| Texto completo | |
| Autor(es): Mostrar menos - |
Ferrari, Aline G.
;
Maranhao, Raul C.
;
Salsoso, Rocio
;
Baldo, Vanessa M. G. T. F.
;
Furtado, Remo H. M.
;
Dalcoquio, Talia F.
;
Nakashima, Carlos A. K.
;
Baracioli, Luciano M.
;
Lima, Felipe G.
;
Morikawa, Aleksandra T.
;
Liberato, Gabriela
;
Rochitte, Carlos E.
;
Nomura, Cesar H.
;
Filho, Roberto Kalil
;
Ridker, Paul M.
;
Giugliano, Robert P.
;
Sabatine, Marc S.
;
Tavoni, Thauany M.
;
Giraldez, Roberto R. C. V.
;
Nicolau, Jose C.
Número total de Autores: 20
|
| Tipo de documento: | Artigo Científico |
| Fonte: | IJC HEART & VASCULATURE; v. 60, p. 7-pg., 2025-08-13. |
| Resumo | |
Background: Inflammation plays a central role in the pathophysiology of ST-elevation myocardial infarction (STEMI), being associated with larger infarct size (IS) and worse left ventricular remodeling (LVR). Methotrexate (MTX) is a potent anti-inflammatory drug with potential benefits in the treatment of STEMI. Experimental studies have suggested that a formulation of MTX incorporated into lipid nanoemulsion (LDE-MTX) could be beneficial and safe. Objectives: To evaluate the efficacy and safety of LDE-MTX in patients with STEMI. Methods: Randomized, double-blinded, placebo-controlled, proof-of-concept study. Patients were randomized 4 f 2 days after first anterior STEMI to receive LDE-MTX (40 mg/m2 intravenous infusion) or LDE-placebo weekly for 6 weeks. The primary efficacy endpoint was left ventricle end-diastolic volume (LVEDV) assessed by cardiac magnetic resonance at 90 f 7 days post-randomization; the main secondary endpoints were changes in LVEDV, other LVR parameters and IS. Results: Due to the COVID-19 pandemic the study was stopped prematurely, with 32 randomized patients (15 LDE-placebo, 17 LDE-MTX) completing the protocol. At 90 days, there was no difference in LVEDV between groups. Among other secondary endpoints, there appeared to be a greater reduction of IS (%LV) in favor of the LDE-MTX group (-3.9 f 6.9 vs-9.4 f 8.4, p = 0.030). LDE-MTX was well tolerated. Conclusions: In patients with STEMI, LDE-MTX appears to be safe but did not influence LVEDV and other LVR parameters, although it possibly reduced infarct size at 90 days. These hypothesis-generating results support further investigation of a novel nanomedicine approach to STEMI in larger trials. (AU) | |
| Processo FAPESP: | 14/01021-4 - Agregação e antiagregação plaquetária em pacientes com doença arterial coronária |
| Beneficiário: | José Carlos Nicolau |
| Modalidade de apoio: | Auxílio à Pesquisa - Temático |
| Processo FAPESP: | 20/16215-0 - Nanopartículas lipídicas (LDE) como veículos de quimioterápicos: novo paradigma para a terapêutica médica |
| Beneficiário: | Raul Cavalcante Maranhao |
| Modalidade de apoio: | Auxílio à Pesquisa - Temático |