a-t 2015; 46: 77

Often diagnosed late - sprue-like enteropathy with olmesartan (OLMETEC, VOTUM): During treatment with VOCADO, a combination of the calcium antagonist amlopidine (NORVASC, generics) and the angiotensin (AT)-II-antagonist olmesartan (OLMETEC, VOTUM) a patient suffered for months from diarrhoea. The patient's body weight decreased dangerously. Only stopping the administration of the antihypertensive brought about an improvement (NETZWERK report 16.810). Severe enteropathy linked to olmesartan is now relatively well documented: in 2012, ten years after the market introduction, an evaluation of 22 patient histories is demonstrating the potential threat caused by this adverse effect. After taking the AT-II-antagonist for months or years, these patients developed sprue-like enteropathy with chronic diarrhoea and weight loss of up to 57 kg, with a median of 18 kg. Those affected were subjected to extensive burdensome diagnostic tests and unsuccessful attempts to treat the condition such as immunosuppressants and gluten-free diet, until the cause was identified. Histological examination of biopsies showed duodenal villous atrophy with different degrees of mucosal inflammation. As soon as olmesartan was stopped, the symptoms mostly subsided rapidly and the histological findings improved (1). Subsequently there have been international warnings about olmesartan enteropathy (2-5). Based on a current assessment by the French Medicines Authority ANSM, a total of 320 reports have been recorded in France to date, 136 (43%) in the 12 months since the authority issued a warning in mid-2014. Olmesartan enteropathy is now identified more rapidly than a year ago (after a median of 40 days compared to 70 days), but still late (5). The number of case reports from Germany is unclear: From the German Federal Institute for Drugs and Medical Devices (BfArM) we received only the number of reports for single-agent preparations (24 reports of suspected cases from Germany (6) with patients showing symptoms of enteropathy). An increased risk of enteropathy has not been demonstrated for other sartans in a French study (3). Olmesartan is a typical me-too preparation. As there is no evidence of an advantage over established antihypertensive drugs (cf. a-t 2002; 33: 111 and 2011; 42: 40), we think withdrawal from the market would be reasonable. If a sartan is to be considered at all for high blood pressure, losartan (LORZAAR, generics) should be used, -Ed.