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Title: Ropinirole (Requip) Linked to Improved Symptoms and Mood in Patient With Restless Legs Syndrome

"Ropinirole (Requip) Linked to Improved Symptoms and Mood in Patient With Restless Legs Syndrome"

By Paula Moyer ATLANTA, GA -- May 31, 2005 -- Ropinirole (Requip) appears to reduce both the direct symptoms of restless legs syndrome (RLS) and RLS-associated mood problems, according to investigators who presented their findings here May 25[^th at the American Psychiatric Association (APA) Annual Meeting.

Although study results of ropinirole for RLS have been presented nationally and internationally, this was the first time that a study on a medication for RLS had been presented at the APA, according to principal investigator Philip M. Becker, MD, President, Sleep Medicine Associates, and Clinical Professor of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas, United States.

The presentation followed shortly after the United States Food and Drug Administration approved ropinirole for this indication.

Ropinirole, like most other dopamine agonists, was first approved as a treatment for Parkinson's disease. Its approval as an RLS therapy is the first approval of a drug in the United States for this indication.

"The approval will help make physicians in general more aware of RLS as a diagnosis, and should lead to a reduction of inappropriate psychiatric referrals when patients say they feel like bugs are crawling on their legs," Dr. Becker said.

"Psychiatrists should also know that many psychotropic therapies, including many selective serotonin reuptake inhibitors [SSRIs], exacerbate RLS," he said, noting that psychiatrists should know whether patients have RLS when they are making treatment decisions.

Dr. Becker and co-investigators conducted a 12-week, phase 3, double-blind study that randomized 187 patients with RLS to treatment with ropinirole 0.25 to 4.0 mg and 194 to placebo. Treatment was to be taken once daily 1 to 3 hours before bedtime.

By the end of the study, the ropinirole group took an average dose of 2.15 mg/day; 19.8% of ropinirole patients were on the maximum daily dose.

Patients in the treatment group had a strongly significant improvement on the International Restless Legs Scale Score (IRLSS). The adjusted mean treatment difference (AMTD) at week 12 in the last observation carried forward (LOCF) was -3.7 (P < .0001).

The overall life impact score on the RLS Quality of Life questionnaire was significantly better in the treated group, with an AMTD of 4.5 (P = .0026).

Patients withdrew due to adverse events at a rate of 3.7% in the treated group and 4.7 % in the placebo group.

The studies were funded by GlaxoSmithKline, the manufacturer of Requip.

[Presentation title: Ropinirole Improves Mood and Reduces Symptoms of Anxiety in RLS. Abstract NR539]

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