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Schwenke K, Agbalaka A and Litzenburger B
Objective: This subgroup analysis of a non-interventional study that included general practitioners and internists, assessed efficacy and safety of tapentadol prolonged release (Palexia® retard) as used in routine clinical practice in Germany for the treatment of severe chronic tumor pain. Study design: Data of all patients in the study cohort who were exclusively diagnosed with ‘tumor pain’ (n=143) were included in this analysis. Data collection during the 3-month observation period included previous analgesic and concomitant treatment, tapentadol PR dosage, pain intensity, sleep and quality of life parameters and tolerability of tapentadol PR. Results: A total of 96.5% of all patients with tumor pain had already received analgesic long-term treatment before initiation of tapentadol PR therapy, 49.0% of those had received strong opioids. Switching to tapentadol PR resulted in a mean pain reduction of 3.8 points from 7.1 ± 1.4 at baseline to 3.3 ± 1.9 at end of observation (NRS-11, 11-point pain scale; descriptive p value<0.001). At end of observation, 67.4% of the patients had experienced a clinically relevant pain relief of >50%, and 89.9% of the patients attained either their desired pain reduction and/or an additional individual treatment goal; both goals had been predefined at start of tapentadol PR treatment. This was accompanied by a significant decrease in pain-related impairments of daily activities and an improvement in quality of life (descriptive p value<0.001) with an overall good tolerability of tapentadol PR. Treatment with tapentadol PR was assessed positively by physicians and patients. Conclusions: In this routine clinical practice non-interventional study, treatment with tapentadol PR resulted in effective and well-tolerated relief of severe tumor pain and improvement of pain-related impairments of daily activities and quality of life. Tapentadol PR, an innovative effective analgesic, may thus provide an alternative treatment option in the management of tumor pain.