Abstract
This observational study examined the outcome of two different therapeutic strategies in the treatment of chronic neuropathic pain by including pregabalin (PGB) as mono- or add-on therapy in one of two treatment options. Patients with a pain score of ≥4, refractory to usual care for neuropathic pain for at least 6 months, were allocated consecutively to one of two treatment strategies according to the decision of the physician: complete switch to a flexible-dosage, monotherapeutic or add-on therapy with pregabalin (PGB group), or change established doses and combinations of pre-existing mono- or combination therapy without pregabalin (non-PGB group). After 4 weeks (primary endpoint) a significant improvement in pain reduction was documented in both intention-to treat (ITT) analysis (PGB group, n = 85: mean pain score reduction of 3.53, SD 2.03, p < 0.001; non-PGB group, n = 102; mean pain score reduction of 2.83, SD 2.23, p < 0.001) and per-protocol (PP) analysis (PGB group, n = 79: mean pain score reduction 3.53 vs. 2.83, p < 0.05; non-PGB group, n = 81; 3.5 vs. 2.9, p < 0.05) compared to baseline. Comparison of the results observed in the two groups shows that patients in the PGB group achieved significantly greater pain reduction. These results demonstrate that PGB administered twice daily is superior to treatment regimes without PGB in reducing pain and pain-related interference in quality of life.
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Acknowledgment
The authors gratefully acknowledge the Austrian Neurological Society and the contributions of all of the investigators for this study. Special thanks to Prof. Stefan Quasthoff, Department of Neurology, Graz Medical University, for fruitful discussion on this paper and valuable suggestions. We would like to thank Dr. Wintersberger from The SPECTRA institute, who was responsible for the coordination, statistical analysis and reporting of the statistics.
Declaration of Interests
Christian Lampl received personal compensation from Glaxo, Pfizer Austria, Mundipharma, Grünenthal, Bayer-Shering, Biogen Idec and Astra Zeneca. Bernhard Haider has nothing to disclose. Christine Schweiger has nothing to disclose. Anita Lechner has nothing to disclose.
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Lampl, C., Schweiger, C., Haider, B. et al. Pregabalin as mono- or add-on therapy for patients with refractory chronic neuropathic pain: a post-marketing prescription-event monitoring study. J Neurol 257, 1265–1273 (2010). https://doi.org/10.1007/s00415-010-5504-9
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DOI: https://doi.org/10.1007/s00415-010-5504-9