RESUMEN
This noninterventional, prospective study investigated the administration of tapentadol prolonged release (PR; the dosage form described in this article is commercially available in Germany as Palexia retard; Grünenthal GmbH, Aachen) for severe chronic pain in routine clinical practice over a 3-month period. Effectiveness analyses included data from 3134 patients; 1331 received World Health Organization (WHO) Step III pretreatment. A total of 97.8% of patients received long-term analgesic pretreatment (42.5% with strong opioids). Switching to tapentadol PR produced a 3.9-point mean pain reduction (baseline, 7.0 ± 1.5; end of observation, 3.1 ± 1.8; 11-point numerical rating scale; descriptive P value ≤.001); 72.1% of patients experienced clinically relevant pain relief (≥50%) at the end of observation. Significant decreases in pain-related impairment of daily activities and improvements in quality of life (descriptive P value ≤.001) were observed with tapentadol PR with good tolerability. Tapentadol PR was effective for various pain indications in patients previously receiving strong opioids (67.2% achieved clinically relevant pain relief). Tapentadol PR can be considered an alternative therapy to classical opioids for treatment of severe chronic pain.
Asunto(s)
Analgésicos Opioides/uso terapéutico , Dolor Crónico/tratamiento farmacológico , Fenoles/uso terapéutico , Calidad de Vida , Actividades Cotidianas , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/efectos adversos , Dolor Crónico/fisiopatología , Preparaciones de Acción Retardada , Femenino , Alemania , Humanos , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Fenoles/administración & dosificación , Fenoles/efectos adversos , Estudios Prospectivos , Índice de Severidad de la Enfermedad , Tapentadol , Resultado del TratamientoRESUMEN
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.