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A gastroretentive gabapentin formulation for the treatment of painful diabetic peripheral neuropathy: efficacy and tolerability in a double-blind, randomized, controlled clinical trial.

AbstractAIMS:
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.
AuthorsDavid Sandercock, Marilou Cramer, Victor Biton, Verne E Cowles
JournalDiabetes research and clinical practice (Diabetes Res Clin Pract) Vol. 97 Issue 3 Pg. 438-45 (Sep 2012) ISSN: 1872-8227 [Electronic] Ireland
PMID22497967 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
CopyrightCopyright © 2012 Elsevier Ireland Ltd. All rights reserved.
Chemical References
  • Amines
  • Analgesics
  • Cyclohexanecarboxylic Acids
  • Placebos
  • gamma-Aminobutyric Acid
  • gabapentin
Topics
  • Aged
  • Algorithms
  • Amines (adverse effects, therapeutic use)
  • Analgesics (adverse effects, therapeutic use)
  • Chemistry, Pharmaceutical
  • Cyclohexanecarboxylic Acids (adverse effects, therapeutic use)
  • Diabetic Neuropathies (drug therapy, epidemiology)
  • Double-Blind Method
  • Drug-Related Side Effects and Adverse Reactions (epidemiology)
  • Female
  • Gastric Emptying (drug effects)
  • Humans
  • Male
  • Middle Aged
  • Placebos
  • Treatment Outcome
  • gamma-Aminobutyric Acid (adverse effects, therapeutic use)

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