SUMMARY 

Objective: A 3-month evaluation of transdermal buprenorphine (Transtec®) in routine clinical practice in the Czech Republic.

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.

Conclusions: 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.