LYCOS RETRIEVER 
Requip: Patients
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GlaxoSmithKline, makers of Requip, provided only one instance where an elevated INR was associated with the initiation of Requip. An increase in INR test result to 4.6 nine days after Requip was reported in a Parkinson ’s disease patient. The patient’s INR returned to baseline upon discontinuation of Requip.
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Requip triggers the same effects as a natural chemical that is known to naturally occur in the human body that is called dopamine. A low level of this chemical has been linked to Parkinson’s disease. This medicine is prescribed to patients who are suffering from this medical condition as it is known to ease some of its symptoms (stiffness, muscle spasms, tremors, and poor muscular control).
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The study met the primary endpoint, showing that Requip decreased RLS symptom severity according to the IRLS total score when measured at Week 12 compared to placebo. Using the same scale, patients taking Requip reported significant improvement in symptoms after two nights of treatment versus placebo.
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In this trial, patients taking Requip demonstrated a significantly lower relapse rate compared with patients randomized to placebo (32.6 percent vs. 57.8 percent, p=0.0156). In clinical trials in the treatment of moderate-to-severe primary RLS, the most commonly observed adverse events for Requip (n=496) versus placebo (n=500) were nausea (40 percent versus 8 percent), somnolence (12 percent versus 6 percent), vomiting (11 percent versus 2 percent) ,dizziness (11 percent versus 5 percent) and fatigue (8 percent versus 4 percent). Occurrences of nausea in clinical trials were generally mild to moderate in intensity. About RLS In general, many people with RLS report a significant impact on their daily activities. In addition to feeling less alert during the day, RLS sufferers may ... have difficulty with activities that require prolonged sitting such as movies, long car rides or airline flights. Difficulty falling asleep may frequently be associated with moderate-to-severe primary RLS.
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Patients in this trial experienced significant improvement in their symptoms at one week of treatment with Requip, continuing through week 12. In total, 267 patients ages 18-79, with moderate-to-severe primary RLS, were randomized to Requip (0.25-4.0 mg/day) or placebo, 1-3 hours before bedtime. The primary endpoint was the change in International RLS Rating Scale (IRLS Scale) score at week 12. Improvements were significantly better for Requip than placebo on the IRLS Scale (–11.2 vs. –8.7; p = 0.0197).
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The US FDA has approved Requip� (ropinirole HCl) Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults, GlaxoSmithKline announced today. Requip is the first and only FDA-approved treatment for those patients with moderate-to-severe primary RLS, a chronic and disruptive neurological condition.
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