Real-life efficacy of pregabalin for the treatment of peripheral neuropathic pain in daily clinical practice in Denmark: the NEP-TUNE study
Authors Crawford M, Poulsen PB, Sciøttz-Christensen B, Habicht A, Strand M, Bach F
Received 18 December 2015
Accepted for publication 26 January 2016
Published 20 May 2016 Volume 2016:9 Pages 293—302
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Michael Schatman
Michael E Crawford,1 Peter Bo Poulsen,2 Berit Schiøttz-Christensen,3 Andreas Habicht,4 Mette Strand,2 Flemming W Bach5
1Copenhagen City Pain Clinic, Copenhagen K, 2Pfizer Denmark ApS, Ballerup, 3Spine Center Southern Denmark, Lillebælt Hospital, Middelfart, 4Signifikans ApS, Vedbæk, 5Department of Neurology, Aalborg University Hospital, Aalborg, Denmark
Objective: The aim of this study was to provide evidence regarding the real-life efficacy of pregabalin in the treatment of peripheral neuropathic pain (NeP) in Denmark.
Methods: In this prospective, observational, noninterventional study, pregabalin (Lyrica®) was prescribed following usual clinical practice. Compared with baseline, the primary study end points after 3 months of observation were changes in 1) the average level of pain during the past week, 2) the worst level of pain during the past week, and 3) the least level of pain during the past week. The Wilcoxon signed-rank test was used to perform paired analyses, and a multivariate regression analysis investigated factors driving change in pain.
Results: A total of 86 of the 128 patients included were regarded as efficacy evaluable (those completing 3 months of pregabalin treatment). Patients (59 years) were long-time sufferers of peripheral NeP, and 38% of them had comorbidities. The majority had previously been treated with tricyclic antidepressants or gabapentin. The average dose of pregabalin was 81.5 mg/d at baseline and 240 mg/d after 3 months. A clinically and statistically significant improvement of 2.2 points in the average level of pain intensity was found after 3 months. The higher the pain intensity at baseline, the higher was the reduction of the pain score. Positive results were also found for pain-related sleep interference, patients’ global impression of change, quality of life, and work and productivity impairment. Twenty-one patients reported 28 adverse events.
Conclusion: This real-life study indicates that for some patients (two-thirds), addition of pregabalin for peripheral NeP helps to reduce their pain intensity significantly.
Keywords: noninterventional study, pain intensity, usual clinical practice, sleep interference and quality of life
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