Key result
SGLT2 inhibitor use was associated with significantly higher reporting of all ischemic stroke (ROR 12.7), thrombosis (ROR 21.7), and lacunar infarction (ROR 48.9), but not hemorrhagic stroke.
Why the study?
Volume depletion from SGLT2 inhibitors raised concern for lacunar stroke, but prior meta-analyses did not distinguish stroke subtypes.
Does the use of SGLT2 inhibitors increase the reporting of specific stroke subtypes compared to other drugs in a pharmacovigilance database?
Observational (n=500,000)
Does the use of SGLT2 inhibitors increase the reporting of specific stroke subtypes compared to other drugs in a pharmacovigilance database?
Pharmacovigilance data suggests a disproportionately higher reporting of ischemic stroke subtypes, particularly lacunar infarction, with SGLT2 inhibitors, highlighting the need for further observational studies.
May signal ischemic stroke risk with SGLT2 inhibitors; hypothesis-generating and requires RCT confirmation before practice change.
Volume depletion as an adverse events (AE) caused by sodium-glucose cotransporter-2 inhibitors (SGLT2i) because of their diuretic effect may raise the concern about the risk of lacunar stroke; however, an earlier meta-analysis reported no significant increase in the incidence of stroke without clearly distinguishing stroke subtypes. Here, aiming to investigate subtype-wise reporting of stroke potentially related to SGLT2i treatment, we conducted a disproportionality analysis using the Japanese Adverse Drug Event Report database, which contains approximately 500 000 cases recorded between April 2004 and March 2019 to detect stroke as AE signals associated with SGLT2i treatment by calculating the reporting odds ratio (ROR). As a result, we identified 532 stroke event reports with the use of SGLT2i. The SGLT2i showed varying degrees of significantly higher reporting (lower 95% ROR > 1) for all ischemic stroke (ROR, 12.7), thrombosis (ROR, 21.7), lacunar infarction (ROR, 48.9), and embolism (ROR, 2.51), but no significantly higher reporting for hemorrhagic stroke. Current pharmacovigilance results showed that the RORs for stroke following SGLT2i use differ greatly depending on the stroke subtypes. It suggests the need for an observational cohort study to be conducted to investigate the incidence of each stroke subtype as the effect of SGLT2i.
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Sato et al. (2019) conducted an observational in Adverse drug events (n=500,000). SGLT2 inhibitors was evaluated on All ischemic stroke (ROR 12.7). SGLT2 inhibitor use was associated with significantly higher reporting of all ischemic stroke (ROR 12.7), thrombosis (ROR 21.7), and lacunar infarction (ROR 48.9), but not hemorrhagic stroke.
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