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Study sheds light on treatment for Willis-Ekbom disease (restless legs syndrome)
Thursday, February 20, 2014
Study sheds light on
treatment for Willis-Ekbom disease (restless legs syndrome): Pregabalin (Lyrica)
found as effective as FDA-approved pramipexole (Mirapex) without causing the worsening
of symptoms that commonly occurs with pramipexole.
Rochester,
Minn. - February 20, 2014 – A large-scale study of treatment
for Willis-Ekbom disease (restless legs syndrome, or WED/RLS) published February
14 in the New England Journal of Medicine
shows that the drug pregabalin (Lyrica) controls symptoms as well as pramipexole
(Mirapex), but with significantly lower incidence of augmentation. Augmentation
is a worsening of symptoms with long-term use, and occurs in about one third of
WED/RLS patients who take the intermediate-acting dopamine drugs pramipexole
and ropinirole (Requip). Both pramipexole and ropinirole are FDA approved for
treating WED/RLS and commonly used as first-line therapy.
“Over the long term, the most commonly used treatments
for WED/RLS make a bad disease worse,” says Richard P. Allen, PhD, who is first author of the report. Allen is an
associate professor in the Department of Neurology at Johns Hopkins University past
chair of the WED Foundation’s medical advisory board.
“This study is an important contribution to our
knowledge of the treatment of a widespread and very serious medical condition,”
said Karla Dzienkowski, executive director of the Willis-Ekbom Disease
Foundation, headquartered in Rochester, Minn.
WED/RLS is a disease that produces an overwhelming
evening and nighttime urge to move the legs. It wreaks havoc on sleep, disrupts
quality of life, and is associated with increased risk of cardiovascular
disease. Clinically significant WED/RLS affects from 2 to 3 percent of adults
and progressively worsens over time.
While previous studies found that one third of
patients became worse over three years of taking ropinirole and pramipexole, it
was unclear whether this was caused by the drugs themselves or by natural
worsening of symptoms over time.
The new study used a head-to-head comparison of two
drugs at their usual doses for treating WED/RLS: Pramipexole is a drug that
mimics dopamine in the brain and is FDA approved for treating WED/RLS. Pregabalin
is a pain medication that is neither FDA approved for treating WED/RLS nor
commonly used to manage the condition.
In the study, 719 patients received standard doses of
either 0.25 or 0.5 mg pramipexole or 300 mg pregabalin. Both drugs were found
equally effective in initially relieving WED/RLS symptoms, but after one year
of treatment, pregabalin showed a better outcome.
Prior studies found that pramipexole and ropinirole (another
dopamine mimic) deceptively provide effective initial treatment followed by an
insidious worsening of the disease. This often results in very severe—even
painful—symptoms that require a very difficult withdrawal from the medication. “What
starts as an evening or nighttime disorder expands to affect the afternoon and
even the entire day of some WED/RLS patients, totally disrupting life and the
ability to work efficiently,” says Allen.
The new research found worsening of WED/RLS symptoms
in only 1–2% of patients taking pregabalin—consistent with the rate of expected
natural disease progression. In contrast, a dramatically higher rate of
worsening symptoms occurred with pramipexole: 7–9%, mostly during the second
half of the 12-month study.
The company producing pregabalin (sold as Lyrica) has not made plans to seek FDA approval for treating
WED/RLS. The similar drug gabapentin enacarbil (sold as Horizant) was approved for treatment of WED/RLS in 2011.
Researchers from Pfizer, Massachusetts General
Hospital in Boston, the Sleep Research Institute in Madrid, and Tampere
University Hospital in Tampere, Finland, also contributed to the study.
###
About
the WED Foundation
The WED Foundation is dedicated to improving the
lives of men, women and children who live with Willis-Ekbom disease (restless
legs syndrome, or WED/RLS). Founded in 1989 in Rochester, Minn., the
Foundation’s goals are to increase awareness, improve treatments, and through
research, find a cure. The Foundation serves health care providers,
researchers, over 5,000 members, and an estimated seven million individuals in
the United States and Canada who have the disease. The WED Foundation Research
Grant Program has awarded $1.4 million to fund medical research on WED/RLS
causes and treatments. For more information, visit www.willis-ekbom.org.
CONTACT:
Karla Dzienkowski
Interim Executive Director
The Willis-Ekbom Disease Foundation
507-287-6465
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