Response by Zinman et al to Letter Regarding Article, “Empagliflozin and Cerebrovascular Events in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk”
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Tampaki et al1 raise concerns about the numerically higher proportion of patients treated with empagliflozin than placebo who had stroke events in the EMPA-REG OUTCOME trial. As previously described, the numeric (but not statistically significant) difference between treatment groups was primarily because of events that occurred >90 days after last intake of study drug. Our analysis demonstrating that patients with the largest increases in hematocrit did not have an increased risk of stroke should assuage concerns about increased blood viscosity leading to cerebral ischemia. Furthermore, systolic blood pressure and hematocrit returned to near baseline levels within 30 days of the last intake of study drug, making it unlikely that the imbalance in stroke was related to hemodynamic effects. The differences in stroke risk between Europe and other regions were within the realm of chance variation given the large number of subgroup factors and tests conducted.2
We disagree with the …