Transdermal buprenorphine in clinical practice: a multicenter, noninterventional postmarketing study in the Czech Republic.

UNLABELLED 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.