title: A gastroretentive gabapentin formulation for the treatment of painful diabetic peripheral neuropathy: efficacy and tolerability in a double-blind, randomized, controlled clinical trial.
abstract: OBJECTIVE
  A randomized, double-blind, placebo-controlled study was conducted in 147 patients to determine the efficacy and safety of a gastroretentive formulation of gabapentin (G-GR) in treating painful diabetic peripheral neuropathy (DPN).
  
  
  METHODS
  Diabetic patients with symmetrical painful symptoms in distal extremities for 1-5 years and a baseline average daily pain (ADP) score of ≥4 received G-GR 3000mg, as a single evening daily dose (G-GR-QD) or a divided dose (G-GR-DD, 1200mg AM/1800mg PM), or placebo for 4 weeks. G-GR was titrated from 300 to 3000mg/day over 2 weeks, followed by 2 additional weeks at 3000mg/day. Efficacy measures included changes from baseline to Week 4 in ADP score and average daily sleep interference score (SIS).
  
  
  RESULTS
  A significantly larger decrease in ADP score was observed in the G-GR-QD dose group compared with placebo (-2.50 versus -1.30; p=0.002). A ≥50% reduction in ADP score was achieved in 34.8% of G-GR-QD recipients compared with 7.8% of placebo recipients (p=0.001). Similar results were observed for changes in SIS. The incidences of dizziness and somnolence, commonly associated with gabapentin, were low.
  
  
  CONCLUSIONS
  Once-daily G-GR was effective and well tolerated for the treatment of pain due to DPN.
authors.affiliation: North San Antonio Healthcare, San Antonio, TX, United States.
authors.forename: David
authors.initials: D
authors.lastname: Sandercock
authors.forename: Marilou
authors.initials: M
authors.lastname: Cramer
authors.forename: Victor
authors.initials: V
authors.lastname: Biton
authors.forename: Verne E
authors.initials: VE
authors.lastname: Cowles
mesh_terms: D000368:Aged; D000465:Algorithms; D000588:Amines / Q000009:adverse effects* / Q000627:therapeutic use*; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical; D003509:Cyclohexanecarboxylic Acids / Q000009:adverse effects* / Q000627:therapeutic use*; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000453:epidemiology; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D000077206:Gabapentin; D005746:Gastric Emptying / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects* / Q000627:therapeutic use*
chemical_list: D000588:Amines; D000700:Analgesics; D003509:Cyclohexanecarboxylic Acids; D010919:Placebos; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin