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KMID : 1011320120050010025
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Journal of Pharmacoepidemiology and Risk Management
2012 Volume.5 No. 1 p.25 ~ p.30
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A Post-marketing Surveillance to Monitor the Safety of Ropinirole (Requip) in Korean Patients with Restless Legs Syndrome
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Kim Ji-Yun
Oh Shin-Young
Lee Han-Kyu
Lee Yil-Seob
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Abstract
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Objective: To monitor the safety of ropinirole in Korean restless legs syndrome (RLS) patients.
Methods: A total of 755 Korean RLS patients were enrolled consecutively by 38 physicians from November 2006 to November 2007. Patients who were administered ropinirole at least once were included in the analysis. Primary endpoint was to record the incidence of adverse events (AEs) and serious adverse events (SAEs) among the Korean restless legs syndrome patients treated with ropinirole according to the prescribing information in a real world setting. The incidence of any AEs and SAEs were estimated with a 95% confidence interval (CI).
Results: Out of a total of 755 patients, evaluable data were obtained from 747 patients. The patient characteristics were: mean age of 60.9 years and male percentages of 41.1%. Seventy-one AEs were reported by 44 patients. The most frequent AEs were insomnia (1.7%), followed by nausea (1.5%) and dizziness (1.1%). The total incidence of AEs was 5.9% (44/747, 71 cases). Among the 71 AEs, only one case of nausea and one case of appendicitis were assessed as being not related to ropinirole by the physicians. However, all other cases were not assessed for their causal relationship to ropinirole. SAEs such as abdominal pain, appendicitis, dizziness and melena were reported in 3 subjects.
Conclusion: The result suggests that ropinirole administered to Korean RLS patients according to the prescribing information was well tolerated.
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KEYWORD
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Ropinirole, Restless legs syndrome, Requip, Post marketing surveillance, Adverse event, Dopamine agonist
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