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KMID : 1011320160080010024
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Journal of Pharmacoepidemiology and Risk Management
2016 Volume.8 No. 1 p.24 ~ p.28
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A Post-marketing Surveillance to Evaluate the Safety of Ibandronate Injection in Korean Women with Postmenopausal Osteoporosis
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Bae Ji-Young
Lee Han-Kyu
Lee Yil-Seob
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Abstract
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Objective: The aim of this study was to evaluate the safety of ibandronate injection in Korean women with postmenopausal osteoporosis.
Methods: A total of 657 patients were enrolled consecutively by 20 physicians. Subjects who were administered ibandronate injection 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 injection according to the prescribing information in a real world setting. Effectiveness was evaluated through overall evaluation by physicians.
Results: Evaluable data were obtained from 628 out of 657 patients. The mean age of subjects was 67.1±9.4 years old. The overall incidence of AE was 9.4% (102 cases). The most frequent AEs were myalgia (2.2%), followed by dyspepsia (1.4%), arthralgia (1.1%), and musculoskeletal pain (1.1%). Among 102 AE reports, 60 AEs were reported to be related with the use of ibandronate injection. The incidence of Serious AE was 0.5% (3 cases). Out of the 346 subjects analysed for efficacy, most subjects (87.9%) showed overall improvement after treatment of ibandronate injection.
Conclusion: The results suggest that ibandronate injection 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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