49EVALUATION OF BUPRENORPHINE TRANSDERMAL SYSTEM (BTDS) AMONG ELDERLY SUBJECTS WITH CHRONIC, MODERATE-TO-SEVERE OSTEOARTHRITIS PAIN OF THE HIP AND/OR KNEE

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Abstract

Introduction: Buprenorphine transdermal system (BTDS) provides a suitable option for pain relief compared with other low potency opioids in the elderly patients due to the pharmacokinetic profile and the transdermal route of administration. However, specific data on the use in elderly subjects are limited.

Methods: Subjects divided into two age groups, 50–60 years and ≥75 years, with osteoarthritis (OA) of the hip and/or knee and moderate-to-severe chronic pain confirmed by an average Box Scale-11 (BS-11) score ≥ 4 during the previous week, were enrolled. The subjects had a history of inadequate pain relief from previous treatment with 2,000–4,000 mg paracetamol daily. All the subjects started the treatment with BTDS 5 µg/h with subsequent titration to a maximum of BTDS 40 µg/h to achieve a stable pain control during the study period of 3 months.

The primary endpoint was the difference in the BS-11 pain score from baseline to completion of the study. Safety was assessed via adverse events (AEs) and laboratory parameters.

Results: In total, 80 patients completed the study per protocol (PP). Both age groups showed a significant reduction in pain from baseline to completion. The reduction in mean BS-11 scores for the PP population was 2.05 (CI: −1.30 to 2.80) versus 2.49 (CI: −1.78 to 3.20) for the young and the elderly, respectively. The difference in change in the mean BS-11 between the two age groups was −0.44 (CI: −0.55 to 1.42). The lower limit was >−1.5 which was within the pre-specified non-inferiority parameters and therefore demonstrates that the efficacy of the elderly subjects is not inferior to the younger subjects. Patients with at least one AE was similar for both age groups.

Conclusion: The BTDS is an effective and well-tolerated analgesic in the elderly in the treatment of chronic joint pain associated with OA.

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