title: Efficacy and safety of carisbamate in patients with diabetic neuropathy or postherpetic neuralgia: results from 3 randomized, double-blind placebo-controlled trials.
abstract: The results of 3 proof-of-concept studies to evaluate carisbamate's efficacy and safety in treating neuropathic pain are presented. In studies 1 (postherpetic neuralgia, n = 91) and 2 (diabetic neuropathy, n = 137), patients received carisbamate 400 mg/day or placebo for 4 weeks and then crossed over to the other treatment for 4 weeks. In study 3 (diabetic neuropathy, higher carisbamate doses), patients (n = 386) were randomized (1:1:1:1) to receive either carisbamate 800 mg/day, 1200 mg/day, pregabalin 300 mg/day or placebo for 15 weeks. Primary efficacy end point was the mean of the last 7 average daily pain scores obtained on days the study drug was taken, for all 3 studies. Least square mean (95% CI) differences between carisbamate and placebo groups on the primary end point were as follows: study 1: -0.512 (-1.32, 0.29) carisbamate 400 mg/day; study 2: -0.307 (-0.94, 0.33) carisbamate 400 mg/day; and study 3: -0.51 (-1.10, 0.08), carisbamate 800 mg/day; -0.55 (-1.13, 0.04), carisbamate 1200 mg/day; and -0.43 (-1.01, 0.15), pregabalin 300 mg/day. Neither carisbamate (all 3 studies) nor pregabalin (study 3) significantly differed from placebo, although multiple secondary end points showed significant improvement in efficacy with carisbamate in studies 1 and 2. Dizziness was the only treatment-emergent adverse event occurring at ≥10% difference in carisbamate groups versus placebo (study 1: 12% vs. 1%; study 3: 14% vs. 4%; study 2: 1% vs. 2%). Carisbamate, although well tolerated, did not demonstrate efficacy in neuropathic pain across these studies, nor did the active comparator pregabalin (study 3).
authors.affiliation: Mercy Health Research, Center for Innovative Care, Mercy Health, St. Louis, Missouri, U.S.A.
authors.forename: Timothy
authors.initials: T
authors.lastname: Smith
authors.forename: Allitia
authors.initials: A
authors.lastname: DiBernardo
authors.forename: Yingqi
authors.initials: Y
authors.lastname: Shi
authors.forename: Mike J
authors.initials: MJ
authors.lastname: Todd
authors.forename: H Robert
authors.initials: HR
authors.lastname: Brashear
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Ford
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002219:Carbamates / Q000627:therapeutic use*; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D051474:Neuralgia, Postherpetic / Q000188:drug therapy*; D018377:Neurotransmitter Agents / Q000627:therapeutic use*; D010147:Pain Measurement; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002219:Carbamates; D018377:Neurotransmitter Agents; C518914:S-2-O-carbamoyl-1-o-chlorophenyl-ethanol
keywords: carisbamate; diabetic peripheral neuropathy; postherpetic neuralgia; pregabalin