Abstract
Pregabalin is increasingly being used as a first-line treatment for symptomatic control of restless legs syndrome (RLS). This study aimed to evaluate the efficacy and safety of pregabalin as add-on therapy in RLS patients already taking dopamine agonists (DA) but still in need of further management. Patients with idiopathic RLS were enrolled, and all had already been prescribed DA for at least 3 months but still had either persistent symptoms, side effects, or comorbid insomnia. An initial dose of 75 mg pregabalin was begun, adjusted as needed, and maintained at a stable dose for 4 weeks, followed by observation for a total of 8 weeks. RLS symptoms and insomnia scores were evaluated before and after add-on pregabalin treatment. Patients were monitored for side effects that could be attributed to pregabalin. A total of 32 RLS patients were enrolled, and 20 subjects remained until the endpoint. After the pregabalin add-on, the mean IRLS score showed significant improvement compared to the baseline (p < 0.001). The insomnia severity index score also improved (p = 0.036), and no serious adverse effects were observed. Our preliminary data suggests the potential for pregabalin as an add-on therapy to DA with regards to both efficacy and safety in patients who have inadequate RLS improvement.
Highlights
Restless legs syndrome is a sensorimotor neurological disorder with a worldwide prevalence of 5–10%, and 2–3% of patients having symptoms severe enough to seek treatment [1]
We evaluated for augmentation using the National Institutes of Health (NIH) criteria for augmentation [13]
This study showed the usefulness of pregabalin as an add-on treatment in patients who continue to have problems with restless legs syndrome (RLS), despite Dopamine agonists (DA) use, over 8 weeks
Summary
Restless legs syndrome is a sensorimotor neurological disorder with a worldwide prevalence of 5–10%, and 2–3% of patients having symptoms severe enough to seek treatment [1]. The discomfort and urge to move the legs, which is the prominent symptom of restless legs syndrome (RLS), occurs mainly at night. Symptomatic patients suffer from sleep disturbance and their quality of life deteriorates as a consequence [2]. Acute treatment with DA can result in side effects that may limit dose escalation and limit the ability of DA to fully treat the symptoms. Previous studies have demonstrated that despite improving symptoms, DA does not always improve sleep quality [7] and it may cause insomnia in some patients. Treatment options for physicians who have to deal with these problems when trying to treat patients include
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