Posted by: Thixia | June 9, 2008

Restless Legs Syndrome Patch

Restless Legs Syndrome Relieved Day and Night by Rotigotine Skin Patches

 

LONDON

 

Use of skin patches containing the drug rotigotine can relieve restless legs syndrome (RLS) during both the day and night.  These are the conclusions of authors of an article to be published in the July edition of [The Lancet Neurology. 

Recent studies on the genetic basis of RLS have suggested that this condition needs to be treated as a general neurological disorder.  Dopaminergic drugs are currently used as the first-line treatment for this condition.  Rotigotine is a dopaminergic drug that is already used for treating Parkinson’s disease.  Claudia Trenkwalder, MD, Centre of Parkinsonism and Movement Disorders, Paracelsus-Elena Hospital, Kassel, Germany, and colleagues performed a randomised, controlled trial to investigate the efficacy of transdermal rotigotine patches in the treatment of RLS.

The trial analysed 458 patients with moderate to severe RLS, with an average baseline score on the International Restless Leg Syndrome Study Group Severity Rating Scale (IRLS) of 28.1 and a score of 4 or more on the Clinical Global Impressions (CGI) item 1 score, which measures severity of symptoms.  The patients were randomly assigned to receive transdermal rotigotine 1 mg, 2 mg, 3 mg, or placebo over 24 hours.  The medication was delivered via patches, applied once a day for 6 months.

The researchers found that mean change in IRLS score was -13.7 in the 1-mg group, -16.2 in the 2-mg group, -16.8 in the 3-mg group, and -8.6 in the placebo group.  The change in CGI item 1 score was -2.09 in the 1-mg group, -2.41 in the 2-mg group, -2.55 in the 3-mg group, and -1.34 in the placebo group.  Skin reactions, mostly mild or moderate, were seen in 43% of patients who received rotigotine.  Ten patients had serious adverse events that were deemed to be related to rotigotine.

The authors concluded, “The results of this 6-month trial indicate that transdermal delivery of low doses of rotigotine for 24 hours per day are more effective than placebo in relieving the symptoms of RLS in patients who are moderately to severely affected.  There exists a clear therapeutic window in terms of dose of rotigotine to treat restless legs syndrome between 1 mg over 24 hours to 3 mg over 24 hours.”

In an accompanying comment, Kapil Sethi, MD, Medical College of Georgia, Augusta, Georgia, says: “The introduction of a patch with a constant delivery of a dopamine agonist is a welcome addition to the armamentarium.  Unfortunately, the rotigotine patch has been temporarily withdrawn from the US market because of problems with manufacturing and the unreliable delivery of the drug.”

Dr. Sethi continued, “RLS causes significant discomfort and adversely affects the quality of life of patients.  Whether it has more ominous consequences is unclear.  A recent study showed that RLS is associated with a greater risk of cardiovascular disease, particularly in patients with greater frequency or severity of RLS symptoms.  Whether treatment of RLS will reduce this risk is unknown, and further studies should help answer this question.”

 

 

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Responses

  1. I’ve had rest legs since I was in my mid-teens. I saw a doctor once but it was pointless. He gave me sleeping pills that made me even more tired the next day.

    Anyway, about four months ago I noticed that the symptoms got worse the more caffeine and sugar I consumed. I cut them both out (sadly) and now I’m pretty much fine. If I do ever have caffeine then the symptoms return.

    Just thought I’d pass it on!

  2. Hmmm. Cut down on caffeine & sugar? Oh man…


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