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Gabapentin Enacarbil

In Patients with Restless Legs Syndrome

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An Erratum to this article was published on 09 January 2013

An Erratum to this article was published on 19 December 2012

Abstract

Oral gabapentin enacarbil is approved in adult patients for the treatment of moderate to severe primary restless legs syndrome (RLS) [featured indication] and the management of postherpetic neuralgia. In the 12-week Patient Improvements in Vital Outcomes following Treatment (PIVOT) RLS I and II trials in adult patients with moderate to severe primary RLS (n > 500 total evaluable), once-daily gabapentin enacarbil 600 or 1,200 mg significantly improved mean International Restless Legs Scale (IRLS) total scores compared with placebo, with significantly higher investigator-rated Clinical Global Impression-Improvement (CGI-I) responder rates in gabapentin enacarbil groups than in placebo groups. Improvements in other sleep outcomes (assessed using various scales) also generally favoured gabapentin enacarbil treatment. These data are supported by results from a polysomnography, crossover (two 4-week treatment periods) trial (n > 100 evaluable). Improvements in RLS symptoms with gabapentin enacarbil were maintained in a 52-week extension study of clinical trials, including PIVOT RLS I and II. The longer-term efficacy of gabapentin enacarbil in patients with moderate to severe RLS was also demonstrated in the 36-week PIVOT RLS Maintenance study and a 52-week noncomparative study conducted in Japan. Gabapentin enacarbil was generally well tolerated in adult patients with RLS participating in short- and longer-term clinical trials. The most common treatment-emergent adverse events were somnolence/sedation and dizziness. Most adverse events were of mild to moderate severity, with relatively few patients discontinuing treatment because of an adverse event.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

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  1. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand

    Lesley J. Scott

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  1. Lesley J. Scott
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Correspondence to Lesley J. Scott.

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The manuscript was reviewed by: J. Chen, Lorna Linda University Movement Disorders Center, Schools of Medicine and Pharmacy, Lorna Linda, California, USA; C. Guilleminault, Stanford University Sleep Medicine Division, Redwood, California, USA; H.B. Lee, John Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences, Baltimore, Maryland, USA.

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Scott, L.J. Gabapentin Enacarbil. CNS Drugs 26, 1073–1083 (2012). https://doi.org/10.1007/s40263-012-0020-3

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