Bibliographic Details
| Title: |
Pharmacovigilance study of anti-infective-related acute kidney injury using the Japanese adverse drug event report database |
| Authors: |
Satoshi Nakao, Shiori Hasegawa, Ryogo Umetsu, Kazuyo Shimada, Ririka Mukai, Mizuki Tanaka, Kiyoka Matsumoto, Yu Yoshida, Misaki Inoue, Riko Satake, Yuri Nishibata, Jun Liao, Mitsuhiro Nakamura |
| Source: |
BMC Pharmacology and Toxicology, Vol 22, Iss 1, Pp 1-11 (2021) |
| Publisher Information: |
BMC, 2021. |
| Publication Year: |
2021 |
| Collection: |
LCC:Therapeutics. Pharmacology
LCC:Toxicology. Poisons |
| Subject Terms: |
Acute kidney injury, Anti-infective, Japanese adverse drug event report database, Propensity score, JADER, Polypharmacy, Therapeutics. Pharmacology, RM1-950, Toxicology. Poisons, RA1190-1270 |
| More Details: |
Abstract Background Acute kidney injury (AKI) is associated with significant increases in short- and long-term morbidity and mortality. Drug-induced AKI is a major concern in the present healthcare system. Our spontaneous reporting system (SRS) analysis assessed links between AKI, along with patients’ age, as healthcare-associated risks and administered anti-infectives. We also generated anti-infective-related AKI-onset profiles. Method We calculated reporting odds ratios (RORs) for reports of anti-infective-related AKI (per Medical Dictionary for Regulatory Activities) in the Japanese Adverse Drug Event Report database and evaluated the effect of anti-infective combination therapy. The background factors of cases with anti-infective monotherapy and combination therapy (≥ 2 anti-infectives) were matched using propensity score. We evaluated time-to-onset data and hazard types using the Weibull parameter. Results Among 534,688 reports (submission period: April 2004–June 2018), there were 21,727 AKI events. The reported number of AKI associated with glycopeptide antibacterials, fluoroquinolones, third-generation cephalosporins, triazole derivatives, and carbapenems were 596, 494, 341, 315, and 313, respectively. Crude RORs of anti-infective-related AKI increased among older patients and were higher in anti-infective combination therapies [anti-infectives, ≥ 2; ROR, 1.94 (1.80–2.09)] than in monotherapies [ROR, 1.29 (1.22–1.36)]. After propensity score matching, the adjusted RORs of anti-infective monotherapy and combination therapy (≥ 2 anti-infectives) were 0.67 (0.58–0.77) and 1.49 (1.29–1.71), respectively. Moreover, 48.1% of AKI occurred within 5 days (median, 5.0 days) of anti-infective therapy initiation. Conclusion RORs derived from our new SRS analysis indicate potential AKI risks and number of administered anti-infectives. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
2050-6511 |
| Relation: |
https://doaj.org/toc/2050-6511 |
| DOI: |
10.1186/s40360-021-00513-x |
| Access URL: |
https://doaj.org/article/4c3603a8eefd411aa1be45816279be78 |
| Accession Number: |
edsdoj.4c3603a8eefd411aa1be45816279be78 |
| Database: |
Directory of Open Access Journals |
