title: Losartan added to β-blockade therapy for aortic root dilation in Marfan syndrome: a randomized, open-label pilot study.
abstract: OBJECTIVE
  To assess the tolerability and efficacy of the investigational use of the angiotensin II receptor blocker losartan added to β-blockade (BB) to prevent progressive aortic root dilation in patients with Marfan syndrome (MFS).
  
  
  METHODS
  Between May 1, 2007, and September 31, 2011, 28 patients with MFS (11 males [39%]; mean ± SD age, 13.1±6.3 years) with recognized aortic root dilation (z score >2.0) and receiving BB (atenolol or propranolol) treatment were enrolled. They were randomized to receive BB (BB: 13 patients) or β-blockade and losartan (BB-L: 15 patients) for 35 months.
  
  
  RESULTS
  In the BB-L group, aortic root dilation was reduced with treatment, and the annual dilation rate of the aortic root was significantly lower than that of the BB group (0.10 mm/yr vs 0.89 mm/yr; P=.02). The absolute aortic diameters at the sinus of Valsalva, annulus, and sinotubular junction showed similar trends, with a reduced rate of dilation in the BB-L group (P=.02, P=.03, and P=.03, respectively). Five patients (33%) treated with BB-L were noted to have a reduced aortic root diameter. However, the differences between the groups regarding changes in aortic stiffness and cross-sectional compliance were not statistically significant.
  
  
  CONCLUSIONS
  This randomized, open-label, active controlled trial mostly based on a pediatric population demonstrated for the first time that losartan add-on BB therapy is safe and provides more effective protection to slow the progression of aortic root dilation than does BB treatment alone in patients with MFS.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00651235.
authors: Department of Pediatrics, National Taiwan University Hospital Yun-Lin branch, Taipei, Taiwan.
authors: Hsin-Hui
authors: HH
authors: Chiu
authors: Mei-Hwan
authors: MH
authors: Wu
authors: Jou-Kou
authors: JK
authors: Wang
authors: Chun-Wei
authors: CW
authors: Lu
authors: Shuenn-Nan
authors: SN
authors: Chiu
authors: Chun-An
authors: CA
authors: Chen
authors: Ming-Tai
authors: MT
authors: Lin
authors: Fu-Chang
authors: FC
authors: Hu
mesh_terms: D000293:Adolescent; D058671:Adrenergic beta-1 Receptor Antagonists / Q000627:therapeutic use*; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use*; D001018:Aortic Diseases / Q000188:drug therapy* / Q000209:etiology; D001262:Atenolol / Q000627:therapeutic use*; D002648:Child; D004108:Dilatation, Pathologic / Q000188:drug therapy / Q000209:etiology; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019808:Losartan / Q000627:therapeutic use*; D008297:Male; D008382:Marfan Syndrome / Q000150:complications*; D010865:Pilot Projects; D011433:Propranolol / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058671:Adrenergic beta-1 Receptor Antagonists; D047228:Angiotensin II Type 1 Receptor Blockers; D001262:Atenolol; D011433:Propranolol; D019808:Losartan