Efficacy and safety of lacosamide in painful diabetic neuropathy.

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F10%3A00103128" target="_blank" >RIV/00843989:_____/10:00103128 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.2337/dc09-1578" target="_blank" >http://dx.doi.org/10.2337/dc09-1578</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.2337/dc09-1578" target="_blank" >10.2337/dc09-1578</a>

Result language
angličtina
Original language name
Efficacy and safety of lacosamide in painful diabetic neuropathy.
Original language description
To evaluate efficacy and safety of lacosamide compared with placebo in painful diabetic polyneuropathy. Diabetic patients with at least moderate neuropathic pain were randomized to placebo or lacosamide 400 (in a slow or standard titration) or 600 mg/dayover 6-week titration and 12-week maintenance periods. Primary efficacy criterion was intra-individual change in average daily Numeric Pain Rating Scale score from baseline to the last 4 weeks. RESULTS: For the primary end point, pain reduction was numerically but not statistically greater with lacosamide compared with placebo (400 mg/day, P = 0.12; 600 mg/day, P = 0.18). Both doses were significantly more effective compared with placebo over the titration (P = 0.03, P = 0.006), maintenance (P = 0.01,P = 0.005), and entire treatment periods (P = 0.03, P = 0.02). Safety profiles between titration schemes were similar. CONCLUSIONS: Lacosamide reduced neuropathic pain and was well tolerated in diabetic patients, but the primary efficacy
Czech name
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Czech description
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Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FH - Neurology, neuro-surgery, nuero-sciences
OECD FORD branch
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Publication year
2010
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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