Study objective: To assess effectiveness and tolerability of tapentadol prolonged release (PR, Palexia® retard) for the treatment of severe chronic pain under routine clinical practice conditions in Germany.
Methods: In this prospective non-interventional study, data regarding previous and concomitant analgesic treatment, tapentadol dosage, pain intensity, functionality, quality of life, and tolerability of tapentadol PR were collected over a 3-month observation period. A total of 5,002 patients were included in the effectiveness analysis; a subgroup analysis assessed effectiveness for all patients receiving tapentadol monotherapy (n = 1476).
Results: Nearly all patients of the total study population (95.9%) had already received analgesic long-term treatment (31.7% strong opioids) prior to the start of the study. Treatment with tapentadol PR (mean daily dose 216 ± 103 mg at end of observation) resulted in a reduction in pain intensity of 3.9 points from 7.2 ± 1.4 at baseline (95%CI -3.93; -3.83; p ≤ 0.001; NRS-11); clinically relevant pain relief ≥ 50% was documented for 65.1% of the patients. All 4 evaluated aspects regarding pain-related functionality, and quality of life of the patients also improved significantly. Compared to the total patient population, pain relief was greater in the subgroup receiving tapentadol monotherapy; baseline pain intensity was comparable between the groups. Pain-related functional impairment also declined to a slightly greater extent, and quality of life was rated more positively at end of observation.
Conclusions: Analgesic treatment with tapentadol PR in routine clinical practice resulted in a marked reduction of severe chronic pain with significant improvements of functionality and quality of life. On the basis of these results and the favourable safety profile, tapentadol PR can thus be considered an alternative to classical opioids in the treatment of severe chronic pain.