Driving Ability in Patients with Severe Chronic Low Back or Osteoarthritis Knee Pain on Stable Treatment with Tapentadol Prolonged Release: A Multicenter, Open-label, Phase 3b Trial

被引:11
|
作者
Sabatowski R. [1 ]
Scharnagel R. [1 ]
Gyllensvärd A. [2 ]
Steigerwald I. [3 ]
机构
[1] Comprehensive Pain Center, University Hospital Carl Gustav Carus, Dresden
[2] Global Drug Safety, Grünenthal GmbH, Aachen
[3] Medical Affairs Europe and Australia, Grünenthal GmbH, Aachen
关键词
Chronic pain; Driving ability; Opioids; Pain; Tapentadol prolonged release;
D O I
10.1007/s40122-014-0025-3
中图分类号
学科分类号
摘要
Introduction: Strong centrally acting analgesics, including tapentadol prolonged release (PR), have demonstrated efficacy for the management of non-malignant, chronic pain. Maintaining patient independence, including the ability to drive safely, is a key goal of long-term analgesic therapy. This multicenter, open-label, phase 3b trial evaluated the effects of tapentadol PR on driving ability.Methods: This study included patients who had completed previous tapentadol PR trials for severe low back or osteoarthritis pain. After at least 6 weeks of dose stability, patients continued taking tapentadol PR (50–250 mg twice daily) and could take supplemental immediate-release tapentadol 50 mg, except on the day before or day of the driving test (before the test). Pain intensity was assessed using an 11-point numerical rating scale. The Vienna Test System-Traffic Plus was used to assess cognitive and psychomotor function. The key surrogate parameter for driving ability was a global judgment based on 6 battery tests.Results: Thirty-eight patients enrolled and completed the trial, and 35 patients completed all 6 tests. Pain scores remained unchanged from enrollment to final visit [mean (standard deviation) change, –0.2 (1.0)]. Approximately two-thirds [65.7% (23/35)] of patients were classified as fit to drive based on the global judgment of driving-specific ability [34.3% (12/35) not fit to drive]. Total daily tapentadol PR dose (>200 vs. ≤200 mg/day) did not affect global judgment of driving ability (P = 0.4885). Two adverse events (considered unrelated to study drug) were reported.Conclusion: Results suggest that most patients receiving a stable dose of tapentadol PR for severe, chronic pain would be able to drive, consistent with earlier studies evaluating stable treatment with strong opioids. Study design limitations and needs for individual patient assessment must be considered in clinical practice. © 2014, The Author(s).
引用
收藏
页码:17 / 29
页数:12
相关论文
共 50 条
  • [1] Tapentadol Prolonged Release Versus Strong Opioids for Severe, Chronic Low Back Pain: Results of an Open-Label, Phase 3b Study
    Rafael Gálvez
    Michael Schäfer
    Guy Hans
    Dietmar Falke
    Ilona Steigerwald
    Advances in Therapy, 2013, 30 : 229 - 259
  • [2] Tapentadol Prolonged Release Versus Strong Opioids for Severe, Chronic Low Back Pain: Results of an Open-Label, Phase 3b Study
    Galvez, Rafael
    Schaefer, Michael
    Hans, Guy
    Falke, Dietmar
    Steigerwald, Ilona
    ADVANCES IN THERAPY, 2013, 30 (03) : 229 - 259
  • [3] Effectiveness and safety of tapentadol prolonged release for severe, chronic low back pain with or without a neuropathic pain component: results of an open-label, phase 3b study
    Steigerwald, Ilona
    Mueller, Matthias
    Davies, Anthony
    Samper, Daniel
    Sabatowski, Rainer
    Baron, Ralf
    Rozenberg, Sylvie
    Szczepanska-Szerej, Anna
    Gatti, Antonio
    Kress, Hans G.
    CURRENT MEDICAL RESEARCH AND OPINION, 2012, 28 (06) : 911 - 936
  • [4] Effectiveness and Tolerability of a Moderate Dose of Tapentadol Prolonged Release for Managing Severe, Chronic Low Back Pain with a Neuropathic Component: An Open-label Continuation Arm of a Randomized Phase 3b Study
    Baron, Ralf
    Kern, Uwe
    Mueller, Matthias
    Dubois, Cecile
    Falke, Dietmar
    Steigerwald, Ilona
    PAIN PRACTICE, 2015, 15 (05) : 471 - 486
  • [5] Tolerability, Safety, and Quality of Life with Tapentadol Prolonged Release (PR) Compared with Oxycodone/Naloxone PR in Patients with Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-label, Phase 3b/4 Trial
    Baron, Ralf
    Jansen, Jan-Peter
    Binder, Andreas
    Pombo-Suarez, Manuel
    Kennes, Lieven
    Mueller, Matthias
    Falke, Dietmar
    Steigerwald, Ilona
    PAIN PRACTICE, 2016, 16 (05) : 600 - 619
  • [6] Tapentadol Extended Release in the Treatment of Severe Chronic Low Back Pain and Osteoarthritis Pain
    Pergolizzi, Joseph V., Jr.
    Taylor, Robert, Jr.
    Jo Ann LeQuang
    Raffa, Robert B.
    Bisney, John
    PAIN AND THERAPY, 2018, 7 (01) : 37 - 57
  • [7] Tapentadol Extended Release in the Treatment of Severe Chronic Low Back Pain and Osteoarthritis Pain
    Joseph V. Pergolizzi
    Robert Taylor
    Jo Ann LeQuang
    Robert B. Raffa
    John Bisney
    Pain and Therapy, 2018, 7 : 37 - 57
  • [8] Effectiveness of Tapentadol Prolonged Release (PR) Compared with Oxycodone/Naloxone PR for the Management of Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-Label, Phase 3b/4 Study
    Baron, Ralf
    Likar, Rudolf
    Martin-Mola, Emilio
    Blanco, Francisco J.
    Kennes, Lieven
    Mueller, Matthias
    Falke, Dietmar
    Steigerwald, Ilona
    PAIN PRACTICE, 2016, 16 (05) : 580 - 599
  • [9] Open-label placebo treatment in chronic low back pain: a randomized controlled trial
    Carvalho, Claudia
    Caetano, Joaquim Machado
    Cunha, Lidia
    Rebouta, Paula
    Kaptchuk, Ted J.
    Kirsch, Irving
    PAIN, 2016, 157 (12) : 2766 - 2772
  • [10] Open-Label Placebo Trial among Japanese Patients with Chronic Low Back Pain
    Ikemoto, Tatsunori
    Ueno, Takefumi
    Arai, Young-Chang
    Wakao, Norimitsu
    Hirasawa, Atsuhiko
    Hayashi, Kazuhiro
    Deie, Masataka
    PAIN RESEARCH & MANAGEMENT, 2020, 2020