Direct conversion from tramadol to tapentadol prolonged release for moderate to severe, chronic malignant tumour-related pain

H G Kress, E D Koch, H Kosturski, A Steup, K Karcher, C Dogan, M Etropolski, M Eerdekens, H G Kress, E D Koch, H Kosturski, A Steup, K Karcher, C Dogan, M Etropolski, M Eerdekens

Abstract

Background: A recent randomized-withdrawal, active- and placebo-controlled, double-blind phase 3 study showed that tapentadol prolonged release (PR) was effective and well tolerated for managing moderate to severe, chronic malignant tumour-related pain in patients who were opioid naive or dissatisfied with current treatment (Pain Physician, 2014, 17, 329-343). This post hoc, subgroup analysis evaluated the efficacy and tolerability of tapentadol PR in patients who previously received and were dissatisfied with tramadol for any reason and who had a pain intensity ≥5 (11-point numerical rating scale) before converting directly to tapentadol PR.

Methods: In the original study, eligible patients had been randomized (2:1) and titrated to their optimal dose of tapentadol PR (100-250 mg bid) or morphine sulphate-controlled release (40-100 mg bid) over 2 weeks. The present report focuses on results during the titration period for a subgroup of patients randomized to tapentadol PR after having been on tramadol treatment prior to randomization in the study (n = 129). Results for this subgroup are compared with results for all 338 patients who received tapentadol PR during titration (overall tapentadol PR group).

Results: Responder rates (responders: completed titration, mean pain intensity <5 [0-10 scale] and ≤20 mg/day rescue medication during last 3 days) were slightly better for the tramadol/tapentadol PR subgroup (69.8% [90/129]) vs. the overall tapentadol PR group (63.9% [214/335]). Tolerability profiles were comparable for both groups.

Conclusions: Results of this subgroup analysis indicate that patients with cancer pain could safely switch from prior treatment with the weak centrally acting analgesic tramadol directly to the strong centrally acting analgesic tapentadol PR, for an improved analgesic therapy for severe pain. WHAT DOES THIS STUDY ADD?: Results of this post hoc analysis show that patients who had received prior tramadol therapy could switch directly to tapentadol PR, with the majority (˜70%) experiencing improved efficacy.

© 2016 The Authors. European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation - EFIC®.

References

    1. Caraceni, A. , Hanks, G. , Kaasa, S. , Bennett, M.I. , Brunelli, C. , Cherny, N. , Dale, O. , De Conno, F. , Fallon, M. , Hanna, M. , Haugen, D.F. , Juhl, G. , King, S. , Klepstad, P. , Laugsand, E.A. , Maltoni, M. , Mercadante, S. , Nabal, M. , Pigni, A. , Radbruch, L. , Reid, C. , Sjogren, P. , Stone, P.C. , Tassinari, D. , Zeppetella, G. (2012). Use of opioid analgesics in the treatment of cancer pain: Evidence‐based recommendations from the EAPC. Lancet Oncol 13, e58–e68.
    1. Droney, J. , Riley, J. (2009). Recent advances in the use of opioids for cancer pain. J Pain Res 2, 135–155.
    1. Droney, J. , Ross, J. , Gretton, S. , Welsh, K. , Sato, H. , Riley, J. (2008). Constipation in cancer patients on morphine. Support Care Cancer 16, 453–459.
    1. Imanaka, K. , Tominaga, Y. , Etropolski, M. , Van Hove, I. , Ohsaka, M. , Wanibe, M. , Hirose, K. , Matsumura, T. (2013). Efficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe, chronic malignant tumor‐related pain. Curr Med Res Opin 29, 1399–1409.
    1. Imanaka, K. , Tominaga, Y. , Etropolski, M. , Ohashi, H. , Hirose, K. , Matsumura, T. (2014). Ready conversion of patients with well‐controlled, moderate to severe, chronic malignant tumor‐related pain on other opioids to tapentadol extended release. Clin Drug Investig 34, 501–511.
    1. Kress, H.G. (2010). Tapentadol and its two mechanisms of action: Is there a new pharmacological class of centrally‐acting analgesics on the horizon? Eur J Pain 14, 781–783.
    1. Kress, H.G. , Koch, E.D. , Kosturski, H. , Steup, A. , Karcher, K. , Lange, B. , Dogan, C. , Etropolski, M. , Eerdekens, M. (2014). Tapentadol prolonged release for managing moderate to severe, chronic malignant tumor‐related pain. Pain Physician 17, 329–343.
    1. Leppert, W. , Luczak, J. (2005). The role of tramadol in cancer pain treatment – A review. Support Care Cancer 13, 5–17.
    1. Mandala, M. , Moro, C. , Labianca, R. , Cremonesi, M. , Barni, S. (2006). Optimizing use of opiates in the management of cancer pain. Ther Clin Risk Manag 2, 447–453.
    1. Tzschentke, T.M. , De Vry, J. , Terlinden, R. , Hennies, H.H. , Lange, C. , Strassburger, W. , Haurand, M. , Kolb, J. , Schneider, J. , Buschmann, H. , Finkam, M. , Jahnel, U. , Friderichs, E. (2006). Tapentadol hydrochloride. Analgesic, mu‐opioid receptor agonist, noradrenaline reuptake inhibitor. Drugs Future 31, 1053–1061.
    1. Tzschentke, T.M. , Jahnel, U. , Kogel, B. , Christoph, T. , Englberger, W. , De Vry, J. , Schiene, K. , Okamoto, A. , Upmalis, D. , Weber, H. , Lange, C. , Stegmann, J.U. , Kleinert, R. (2009). Tapentadol hydrochloride: A next‐generation, centrally acting analgesic with two mechanisms of action in a single molecule. Drugs Today (Barc) 45, 483–496.
    1. Vargas‐Schaffer, G. (2010). Is the WHO analgesic ladder still valid? Twenty‐four years of experience. Can Fam Physician 56, 514–515.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit