Korean J Intern Med.  2019 Jan;34(1):90-98. 10.3904/kjim.2017.002.

Olmesartan is not associated with the risk of enteropathy: a Korean nationwide observational cohort study

• You SC
• Park H
• Yoon D
• Park S
• Joung B
• Park RW

• KMID: 2452492
• DOI: http://doi.org/10.3904/kjim.2017.002

Abstract

BACKGROUND/AIMS
Olmesartan, a widely used angiotensin II receptor blocker (ARB), has been linked to sprue-like enteropathy. No cases of olmesartan-associated enteropathy have been reported in Northeast Asia. We investigated the associations between olmesartan and other ARBs and the incidence of enteropathy in Korea.
METHODS
Our retrospective cohort study used data from the Korean National Health Insurance Service to identify 108,559 patients (58,186 females) who were initiated on angiotensin converting enzyme inhibitors (ACEis), olmesartan, or other ARBs between January 2005 and December 2012. The incidences of enteropathy were compared among drug groups. Changes in body weight were compared after propensity score matching of patients in the ACEis and olmesartan groups.
RESULTS
Among 108,559 patients, 31 patients were diagnosed with enteropathy. The incidences were 0.73, 0.24, and 0.37 per 1,000 persons, in the ACEis, olmesartan, and other ARBs groups, respectively. Adjusted rate ratios for enteropathy were: olmesartan, 0.33 (95% confidential interval [CI], 0.10 to 1.09; p = 0.070) and other ARBs, 0.34 (95% CI, 0.14 to 0.83; p = 0.017) compared to the ACEis group after adjustment for age, sex, income level, and various comorbidities. The post hoc analysis with matched cohorts revealed that the proportion of patients with significant weight loss did not differ between the ACEis and olmesartan groups.
CONCLUSIONS
Olmesartan was not associated with intestinal malabsorption or significant body weight loss in the general Korean population. Additional large-scale prospective studies of the relationship between olmesartan and the incidence of enteropathy in the Asian population are needed.

Keyword

Angiotensin receptor antagonists; Olmesartan; Insurance claim review; Drug-related side effects and adverse reactions; Intestinal diseases

MeSH Terms

Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Asia
Asian Continental Ancestry Group
Body Weight
Cohort Studies*
Comorbidity
Drug-Related Side Effects and Adverse Reactions
Humans
Incidence
Insurance Claim Review
Intestinal Diseases
Korea
National Health Programs
Propensity Score
Prospective Studies
Receptors, Angiotensin
Retrospective Studies
Weight Loss
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Receptors, Angiotensin