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In the February issue of Prescrire International: Pramipexole

FREE DOWNLOAD Restless legs syndrome does not lead to any physical complications. Various treatments have been tried but none has shown any substantial efficacy in the few available comparative trials. It is better to avoid treating patients with restless legs syndrome with pramipexole (or with ropinirole). It’s better to wait until a satisfactory treatment is available.
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Abstract

  • Restless legs syndrome consists of generally harmless but unpleasant sensory and motor symptoms affecting the lower limbs. Restless legs syndrome does not lead to any physical complications.
  • Various drug and non drug treatments have been tried but none has shown any substantial efficacy in the few available comparative trials.
  • Ropinirole, a dopamine receptor agonist, was the first drug to be approved for this syndrome in France. However, it is only marginally beneficial and can lead to potentially severe adverse effects.
  • Pramipexole (Sifrol°, Boehringer Ingelheim), a dopamine agonist used for Parkinson’s disease, is now approved in the EU for the treatment of the restless legs syndrome.
  • Two non comparative prospective follow- up studies and two retrospective analyses of several dozen patients showed that, during the first year of treatment, the symptoms of up to one-third of patients became worse
  • Classic adverse effects observed with dopamine agonists were reported in the observational studies, including nausea, headache, insomnia (potentially compounding sleep disturbances caused by restless legs syndrome), daytime drowsiness, and dizziness.