Efficacy of losartan vs. atenolol for the prevention of aortic dilation in Marfan syndrome: a randomized clinical trial

• Published in: European heart journal Vol. 37; no. 12; pp. 978 - 985
• Main Authors: Forteza, Alberto, Evangelista, Arturo, Sánchez, Violeta, Teixidó-Turà, Gisela, Sanz, Paz, Gutiérrez, Laura, Gracia, Teresa, Centeno, Jorge, Rodríguez-Palomares, José, Rufilanchas, Juan Jose, Cortina, José, Ferreira-González, Ignacio, García-Dorado, David
• Format: Journal Article
• Language: English
• Published: England 21-03-2016
• Subjects: Adolescent; Adult; Angiotensin II Type 1 Receptor Blockers - therapeutic use; Aorta; Aortic Aneurysm - prevention & control; Atenolol - therapeutic use; Child; Child, Preschool; Double-Blind Method; Humans; Losartan - therapeutic use; Magnetic Resonance Angiography; Magnetic Resonance Imaging, Cine; Marfan Syndrome - complications; Middle Aged; Treatment Outcome; Young Adult; Aorta; Magnetic resonance imaging; Marfan; Losartan
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1093/eurheartj/ehv575

To determine the efficacy of losartan vs. atenolol in aortic dilation progression in Marfan syndrome (MFS) patients.
A phase IIIb, randomized, parallel, double-blind study was conducted in 140 MFS patients, age range: 5-60 years, with maximum aortic diameter <45 mm who received losartan (n = 70) or atenolol (n = 70). Doses were raised to a maximum of 1.4 mg/kg/day or 100 mg/day. The primary end-point was the change in aortic root and ascending aorta maximum diameter indexed by body surface area on magnetic resonance imaging after 36 months of treatment. No serious drug-related adverse effects were observed. Five patients presented aortic events during a follow-up (one in the losartan and four in the atenolol groups, P = 0.366). After 3 years of follow-up, aortic root diameter increased significantly in both groups: 1.1 mm (95% CI 0.6-1.6) in the losartan and 1.4 mm (95% CI 0.9-1.9) in the atenolol group, with aortic dilatation progression being similar in both groups: absolute difference between losartan and atenolol -0.3 mm (95% CI -1.1 to 0.4, P = 0.382) and indexed by BSA -0.5 mm/m2 (95% CI -1.2 to 0.1, P = 0.092). Similarly, no significant differences were found in indexed ascending aorta diameter changes between the losartan and atenolol groups: -0.3 mm/m2 (95% CI -0.8 to 0.3, P = 0.326).
Among patients with MFS, the use of losartan compared with atenolol did not result in significant differences in the progression of aortic root and ascending aorta diameters over 3 years of follow-up.