Assessment of Transdermal Buprenorphine Patches for the Treatment of Chronic Pain in a UK Observational Study

Abstract

Background: Opioids provide effective analgesia for moderate-to-severe, chronic pain. Transdermal buprenorphine (TDB) is available in the UK as weekly, lower-dose (5-20 μg/h) patches and twice-weekly, higher dose (35-70 μg/h) patches. This prospective, observational, multicenter study of patients with various chronic pain conditions assessed the safety, perceptions, and discontinuation of treatment with TDB in a real-world, non-interventional setting (ClinicalTrials.gov study ID: NCT01225861).

Methods: Patients aged ≥18 years who were already receiving or initiating treatment with TDB were recruited in the UK during routine clinical visits and were followed for 6 visits or 9 months (whichever came first). Self-reported treatment adherence, patient satisfaction, and safety data were collected at each study visit.

Results: Of 465 patients, 272 were already receiving 7-day TDB at the study start (TDB experienced), 146 were TDB naïve, and 47 were prescribed twice-weekly TDB. Most patients were female (72.9 %) and overweight/obese (body mass index ≥25: 75.3 %). The median age was 67 years, and the mean duration of pain was 11.1 years. Arthritis/other musculoskeletal disorders (39.6 %) were the most common causes of pain. Mild adverse events were commonly reported. Skin irritations, which were most frequent in 7-day TDB-experienced patients (45.6 %), rarely resulted in treatment discontinuation (8.8 %). Nearly all patients used TDB in accordance with treatment recommendations. Most patients reported that TDB was 'effective'/'very effective' at relieving pain and were 'satisfied'/'very satisfied' with TDB therapy.

Conclusion: In everyday clinical practice, TDB was well tolerated and patients were satisfied with their therapy. Self-reported adherence to TDB was very high, and adverse events rarely resulted in treatment discontinuation. Opportunities were identified to limit common adverse events associated with TDB.

Figures

Fig. 1

The study comprised a baseline period [during which patients already receiving or initiating treatment with transdermal buprenorphine (TDB) were recruited during routine clinical care, and Physician Questionnaire A and Patient Questionnaire A were completed] and an observational (follow-up period) of 9 months or six follow-up visits (whichever came first). At each study visit, Physician Questionnaire B and Patient Questionnaire B were completed. A Study Discontinuation Form was completed at study discontinuation

Fig. 2

The reasons for discontinuing treatment with transdermal buprenorphine in the overall population (n = 465) were adverse events (12.0 %), lack of effectiveness (4.1 %), other reasons (3.9 %), and lack of self-reported adherence (0.6 %)

Fig. 3

The most common patient-reported actions (n = 216) with transdermal buprenorphine (TDB) patches in response to skin irritation (a multiresponse question) were ‘removed patch and applied a new patch to another location’ (32.9 %), ‘other’ response (including ‘cream applied’, ‘kept patch on, no action’, ‘reduced dosage’, ‘scratch’, ‘took antihistamines’, and ‘washed and dried site’; 30.6 %), and ‘visited study doctor’ (22.7 %)

Fig. 4

Patient-reported satisfaction with transdermal buprenorphine patches (in all patients with available data). a Overall treatment effectiveness (only in patients receiving 7-day TDB). b Skin tolerability of treatment. c Overall satisfaction with treatment