Treatment initiation and utilization patterns of pharmacotherapies for early-onset idiopathic restless legs syndrome

• Published in: Sleep medicine 2022-08, Vol.96, p.70-78
• Main Authors: Costales, Brianna, Vouri, Scott M., Brown, Joshua D., Setlow, Barry, Goodin, Amie J.
• Format: Article
• Language: English
• Subjects: Adult; Cross-Sectional Studies; Dopamine agonists; Dopamine Agonists - therapeutic use; Gabapentin - therapeutic use; Gabapentinoids; Humans; Idiopathic; Pramipexole - therapeutic use; Restless legs syndrome; Restless Legs Syndrome - diagnosis; Restless Legs Syndrome - drug therapy; Restless Legs Syndrome - epidemiology; Retrospective Studies; Treatment patterns; Willis-ekbom disease
• ISSN: 1389-9457; 1878-5506; 1878-5506
• DOI: 10.1016/j.sleep.2022.05.003

Restless legs syndrome (RLS) is a complex condition associated with circadian rhythm that disrupts sleep and can cause multisystemic consequences. This study assesses pharmacotherapy treatment initiation, estimates annual treatment prevalence, and assesses treatment patterns for early-onset idiopathic RLS. We used the MarketScan Commercial Claims Database from 2012 to 2019 to conduct a new user retrospective cohort study. Annual treatment prevalence was calculated from a cross-sectional sample. Newly diagnosed adults with early-onset (18–44 years) idiopathic RLS who initiated on and off-label gabapentinoids, dopamine agonists, or levodopa/carbidopa were included. Among monotherapy users who had one year of insurance enrollment, treatment patterns (single fill, continuous use of initiated therapy, switching, and add-on therapy) were examined and mean time on the initial treatment (as a measure of persistence) was calculated. In total, 6, 828 patients were initiated on monotherapy treatment for early-onset idiopathic RLS in which 4,638 met all inclusion criteria. In 2019, annual prevalence of monotherapy treatment of diagnosed patients for ropinirole was 171.3/1,000 patients; 85.0/1,000 patients for pramipexole; and 132.1/1,000 patients for gabapentin. Overall, 22.3% (n = 1,033) of patients maintained their initiated pharmacotherapy for the entire year. Rotigotine had the longest persistence (mean 185.4 [161.4 SD] days) but this user group was the smallest (n = 29). Gabapentin enacarbil, pregabalin, and rotigotine use was low (2.8% total). Ropinirole, pramipexole, and gabapentin were initiated most often for early-onset idiopathic RLS. FDA-approved agents for RLS, including gabapentin enacarbil and rotigotine, were used less frequently. In general, persistence was low for all RLS study drugs examined. •Ropinirole, pramipexole, and gabapentin were initiated most often for patients with newly diagnosed early-onset idiopathic RLS.•From 2012 to 2015, ropinirole was prescribed the most. Gabapentin became the second most prescribed from 2016-2019.•Recommended first-line treatment (i.e., gabapentin enacarbil, pregabalin, and rotigotine) use was minimal.•Mean time on therapy as measure of persistence was low (range 138.6–185.4 days) for all RLS study drugs examined.•Most frequent diagnoses at baseline concurrent with RLS diagnosis were anxiety, hypertension, and insomnia.