| Topiramate in painful diabetic polyneuropathy: findings from three double-blind placebo-controlled trials. | |
| | |
MedLine Citation:
|
PMID: 15355485 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
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. |
| | |
Authors:
|
U Thienel; W Neto; S K Schwabe; U Vijapurkar; |
Related Documents
:
|
19712785 - Chiropractic care for older adults: effects on balance, dizziness, and chronic pain. 9653685 - The effect of joint mobilization as a component of comprehensive treatment for primary ... 17951095 - Sustained natural apophyseal glides (snags) are an effective treatment for cervicogenic... 22892055 - Transient pharmacologic lowering of aß production prior to deposition results in susta... 16629765 - Predictors of good prognosis in total anterior circulation infarction within 6 h after ... 12519645 - Measurement of impaired self-awareness after traumatic brain injury: a comparison of th... |
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: 2006-11-15 |
Medline Journal Info:
|
Nlm Unique ID: 0370336 Medline TA: Acta Neurol Scand Country: Denmark |
Other Details:
|
Languages: eng Pagination: 221-31 Citation Subset: IM |
Affiliation:
|
Therakos, Exton, PA, USA. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Adolescent Adult Aged Aged, 80 and over Diabetic Neuropathies / complications* Dose-Response Relationship, Drug Double-Blind Method Fructose / administration & dosage, analogs & derivatives*, therapeutic use* Humans Male Middle Aged Neuralgia / drug therapy*, etiology Neuroprotective Agents / administration & dosage, therapeutic use* Pain Measurement |
| Chemical | |
Reg. No./Substance:
|
0/Neuroprotective Agents; 30237-26-4/Fructose; 97240-79-4/topiramate |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: The psychiatric comorbidity of epilepsy.
Next Document: Intraoperative human vagus nerve compound action potentials.