Efficacy and safety of lacosamide in painful diabetic neuropathy.

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

Efficacy and safety of lacosamide in painful diabetic neuropathy.

Popis výsledku v původním jazyce

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

Název v anglickém jazyce

Efficacy and safety of lacosamide in painful diabetic neuropathy.

Popis výsledku anglicky

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

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FH - Neurologie, neurochirurgie, neurovědy

OECD FORD obor

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Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2010

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Diabetes Care

ISSN

0149-5992

e-ISSN

—

Svazek periodika

33

Číslo periodika v rámci svazku

4

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

3

Strana od-do

839-841

Kód UT WoS článku

000276793200031

EID výsledku v databázi Scopus

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