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KMID : 1011320090020010030
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Journal of Pharmacoepidemiology and Risk Management
2009 Volume.2 No. 1 p.30 ~ p.37
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Post-marketing Surveillance for the Safety and Efficacy of Irbesartan in Patients with Hypertension
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Lee Hye-Ree
Kim Young-Sik
Shin Jin-Hee
Sun Woo-Sung
Paek Yu-Jin
Won Chang-Won
Kim Dae-Hyun
Korean Post-Marketing Surveillance Research Group
Song Sang-Wook
Kang Hee-Cheol
Jeong Young-Jin
Lee Sang-Yeoup
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Abstract
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Objective: In order to investigate the safety and efficacy of irbesartan among Korean patients with hypertension in primary care setting, an observational study was carried out.
Methods: A total of 1,166 patients with hypertension were enrolled by 28 participating family physicians between March 2002 and September 2003. To ascertain the safety and efficacy, patients were followed up at regular intervals of 4, 12, and 24 weeks. For the safety assessment, investigators recorded the occurrence of observed and patient-reported adverse events throughout the course of treatment. We defined controlled blood pressure as a measurement of less than 140 mmHg systolic and 90 mmHg diastolic at 24 weeks from the beginning of treatment.
Results: Of the 1,166 patients, 1,034 were evaluated for safety and 1,021 for efficacy assessment. A total of 79 adverse events were reported in 58 patients (5.8%). Most frequently reported adverse event was dizziness (1.1%) and followed by headache (0.9%), puffiness (0.8%), and indigestion (0.4%). Adverse events were assessed as mild in 67.9% and moderate in 32.1%. Twentyone patients (2.0%) discontinued irbesartan as a direct result of adverse events. They were divided into two groups: controlled (645, 63.2%) group and uncontrolled (376, 36.8%) group. Factors associated with the controlled group were stage 1 hypertension (OR 1.94, 95%CI 1.31-2.86) and good compliance (OR 5.91, 95%CI 3.07-11.40).
Conclusion: Irbesartan was well tolerated, and the factors associated with good efficacy were stage 1 hypertension and good compliance.
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KEYWORD
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Hypertension, Irbesartan, Safety, Efficacy, Compliance
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