Reduced response to gabapentin enacarbil in restless legs syndrome following long-term dopaminergic treatment

To determine whether long-term treatment with dopaminergic agents (DAs) might dampen the response to a non-dopaminergic agent, such as gabapentin enacarbil. We performed a two-week randomized, double-blind, crossover, and placebo-controlled study in a single, referral center in dopamine treatment-na...

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Bibliographic Details
Published in:Sleep medicine 2019-03, Vol.55, p.74-80
Main Authors: Garcia-Borreguero, Diego, Cano-Pumarega, Irene, Garcia Malo, Celia, Cruz Velarde, Jose Antonio, Granizo, Juan José, Wanner, Vivian
Format: Article
Language:English
Subjects:
Aged
Alpha-2 delta ligands
Augmentation
Carbamates - administration & dosage
Cross-Over Studies
Dopamine Agents - administration & dosage
Dopamine agonists
Double-Blind Method
Drug Administration Schedule
Female
gamma-Aminobutyric Acid - administration & dosage
gamma-Aminobutyric Acid - analogs & derivatives
Humans
Male
Middle Aged
Restless legs syndrome
Restless Legs Syndrome - diagnosis
Restless Legs Syndrome - drug therapy
Restless Legs Syndrome - physiopathology
Time Factors
Treatment failure
Treatment Outcome
Willis Ekbom disease
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Summary:To determine whether long-term treatment with dopaminergic agents (DAs) might dampen the response to a non-dopaminergic agent, such as gabapentin enacarbil. We performed a two-week randomized, double-blind, crossover, and placebo-controlled study in a single, referral center in dopamine treatment-naive patients and non-augmented patients continuously treated with dopaminergics for the last five consecutive years. Following washout from any previous CNS-active drugs, patients were randomized into one of two groups for two consecutive two-week treatment periods with gabapentin enacarbil (GBPen) and placebo. Treatment was administered at 7 PM at a fixed dose of 600 mg/day. RLS severity was measured weekly using the International RLS Scale (IRLS) and Clinical Global Improvement (CGI). An M-SIT was also performed between 6 pm and midnight at the end of each treatment condition. There were no significant differences between groups in age, sex, duration of disease, ferritin levels, RLS severity at baseline, or existing concomitant conditions. Both groups improved more during treatment with GBPen than during placebo on the IRLS scale, CGI and mSIT. However, improvements were greater in the DA-naïve group than in long-term treatment with DAs group on the IRLS (p 
ISSN:1389-9457
1878-5506
DOI:10.1016/j.sleep.2018.11.025