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 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 (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: 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.
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Authors | Sebastiano Mercadante, Giampiero Porzio, Patrizia Ferrera, Federica Aielli, Claudio Adile, Corrado Ficorella, Antonello Giarratano, Alessandra Casuccio |
Journal | Current medical research and opinion
(Curr Med Res Opin)
Vol. 28
Issue 11
Pg. 1775-9
(Nov 2012)
ISSN: 1473-4877 [Electronic] England |
PMID | 23057488
(Publication Type: Clinical Trial, Journal Article)
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Chemical References |
- Analgesics
- Phenols
- Tapentadol
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Topics |
- Aged
- Analgesics
(therapeutic use)
- Female
- Humans
- Male
- Middle Aged
- Neoplasms
(complications)
- Pain
(drug therapy, etiology)
- Pain Measurement
- Phenols
(therapeutic use)
- Prospective Studies
- Tapentadol
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