| アブストラクト | Topical prostaglandin F2alpha (PGF2alpha) analogs are widely used as the first line of therapy for glaucoma. Systemic PGF2alpha is suggested to increase blood pressure. Some ophthalmic formulations with beta-receptor blocking or alpha-receptor stimulating actions are reported to cause systemic adverse events such as a decrease in heart rate and blood pressure. The objective of this study was to evaluate the association between topical PGF2alpha analogs and blood pressure elevation. We analyzed the reports obtained from the Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 until the end of 2015 and the Japanese Adverse Drug Event Report (JADER) database from April 2004 to January 2016 for signal detection using reporting odds ratio (ROR), a method of disproportionality analyses. Signals are considered significant if the ROR estimates and lower bound of the 95% confidence interval (CI) exceed 1. Preferred terms in the Medical Dictionary for Regulatory Activities were utilized to define blood pressure elevation. A total of 6156081 reports from the FAERS and 351226 reports from the JADER were analyzed. The significant RORs with 95% CI were calculated to be 1.82 (95% CI: 1.55-2.13) for bimatoprost, 1.69 (95% CI: 1.53-1.85) for latanoprost, and 2.17 (95% CI: 1.82-2.59) for travoprost from the FAERS. From the JADER, 5.01 (95% CI: 1.59-15.8) was calculated for bimatoprost and 8.02 (95% CI: 2.94-21.9) for tafluprost. The resulting data suggest the necessity for further clinical research on blood pressure elevation associated with topical PGF2alpha analogs and close monitoring. |
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| ジャーナル名 | Biological & pharmaceutical bulletin |
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| Pubmed追加日 | 2017/5/2 |
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| 投稿者 | Ohyama, Katsuhiro; Kawakami, Haruna; Inoue, Michiko |
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| 組織名 | Education Center for Experiential Pharmacy Practice, School of Pharmacy, Tokyo;University of Pharmacy and Life Science. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/28458346/ |
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