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KMID : 1011320120050030123
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Journal of Pharmacoepidemiology and Risk Management
2012 Volume.5 No. 3 p.123 ~ p.129
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A Post-marketing Surveillance to Monitor the Safety of Remifentanil in Korean Patients
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Bae Jeong-Youn
Oh Shin-Young
Kim Joon-Hyung
Lee Yil-Seob
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Abstract
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Objective: The aim of this study is to monitor the safety of remifentanil in Korean patients.
Methods: Total 775 patients were enrolled consecutively by 25 physicians from April 2004 to April 2010. Patients who were administered remifentanil at least once were included in the analysis. Primary endpoint was the incidence of adverse events (AEs) and serious adverse events (SAEs) among the Korean patients administered remifentanil according to the prescribing information in a real world setting. Adverse events were coded by World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Results: Out of a total of 775 patients, evaluable data were obtained from 766 patients and 44.8% of the patients were male. The mean age of patients was 45.3 years old. The incidence of AEs was 24.4% (187/766, 286 cases). The most frequent AEs were hypotension (16.06%), followed by bradyarrhythmia (13.71%) and gagging (2.48%). All of the AEs were reported to be related with the use of remifentanil except dysuria and sedation. No SAE was reported.
Conclusion: The result suggests that remifentanil administered to Korean patients according to the prescribing information was well tolerated.
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KEYWORD
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Remifentanil, Post-marketing product surveillance, Adverse drug event, Analgesics, Anesthesia
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