New data, reported for the first time at this year's European Federation of Neurological Societies (EFNS) Annual Meeting in Athens, Greece, support the efficacy and safety of Boehringer Ingelheim's dopamine agonist pramipexole in treating patients with Restless Legs Syndrome (RLS).(1,2) Restless Legs Syndrome is one of the most common, but treatable, neurological conditions in the world. It is estimated that RLS affects up to one in ten of the population aged between 30 to 79 years.(3)

The latest results from the large, double-blind, placebo-controlled European study1,2 in 345 patients suggest that pramipexole is effective in reducing the severity of RLS symptoms, over a six-week period, and is well-tolerated. Efficacy was demonstrated in this study using two measurement criteria: the International RLS Rating Scale of severity (IRLS) and the Clinical Global Impressions Improvement (CGI I) scale. Results after six weeks of trial therapy showed that:

• Improvement in the IRLS was significantly greater for the pramipexole group, compared to the placebo group (adjusted mean change from baseline -12.3 vs -5.7, p= 0.0001).
• On the CGI-I scale almost two-thirds (62.9%) of patients taking pramipexole were classified as "improved" or "much improved," compared to only one-third (32.5%) of patients treated with placebo (p<0.0001).

A new subanalysis of the European study, also presented for the first time, has shown that pramipexole treatment significantly improves patients' quality of life, as measured by the SF-36 (Medical Outcomes Study 36 Item Short Form health survey)2. This assessment test has eight sub-scales upon which patients are scored. Low scores on this scale indicate poor or worsening quality of life; high scores indicate better quality of life. After six weeks of study treatment, compared to placebo, patients treated with pramipexole had statistically significant higher scores for 'Vitality' (i.e. fatigue
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Contact: Anne Marie Kearns
annemarie.kearns@ketchum.com
646-935-4010
Ketchum
9-Dec-2005

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