c i a l D i s t r i b u t i o n U n a u t h o r i z e d u s e p r o h i b i t e d . A u t h o r i s e d u s e r s c a n d o w n l o a d , d i s p l a y , v i e w a n d p r i n t a s i n g l e c o p y f o r p e r s o n a l u s eCurrent Medical Research & Opinion Vol. 28, No. 11, 2012, 1775-1779
AbstractObjectives:The aim of this prospective, open-label study was to evaluate the efficacy and tolerability of tapentadol (TP) in the management of cancer pain.
Methods:A 4 weeks' prospective study was carried out in 50 opioid-naive cancer patients with moderate-severe pain. Each patient initially received twice-daily doses of slow-release TP 50 mg. Doses were then managed to maintain adequate relief or dose-limiting toxicity, on the basis of the clinical response. The following parameters were recorded at weekly intervals for 4 weeks: pain and opioid-related adverse effects, quality of life measured with the Spitzer score, TP escalation index percent (TPEI%) and TP escalation index in mg (TPEImg), calculated at the end of the study, pain mechanisms, and PainDETECT at baseline.
Results:Of 50 patients, 39 completed the entire study and 11 discontinued the treatment for different reasons. Pain intensity significantly decreased from baseline to all the week intervals (p50.0005), and adverse effects did not changed significantly, while quality of life improved. TP escalation indexes were low and no relationship was found with age, gender, and pain mechanisms.
Conclusion:Tapentalol started in doses of 100 mg/day was well-tolerated and effective in opioid-naive patients with cancer pain, regardless of the pain mechanism. It can be considered as a flexible drug to be used in patients with moderate-severe pain.
Limitations:This was an open-label study for exploratory purposes. Data should be confirmed in controlled studies with a larger number of patients.
IntroductionCancer pain management is based on a sequential approach of drugs, as suggested by the WHO, through steps corresponding to drugs with different potencies. Application of the WHO three-step analgesic ladder has been reported to provide satisfactory pain relief in up to 90% of patients with cancer pain 1 . This approach has had an impact of paramount importance in terms of clinical outcome and educational perspective, although evidence is lacking, particularly with regard to possible alternatives, because of the paucity of controlled studies in this field. More recently, studies have examined the role of opioid analgesics and confirmed that more data are necessary 2 . It is anticipated that new drugs will be evaluated in the near future. For personal use only.