How effective are treatment guidelines for augmented RLS?

The objective of this study was to assess the effectiveness of current treatment guidelines for restless legs syndrome (RLS) augmentation in patients on dopamine agonists (DAs) which recommend a cross-titration strategy to an alpha-2-delta ligand (A2D) and/or opioid.

Consecutive new consultations for RLS with both augmentation and active treatment with DAs at the time of initial assessment were included if followed >5 months. Clinical information from the semi-structured initial consultation, and subsequent visits until their most recent/final visit was extracted. Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scores were retrospectively determined by two independent evaluators.

In the 63 patients with augmented RLS on DAs, followed for 5-59 months (mean = 28, SD = 14), the average age was 67.6 (SD = 9.8) and 63% were female. Mean duration of prior dopaminergic therapy was 11.6 years (SD = 6.7) and average pramipexole equivalent dose was 1.23 mg (SD = 1.22 mg). At baseline, RLS was "moderate-markedly" severe (CGI-S = 4.9). At the final/most recent visit, 78% (49/63) were classified as Responders (CGI-I ≤ 2, "Much" or "Very Much Improved") with an average CGI-S of 2.4 ("borderline-mildly ill"). Responders (59%) were more likely to have discontinued DAs than Non-Responders (40%), and mean opioid doses were higher in Responders (39 vs 20 MME). No differences in baseline DA dose, final A2D dose, or iron therapy were observed between groups. Responders did have significantly more severe RLS, more sleep maintenance insomnia, and greater subjective daytime sleepiness at baseline (p < 0.05).

Guideline-based management is effective in most patients with augmented RLS on DAs.