Transdermal Buprenorphine in Clinical Practice: A Multicenter, Noninterventional Postmarketing Study in the Czech Republic

Abstract

SUMMARY Aim: To evaluate the use of transdermal buprenorphine patches (Transtec®) in routine clinical practice. Patients & methods: A prospective, noninterventional, postmarketing study performed in the Czech Republic by 71 investigators in various clinical practice settings. Patients with chronic moderate-to-severe cancer pain, or chronic severe noncancer pain insufficiently controlled by nonopioids, were prescribed buprenorphine transdermal patch 35, 52.5 or 70 µg/h, and evaluated for 3 months. Additional analgesia and adjuvant/supportive treatments were allowed (physician discretion). Results: Data were evaluated for 630 patients (54% female, mean age 64 years). Most (>60%) patients had cancer-related pain. Noncancer pain was musculoskeletal (66.4%), neuropathic (25.9%) or nociceptive (6.0%). The mean dose of transdermal buprenorphine at study initiation was 40.6 µg/h. Compared with baseline (numerical rating scale [NRS]: 6.9), mean pain intensity (0–10 NRS) decreased significantly (p < 0.01) at 1 month (NRS: 2.9) and study end (NRS: 2.2). Most (>90%) patients rated pain relief as ‘very good‘ or ‘good‘, >97% of evaluable patients reported improvements in sleep quality and 87% of all evaluated patients were willing to continue transdermal buprenorphine after study completion. During the study, supplemental analgesic use remained unchanged; laxative/antiemetic use reduced (30.9% of patients [baseline] vs 23.3% [study end]). Twenty four nonserious adverse drug reactions (mainly local skin reactions) occurred in 19 (3%) patients. Conclusion: In routine clinical practice in the Czech Republic, transdermal buprenorphine was efficacious and well tolerated in patients with chronic moderate-to-severe cancer pain or chronic severe noncancer pain insufficiently controlled by nonopioids.

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 thanks DP Figgitt, Content Ed Net, for providing editorial assistance in the preparation of this manuscript. Funding for this editorial assistance was provided 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 thanks DP Figgitt, Content Ed Net, for providing editorial assistance in the preparation of this manuscript. Funding for this editorial assistance was provided by Grünenthal GmbH, Germany.