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Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions

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Abstract

Background and Objective

Limited research exists to support the extrapolation of the analgesic efficacy of pregabalin from one neuropathic pain condition to another. This retrospective analysis evaluated similarities in the efficacy of pregabalin for treating neuropathic pain associated with post-herpetic neuralgia (PHN), diabetic peripheral neuropathy (DPN), and spinal cord injury (SCI) in a Japanese population, as a basis for considering the extrapolation of these data to other neuropathic pain conditions.

Methods

Data were analysed across pregabalin doses within each pain condition, from three comparable 13- to 16-week, randomized, double-blind, placebo-controlled trials (RCTs) and the corresponding 52-week, open-label extension trials of pregabalin in Japanese patients with PHN, DPN or SCI. Efficacy outcomes in the RCTs included endpoint and weekly mean pain and sleep interference scores; endpoint proportions of responders in pain; Patient Global Impression of Change scores; and 36-Item Short Form Health Survey (SF-36) scores or Hospital Anxiety and Depression Scale (HADS) assessments. Study discontinuation rates were compared between treatment groups. The extension trials assessed pain intensity, using the Short-Form McGill Pain Questionnaire.

Results

In the RCTs for all pain conditions, significant improvements in comparison with placebo in mean pain and sleep interference scores were evident after 1 week with pregabalin and were sustained throughout the treatment periods (p < 0.05). At the study endpoint, in comparison with placebo, a significantly greater percentage of pregabalin-treated patients experienced a ≥30 % reduction in pain across the RCTs (p < 0.05), and pregabalin significantly improved six of 16 SF-36 subscale scores in the PHN and DPN trials (p < 0.05). In the SCI trial, pregabalin-treated patients had numerically better outcomes of HADS scores. In the extension trials, improvements in pain intensity were maintained over a 52-week period.

Conclusion

Similarities in the pregabalin efficacy profiles, including time to onset and magnitude of response, were confirmed regardless of the neuropathic pain condition. These data support the potential for extrapolating analgesic efficacy to other neuropathic pain conditions.

ClinicalTrials.gov identifiers

NCT00394901, NCT00553475, NCT00407745, NCT00424372, NCT00553280, NCT01202227.

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Authors and Affiliations

  1. Department of Anesthesiology, Nihon University School of Medicine/Surugadai Nihon University Hospital, Tokyo, Japan

    Setsuro Ogawa

  2. Portfolio and Project Management, Pfizer Japan Inc., Tokyo, Japan

    Akio Arakawa

  3. Medical Affairs, Pfizer Japan Inc., Tokyo, Japan

    Kazuhiro Hayakawa

  4. Clinical Statistics, Pfizer Japan Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan

    Tamotsu Yoshiyama

Authors
  1. Setsuro Ogawa
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  2. Akio Arakawa
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  3. Kazuhiro Hayakawa
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  4. Tamotsu Yoshiyama
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Corresponding author

Correspondence to Tamotsu Yoshiyama.

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Funding

The original studies and the current manuscript were funded by Pfizer. Editorial/medical writing support was provided by Penny Gorringe, MSc, of Engage Scientific Solutions and was funded by Pfizer.

Conflict of interest

Akio Arakawa, Kazuhiro Hayakawa and Tamotsu Yoshiyama are all full-time employees of Pfizer and hold stock in Pfizer. Setsuro Ogawa has received consultancy fees or lecture fees from Janssen, Hisamitsu, Pfizer, Nippon Shinyaku and Showa Yakuhin Kakou.

Ethical approval

All trials included in the current analyses were approved by the appropriate institutional review board or independent ethics committee at each investigational centre. All trials were conducted in compliance with the Declaration of Helsinki and all International Conference on Harmonisation Good Clinical Practice Guidelines.

Informed consent

All patients provided written informed consent prior to participation in any trial procedures.

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Ogawa, S., Arakawa, A., Hayakawa, K. et al. Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions. Clin Drug Investig 36, 877–888 (2016). https://doi.org/10.1007/s40261-016-0423-x

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