LYCOS RETRIEVER 
Requip: Patients
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The approval of Requip for moderate-to-severe primary Restless Legs Syndrome is supported by data from four double-blind, randomized, placebo- controlled clinical trials in adults diagnosed with RLS. Patients with RLS secondary to other conditions (e.g. iron deficiency, pregnancy and renal failure) were excluded from the study groups.
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Requip is a popular medicine that is regularly prescribed to patients who are suffering from Parkinson’s disease or from RLS (restless legs syndrome). However, this medicine may ... be used to treat some other medical disorders that have not been listed here.
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At 12 weeks, Requip significantly improved patients' ability to sleep. Both the primary endpoint (PLMS per hour) and secondary endpoint variable (PLMA per hour) showed large and statistically significant differences in favor of Requip over placebo. With Requip, PLMS per hour were significantly decreased from 48.5 per hour to 11.8 per hour, compared with a decrease from 35.7 per hour to 34.2 per hour in the placebo group (p < 0.0001). Further, at a mean dose of 1.8 mg per day, Requip effectively reduced PLMS to normal levels (less than or equal to 5 per hour) for more than half of the patients (53.6 percent) versus 14.8 percent of patients on placebo. Among other sleep variables, the ability to initiate sleep (known as sleep latency) was significantly improved in patients receiving Requip compared to the placebo group. Average sleep latency in the group treated with Requip decreased from 16.7 to 6.6 minutes compared with an increase in the placebo group from 8.9 to 14.4 minutes (p < 0.01).
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Therapeutic actions: Requip works by stimulating dopamine receptors in the brain... promoting better, easier movement. Requip is not a cure for Parkinson's disease. However, it does alleviate symptoms of the disease, and it can shorten the "off" periods of immobility that patients on long-term levodopa therapy often begin to experience.
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The efficacy of Requip as adjunctive therapy with levodopa in the late stages of Parkinson's disease was confirmed in a double-blind, randomized study comparing patients treated with Requip (n=94) to patients treated with placebo (n=54). Investigators evaluated the number of "responders," defined as patients who were able to achieve: (1) a decrease (compared to baseline) of at least 20 percent in their levodopa dose, and (2) a decrease of at least 20 percent in the proportion of time awake in the "off" condition (period of time during the day when patients are particularly immobile).
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When approved in May 2005 for the treatment of moderate-to-severe primary RLS, Requip became the first and only FDA-approved treatment for RLS of any type or severity. Requip is a second-generation dopamine agonist that is available in a variety of strengths for flexible dosing (up to 4 mg/day for RLS patients) to meet individual patients' needs. Requip has the largest published program of clinical trials in RLS to date.
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