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Risk of diabetes with fibrates and statins: a pharmacoepidemiological study in VigiBase ®
Author(s) -
Montastruc François,
Benevent Justine,
Rousseau Vanessa,
Durrieu Geneviève,
Sommet Agnès,
Montastruc JeanLouis
Publication year - 2019
Publication title -
fundamental and clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.655
H-Index - 73
eISSN - 1472-8206
pISSN - 0767-3981
DOI - 10.1111/fcp.12406
Subject(s) - fibrate , medicine , diabetes mellitus , odds ratio , type 2 diabetes , statin , drug , fenofibrate , pharmacology , endocrinology
In contrast to statins, the risk of diabetes with fibrates was not clearly studied. This study investigates a putative signal of diabetes associated with the use of fibrates using the World Health Organization ( WHO ) global individual case safety reports database, VigiBase ® . We included all reports registered until the 31st December 2017 in VigiBase ® to measure the risk of reporting ‘hyperglycemia or new onset of diabetes’ ( SMQ term) compared with all other reports [as a reporting odds ratio ( ROR 95% CI )] for fibrates, statins, and the combination fibrates + statins. The likelihood that diabetes resulted from statin–fibrate interaction was also estimated. According to the interaction additive model, a ROR value for coexposure exceeding the sum of the ROR s estimated for each individual class of drug supports a potential drug–drug interaction ( DDI ). To assess the stability of our results, we performed several sensitivity analyses, according to outcome definition and after exclusion of putative competitive (hyperglycemic) drugs. We included 19 149 patients exposed to fibrates (without statins), 177 323 to statins (without fibrates) and 3 247 to statins plus fibrates. In contrast to statins ( ROR = 1.75, 95% CI 1.72–1.78), no association was found for fibrates ( ROR = 0.76, 95% CI 0.71–0.82). The ROR value was lower for the combination statins plus fibrates ( ROR = 1.46, 95% CI 1.28–1.67). Similar trends were found in sensitivity analyses. This study, performed in the real conditions of use, failed to find a signal of diabetes with fibrates. It strengths the association previously described with statin without any evidence for a statin–fibrate DDI .