Dados do Trabalho

Título

Cardiovascular Benefit of Evolocumab in 27,564 Patients With and Without Autoimmune or Inflammatory Diseases: An Analysis of the FOURIER Trial

Acrônimo

FOURIER

Resumo

BACKGROUND
Patients with autoimmune or inflammatory diseases (AIID) have higher cardiovascular risk due to systemic inflammation. In FOURIER, the PCSK9i evolocumab reduced LDL-C and the risk of cardiovascular events, but had no effect on C-reactive protein (CRP), vs. placebo in patients with atherosclerotic cardiovascular disease on statins.

METHODS
We compared evolocumab vs. placebo in FOURIER patients with or without AIID, ie, any autoimmune or chronic inflammatory condition. The primary endpoint was cardiovascular death, myocardial infarction, stroke, unstable angina, or coronary revascularization; the key secondary endpoint was cardiovascular death, myocardial infarction, or stroke. Cox models, adjusted for screening LDL-C and region, were used.

RESULTS
Of 27,564 patients (mean 63 years; 75% male), 889 (3.2%) had an AIID. The most common diseases were rheumatoid arthritis (34%) and psoriasis (16%). Baseline LDL-C (mean 97 vs. 98 mg/dL) and reduction with evolocumab (62% vs. 61%) were similar in patients with vs. without an AIID. Baseline hsCRP was higher in AIID vs. non-AIID patients (mean 3.9 vs. 3.4 mg/L) and unaffected by evolocumab. Evolocumab reduced the primary endpoint in patients with (HR, 0.58; 95% CI, 0.38–0.89) and without (HR, 0.86; 95% CI, 0.80–0.93) AIID, with a trend toward more reduction in AIID patients (P-interaction = 0.066) (Figure). The risk of the key secondary endpoint of cardiovascular death, myocardial infarction, or stroke was reduced to greater degree with evolocumab in patients with (HR, 0.42; 95% CI, 0.24–0.74) vs. without AIID (HR 0.81; 95% CI, 0.74–0.89) (P-interaction = 0.022). Evolocumab particularly lowered the risk of myocardial infarction (68% relative reduction) and coronary revascularization (64% relative reduction).

CONCLUSION
Despite similar effect on LDL-C, evolocumab led to potentially greater clinical benefit in patients with autoimmune or inflammatory diseases.

Número de registro do randomized trial

NCT01764633

Data prevista de conclusão do estudo

31/07/2024

Data de apresentação da análise primária

04/05/2017

Palavras Chave

INFLAMAÇÃO; Dislipidemia; autoimune

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