New data demonstrate that pramipexole (Mirapexin/Sifrol) is also efficacious and well-tolerated in Restless Legs Syndrome (RLS) patients with daytime RLS symptoms.
The data was presented this week at the Movement Disorder Society's (MDS) 11th International Congress of Parkinson's Disease and Movement Disorders in Istanbul, Turkey. Pramipexole, taken once daily, was shown to relieve afternoon and early evening RLS symptom onset, and improve the daytime symptoms of the condition, reinforcing the treatment's broad spectrum appeal for patients with moderate-to severe-RLS.
In the analysis conducted by Walters et al, results showed pramipexole to be statistically significantly superior to placebo in treating RLS symptoms in patients who experience symptoms in the afternoon or early evening. The primary efficacy endpoint (IRLS total score) in one double-blind multi-centre trial was analysed among patients with early-onset symptoms (47 percent of total study population). Patients with early-onset symptoms were defined as those with symptoms occurring from 3:00-9:00pm at baseline. Results showed that pramipexole was significantly effective in treating symptoms of RLS in patients who experience early-onset symptoms, results which were comparable to those seen in the total study population. This study highlights the range of patients that may benefit from pramipexole in treating RLS, which affects patients not only at night, but in some patients already in the early afternoon and evening, severely impacting activities of daily living and quality of life.
The second project presented at MDS assessed the efficacy of pramipexole in improving daytime RLS symptoms. Kushida et al presented new data pooled from a series of double-blind trials, demonstrating that pramipexole was generally effective in improving daytime symptoms. In this analysis, patients with a baseline Epworth Sleepiness Scale (ESS) score of > 10 (defined as 'daytime impaired') were compared to the total study population. Nearly a third of patients in these studies (31 per cent) were considered 'daytime impaired'. Results showed a statistically significant improvement from baseline on both IRLS scored daytime sleepiness (-0.46 in total population and -0.37 in daytime impaired) and visual analog scales (VAS) RLS severity during the day (-8.7 in total population and -10.8 in daytime impaired). In addition, ESS scores were significantly improved in patients who were the most impaired based on ESS baseline assessment.
Finally, an analysis by Lainey et al evaluated the impact of RLS symptoms on working life. In the course of enlisting RLS patients for a clinical trial, Lainey et al assessed the impact that symptoms of RLS may have on patients' working lives. In this 12-week double-blind RLS trial, the Johns Hopkins Restless Legs Syndrome Quality of Life (RLS-QOL) questionnaire was used to explore in 337 patients whether patients with moderate-to-severe RLS encountered difficulty in fulfilling work responsibilities. Study results found that a substantial number of workers reported that RLS interfered with work life, with 36 per cent who had difficulty working a full day at least a few times during the preceding month and 32 percent sometimes worked fewer hours than they would have liked. Eight patients ascribed their absence of employment to RLS symptoms.
The data presented at MDS demonstrate that pramipexole, taken once daily, can provide significant benefits to patients with RLS, even if these symptoms occur earlier in the evening or during the day.