Olmesartan vs other ARBs may carry increased risk of enteropathy
There may be an increased rate of enteropathy in users of olmesartan than in users of other angiotensin II receptor blockers (ARBs), a study suggests. However, the absolute incidence rate appears to be low overall.
Researchers looked at a cohort of 1,928,469 patients (mean age 55 years; 58 percent female) who initiated ARBs, among whom 350,790 initiated olmesartan (18 percent) and 1,577,679 initiated other ARBs (82 percent). Commonly used ARBs other than olmesartan were valsartan (n=679,039), losartan (n=543,797), irbesartan (n=171,239) and telmisartan (n=123,089). Most patients had hypertension (77 percent), while 39 percent had dyslipidaemia and 28 percent had diabetes.
During a mean follow-up of 282 days of ARB exposure, coeliac disease developed in 1,227 patients, malabsorption in 2,102, concomitant diagnoses of diarrhoea and weight loss were documented in 2,467, and noninfectious enteropathy in 42,440.
In Cox regression models, the crude hazard ratios with olmesartan vs other ARBs were 1.21 (95 percent CI, 1.05–1.40) for coeliac disease, 1.00 (0.88–1.13) for malabsorption, 1.22 (1.10–1.36) for concomitant diagnoses of diarrhoea and weight loss, and 1.04 (1.01–1.07) for noninfectious enteropathy.
However, after propensity-score matching, olmesartan use was associated with significantly increased rates of coeliac disease (HR, 1.21; 1.05–1.40), concomitant diagnoses of diarrhoea and weight loss (HR, 1.22; 1.10–1.36) and noninfectious enteropathy (HR, 1.04; 1.01–1.07).
Subgroup analyses showed that the risk of enteropathy-related outcomes was greater for patients aged ≥65 years (eg, HR for coeliac disease, 1.57; 1.20–2.05), for those receiving treatment for >1 year (eg, HR for coeliac disease, 1.62; 1.24–2.12) and for those receiving higher cumulative olmesartan doses (eg, HR for coeliac disease, 1.78; 1.33–2.37).
The present data underscore a need to acknowledge the potential olmesartan-associated enteropathy in clinical practice, researchers said. “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.”
Additional prospective studies with primary data on sprue-like enteropathy outcomes, including histology and serology results, are warranted to comprehensively evaluate this safety issue, they added.