Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database.

Abstract

Clostridium difficile-associated colitis (CDAC) may cause gastrointestinal illness, ranging in severity from mild diarrhea to fulminant colitis and even mortality. The purpose of this study was to evaluate anti-infective-related CDAC profiles using the Japanese Adverse Drug Event Report (JADER) database. Methods: We selected case reports of adverse events of CDAC as specified in the Medical Dictionary for Regulatory Activities. The association between the number of administered anti-infectives and aging was evaluated using reporting odds ratio (ROR) and adjusted for covariates using multiple-logistic regression. We also evaluated anti-infective-related CDAC-onset profiles using Weibull shape parameter. Results: The JADER database contained 534 688 reports from April 2004 to June 2018. There were 1222 anti-infective related CDAC events. The top five anti-infectives were as follows: third-generation cephalosporins (Anatomical Therapeutic Chemical (ATC) code: J01DD, 313 cases), fluoroquinolones (ATC code: J01MA, 201 cases), macrolides (ATC code: J01FA, 146 cases), carbapenems (ATC code: J01DH, 143 cases), and penicillins with extended spectrum (ATC code: J01CA, 103 cases). The adjusted RORs (95% confidence interval) in individuals using 1, 2, and ≥ 3 anti-infectives were 8.88 (7.05-11.18), 9.77 (6.89-13.86), and 18.39 (11.85-28.54), respectively. Moreover, 47.2% of CDACs occurred within 7 days of anti-infective therapy initiation. The adjusted ROR of interaction terms of ≥ 70 years × 1 drug was 21.81 (14.56-32.68). Conclusion: Our results suggest that the number of administered anti-infectives and patient age are associated with CDAC. These data may be particularly beneficial to prescribers and would contribute to improving the management of CDAC.

• Authors: Satoshi Nakao, Shiori Hasegawa, Kazuyo Shimada, Ririka Mukai, Mizuki Tanaka, Kiyoka Matsumoto, Hiroaki Uranishi, Mayuko Masuta, Hiroaki Ikesue, Tohru Hashida, Kazuhiro Iguchi, Mitsuhiro Nakamura
• Journal: International journal of medical sciences (Int J Med Sci) Vol. 17 Issue 7 Pg. 921-930 ( 2020) ISSN: 1449-1907 [Electronic] Australia
• PMID: 32308545 (Publication Type: Journal Article)
• Copyright: © The author(s).

Chemical References

• Anti-Infective Agents
• Cephalosporins
• Fluoroquinolones
• Macrolides

Topics

• Aged
• Anti-Infective Agents (adverse effects)
• Cephalosporins (adverse effects)
• Clostridioides difficile
• Databases, Pharmaceutical
• Enterocolitis, Pseudomembranous (chemically induced, epidemiology)
• Fluoroquinolones (adverse effects)
• Humans
• Japan (epidemiology)
• Macrolides (adverse effects)
• Odds Ratio