Olmesartan may be associated with higher rate of enteropathy versus other ARBs

The association appeared to be stronger among patients ages 65 years and older, those who were treated for more than a year, and those with higher cumulative olmesartan doses.


Patients taking olmesartan may have a higher risk for enteropathy than those taking other angiotensin-receptor blockers (ARBs), according to a recent study.

Researchers performed a cohort study using data from five U.S. claims databases from 2002 to 2015 to evaluate whether patients initiating treatment with olmesartan had higher rates of enteropathy than those initiating treatment with other ARBs. The latter group included single and combination products of candesartan, eprosartan, irbesartan, losartan, telmisartan, valsartan, and azilsartan. The date of the first ARB prescription was considered the index date.

Enteropathy-related outcomes included celiac disease, malabsorption, concomitant diagnosis of diarrhea and weight loss, and noninfectious enteropathy. Hazard ratios were estimated after propensity score matching. Study results were published Jan. 22 by Alimentary Pharmacology and Therapeutics.

Overall, 1,928,469 patients were eligible for the study, 350,790 of whom (18%) began treatment with olmesartan. Most patients (58%) were women, and the mean age was 55 years. The mean follow-up was 282 days of ARB exposure. Unadjusted incidence rates per 1,000 person-years were 0.82 for celiac disease, 1.41 for malabsorption, 1.66 for concomitant diagnoses of diarrhea and weight loss, and 29.20 for noninfectious enteropathy. After propensity score matching, hazard ratios for olmesartan versus other ARBs were 1.21 for celiac disease, 1.00 for malabsorption, 1.22 for concomitant diagnoses of diarrhea and weight loss, and 1.04 for noninfectious enteropathy. The association appeared to be stronger among patients ages 65 years and older, those who were treated for more than a year, and those with higher cumulative olmesartan doses.

The researchers noted that their study was based on pharmacy claims data, which indicate that patients filled prescriptions but not whether they took the drugs as prescribed. In addition, they said that follow-up was short and that outcome misclassification and potential confounding may have affected their results. However, they concluded that enteropathy outcomes appear to be more common in patients initiating treatment with olmesartan versus other ARBs.

“Considering the widespread, long-term use of olmesartan in clinical settings and more pronounced relative risk for older patients, those treated for longer periods and those treated with higher cumulative doses, the potential [for] olmesartan-associated enteropathy deserves attention in clinical practice,” the authors wrote. “Until more evidence is available, clinicians should consider olmesartan as a potential cause when evaluating patients with enteropathy and should consider alternative ARBs for these patients.” The authors called for prospective studies with primary data to further investigate this potential association.