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KMID : 1011320140070010028
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Journal of Pharmacoepidemiology and Risk Management
2014 Volume.7 No. 1 p.28 ~ p.32
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A Post-marketing Surveillance to Evaluate the Safety of Ibandronate Sodium 150 mg Tablet in Korean Women with Postmenopausal Osteoporosis
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Oh Shin-Young
Lee Han-Kyu
Lee Yil-Seob
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Abstract
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Objective: The aim of this surveillance was to evaluate the safety of ibandronate sodium tablet in Korean women with postmenopausal osteoporosis.
Methods: Total 659 subjects were enrolled consecutively by 51 physicians. Subjects who received ibandronate sodium tablet at least once and were monitored for safety were included in the analysis. Primary endpoint was the incidence of adverse event (AE) among the Korean subjects administered ibandronate sodium tablet according to the prescribing information in a real world setting. And, we evaluated the effectiveness through overall evaluation by physicians.
Results: Out of a total of 659 subjects, safety evaluable data were obtained from 647 women. The mean age of subjects was 67.5±9.2 years old. The overall incidence of AE was 4.9% (44 events) over a period of treatment of 203.8±57.4 days. The most frequent AEs were dyspepsia (1.9%) and flu-like syndrome (1.9%), followed by myalgia (1.4%). Among 44 AE reports, 42 AEs were reported to be related with the use of ibandronate sodium tablet. No serious AE was reported during surveillance period. And, out of a 466 subjects evaluable for effectiveness, most subjects (92.3%) showed overall improvement after treatment of ibandronate sodium tablet in the effectiveness.
Conclusion: The results suggest that ibandronate sodium tablet administered to Korean subjects according to the prescribing information was well tolerated.
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KEYWORD
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Ibandronate, Adverse event, Postmenopausal osteoporosis, Bisphosphonates
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