms and Treatments

Pain ManagementVol. 2, No. 2 Theme: Transdermal buprenorphine in clinical practice - ForewordFree AccessTransdermal buprenorphine (Transtec®) in clinical practice: an introduction to three short communicationsMarek Hakl, Dana Vondráčková & Nevenka Krcevski SkvarcMarek HaklMasaryk University Brno, St Anne's University Hospital Brno, Department of Anesthesiology, Brno, Czech Republic, Dana VondráčkováCzech Republic Charles University Prague, University Hospital Bulovka, Department of Anesthesiology, Prague, Czech Republic & Nevenka Krcevski Skvarc* Author for correspondenceUniversity Clinical Centre Maribor, Department of Anesthesiology, Intensive Care & Pain Management, Ljubljanska 5, Maribor 2000, Slovenia. Published Online:8 Mar 2012https://doi.org/10.2217/pmt.11.90AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail Data from the International Association on the Study of Pain (IASP) and the European Federation of the IASP Chapters indicate that moderate-to-severe chronic pain affects one in five people, and that one in three are unable, or less able, to maintain an independent lifestyle due to their pain. Approximately 50–60% of people with chronic pain are less able or unable to exercise, enjoy normal sleep, perform household chores, attend social activities, drive a car, walk or have sexual relations [101,102]. Moderate-to-severe chronic pain can be associated with cancer or noncancer conditions (e.g., musculoskeletal, neuropathy and nociceptive pain).WHO advocates the following three-step ladder for the relief of cancer pain: step 1: nonopioids; step 2: weak opioids, as necessary; step 3: strong opioids, until adequate pain relief is achieved [103].Buprenorphine, a centrally acting opioid analgesic, binds with high affinity to µ-opioid receptors (agonist) and to κ-opioid receptors (antagonist) [1,2]. Historically, there were concerns relating to a possible analgesic 'ceiling effect' with buprenorphine but these concerns have since been disproved; on the other hand, buprenorphine displays a ceiling effect for respiratory depression, which is a positive safety characteristic [2]. Initially available in parenteral and sublingual formulations, a transdermal buprenorphine patch (Transtec®, Grünenthal GmbH, Aachen, Germany) was introduced in 2001 [2]. Transtec is available in three dose strengths: 35, 52.5 and 70 µg/h, corresponding to buprenorphine 0.8, 1.2 and 1.6 mg/day, respectively [3,104]. According to the manufacturer's labeling, up to two Transtec patches can be combined, equating to buprenorphine doses of up to 140 µg/h or 3.2 mg/day [104]. Buprenorphine is released from the Transtec patch for up to 96 h [3].Randomized controlled clinical trials established the efficacy and tolerability of transdermal buprenorphine in patients with chronic cancer or noncancer pain [4–6]. These results were subsequently confirmed in several long-term follow-up studies [7], large, prospective, postmarketing surveillance studies in normal clinical practice settings [8,9] and retrospective pharmaco-epidemiological studies [10–12]. In addition, it has been shown that the efficacy and safety of transdermal buprenorphine in elderly patients is similar to that in younger patients [13,14].The three noninterventional, postmarketing studies reported in this issue as short communications evaluated, under routine clinical conditions, the analgesic effectiveness, safety and tolerability of transdermal buprenorphine in >1600 patients with moderate-to-severe chronic pain. Data were collected and analyzed for patients in whom the use of buprenorphine transdermal patches was medically indicated and planned by treating physicians in routine clinical practice across the Czech Republic (two separate studies: Vondráčková D [15] and Hakl M [16]) and Slovenia (Skvarc NK [17]). As discussed in the following three short communications, these data add to the growing body of evidence in support of the effectiveness and general safety profile of the transdermal buprenorphine patch system.Financial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.The authors thank David P Figgitt PhD, Content Ed Net, for providing editorial assistance in the preparation of this Foreword. Funding for editorial assistance was provided by Grünenthal GmbH, Germany.References1 Huang P, Kehner GB, Cowan A, Liu-Chen LY. Comparison of pharmacological activities of buprenorphine and norbuprenorphine: norbuprenorphine is a potent opioid agonist. J. Pharmacol. Exp. Ther.297,688–695 (2001).Medline, CAS, Google Scholar2 Pergolizzi J, Aloisi AM, Dahan A et al. Current knowledge of buprenorphine and its unique pharmacological profile. Pain Pract.10,428–450 (2010).Crossref, Medline, Google Scholar3 Kress HG. Clinical