Restless legs syndrome medical therapy

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Mohamadmostafa Jahansouz M.D.[2]

Medical Therapy

An algorithm for treating Primary RLS (RLS without any secondary medical condition including iron deficiency, varicose vein, thyroid, etc.) was created by leading RLS researchers at the Mayo Clinic and is endorsed by the Restless Legs Syndrome Foundation. This document provides guidance to both the treating physician and the patient and includes both nonpharmacological and pharmacological treatments. Treatment of primary RLS should not be considered unless all the secondary medical conditions are ruled out. Drug therapy in RLS is not curative and is known to have significant side effects and needs to be considered with caution. The secondary form of RLS has the potential for cure if the precipitating medical condition (iron deficiency, venous reflux/varicose vein, thyroid, etc.) is managed effectively.

Pharmacotherapy

For those whose RLS disrupts or prevents sleep or regular daily activities, medication is often required. Many Doctors currently use, and the Mayo Clinic Algorithm includes, medication from four categories:

• 1) Dopamine agonists such as ropinirole, pramipexole, carbidopa/levodopa or pergolide:

There are some issues with the use of dopamine augmentation. Dopamine agonists may cause augmentation. This is a medical condition where the drug itself causes symptoms to increase in severity and/or occur earlier in the day. Dopamine agonists may also cause rebound, when symptoms increase as the drug wears off. Also, a recent study indicated that dopamine agonists used in restless leg patients can lead to an increase in compulsive gambling.

• 2) Opioids such as propoxyphene, oxycodone, or methadone, etc.
• 3) Benzodiazepines, which often assist in staying asleep and reducing awakenings from the movements
• 4) Anticonvulsants, which often help people who experience the RLS sensations as painful, such as gabapentin

In a study of 10 patients, it was reported that partial relief with taking a supplemental magnesium salt such as magnesium oxide or magnesium gluconate once or twice a day, and reducing the dose if diarrhea develops. Magnesium sulfate is the most active form; however, magnesium supplementation can cause complications for patients with renal problems.

Agent	Timeline	Comments
ropinirole	Approved In 2005 by the Food and Drug Administration to treat moderate to severe Restless Legs Syndrome	The drug was first approved for Parkinson's disease in 1997.
pramipexole (Mirapex, Sifrol, Mirapexen in the EU)	In February 2006, the EU Scientific Committee issued a positive recommendation for approving for the treatment of RLS in the EU. US FDA approved Mirapex in 2006.	-
rotigotine	Currently in process for US FDA and EU approval for RLS	Delivered via a transdermal patch
pergolide	In March 2007 was withdrawn from the U.S. market	Withdrawn due to implication in valvular heart disease, that was shown in two independent studies.

Iron supplements

All people with RLS should have their ferritin levels tested; ferritin levels should be at least 50 mcg for those with RLS. Oral iron supplements, taken under a doctor's care, can increase ferritin levels. For some people, increasing ferritin will eliminate or reduce RLS symptoms. A ferritin level of 50 mcg is not sufficient for some sufferers and increasing the level to 80 mcg may greatly reduce symptoms. However, at least 40% of people will not notice any improvement. Treatment with IV iron is being tested at the US Mayo Clinic and Johns Hopkins Hospital. It is dangerous to take iron supplements without first having ferritin levels tested, as many people with RLS do not have low ferritin and taking iron when it is not called for can cause iron overload disorder, potentially a very dangerous condition.

New results from the first ever double-blind clinical study, performed at Örebro University Hospital show that all 29 out of 60 patients that were treated with IV-infusion of up to a total of 1000 mg of iron (in the form of iron saccharose, Venofer), were markedly improved after 3 weeks. The effect lasted for 5-6 months. Those 31 receiving placebo had just a slight effect after 3 weeks that additionally disappeared rapidly.

The treatment was given even if iron deficiency was not shown according to ferritin levels. Worries of anaphylactic reactions did not come true. This is probably due to the form the IV iron was given. Anaphylaxis has been associated predominantly with dextran based infusions.

Non-Pharmacotherpy

Treatment for RLS is based on how disruptive the symptoms are. All people should review their lifestyle and see what changes could be made to reduce or eliminate their RLS symptoms. These include: finding the right level of exercise (too much worsens it, too little may trigger it); eliminating caffeine, smoking, and alcohol; changing the diet to eliminate foods that trigger RLS (different for each person, but may include eliminating sugar, triglycerides, gluten, sugar substitutes (aspartame), following a low-fat diet, etc.); keeping good sleep hygiene; treating conditions that may cause secondary RLS; avoiding or stopping OTC or prescription drugs that trigger RLS; adding supplements such as potassium, magnesium, B-12, folate, vitamin E, and calcium. Some of these changes, such as diet (particularly aspartame) and adding supplements are based on anecdotal evidence from RLS sufferers as few studies have been done on these alternatives.

For those who experience RLS infrequently and do not need or want to try medication, in addition to lifestyle changes they can try:

• Some form of exercise for several minutes such as walking, stretching, meditation, yoga, etc. at bedtime
• Heat or cold, such as a hot or cold bath, a heating pad, a cold cloth, or a fan
• Soaking one's feet in hot water just prior to going to sleep
• Engrossing the mind in a game, the computer, or figuring something out
• Wearing compression stockings, tight pantyhose, or wrapping the legs in elastic bandages
• Placing a pillow between the knees or upper-legs while lying in bed
• Eating porridge oats or almonds daily for their magnesium content
• Hot green tea can relieve symptoms
• Deep breathing for one or two minutes
• Massage and chiropractic spinal manipulation provide significant relief for some patients.

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-in-Chief:

Overview

Pharmacologic medical therapies for [disease name] include (either) [therapy 1], [therapy 2], and/or [therapy 3].

Medical Therapy

• Pharmacologic medical therapy is recommended among patients with persistent or moderate to severe symptoms of restless legs syndrome.
• Pharmacologic medical therapies for restless legs syndrome include dopamine agonists, alpha-2-delta calcium channel ligands and opioids.

• The treatment of restless legs syndrome must be individualized to each patient.
• In patients with mild symptoms, no treatment is required.

Disease Name

• 1 Stage 1 - Name of stage
  • 1.1 Specific Organ system involved 1
    • 1.1.1 Adult
      • Preferred regimen (1): pramipexole
        • Treatment with pramipexole is started at a dosage of 0.25 mg per day, and progressively increase until the optimal therapeutic effect is obtained.
      • Preferred regimen (2): Ropinirole
        • It is important to take ropinirole prior to symptom onset.
        • For daily RLS, ropinirole may be started at 0.25 mg per day at 2 hours before RLS symptom onset, and then increased by 0.25 mg every 2 to 3 days until symptom relief is achieved (Silber et al 2004). Starting dose should be individualized based on RLS severity and age.
        • The effective dose for ropinirole is typically 2 mg or less.
        • Some patients may require doses as high as 6 mg/day.
      • Preferred regimen (3): Carbidopa/levodopa 25/100 mg PO daily at bedtime
      • Alternative regimen (1): Gabapentin 300–1200 mg daily about 1 h before bedtime.
      • Alternative regimen (2): drug name 500 mg PO q12h for 14–21 days
      • Alternative regimen (3): drug name 500 mg PO q6h for 14–21 day