Olmesartan, Other Antihypertensives, and Chronic Diarrhea Among Patients Undergoing Endoscopic Procedures: A Case-Control Study

Abstract

Objective To investigate a recent association between use of the angiotensin receptor-blocker (ARB) olmesartan and a severe enteropathy resembling celiac disease. Patients and Methods We searched our endoscopy database for all outpatient esophagogastroduodenoscopy (EGD) or colonoscopy examinations in patients at least 50 years of age during the dates January 1, 2007 to March 31, 2013. Cases were those whose examination indication was diarrhea, and controls were those whose examination indication was esophageal reflux (EGD) or colorectal cancer screening (colonoscopy). We compared cases to controls with regard to the proportion of those listing olmesartan among their medications. Secondary exposures were the proportion of those taking non-olmesartan ARBs or other anti-hypertensive medications. We also examined biopsy results to determine if there were histologic changes associated with olmesartan use. Results We identified 2088 patients undergoing EGD and 12428 patients undergoing colonoscopy meeting inclusion criteria. On multivariate analysis, there was no statistically-significant association between olmesartan and diarrhea among those undergoing EGD (OR 1.99 95% CI 0.79–5.00) or colonoscopy (OR 0.63 95% CI 0.23–1.74). Review of pathology reports of the EGD and colonoscopy groups showed no association between olmesartan use and the histologic diagnosis of celiac disease (p=0.61) or microscopic colitis (p=1.0), respectively. Conclusions Our findings suggest that neither olmesartan nor other ARBs were associated with diarrhea among patients undergoing endoscopy. The sprue-like enteropathy recently associated with olmesartan is likely a rare adverse effect and milder presentations are unlikely.

The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

“…In July 2013, FDA issued a warning that olmesartan may cause sprue-like enteropathy but this warning was later removed from the label of the drug (110). A case control study published recently (111) showed no statistically significant association between olmesartan and diarrhea among patients undergoing upper endoscopy (OR 1.99; 95% CI, 0.79–5.00) and colonoscopy (OR 0.63; 95% CI 0.23–1.74).…”

Olmesartan-Associated Enteropathy: A Review of Clinical and Histologic Findings

“…Menne and Haller analyzed data collected in the ROADMAP study in which diabetic patients had received either 40 mg/d olmesartan (n ¼ 2232) or placebo (n ¼ 2215), and they found no differences in the occurrence of diarrhea or abdominal discomfort between these two groups. 22 In the retrospective case-control study by Greywoode et al, 23 analysis of clinical data from patients 50 years and older who had undergone esophagogastroduodenoscopy (n ¼ 2088) or colonoscopy (n ¼ 12 428) procedures found no significant association between olmesartan use and diarrhea. They also found no significant association between olmesartan use and histologic diagnosis of celiac disease or microscopic colitis.…”

“…They also found no significant association between olmesartan use and histologic diagnosis of celiac disease or microscopic colitis. 23 The study was limited, however, by the small number of patients taking olmesartan: 22 patients (1%) in the esophagogastroduodenoscopy group and 83 patients (0.7%) in the colonoscopy group.…”

Blockers of Angiotensin Other Than Olmesartan in Patients With Villous Atrophy: A Nationwide Case-Control Study

“…positive celiac disease serology and/or a symptomatic improvement on a gluten free diet. Although questioned by some, 6,7 a number of case series 8,9 and one national case finding study 10 have since then reported additional cases of olmesartan-associated sprue-like enteropathy. Some data have also suggested that other ARBs, besides olmesartan, may induce similar outcomes.…”