Transdermal buprenorphine in clinical practice: results from a multicenter, noninterventional postmarketing study in Slovenia

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 mu g/h were prescribed to patients with chronic moderateto-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.