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Empagliflozin for Patients with Presumed Resistant Hypertension: a Post Hoc Analysis of the EMPA-REG OUTCOME Trial

Abstract : Background: Type 2 diabetes (T2D) and resistant hypertension (rHT) often coexist, greatly increasing risk of target-organ damage and death. We explored the effects of empagliflozin in patients with and without presumed resistant hypertension (prHT) in a post hoc analysis of EMPA-REG OUTCOME (NCT01131676). Methods: Overall, 7020 patients received empagliflozin 10mg, 25mg, or placebo with median follow-up of 3.1 years. We defined baseline prHT as ≥3 classes of antihypertensive drugs including a diuretic and uncontrolled BP (SBP≥140 and/or diastolic BP [DBP]≥90 mmHg), or ≥4 classes of antihypertensive, including a diuretic, and controlled BP. We explored the effect of empagliflozin on CV death, heart failure hospitalization (HHF), 3-point major adverse cardiac events (3P-MACE), all-cause death, and incident/worsening nephropathy by Cox regression and BP over time by a mixed-repeated-measures-model analysis.Results: 1579 (22.5%) patients had prHT. The mean difference in change in SBP from baseline to week 12 versus placebo was -4.5 (95% CI, -5.9 to -3.1) mmHg (p<0.001) in prHT and -3.7 (-4.5, -2.9) mmHg (p<0.001) in patients without prHT. SBP was more frequently controlled (<130/80 mmHg) with empagliflozin than with placebo. Patients with prHT had 1.5 to 2-fold greater risk of HHF, incident/worsening nephropathy and CV death compared to those without prHT. Empagliflozin improved all outcomes in patients with and without prHT (interaction P>0.1 for all outcomes). Conclusions: Empagliflozin induced a clinically relevant reduction in SBP and consistently improved all outcomes regardless of prHT status. Due to these dual effects, empagliflozin should be considered for patients with hypertension and T2D.
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Submitted on : Friday, May 15, 2020 - 8:39:25 AM
Last modification on : Wednesday, February 10, 2021 - 11:54:18 AM

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Joao Pedro Ferreira, David Fitchett, Anne Pernille Ofstad, Bettina Johanna Kraus, Christoph Wanner, et al.. Empagliflozin for Patients with Presumed Resistant Hypertension: a Post Hoc Analysis of the EMPA-REG OUTCOME Trial. American Journal of Hypertension, Oxford University Press (OUP), 2020, 33 (12), ⟨10.1093/ajh/hpaa073⟩. ⟨hal-02585975⟩

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