Cargando…
Severe intestinal malabsorption associated with ACE inhibitor or angiotensin receptor blocker treatment. An observational cohort study in Germany and Italy
PURPOSE: The angiotensin II receptor blocker (ARB) olmesartan has been recently associated with sprue‐like enteropathy (SLE), a gastrointestinal condition characterized by intestinal malabsorption (IM) and severe diarrhea. Whether the increased risk of SLE is substance‐specific or a class effect inv...
Autores principales: | , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6001476/ https://www.ncbi.nlm.nih.gov/pubmed/29457309 http://dx.doi.org/10.1002/pds.4402 |
_version_ | 1783332013464354816 |
---|---|
author | Malfertheiner, Peter Ripellino, Claudio Cataldo, Nazarena |
author_facet | Malfertheiner, Peter Ripellino, Claudio Cataldo, Nazarena |
author_sort | Malfertheiner, Peter |
collection | PubMed |
description | PURPOSE: The angiotensin II receptor blocker (ARB) olmesartan has been recently associated with sprue‐like enteropathy (SLE), a gastrointestinal condition characterized by intestinal malabsorption (IM) and severe diarrhea. Whether the increased risk of SLE is substance‐specific or a class effect involving all ARBs is uncertain. The aim of this study is to assess the risk of enteropathy associated with ARBs and angiotensin converting enzyme inhibitors (ACE‐i) by using data from large administrative and claim databases. METHODS: We obtained data from Italian local health‐care units and a large German claim database and included patients treated with olmesartan, other ARBs, and ACE‐i. In the absence of a specific diagnosis code for SLE, International Classification of Diseases codes for IM were used. Analysis implemented a Poisson regression with robust error variance procedure, which allowed accounting for different clusters (local health‐care units and countries) and correctly estimating the standard error for the relative risk of rare event occurrence. RESULTS: Patients were divided into 3 groups: olmesartan (25.591, 5.5%), other ARBs (104.901, 22.5%), and ACE‐i patients (334.951, 72.0%). Baseline characteristics were similar overall. The incidence of unspecified IM in ACE‐i patients was not different compared with that of olmesartan, whereas a higher rate ratio was observed when comparing ARB patients with the olmesartan group (RR: 2.50, 95% CI 1.21 to 5.19, P .01). When International Classification of Diseases codes for coeliac disease were included, no differences were observed. CONCLUSIONS: We could not confirm previous findings of a higher risk of malabsorption in olmesartan‐only patients, and drug‐induced enteropathy should be considered the result of exposure to the class of ARBs rather than a specific drug‐related effect. |
format | Online Article Text |
id | pubmed-6001476 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-60014762018-06-21 Severe intestinal malabsorption associated with ACE inhibitor or angiotensin receptor blocker treatment. An observational cohort study in Germany and Italy Malfertheiner, Peter Ripellino, Claudio Cataldo, Nazarena Pharmacoepidemiol Drug Saf Original Reports PURPOSE: The angiotensin II receptor blocker (ARB) olmesartan has been recently associated with sprue‐like enteropathy (SLE), a gastrointestinal condition characterized by intestinal malabsorption (IM) and severe diarrhea. Whether the increased risk of SLE is substance‐specific or a class effect involving all ARBs is uncertain. The aim of this study is to assess the risk of enteropathy associated with ARBs and angiotensin converting enzyme inhibitors (ACE‐i) by using data from large administrative and claim databases. METHODS: We obtained data from Italian local health‐care units and a large German claim database and included patients treated with olmesartan, other ARBs, and ACE‐i. In the absence of a specific diagnosis code for SLE, International Classification of Diseases codes for IM were used. Analysis implemented a Poisson regression with robust error variance procedure, which allowed accounting for different clusters (local health‐care units and countries) and correctly estimating the standard error for the relative risk of rare event occurrence. RESULTS: Patients were divided into 3 groups: olmesartan (25.591, 5.5%), other ARBs (104.901, 22.5%), and ACE‐i patients (334.951, 72.0%). Baseline characteristics were similar overall. The incidence of unspecified IM in ACE‐i patients was not different compared with that of olmesartan, whereas a higher rate ratio was observed when comparing ARB patients with the olmesartan group (RR: 2.50, 95% CI 1.21 to 5.19, P .01). When International Classification of Diseases codes for coeliac disease were included, no differences were observed. CONCLUSIONS: We could not confirm previous findings of a higher risk of malabsorption in olmesartan‐only patients, and drug‐induced enteropathy should be considered the result of exposure to the class of ARBs rather than a specific drug‐related effect. John Wiley and Sons Inc. 2018-05-01 2018-06 /pmc/articles/PMC6001476/ /pubmed/29457309 http://dx.doi.org/10.1002/pds.4402 Text en © 2018 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Reports Malfertheiner, Peter Ripellino, Claudio Cataldo, Nazarena Severe intestinal malabsorption associated with ACE inhibitor or angiotensin receptor blocker treatment. An observational cohort study in Germany and Italy |
title | Severe intestinal malabsorption associated with ACE inhibitor or angiotensin receptor blocker treatment. An observational cohort study in Germany and Italy |
title_full | Severe intestinal malabsorption associated with ACE inhibitor or angiotensin receptor blocker treatment. An observational cohort study in Germany and Italy |
title_fullStr | Severe intestinal malabsorption associated with ACE inhibitor or angiotensin receptor blocker treatment. An observational cohort study in Germany and Italy |
title_full_unstemmed | Severe intestinal malabsorption associated with ACE inhibitor or angiotensin receptor blocker treatment. An observational cohort study in Germany and Italy |
title_short | Severe intestinal malabsorption associated with ACE inhibitor or angiotensin receptor blocker treatment. An observational cohort study in Germany and Italy |
title_sort | severe intestinal malabsorption associated with ace inhibitor or angiotensin receptor blocker treatment. an observational cohort study in germany and italy |
topic | Original Reports |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6001476/ https://www.ncbi.nlm.nih.gov/pubmed/29457309 http://dx.doi.org/10.1002/pds.4402 |
work_keys_str_mv | AT malfertheinerpeter severeintestinalmalabsorptionassociatedwithaceinhibitororangiotensinreceptorblockertreatmentanobservationalcohortstudyingermanyanditaly AT ripellinoclaudio severeintestinalmalabsorptionassociatedwithaceinhibitororangiotensinreceptorblockertreatmentanobservationalcohortstudyingermanyanditaly AT cataldonazarena severeintestinalmalabsorptionassociatedwithaceinhibitororangiotensinreceptorblockertreatmentanobservationalcohortstudyingermanyanditaly |