Tapentadol in cancer pain management: a prospective open-label study.
Curr Med Res Opin. 2012 Oct 11;
Authors: Mercadante S, Gianpiero P, Ferrera P, Federica A, Adile C, Ficorella C, Giarratano A, Casuccio A
Abstract Objectives: 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 four 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 week intervals for four weeks: pain and opioid-related adverse effects, quality of life measured with Spitzer score, TP escalation index per cent (TPEI%) and TP escalation index in mg (TPEImg), calculated at the end of the study, pain mechanisms, and PainDETECT at baseline. Results: Of fifty patients, 39 patients concluded the entire study and 11 discontinued the treatment for different reasons. Pain intensity significantly decreased from baseline to all the week intervals (P<0.0005), 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: TP 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 could be considered as a flexible drug to be used in patients with moderate-severe pain. Limitations: This was an open-label study with exploratory purposes. Data should be confirmed in controlled studies with a large number of patients.
PMID: 23057488 [PubMed - as supplied by publisher]