Pramipexole impact on RLS related quality of life: a 12-weeks observational study in patients with primary RLS

Objectives: To evaluate the effectiveness of pramipexole on RLS symptom severity and the impact on quality of life in patients with primary Restless Legs Syndrome (RLS) in routine clinical practice.

Methods: This was an open-label, 12 week-prospective, non-controlled, non-interventional trial in patients with moderate to severe primary RLS being treated with the non-ergot dopamine agonist pramipexole by General Practitioners across Germany under routine conditions. RLS severity was measured by the International RLS Study Group Rating Scale (IRLS, score range 0–40) and the Clinical Global Impression-Global Improvement (CGI-I) questionnaire. As little information is available on the impact of RLS on patient reported quality of life (QoL), the „Johns Hopkins RLS-QoL questionnaire“ (RLS-QoL, 18 items) was used to assess the impact of RLS on daily life, emotional well-being, social life (10 item sum score) and ability to work ('Ability to work a full day').

Results: A total of 2,023 patients (mean age: 65.3 years, 68.2% females, 31.8% pre-treated for RLS) suffering from moderate to severe RLS were evaluated at 1292 sites. Quality of life at baseline was clearly impaired with only 47,5% (100%=full quality of life). Median duration of observation was 94 days. Patients were starting with a median initial pramipexole dose of 0.088mg/d (base), were flexibly titrated and had a median final maintenance dose of 0.35mg/d. The maintenance dose was reached after four weeks by 69.6% of the patients. After 12 weeks of treatment RLS severity was clearly improved: IRLS median total score alleviated from „severe“ (27) at baseline to „mild“ (8) after 3 months of therapy. CGI-I was rated as „much improved“ or better in 92.5% of the patients. RLS-QoL sum score improved substantially from 47.5% at baseline to 85.0% (change of 35.0%) after 12 weeks of treatment. Similarly, work ability improved in 78.7% of the 362 patients still working at the end of the observation.

Pramipexole treatment was well tolerated: Only 56 patients (2.8%) experienced adverse events, most of which were general, nervous system and gastrointestinal disorders.

Conclusions: Pramipexole showed to be highly effective in the treatment of RLS in routine care. Quality of life as well as the ability to work a full day were clearly improved after 3 months of treatment.