Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study

Abstract

Objective: To evaluate the efficacy and safety of tapentadol extended release (ER) for the management of moderate to severe chronic low back pain.

Research design: Patients (N = 981) were randomized 1:1:1 to receive tapentadol ER 100 – 250 mg b.i.d., oxycodone HCl controlled release (CR) 20 – 50 mg b.i.d., or placebo over 15 weeks (3-week titration period, 12-week maintenance period).

Main outcome measures: Efficacy was assessed as change from baseline in average pain intensity (11-point NRS) at week 12 of the maintenance period and throughout the maintenance period; last observation carried forward was used to impute missing pain scores. Adverse events (AEs) were monitored throughout the study.

Results: Tapentadol ER significantly reduced average pain intensity versus placebo at week 12 (least squares mean difference vs placebo [95% confidence interval], −0.8 [−1.22, −0.47]; p < 0.001) and throughout the maintenance period (−0.7 [−1.06,−0.35]; p < 0.001). Oxycodone CR significantly reduced average pain intensity versus placebo at week 12 (−0.9 [−1.24,−0.49]; p < 0.001) and throughout the maintenance period (−0.8 [−1.16,−0.46]; p < 0.001). Tapentadol ER was associated with a lower incidence of treatment-emergent AEs (TEAEs) than oxycodone CR. Gastrointestinal TEAEs, including constipation, nausea, and vomiting, were among the most commonly reported TEAEs (placebo, 26.3%; tapentadol ER, 43.7%; oxycodone CR, 61.9%). The odds of experiencing constipation or the composite of nausea and/or vomiting were significantly lower with tapentadol ER than with oxycodone CR (both p < 0.001).

Conclusions: Tapentadol ER (100 – 250 mg b.i.d.) effectively relieved moderate to severe chronic low back pain over 15 weeks and had better gastrointestinal tolerability than oxycodone HCl CR (20 – 50 mg b.i.d.).

Keywords::

• analgesic
• chronic pain
• low back pain
• opioid
• oxycodone
• tapentadol

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Acknowledgements

Data presented in this manuscript have been presented at the 134th Annual Meeting of the American Neurological Association (ANA), 11 – 14 October 2009, Baltimore, MD, USA; the Annual Scientific Meeting of the British Pain Society (BPS), 13 – 16 April 2010, Manchester, England; the 10th Annual Congress of the European League Against Rheumatism (EULAR), 10 – 13 June 2009, Copenhagen, Denmark; the 24th Annual Meeting of the North American Spine Society (NASS), 10 – 19 November 2009, San Francisco, CA, USA; the 28th Annual Scientific Meeting of the American Pain Society (APS), 7 – 9 May 2009, San Diego, CA, USA; the 6th Triennial Congress of the European Federation of IASP Chapters (EFIC), 9 – 12 September 2009, Lisbon, Portugal; the Proceedings of the American College of Rheumatology (ACR), 16 – 21 October 2009, Philadelphia, PA, USA; the Congress of the German Society for Pain Therapy (DGS), 18 – 20 March 2010, Frankfurt, Germany; the American Academy of Physical Medicine & Rehabilitation (AAPM&R), 22 – 25 October 2009, Austin, TX, USA; the National Conference on Pain for Frontline Practitioners (PAINWeek), 9 – 13 September 2009, Las Vegas, NV, USA; the 20th Annual Clinical Meeting of the American Academy of Pain Management (AAPM), 8 – 11 October 2009, Phoenix, AZ, USA; and the 2009 Fall Proceedings of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), 24 – 27 October 2009, Paris, France.

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