Strong data for BI's pramipexole in broad range of RLS patients, even those with concomitant diseases

German drug major Boehringer Ingelheim welcomed new data presented at the 10th International Congress of Parkinson's Disease and Movement Disorders, held in Kyoto, Japan, showing that patients on Mirapexin/ Sifrol (pramipexole) experience significant improvements in a broad range of symptoms associated with Restless Legs Syndrome. Additional data presented at the congress found that pramipexole was also well-tolerated by RLS sufferers affected by concomitant diseases, which are commonly experienced in this patient group.

In all studies presented, patients taking pramipexole rated clinically-meaningful improvements to their night and day-time symptoms, as measured on the International Restless Legs Scale, which measures several aspects of the condition, ranging from discomfort, the need to move around and relief by moving around, to specific RLS symptoms such as sleep disturbance, day-time tiredness, mood disorder, as well as addressing overall severity, weekly frequency, daily severity, and impact on daily activities.

IRLS data were pooled from a total of 564 pramipexole recipients and 220 patients on placebo, all of whom had participated in one of three placebo-controlled, double-blind, randomized trials of the agent in RLS. BI noted that the mean improvement in the pramipexole arm ranged from 0.9 points for "impact on daily activities" and 1.0 for "mood disturbance," to 1.8 points for "need to move due to discomfort." These results, confirmed by patients themselves, reinforce the overall benefits of pramipexole, according to the firm, which noted that the agent was first licenced in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson's disease.