Effectiveness of pregabalin for the treatment of chronic low back pain with accompanying lower limb pain (neuropathic component): a non-interventional study in Japan.
OBJECTIVE
To evaluate the impact of pregabalin on sleep, pain, function, and health status in patients with chronic low back pain with accompanying neuropathic pain (CLBP-NeP) under routine clinical practice.


METHODS
This prospective, non-interventional, observational study enrolled Japanese adults (≥18 years) with CLBP-NeP of duration ≥3 months and severity ≥5 on a numerical rating scale (0= no pain, 10= worst possible pain). Treatment was 8 weeks with pregabalin (n=157) or usual care alone (n=174); choice of treatment was determined by the physician. The primary efficacy outcome was change from baseline to 8 weeks in pain-related interference with sleep, assessed using the Pain-Related Sleep Interference Scale (PRSIS; 0= did not interfere with sleep, 10= completely interferes with sleep). Secondary endpoints were changes in PRSIS at week 4, and changes at weeks 4 and 8 in pain (numerical rating scale), function (Roland-Morris Disability Questionnaire), and quality of life (EuroQol 5D-5L); global assessments of change were evaluated from the clinician and patient perspectives at the final visit.


RESULTS
Demographic characteristics were similar between cohorts, but clinical characteristics suggested greater disease severity in the pregabalin group including a higher mean (standard deviation) pain score, 6.3 (1.2) versus 5.8 (1.1) (P<0.001). For the primary endpoint, pregabalin resulted in significantly greater improvements in PRSIS at week 8, least-squares mean changes of -1.3 versus -0.4 for usual care (P<0.001); pregabalin also resulted in greater PRSIS improvement at week 4 (P=0.012). Relative to usual care at week 8, pregabalin improved pain and function (both P<0.001), and showed global improvements since beginning study medication (P<0.001). Pregabalin was well tolerated.


CONCLUSIONS
In clinical practice in patients with CLBP-NeP, pregabalin showed significantly greater improvements in pain-related interference with sleep relative to usual care. In addition, pregabalin significantly improved pain, function, and health status, suggesting the benefits of pregabalin for overall health and well-being relative to usual care in these patients. (Clinicaltrials. gov identifier NCT02273908).
Department of Orthopaedic Surgery, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan.
Toshihiko
T
Taguchi
Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.
Ataru
A
Igarashi
Pfizer Inc., New York, NY, USA.
Stephen
S
Watt
Pfizer Inc., New York, NY, USA.
Bruce
B
Parsons
Pfizer Inc., New York, NY, USA.
Alesia
A
Sadosky
Pfizer Japan, Inc., Tokyo, Japan.
Kazutaka
K
Nozawa
Pfizer Japan, Inc., Tokyo, Japan.
Kazuhiro
K
Hayakawa
Pfizer Japan, Inc., Tokyo, Japan.
Tamotsu
T
Yoshiyama
Pfizer Japan, Inc., Tokyo, Japan.
Nozomi
N
Ebata
Pfizer Japan, Inc., Tokyo, Japan.
Koichi
K
Fujii
chronic low back pain; neuropathic pain; non-interventional study; pregabalin; sleep; usual care