Document Detail

Topiramate in painful diabetic polyneuropathy: findings from three double-blind placebo-controlled trials.
MedLine Citation:
PMID:  15355485     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: To evaluate the efficacy and tolerability of topiramate in patients with painful diabetic polyneuropathy.
MATERIALS AND METHODS: Patients with moderate to extreme pain (0-4 Categorical Pain Scale score > or = 2) were randomized to placebo or topiramate (100, 200, or 400 mg/day) in three similar double-blind trials. The primary efficacy analysis was pain reduction from final visit to baseline in the 100-mm Visual Analog Scale (VAS) for the intent-to-treat populations.
RESULTS: After 18-22 weeks of double-blind treatment, pain reductions were numerically greater with topiramate in two studies but differences between topiramate and placebo in VAS scores or in the secondary efficacy endpoints did not reach statistical significance in any of the three studies. Across all studies, 24% of topiramate-treated patients and 8% of placebo-treated patients discontinued due to adverse events; groups did not differ in the occurrence of serious adverse events.
CONCLUSION: These studies did not find topiramate to be significantly more effective than placebo in reducing pain scores in patients with painful diabetic polyneuropathy. Several design features may have precluded the studies from having sufficient sensitivity to differentiate effective and ineffective treatments. The study design and results are instructive for other investigators designing future clinical studies in neuropathic pain.
U Thienel; W Neto; S K Schwabe; U Vijapurkar;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Acta neurologica Scandinavica     Volume:  110     ISSN:  0001-6314     ISO Abbreviation:  Acta Neurol. Scand.     Publication Date:  2004 Oct 
Date Detail:
Created Date:  2004-09-09     Completed Date:  2004-12-23     Revised Date:  2013-08-21    
Medline Journal Info:
Nlm Unique ID:  0370336     Medline TA:  Acta Neurol Scand     Country:  Denmark    
Other Details:
Languages:  eng     Pagination:  221-31     Citation Subset:  IM    
Therakos, Exton, PA, USA.
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MeSH Terms
Aged, 80 and over
Diabetic Neuropathies / complications*
Dose-Response Relationship, Drug
Double-Blind Method
Fructose / administration & dosage,  analogs & derivatives*,  therapeutic use*
Middle Aged
Neuralgia / drug therapy*,  etiology
Neuroprotective Agents / administration & dosage,  therapeutic use*
Pain Measurement
Reg. No./Substance:
0/Neuroprotective Agents; 0H73WJJ391/topiramate; 30237-26-4/Fructose

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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