A Randomized, Controlled Trial of Gabapentin Enacarbil in Subjects with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy.
Background Gabapentin enacarbil ( GEn), a transported prodrug of gabapentin, provides sustained, dose-proportional gabapentin exposure. The purpose of this study was to investigate the dose response of GEn to select the optimal dose(s) for clinical use in subsequent diabetic peripheral neuropathy (...
| Publicado en: | Pain Practice Vol. 13; no. 6; pp. 485 - 497 |
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| Autores principales: | , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Wiley-Blackwell
Jul2013
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104190237&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104190237 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15307085 HYN jtl: Pain Practice issn: 15307085 maglogo: Y pubinfo: dt: Jul2013 vid: 13 iid: 6 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 104190237 88904647 10.1111/papr.12014 NLM23186035 104190237 ppf: 485 ppct: 12 formats: fmt: @attributes: type: P tig: atl: A Randomized, Controlled Trial of Gabapentin Enacarbil in Subjects with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy. aug: au: Rauck, Richard Makumi, Clare W. Schwartz, Sherwyn Graff, Ole Meno-Tetang, Guy Bell, Christopher F. Kavanagh, Sarah T. McClung, Carrie L. affil: Carolinas Pain Institute sug: subj: Diabetic Neuropathies Drug Therapy Peripheral Nervous System Diseases Drug Therapy Gabapentin Administration and Dosage Treatment Outcomes Chronic Pain Drug Therapy Dose-Response Relationship, Drug Randomized Controlled Trials Multicenter Studies Double-Blind Studies Human Male Female Descriptive Statistics Pretest-Posttest Design Short Form-36 Health Survey (SF-36) Scales Questionnaires Clinical Assessment Tools Funding Source Models, Statistical Repeated Measures Multimethod Studies Sensitivity and Specificity Analysis of Covariance Logistic Regression Middle Age Adult Aged Aged, 80 and Over Parametric Statistics Confidence Intervals Gabapentin Adverse Effects Middle Aged: 45-64 years Adult: 19-44 years Aged: 65+ years Aged, 80 & over Male Female ab: Background Gabapentin enacarbil ( GEn), a transported prodrug of gabapentin, provides sustained, dose-proportional gabapentin exposure. The purpose of this study was to investigate the dose response of GEn to select the optimal dose(s) for clinical use in subsequent diabetic peripheral neuropathy ( DPN) trials. Methods This was a multicenter, randomized, double-blind, double-dummy, parallel group, placebo-controlled trial with a study duration of approximately 20 weeks (Clinicaltrials.gov database, Identifier ! NCT00643760). Pregabalin ( PGB) (Lyrica®; Pfizer Inc.) was used as an active control to provide assay sensitivity of the trial. A total of 421 adult subjects with DPN were randomized in a ratio of 2:1:1:1:2 to receive oral GEn 3,600 mg/day, GEn 2,400 mg/day, GEn 1,200 mg/day, PGB 300 mg/day, or matching placebo, respectively. The primary efficacy endpoint was change from baseline to end of maintenance treatment with respect to the mean 24-hour average pain intensity score based on an 11-point Pain Intensity Numerical Rating Scale ( PI- NRS). Safety and tolerability assessments included treatment-emergent adverse events ( TEAEs), laboratory evaluations, vital signs, electrocardiograms ( ECG), neurological examination, and pedal edema. Results The adjusted mean difference vs. placebo at the end of maintenance treatment with respect to the mean 24-hour average PI- NRS pain intensity score for GEn 1,200 mg (−0.35; [95% CI: −1.02, 0.31]; P = 0.295), GEn 2,400 mg (−0.02; [95% CI: −0.71, 0.66]; P = 0.946), and GEn 3,600 mg (−0.55; [95% CI: −1.10, 0.01]; P = 0.105) was not statistically significant. The active control, PGB (300 mg/day), did not differentiate from placebo. Conclusion Overall, none of the GEn treatment groups differentiated from placebo. Analyses of the secondary endpoints showed comparable results across treatment groups. However, the majority of the endpoints, including all of the pain endpoints, showed the largest numerical treatment difference was between GEn 3,600 mg and placebo. The active control, PGB (300 mg/day), did not differentiate from placebo. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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