Transdermal buprenorphine in clinical practice – a post‐marketing surveillance study in 13 179 patients

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Abstract
Objective: The objective of this post-marketing surveillance study was to collect effectiveness and safety data on the labelled use of buprenorphine transdermal patches (Transtec) under routine clinical conditions. * Transtec is a registered trademark of Grünenthal GmbH, Aachen, GermanyResearch design and methods: For this open, observational study, patients with moderate to severe cancer or non-cancer pain requiring treatment with an opioid analgesic were recruited at hospitals, outpatient clinics and general practitioners’ practices in Germany. Buprenorphine transdermal patches (35 µg/h, 52.5 µg/h or 70 µg/h) were prescribed at physicians’ discretion in accordance with the product's Summary of Product Characteristics (SmPC). Patients assessed their pain relief as ‘very good’, ‘good’, ‘satisfactory’, ‘poor’ or ‘no effect’. Investigators were instructed to report all adverse events throughout the observation period. On completion, effectiveness and tolerability were evaluated for the overall study...