Transdermal Buprenorphine in Clinical Practice: A Multicenter, Postmarketing Study in the Czech Republic, with a Focus on Neuropathic Pain Components

Abstract

SUMMARY Aim: A 3-month evaluation of transdermal buprenorphine (Transtec®) in routine clinical practice in the Czech Republic. Patients & methods: A prospective, noninterventional, postmarketing study performed in 45 clinical practices (82 investigators). Buprenorphine transdermal patches 35, 52.5 or 70 µg/h were prescribed to patients with chronic moderate-to-severe cancer pain or chronic severe noncancer pain insufficiently controlled by nonopioids. Additional analgesia and adjuvant/supportive treatment was allowed at the discretion of the physician. Results: Data were evaluated for 617 patients (59% female, mean age 65 years). 55% of patients had cancer-related pain; 33% of all patients had neuropathic pain components. At month 3 (study end), mean pain intensity was reduced significantly from baseline (p < 0.01). Similar effectiveness outcomes were observed in patients (n = 203) with neuropathic pain components. Most patients rated pain relief as ‘very good‘ (47.7%) or ‘good‘ (45.7%) and >98% of evaluable patients reported improvements in sleep quality. During the study, supplemental analgesic use remained unchanged; laxative/antiemetic use was reduced (25.1% of patients [baseline] vs 17.7% [study end]). A total of 22 nonserious adverse drug reactions (mainly local skin reactions) occurred in 14 (2.3%) patients; no previously unknown adverse drug reactions occurred. Conclusion: In routine clinical practice, transdermal buprenorphine provided efficacious analgesia and was well-tolerated in patients with chronic moderate-to-severe cancer pain or chronic severe nonmalignant pain insufficiently controlled by nonopioids, including pain with neuropathic components.

Financial & competing interests disclosure

This study was funded by Grünenthal Czech s.r.o. The author has no other 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 apart from those disclosed.

The author would like to thank DP Figgitt, Content Ed Net, for providing editorial assistance in the preparation of this manuscript. Editorial assistance was funded by Grünenthal GmbH, Germany.

Ethical conduct of research

The author states that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Additional information

Funding

This study was funded by Grünenthal Czech s.r.o. The author has no other 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 apart from those disclosed. The author would like to thank DP Figgitt, Content Ed Net, for providing editorial assistance in the preparation of this manuscript. Editorial assistance was funded by Grünenthal GmbH, Germany.