Long-term, prolonged-release oral tapentadol for treatment of refractory chronic low back pain: a single-center, observational study

BACKGROUND: Chronic back pain is a leading cause of disability worldwide and it is still inadequately treated. Tapentadol is a dual-acting analgesic drug μ-opioid receptor (MOR) agonist/norepinephrine reuptake inhibitor, carrying a lower risk for opioid withdrawal symptoms and opioid-related adverse effects in comparison to potent opioid drugs. This study investigates the effectiveness, safety and tolerability of the prolonged release oral formulation of tapentadol (tapentadol PR) in 27 patients affected by refractory chronic low back pain during a long-term follow-up (up to 51 months). METHODS: This is an observational study conducted at the Pain Therapy and Palliative Care Unit of University Hospital of Cagliari, Italy. We enrolled 27 patients affected by chronic low back pain refractory to other pharmacological treatments according to the inclusion criteria. We prospectively evaluated oral tapentadol PR therapy during a long-term follow-up (up to 51 months) according to the following outcomes: pain intensity during the previous 72 hours (Numeric Rating Scale 3), quality of life (Short Form-12 Health Survey), self-reported treatment effectiveness (Patient Global Impression of Change scale), physician evaluation of treatment effectiveness (Clinician Global Impression of Change scale), treatment-related adverse effects, reason for tapentadol therapy interruption and tapentadol dosage. RESULTS: All the patients reported a significant improvement of pain intensity and quality of life at the last follow-up. CONCLUSIONS: These results show the long-term effectiveness, safety and tolerability of oral tapentadol PR for the treatment of refractory chronic low back pain in a real-life clinical setting.