Resumo (PT):
Abstract (EN):
<jats:title>Abstract</jats:title><jats:sec>
<jats:title>Background</jats:title>
<jats:p>Patients with type 2 diabetes (T2D) and metabolic syndrome (MetS) are at greater cardiovascular risk than those with T2D without MetS. In the current report we aim to study the characteristics, cardio-renal outcomes and the effect of empagliflozin in patients with MetS enrolled in the EMPA-REG OUTCOME trial.</jats:p>
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<jats:title>Methods</jats:title>
<jats:p>A total of 7020 patients with T2D and atherosclerotic cardiovascular disease were treated with empagliflozin (10 mg or 25 mg) or placebo for a median of 3.1 years. The World Health Organization MetS criteria could be determined for 6985 (99.5%) patients. We assessed the association between baseline MetS and multiple cardio-renal endpoints using Cox regression models, and we studied the change in the individual component over time of the MetS using mixed effect models.</jats:p>
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<jats:title>Results</jats:title>
<jats:p>MetS at baseline was present in 5740 (82%) patients; these were more often white and had more often albuminuria and heart failure, had lower eGFR and HDL-cholesterol, and higher blood pressure, body mass index, waist circumference, and triglycerides. In the placebo group, patients with MetS had a higher risk of all outcomes including cardiovascular death: HR¿=¿1.73 (95% CI¿1.01¿2.98), heart failure hospitalization: HR¿=¿2.64 (95% CI¿1.22, 5.72), and new or worsening nephropathy: HR¿=¿3.11 (95% CI¿2.17¿4.46). The beneficial effect of empagliflozin was consistent on all cardio-renal outcomes regardless of presence of MetS.</jats:p>
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<jats:title>Conclusions</jats:title>
<jats:p>A large proportion of the EMPA-REG OUTCOME population fulfills the criteria for MetS. Those with MetS had increased risk of adverse cardio-renal outcomes. Compared with placebo, empagliflozin improved cardio-renal outcomes in patients with and without MetS.</jats:p>
<jats:p><jats:italic>Trial registration</jats:italic> Clinical Trial Registration: URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link>. Unique identifier: NCT 01131676</jats:p>
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Language:
English
Type (Professor's evaluation):
Dissemination