Use of olmesartan and enteropathy outcomes: a multi-database study

Area of Science:

• Gastroenterology
• Pharmacovigilance
• Epidemiology

Background:

• Case reports suggest a link between olmesartan and sprue-like enteropathy.
• Previous epidemiological studies on this association have yielded mixed results.
• A need exists to clarify the risk of enteropathy with olmesartan versus other angiotensin II receptor blockers (ARBs).

Purpose of the Study:

• To investigate the association between olmesartan and enteropathy.
• To compare the rate of enteropathy in patients initiating olmesartan versus other ARBs.

Main Methods:

• A cohort study was conducted using 5 US claims databases.
• Propensity score (PS) matching was employed to compare olmesartan initiators with initiators of other ARBs.
• Cox regression models assessed hazard ratios (HRs) for enteropathy-related outcomes, including celiac disease, malabsorption, diarrhea with weight loss, and non-infectious enteropathy.

Main Results:

• The study included over 1.9 million ARB initiators.
• Olmesartan initiators showed higher HRs for celiac disease (1.21) and diarrhea with weight loss (1.22) compared to other ARBs.
• Increased risks were observed in older patients, those on treatment >1 year, and with higher cumulative olmesartan doses.

Conclusions:

• This large-scale study identified a higher rate of enteropathy among olmesartan initiators versus other ARBs.
• The absolute incidence of enteropathy remained low in both groups.
• Findings suggest a potential link between olmesartan and enteropathy, particularly in specific patient subgroups.