STUDY OBJECTIVE: This prospective, non-interventional study involving general practitioners and internists in Germany investigated the administration of tapentadol prolonged release (Palexia retard) for the treatment of severe chronic pain in routineclinical practice over a 3-month observation period. METHODS: Collected data included tapentadol PR dosage, previous and concomitant analgesic treatment, pain intensity, sleep and quality of life parameters, and tolerability of tapentadol PR. Effectiveness was analyzed for 3134 patients; additionally, a subgroup analysis was performed in 1331 patients with WHO III pretreatment. RESULTS: A total of 97.8% of all patients received analgesic long-term pretreatment, 42.5% of those strong opioids. Switching to tapentadol PR resulted in a mean pain reduction of 3.9 points from 7.0 +/- 1.5 at baseline to 3.1 +/- 1.8 at end of observation (NRS-11, 11-point pain scale; descriptive p value < or = 0.001); 72.1% of patients experienced a clinically relevant pain relief of > or = 50% at end of observation. A total of 89.4% of the patients attained either their intended pain reduction and/or an additional individual treatment goal at end of observation; both were established 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 < or = 0.001) with an overall good tolerability of tapentadol PR. In particular, good effectiveness of tapentadol PR treatment was reported for various pain indications in patients who had already previously been treated with strong opioids. A clinically relevant pain reduction > or = 50% was achieved in 67.2% of these patients. CONCLUSIONS: Tapentadol PR can be considered an alternative therapy to classical opioids for the treatment of severe chronic pain. Particularly for severe chronic pain requiring long-term medication, a reduction of common opioid side-effects with tapentadol PR therapy could contribute to better patient compliance.
STUDY OBJECTIVE: This prospective, non-interventional study involving general practitioners and internists in Germany investigated the administration of tapentadol prolonged release (Palexia retard) for the treatment of severe chronic pain in routineclinical practice over a 3-month observation period. METHODS: Collected data included tapentadol PR dosage, previous and concomitant analgesic treatment, pain intensity, sleep and quality of life parameters, and tolerability of tapentadol PR. Effectiveness was analyzed for 3134 patients; additionally, a subgroup analysis was performed in 1331 patients with WHO III pretreatment. RESULTS: A total of 97.8% of all patients received analgesic long-term pretreatment, 42.5% of those strong opioids. Switching to tapentadol PR resulted in a mean pain reduction of 3.9 points from 7.0 +/- 1.5 at baseline to 3.1 +/- 1.8 at end of observation (NRS-11, 11-point pain scale; descriptive p value < or = 0.001); 72.1% of patients experienced a clinically relevant pain relief of > or = 50% at end of observation. A total of 89.4% of the patients attained either their intended pain reduction and/or an additional individual treatment goal at end of observation; both were established 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 < or = 0.001) with an overall good tolerability of tapentadol PR. In particular, good effectiveness of tapentadol PR treatment was reported for various pain indications in patients who had already previously been treated with strong opioids. A clinically relevant pain reduction > or = 50% was achieved in 67.2% of these patients. CONCLUSIONS:Tapentadol PR can be considered an alternative therapy to classical opioids for the treatment of severe chronic pain. Particularly for severe chronic pain requiring long-term medication, a reduction of common opioid side-effects with tapentadol PR therapy could contribute to better patient compliance.