update on the pharmacology, efficacy and safety of transdermal buprenorphine. Eur. J. Pain13,219–230 (2009).Crossref, Medline, CAS, Google Scholar4 Böhme K, Likar R. Efficacy and tolerability of a new opioid analgesic formulation, buprenorphine transdermal therapeutic system (TDS), in the treatment of patients with chronic pain. A randomised, double-blind, placebo-controlled study. Pain Clinic15,193–202 (2003).Crossref, Google Scholar5 Sittl R, Griessinger N, Likar R. Analgesic efficacy and tolerability of transdermal buprenorphine in patients with inadequately controlled chronic pain related to cancer and other disorders: a multicenter, randomized, double-blind, placebo-controlled trial. Clin. Ther.25,150–168 (2003).Crossref, Medline, CAS, Google Scholar6 Sorge J, Sittl R. Transdermal buprenorphine in the treatment of chronic pain: results of a Phase III, multicenter, randomized, double-blind, placebo-controlled study. Clin. Ther.26,1808–1820 (2004).Crossref, Medline, CAS, Google Scholar7 Likar R, Kayser H, Sittl R et al. Long-term management of chronic pain with transdermal buprenorphine: a multicenter, open-label, follow-up study in patients from three short-term clinical trials. Clin. Ther.28,943–952 (2006).Crossref, Medline, CAS, Google Scholar8 Griessinger N, Sittl R, Likar R. Transdermal buprenorphine in clinical practice – a post-marketing surveillance study in 13,179 patients. Curr. Med. Res. Opin.21,1147–1156 (2005).Crossref, Medline, CAS, Google Scholar9 Muriel C, Failde I, Micó JA et al. Effectiveness and tolerability of the buprenorphine transdermal system in patients with moderate to severe chronic pain: a multicenter, open-label, uncontrolled, prospective, observational clinical study. Clin. Ther.27,451–462 (2005).Crossref, Medline, CAS, Google Scholar10 Barutell C, Camba A, González-Escalada JR et al. Efficacy and safety of buprenorphine TDS in conjunction with oral tramadol or morphine as rescue medication in the treatment of 390 patients with chronic pain: a summary of two retrospective Spanish multicentre studies. J. Appl. Ther. Res.6,14–24 (2007).Google Scholar11 Camba MA, Rodríguez-López MJ, Muriel C; Grupo de Studio de Opioides de la Socieda Española del Dolor. Buprenorphine TDS in the treatment of chronic nociceptive, neuropathic and cancer-related pain. J. Appl. Ther. Res.6,3–13 (2007).CAS, Google Scholar12 Barutell C, Camba A, González-Escalada JR et al. High dose transdermal buprenorphine for moderate to severe pain in Spanish pain centres – a retrospective multicenter safety and efficacy study. Pain Pract.8,355–361 (2008).Crossref, Medline, Google Scholar13 Likar R, Vadlau EM, Breschan C et al. Comparable analgesic efficacy of transdermal buprenorphine in patients over and under 65 years of age. Clin. J. Pain24,536–543 (2008).Crossref, Medline, Google Scholar14 Muriel Villoria C, Perez-Castejon Garotte JM, Sanchez Magro I, Neira Alvarez I. Effectiveness and safety of transdermal buprenorphine for chronic pain treatment in the elderly: a prospective observational study. Med. Clin.128,204–210 (2007).Crossref, Medline, Google Scholar15 Vondrácková D. Transdermal buprenorphine in clinical practice: a multicenter, noninterventional postmarketing study in the Czech Republic. Pain Manage.2(2),163–168 (2012).Link, Google Scholar16 Hakl M. Transdermal buprenorphine in clinical practice: a multicenter, postmarketing study in the Czech Republic, with a focus on neuropathic pain components. Pain Manage.2(2),169–175 (2012).Link, Google Scholar17 Skvarc NK. Transdermal buprenorphine in clinical practice: results from a multicenter, noninterventional postmarketing study in Slovenia. Pain Manage.2(2),177–183 (2012).Link, Google Scholar101 European Federation of IASP Chapters. www.efic.org (Accessed 8 March 2011)Google Scholar102 International Association for the Study of Pain. www.iasp-pain.org (Accessed 8 March 2011)Google Scholar103 WHO. WHO's pain ladder. www.who.int/cancer/palliative/painladder/en (Accessed 8 March 2011)Google Scholar104 Grünenthal GmbH. Transtec 35, 52.5 and 70 micrograms per hour transdermal patch – summary of product characteristics. www.grunenthal.com/cms/cda/_common/inc/display_file.jsp?fileID=9400035 (Accessed 8 March 2011)Google ScholarFiguresReferencesRelatedDetails Vol. 2, No. 2 Follow us on social media for the latest updates Metrics Downloaded 868 times History Published online 8 March 2012 Published in print March 2012 Information© Future Medicine LtdFinancial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.The authors thank David P Figgitt PhD, Content Ed Net, for providing editorial assistance in the preparation of this Foreword. Funding for editorial assistance was provided by Grünenthal GmbH, Germany.PDF download