Effectiveness of Pregabalin Treatment for Neuropathic Pain in Patients with Spine Diseases: A Pooled Analysis of Two Multicenter Observational Studies in Japan
Authors Taguchi T, Nakano S, Nozawa K
Received 27 November 2020
Accepted for publication 18 February 2021
Published 16 March 2021 Volume 2021:14 Pages 757—771
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Krishnan Chakravarthy
Toshihiko Taguchi,1 Shogo Nakano,2 Kazutaka Nozawa2
1Japan Organization of Occupational Health and Safety, Yamaguchi Rosai Hospital, Sanyo-Onoda, Yamaguchi, Japan; 2Pfizer Japan, Inc., Tokyo, Japan
Correspondence: Kazutaka Nozawa Email [email protected]
Purpose: Neuropathic pain (NeP) is common among patients with chronic pain associated with spine diseases. Practical effectiveness of pregabalin, one of the first-line treatments for NeP, has not been evaluated in an entire population of patients with spine diseases, including various pathophysiological conditions. This pooled analysis aimed to evaluate the therapeutic value of pregabalin for chronic pain with NeP component in patients with spine diseases in routine primary care settings.
Patients and Methods: We pooled data from two 8-week prospective observational cohort studies for patients with chronic low back pain with accompanying lower limb pain (NeP component), and patients with chronic cervical pain and accompanying upper limb radiating pain (NeP component) in routine primary care settings in Japan. For both studies, patients were treated for 8 weeks with pregabalin (alone/with other analgesics) or usual care with conventional analgesics (eg, non-steroidal anti-inflammatory drugs). Changes in pain numerical rating scale (NRS), Pain-Related Sleep Interference Scale (PRSIS), and EuroQol 5-dimension 5-level (EQ-5D-5L) scores from baseline to week 8 were summarized and compared between the pregabalin and usual care groups, and also for subgroups of primary diagnosis. Safety was evaluated by adverse events (AEs) in the pregabalin group.
Results: The pooled dataset comprised 700 patients (pregabalin group: 302; usual care group: 398). All patient-reported outcomes (PRO) scores significantly improved from baseline to week 8 in the pregabalin than in the usual care group (NRS: P< 0.0001; PRSIS: P< 0.0001, and EQ-5D-5L: P=0.0006). Overall, all three PRO measures showed greater improvement in the pregabalin than in the usual care group, irrespective of the primary diagnosis. AEs were reported in 36.1% of the pregabalin group.
Conclusion: This analysis suggested multi-faceted effectiveness of treatment with pregabalin from the patient’s perspectives under a “real-world” practice in all patients with chronic NeP from various spine diseases.
Keywords: neuropathic pain, chronic pain, spine diseases, pregabalin, pooled analysis
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