Olmesartan-associated enteropathy: Belgian survey

Allaoui, Abire; Marcoux, Diane; Vokaer, Benoît; Couturier, Bruno

doi:10.1016/j.therap.2020.02.023

Cited by 2 publications

(3 citation statements)

References 11 publications

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“…As far as we know, these results are new and never reported before. In fact, this ADR is now well described with olmesartan [1][2][3][4][5]. Thus, after exclusion of olmesartan, in order to reduce a very likely notoriety bias, we found that, when compared with all other ARBs, only two ARBs were associated with diarrhea: telmisartan and eprosartan, but not the six others: azilsartan, candesartan, fimasartan, irbesartan, losartan, or valsartan.…”

Section: Discussionmentioning

confidence: 76%

See 1 more Smart Citation

Diarrhea and angiotensin II receptor blockers: Is there any difference between the different drugs?

Guion-Firmin

Tessier

Montastruc

2021

Fundamemntal Clinical Pharma

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Diarrhea is an adverse drug reaction (ADR) widely reported with olmesartan, an angiotensin II receptor blocker (ARB). Isolated case reports described this ADR with other ARBs. The present study was performed to investigate if, among the different ARBs, some drugs are more at risk of diarrhea than others. Using VigiBase ® , the WHO pharmacovigilance database, we performed a disproportionality analysis (case/noncase study). Cases were reports with the MedDRA PT term « diarrhea » and noncases all other reports registered during the same period in Vigibase ® from April 6, 1995 to December 31, 2020. After comparison of ARBs and angiotensin converting enzyme inhibitors (ACEIs), the main analysis was a comparison of the diarrhea reporting risk between each ARB and the seven other ARBs. Results are reported as reporting odds ratio (ROR) adjusted on age, gender, exposure to antihypertensive, and antidiabetic drugs with their 95% confidence interval. Among the 22,429,334 deduplicated reports registered in VigiBase ® during the study period, 73,507 involved ARBs, including 2119 diarrhea. The reporting risk of diarrhea was higher with ARBs than with ACEIs (ROR = 2.06 (1.55-2.17)). Diarrhea with ARBs mainly occurred in females with a mean age of 65 years. After exclusion of olmesartan (to minimize a notoriety bias), two ARBs were significantly associated with diarrhea: eprosartan (ROR = 1.93 (1.32-2.72) and telmisartan (ROR = 1.41 (1.23-1.62) but not the six others. The present study found first that diarrhea is more frequently reported with ARBs than with ACEIs and second that the risk of diarrhea differs according to the different ARBs. Diarrhea with ARBs is not a class effect.

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Section: Discussionmentioning

confidence: 76%

“…Diarrhea is an adverse drug reaction (ADR) widely described for several years in the literature with olmesartan, an angiotensin II receptor blocker (ARB) [1][2][3][4][5]. More recently, isolated case reports described this ADR with other ARBs, like telmisartan [6], valsartan [7], losartan [8], candesartan [9], or eprosartan [10].…”

Section: Introductionmentioning

confidence: 99%

Diarrhea and angiotensin II receptor blockers: Is there any difference between the different drugs?

Guion-Firmin

Tessier

Montastruc

2021

Fundamemntal Clinical Pharma

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“…In fact, diarrhoea is an 'expected' ADR, that is, an ADR listed in the SPC (Summary of Product Characteristics) of sacubitril + valsartan. Diarrhoea was also described with olmesartan [4][5][6][7][8] and more recently, as isolated case reports, with other ARBs, like telmisartan, [9] valsartan [10], losartan [11], candesartan [12] or eprosartan [13]. However, the relative role of sacubitril and valsartan in the occurrence of this ADR remains unknown.…”

Section: Introductionmentioning

confidence: 99%

Diarrhoea with the angiotensin receptor neprilysin inhibitor sacubitril + valsartan: A pharmacovigilance study

Guion-Firmin

Tessier

Lepelley

et al. 2021

Fundamemntal Clinical Pharma

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Diarrhoea is an adverse drug reaction of the angiotensin receptor neprilysin inhibitor (ARNI) sacubitril + valsartan. It was also described with olmesartan and more recently with other angiotensin receptor blockers. The study was performed to compare diarrhoea reports in pharmacovigilance databases with sacubitril + valsartan and valsartan. The study used reports of diarrhoea with the ARNI sacubitril + valsartan registered: first in the French PharmacoVigilance Database (FPVD) and second in Vigibase®, the WHO Global Individual Case Safety Report database. After description of the main characteristics, disproportionality analyses were performed. Results are reported as reporting odds ratios (ROR) with 95% confidence interval. We found 29 reports of diarrhoea with sacubitril + valsartan in the FPVD and 686 in Vigibase®. With sacubitril + valsartan, diarrhoea occurred more frequently in males around 70 years with a median delay of 3 days. With valsartan, diarrhoea occurred more frequently in females around 68 years with a median delay of 0.5 days. In the FPVD, a significant association was found with sacubitril + valsartan in comparison with valsartan alone before (ROR = 8.78 [5.19–14.85]) and after (ROR = 11.19 [5.89–21.25]) exclusion of concomitant drugs known to be associated with diarrhoea. A significant association was also found in Vigibase® after adjustment on age, sex, reporter and its location (ROR = 1.31 [1.14–1.50]). Diarrhoea reported with sacubitril + valsartan has marked differences in gender, delay of occurrence and frequency of reporting in comparison with diarrhoea with valsartan. From a pharmacodynamic point of view, these results suggest a specific role of sacubitril in diarrhoea.

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Olmesartan-associated enteropathy: Belgian survey

Cited by 2 publications

References 11 publications

Diarrhea and angiotensin II receptor blockers: Is there any difference between the different drugs?

Diarrhea and angiotensin II receptor blockers: Is there any difference between the different drugs?

Diarrhoea with the angiotensin receptor neprilysin inhibitor sacubitril + valsartan: A pharmacovigilance study

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