Transdermal Buprenorphine in Clinical Practice: Results from a Multicenter, Noninterventional Postmarketing Study in Slovenia

Abstract

SUMMARY Aim: A 3-month routine clinical practice evaluation of buprenorphine transdermal patch use in Slovenia. Patients & methods: A prospective, noninterventional, postmarketing study performed by 68 investigators in 42 clinical practice settings. 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 nonopioid analgesics or weak opioids. At physician discretion, additional analgesia and adjuvant/supportive treatment was allowed. Results: Data were evaluated for 374 patients (56% female, mean age 69 [range 35–100] years), with cancer-related (53%) or noncancer (46%) pain. Reasons for switching to transdermal buprenorphine included intense pain (insufficient pain relief), good prior patient experience with transdermal buprenorphine, adverse reaction or development of tolerance to previous pain therapy, and the beneficial safety profile of transdermal buprenorphine. Mean pain intensity (baseline: 7.4; 0–10 numerical rating scale) was reduced at final assessment (2.3). Pain relief was rated ‘very good‘ or ‘good‘ in 82% of patients at final assessment. Dose stability was good throughout the study; overall, more patients received supportive antiemetics/laxatives during the study than prior to starting transdermal buprenorphine. One hundred and seventy seven nonserious adverse drug reactions (mainly local skin reactions) occurred in 100 (27%) patients. Treatment was discontinued due to unsatisfactory pain relief (4.6%) or adverse drug reactions (7%). Conclusion: In routine Slovenian clinical practice, transdermal buprenorphine provided efficient analgesia and was well-tolerated in patients with chronic moderate-to-severe cancer pain or chronic severe noncancer pain insufficiently controlled by nonopioids and, as the study results indicate, also in chronic severe noncancer pain insufficiently controlled by weak opioids.

Acknowledgements

The author thanks all general practitioners and pain specialists who participated in the study.

Financial & competing interests disclosure

This study was funded by Grünenthal d.o.o, Slovenia. 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 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 d.o.o, Slovenia. 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 editorial assistance was provided by Grünenthal GmbH, Germany.