title: Efficacy and Safety of Pregabalin for the Treatment of Neuropathic Pain in Patients Undergoing Hemodialysis.
abstract: OBJECTIVE
  Pregabalin is a gamma aminobutyric acid derivative administered for neuropathic pain. It binds to α2δ subunits of voltage-dependent calcium channels, and inhibits calcium inflow of synapses and the release of excitatory neurotransmitters. This study investigated the efficacy and safety of pregabalin in patients with peripheral neuropathic pain undergoing maintenance hemodialysis.
  
  
  METHODS
  This study was a prospective, open-label, single-arm, multi-center trial. Patients were treated with an initial dose of pregabalin at 25 mg; this was then increased up to a maximum of 150 mg depending on the patient during a 12-week study period. Visual Analog Scale, Eight-Item Short Form Health Survey (SF-8), and laboratory data were collected at baseline and the end of the study.
  
  
  RESULTS
  A total of 45 patients with peripheral neuropathic pain were included, of whom 35 patients were analyzed. The final mean dose of pregabalin was 50.7 mg daily. Mean Visual Analog Scale scores significantly decreased from 52.4 mm at baseline to 34.1 mm at the end of the study (p < 0.0001). Scores for all eight categories of the SF-8 significantly increased compared with baseline (p < 0.05). Both physical and mental component summary scores of the SF-8 also significantly increased (p < 0.05). Ten patients were withdrawn from the study because of drowsiness, dizziness, and invalidity; however, no serious adverse drug reactions were recorded.
  
  
  CONCLUSIONS
  If adverse effects are carefully monitored and the administered dosage prudently determined, pregabalin can be an effective treatment for peripheral neuropathic pain in patients undergoing hemodialysis.
  
  
  BACKGROUND
  UMIN000023117.
authors.affiliation: Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, 30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo, 173-8610, Japan.
authors.forename: Tomoyasu
authors.initials: T
authors.lastname: Otsuki
authors.affiliation: Department of Nephrology, Keiai Hospital, Tokyo, Japan.
authors.forename: Terumi
authors.initials: T
authors.lastname: Higuchi
authors.affiliation: Department of Nephrology, Keiai Hospital, Tokyo, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Yamazaki
authors.affiliation: Department of Nephrology, Keiai Hospital, Tokyo, Japan.
authors.forename: Erina
authors.initials: E
authors.lastname: Okawa
authors.affiliation: Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, 30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo, 173-8610, Japan.
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Okada
authors.affiliation: Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, 30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo, 173-8610, Japan. abe.masanori@nihon-u.ac.jp.
authors.forename: Masanori
authors.initials: M
authors.lastname: Abe
mesh_terms: D000368:Aged; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D009437:Neuralgia / Q000188:drug therapy*; D000069583:Pregabalin / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D006435:Renal Dialysis; D064232:Visual Analog Scale; D055815:Young Adult
chemical_list: D000700:Analgesics; D000069583:Pregabalin