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Expert Opin Drug Saf. 2016 Dec;15(12):1589-1595. Epub 2016 Sep 27.

Proton pump inhibitors and risk of Clostridium difficile infection: a multi-country study using sequence symmetry analysis.

Author information

1
a Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute for Health Research , University of South Australia , Adelaide , Australia.
2
b Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy , The University of Hong Kong , Hong Kong , Hong kong.
3
c Institute of Environmental Medicine, Medical Research Center , Seoul National University , Seoul , Korea.
4
d Division of Pharmacoepidemiology and Pharmacoeconomics , Brigham and Women's Hospital and Harvard Medical School , Boston , MA , USA.
5
e Marketed Health Products Directorate , Health Products and Food Branch, Health Canada , Ottawa , ON , Canada.
6
f Department of Preventive Medicine , Seoul National University College of Medicine , Seoul , Korea.
7
g Medical Research Collaborating Centre , Seoul National University College of Medicine, Seoul National University Hospital , Seoul , Korea.
8
h Department of Medical Informatics , Hamamatsu University, School of Medicine , Shizuoka , Japan.
9
i Medical Affairs , Astellas Pharma Inc , Tokyo , Japan.
10
j Department of Pharmacoepidemiology , University of Tokyo Graduate School of Medicine , Tokyo , Japan.
11
k NPO Drug Safety Research Unit , Tokyo , Japan.
12
l School of Pharmacy and Institute of Clinical Pharmacy and Pharmaceutical Sciences, Health Outcome Research Centre , National Cheng Kung University , Tainan , Taiwan.
13
m Department of Epidemiology, Biostatistics, and Occupational Health , McGill University , Montreal , Canada.
14
n Research Department of Practice and Policy , UCL School of Pharmacy , London , England.

Abstract

OBJECTIVE:

To determine the association between incident proton pump inhibitor (PPI) use and Clostridium difficile infections across multiple countries Method: National data covering the total population in Australia and Korea, the Canadian population over 65 years and a 3 million person random sample data set from Taiwan were assessed, as were data from a worker insurance population and a hospital inpatient/outpatient population in Japan. Sequence symmetry analysis was used to assess the association with oral vancomycin dispensing as the outcome of interest.

RESULTS:

54,957 patients were included. Positive associations were observed in Australia; adjusted sequence ratio (ASR) 2.48 (95% CI 1.90, 3.12), Korea ASR 2.15 (95%CI 2.11, 2.19), Canada ASR 1.45 (95% CI 1.16, 1.79), Japan hospital dataset ASR 3.21 (95%CI 2.12, 4.55) and Japan worker insurance dataset ASR 5.40 (95% CI 2.73, 8.75). The pooled result was ASR 2.40 (95%CI 1.88, 3.05) and 3.16 (95%CI 1.95, 5.10) when limited to Japan, Korean and Taiwan. Results did not vary by individual PPI. The temporal analysis showed effects within the first two weeks of PPI initiation.

CONCLUSION:

Our study confirms the association between PPI initiation and C. difficile infections across countries in the Asia-Pacific region.

KEYWORDS:

Asia; Clostridium difficile; Proton pump inhibitors; adverse event; sequence symmetry analysis

PMID:
27645304
DOI:
10.1080/14740338.2016.1238071
[Indexed for MEDLINE]

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