Abstract | AIMS: 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.
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Authors | David Sandercock, Marilou Cramer, Victor Biton, Verne E Cowles |
Journal | Diabetes research and clinical practice
(Diabetes Res Clin Pract)
Vol. 97
Issue 3
Pg. 438-45
(Sep 2012)
ISSN: 1872-8227 [Electronic] Ireland |
PMID | 22497967
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | Copyright © 2012 Elsevier Ireland Ltd. All rights reserved. |
Chemical References |
- Amines
- Analgesics
- Cyclohexanecarboxylic Acids
- Placebos
- gamma-Aminobutyric Acid
- Gabapentin
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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
- Gabapentin
- Gastric Emptying
(drug effects)
- Humans
- Male
- Middle Aged
- Placebos
- Treatment Outcome
- gamma-Aminobutyric Acid
(adverse effects, therapeutic use)
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