(RxWiki News) While restless legs syndrome seems like an odd disorder that some people may find hard to believe, people who suffer the discomfort have no doubt this disorder exists. And now patients have effective treatment choices.
While Mirapex (pramipexole) has been considered an effective treatment for restless legs syndrome, there has been no long-term clinical evidence since no trial has lasted longer than 12 weeks.
A new and longer 26–week study has shown Mirapex to be effective in treating restless legs syndrome (RLS).
"Keep a restless legs symptom log to discuss with your doctor."
"Augmentation" in RLS is when symptoms of the disorder return with greater intensity, happen earlier in the day, and earlier during periods of rest, as a side effect of medication that increase dopamine in the brain.
Augmentation is not permanent, and doctors usually treat it by prescribing a different class of medication for a period of time.
Given the threat of augmentation posed by such drugs as Mirapex, Birgit Hogl and her team at Innsbruck Medical University considered it necessary to carry on a longer clinical study of the drug.
The new study evaluated efficacy of Mirapex and its tendency toward augmentation. The double-blind study involved 234 patients who completed all 26 weeks, who were randomly assigned to take either Mirapex or a placebo or "sugar pill".
The dosage of Mirapex varied between .125 and .75 mg per day.
The primary scale of the drug's effectiveness was the international restless legs syndrome study group rating scale. Other measures of effectiveness included change in symptoms and quality of life.
On the international restless legs syndrome rating scale, patients taking Mirapex saw a statistically significant improvement as compared to those taking a placebo. However, the study's results varied considerably from country to country.
The rate of augmentation for Mirapex was not much higher than that of the control group. This means that if Mirapex caused some amount of augmentation, it was not serious or widespread, however the authors recommended longer trials to assess the risk.
These findings were published in Sleep Medicine.