Efficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe, chronic malignant tumor-related pain

Abstract

Tapentadol ER (25-200 mg bid) provides analgesic efficacy that is non-inferior to that provided by oxycodone HCl CR (5-40 mg bid) for the management of moderate to severe, chronic malignant tumor-related pain, and is well tolerated overall, with a better gastrointestinal tolerability profile than oxycodone CR.

Impact of Prolonged-release Oxycodone/Naloxone on Outcomes Affecting Patients' Daily Functioning in Comparison With Extended-release Tapentadol: A Systematic Review

“…Of the 15 included RCTs, 8 evaluated the efficacy and tolerability of tapentadol, [28][29][30][31][32][33][34][35] and 7 investigated the efficacy and tolerability of oxycodone/naloxone. 16,18,[36][37][38][39] Most trials were in Phase III (11 trials), 2 trials were in Phase II, 30,37 and 1 trial was in Phase IV.…”

“…The study by Cloutier et al 36 and the OXN4502 trial 39 were conducted at multiple centers in Canada and the United Kingdom, respectively. The method of randomization generation and concealment of allocation were judged to be adequate in 7 trials, 28,29,[31][32][33]36,37 whereas in the remaining 8 trials these were unclear.…”

Practical Considerations for the Use of Tapentadol Prolonged Release for the Management of Severe Chronic Pain

“…[36][37][38]42,45,56 The concomitant use of WHO step I analgesics and coanalgesics was permitted in the 4 previously described open-label, Phase IIIb studies of tapentadol PR in patients with low back pain with or without a neuropathic pain component 37,45 or with osteoarthritis knee pain. 38 42,85,86 tapentadol PR used concomitantly with morphine IR and oxycodone IR was well tolerated. Although only the concomitant use of morphine IR and oxycodone IR for breakthrough pain has been evaluated, these findings suggest that other IR opioids could be safely used as well.…”

Spinal neuronal correlates of tapentadol analgesia in cancer pain: A back‐translational approach

“…In cancer patients, controlled studies of tapentadol are still lacking. However, the existing data are encouraging; a slow development of tolerance and fewer adverse effects (Mercadante et al, 2012b;Imanaka et al, 2013) and an unexpected beneficial effect in incident bone pain previously treated with methadone (Mercadante et al, 2012a), possibly explained by bone pain having a masked state of hyperalgesia (Portenoy, 2011). This prompted us to perform an experimental analysis of tapentadol on spinal neuronal signalling in a rat model of metastatic bone pain to reveal the potential mechanisms underlying the analgesic effect observed in cancer patients with bone metastases.…”