Regional Pharmacovigilance Centre, Department of Pharmacology, CHU Bordeaux, Bordeaux, France; Univ Bordeaux, Bordeaux, France; INSERM U657, Bordeaux, France.
Gastroenterology Department, Private General Hospital, Côte Basque Sud, Saint Jean de Luz, France.
Dig Liver Dis. 2014 May;46(5):465-9. doi: 10.1016/j.dld.2013.12.014. Epub 2014 Jan 26.
We describe five cases of sprue-like enteropathy during treatment with olmesartan, an angiotensin II receptor antagonist indicated for the treatment of hypertension. Patients presented severe diarrhoea, significant weight loss or dehydration, with or without intestinal villous atrophy. Clinical signs ceased upon drug discontinuation in all cases; olmesartan was reintroduced in two cases and rechallenge was positive in both. These add to the previously reported cases that led to a label change for olmesartan in the United States. However, all cases were observed in a small gastroenterology unit, which suggests that this adverse effect may not be rare. A preliminary search for the other angiotensin II receptor antagonists in the French pharmacovigilance system found severe diarrhoea and colitis, but no case with villous atrophy. Therefore, in the presence of severe diarrhoea, olmesartan or other angiotensin II receptor antagonists should be discontinued, even if the treatment has been taken for several months or years.
我们描述了五例在使用奥美沙坦(一种用于治疗高血压的血管紧张素 II 受体拮抗剂)治疗期间出现的类脂性腹泻样肠病。这些患者均表现出严重腹泻、明显体重减轻或脱水,伴有或不伴有肠绒毛萎缩。所有病例均在停药后临床症状消失;奥美沙坦在两例患者中再次使用,在这两例患者中再次出现阳性反应。这些病例增加了之前在美国报告的导致奥美沙坦标签改变的病例。然而,所有病例均在一个小型胃肠病学单位中观察到,这表明这种不良反应可能并不罕见。在法国药物警戒系统中对其他血管紧张素 II 受体拮抗剂进行的初步搜索发现了严重腹泻和结肠炎,但没有绒毛萎缩的病例。因此,即使治疗已经进行了数月或数年,如果出现严重腹泻,应停用奥美沙坦或其他血管紧张素 II 受体拮抗剂。