دورية أكاديمية
Efficacy and safety of lacosamide in painful diabetic neuropathy
| العنوان: | Efficacy and safety of lacosamide in painful diabetic neuropathy |
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| المؤلفون: | Ziegler, Dan, Hidvégi, Tibor, Gurieva, Irina, Bongardt, Sabine, Freynhagen, Rainer, Sen, David, Sommerville, Kenneth, on behalf of the Lacosamide SP743 Study Group |
| المساهمون: | Mathieu, Chantal, U0009139 |
| بيانات النشر: | American Diabetes Association |
| سنة النشر: | 2010 |
| المجموعة: | KU Leuven: Lirias |
| مصطلحات موضوعية: | Acetamides, Diabetic Neuropathies, Humans, Placebo Effect, Treatment Outcome |
| الوصف: | OBJECTIVE: To evaluate efficacy and safety of lacosamide compared with placebo in painful diabetic polyneuropathy. RESEARCH DESIGN AND METHODS: Diabetic patients with at least moderate neuropathic pain were randomized to placebo or lacosamide 400 (in a slow or standard titration) or 600 mg/day over 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 criterion was not met, possibly due to an increased placebo response over the last 4 weeks. ; status: published |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0149-5992 |
| العلاقة: | Diabetes Care vol:33 issue:4 pages:839-41; https://lirias.kuleuven.be/handle/123456789/276669Test; http://care.diabetesjournals.org/cgi/pmidlookup?view=long&pmid=20067958Test |
| الإتاحة: | https://lirias.kuleuven.be/handle/123456789/276669Test http://care.diabetesjournals.org/cgi/pmidlookup?view=long&pmid=20067958Test |
| رقم الانضمام: | edsbas.3AE78441 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 01495992 |
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