ORIGINAL ARTICLE   

Minerva Ortopedica e Traumatologica 2020 December;71(4):168-76

DOI: 10.23736/S0394-3410.20.04023-0

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: English

Effectiveness and tolerability of tapentadol PR in the management of vertebral fracture pain due to bone fragility

Alfonso ORIENTE ✉, Elsa MAZZARELLA, Antonio DEL PUENTE

Unit of Reumatology, Department of Clinical Medicine and Surgery, University Federico II, Naples, Italy

BACKGROUND: Fragility fractures are frequent complications of osteoporosis and are associated with acute pain that very often evolves into chronic pain.
METHODS: This prospective, open-label, single-center, observational study evaluated effectiveness and tolerability of tapentadol prolonged release and assessed the association of tapentadol treatment with sleep quality, physical well-being, patient satisfaction and quality of life in patients with pain after vertebral fracture due to bone fragility.
RESULTS: Among 35 patients, a total of 29 (83%) achieved a ≥30% reduction of pain intensity and 13 (37%) patients showed a reduction of the pain on movement and at rest ≥50% after 180 days of treatment. A total of 24 adverse events occurred in 16 patients (46%), 15 of them were mild and nine were moderate, the most frequent events were headache and sleepiness. Sleep quality, physical well-being, Brief Pain Inventory Questionnaire scores and SF12 Questionnaire scores significantly improved (P<0.01) at the end of the treatment. All patients were “satisfied” or “very satisfied” with the treatment after 20 days.
CONCLUSIONS: These results highlighted the beneficial effects of tapentadol prolonged release in terms of pain intensity reduction, quality of life and functionality in patients with vertebral fracture caused by bone fragility.

KEY WORDS: Tapentadol; Pain; Osteoporosis