Letter by Tampaki et al Regarding Article, “Empagliflozin and Cerebrovascular Events in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk”
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To the Editor:
The unfavorable stroke-related results in the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) could be pure chance or a warning requiring further elucidation.
Confirmed by the authors,1 the population from Europe accounting >40% of the study population experienced strokes driving the event rate. The Endocrine and Metabolic Drug Advisory of the Food and Drug Administration correlated increased stroke risk with patient subgroups coming from Europe, of age <65 years, with baseline hemoglobin A1c >8.5% and on insulin treatment.2
Possible aggravating factors included lack of detailed medication changes recording, vital signs and laboratory tests performed not timely close to stroke events, and intermittent interruptions in empagliflozin therapy because of hypoglycemia episodes, leading to different drug exposures, whereas patients lacked a baseline …