Document Detail


Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial.
MedLine Citation:
PMID:  20825986     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Vascular Ehlers-Danlos syndrome is a rare severe disease that causes arterial dissections and ruptures that can lead to early death. No preventive treatment has yet been validated. Our aim was to assess the ability of celiprolol, a β(1)-adrenoceptor antagonist with a β(2)-adrenoceptor agonist action, to prevent arterial dissections and ruptures in vascular Ehlers-Danlos syndrome.
METHODS: Our study was a multicentre, randomised, open trial with blinded assessment of clinical events in eight centres in France and one in Belgium. Patients with clinical vascular Ehlers-Danlos syndrome were randomly assigned to 5 years of treatment with celiprolol or to no treatment. Randomisation was done from a centralised, previously established list of sealed envelopes with stratification by patients' age (≤32 years or >32 years). 33 patients were positive for mutation of collagen 3A1 (COL3A1). Celiprolol was uptitrated every 6 months by steps of 100 mg to a maximum of 400 mg twice daily. The primary endpoints were arterial events (rupture or dissection, fatal or not). This study is registered with ClinicalTrials.gov, number NCT00190411.
FINDINGS: 53 patients were randomly assigned to celiprolol (25 patients) or control groups (28). Mean duration of follow-up was 47 (SD 5) months, with the trial stopped early for treatment benefit. The primary endpoints were reached by five (20%) in the celiprolol group and by 14 (50%) controls (hazard ratio [HR] 0·36; 95% CI 0·15-0·88; p=0·040). Adverse events were severe fatigue in one patient after starting 100 mg celiprolol and mild fatigue in two patients related to dose uptitration.
INTERPRETATION: We suggest that celiprolol might be the treatment of choice for physicians aiming to prevent major complications in patients with vascular Ehlers-Danlos syndrome. Whether patients with similar clinical presentations and no mutation are also protected remains to be established.
FUNDING: French Ministry of Health, Programme Hospitalier de Recherche Clinique 2001.
Authors:
Kim-Thanh Ong; Jérôme Perdu; Julie De Backer; Erwan Bozec; Patrick Collignon; Joseph Emmerich; Anne-Laure Fauret; Jean-Noël Fiessinger; Dominique P Germain; Gabriella Georgesco; Jean-Sebastien Hulot; Anne De Paepe; Henri Plauchu; Xavier Jeunemaitre; Stéphane Laurent; Pierre Boutouyrie
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-09-07
Journal Detail:
Title:  Lancet     Volume:  376     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-11-01     Completed Date:  2010-11-30     Revised Date:  2010-12-10    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  1476-84     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2010 Elsevier Ltd. All rights reserved.
Affiliation:
Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00190411
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adrenergic beta-Agonists / therapeutic use*
Adrenergic beta-Antagonists / therapeutic use*
Adult
Aneurysm, Dissecting / etiology,  prevention & control
Aneurysm, Ruptured / etiology,  prevention & control
Celiprolol / therapeutic use*
Collagen Type III / genetics
Ehlers-Danlos Syndrome / complications*,  diagnosis,  genetics
Female
Humans
Male
Middle Aged
Mutation
Vascular Diseases / etiology,  prevention & control*
Young Adult
Chemical
Reg. No./Substance:
0/Adrenergic beta-Agonists; 0/Adrenergic beta-Antagonists; 0/COL3A1 protein, human; 0/Collagen Type III; 56980-93-9/Celiprolol
Comments/Corrections
Comment In:
Nat Rev Cardiol. 2010 Dec;7(12):664
Lancet. 2010 Oct 30;376(9751):1443-4   [PMID:  20825985 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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