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Colchicine in acutely decompensated heart failure: the COLICA trial

2024; Oxford University Press; Linguagem: Inglês

10.1093/eurheartj/ehae538

1522-9645

Domingo A. Pascual‐Figal, Julio Núñez, Teresa Martı́nez, José Ramón González–Juanatey, Mikel Taibo Urquía, Pau Llácer, Juan F. Delgado, Sandra Villar, Sònia Mirabet, Alberto Aimo, Alejandro Riquelme‐Pérez, Manuel Anguita Sánchez, Manuel Martínez‐Sellés, José Antonio Noguera Velasco, Borja Ibáñez, Antoni Bayés‐Genís, Domingo A. Pascual‐Figal, Maria Teresa Pérez‐Martínez, Andrés Ramón Martínez, Alejandro Riquelme Pérez, Iris Paula Garrido Bravo, A López, Francisco J. Pastor Pérez, Noelia Fernández Villa, Álvaro Hernández Vicente, Rocio Muñiz Anquela, Carmen Sánchez Pérez, Julio Núñez, Sandra Villar, Anna Mollar, José Ramón González–Juanatey, José Seijas‐Amigo, Borja Ibáñez, Mikel Taibo Urquía, Sandra Gómez Talavera, María López Álvarez, Alba María Vega Viyuela, Pablo Gil Pérez, Jorge Balaguer‐Germán, María José Díez Medrado, Javier González Martín, Laura Morán Fernandez, Juan Carlos López‐Azor, Javier de Juan Bagudá, María Dolores García‐Cosío Carmena, Juan F. Delgado, Pau Llácer, Luís Manzano, Raúl Ruiz, Genoveva López, Antoni Bayés‐Genís, Meritxell Soler, Cinta Llibre, Sònia Mirabet, Marta de Antonio, Carlos Moliner‐Abós, Antonia Pomares, Alberto Aimo, Michele Emdin, Manuel Martínez‐Sellés, Iago Sousa, Eduardo Zatarain‐Nicolás, Manuel Anguita, Pedro Luis Sanchez,

Inflammasome and immune disorders

Abstract Background and Aims Acute heart failure (AHF) promotes inflammatory activation, which is associated with worse outcomes. Colchicine has proven effective in other cardiovascular conditions characterized by inflammatory activation, but has never been evaluated in the setting of AHF. Methods This multicenter, randomized, double-blind and placebo-controlled trial included patients with AHF, requiring ≥40 mg of intravenous furosemide, regardless of their left ventricular ejection fraction (LVEF) and inpatient or outpatient setting. Patients were randomized within the first 24 hours of presentation to receive either colchicine or placebo, with loading dose of 2 mg followed by 0.5 mg every 12 hours for 8 weeks. Results A total of 278 patients (median age 75 years, LVEF 40%, baseline N-terminal pro-B-type natriuretic peptide [NT-proBNP] 4390 pg/mL) were randomized to colchicine (n=141) or placebo (n=137). The primary endpoint, the time-averaged reduction in NT-proBNP levels at 8 weeks, did not differ between the colchicine group (-62.2%, 95% confidence interval [CI] -68.9% to -54.2%) and the placebo group (-62.1%, 95% CI -68.6% to -54.3%) (ratio of change 1.0). The reduction in inflammatory markers was significantly greater with colchicine: ratio of change 0.60 (p<0.001) for C-reactive protein and 0.72 (p=0.019) for interleukin-6. No differences were found in new worsening heart failure episodes (14.9% with colchicine vs. 16.8% with placebo, p=0.698); however, the need for intravenous furosemide during follow-up was lower with colchicine (p=0.043). Diarrhea was slightly more common with colchicine, but it did not result in differences in medication withdrawal (8.5% vs. 8.8%). Conclusions Colchicine was safe and effective in reducing inflammation in patients with AHF, however colchicine and placebo exhibited comparable effects on reducing NT-proBNP and preventing new worsening heart failure events.