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. 2013 Dec 12:5:ecurrents.md.2cc69a1dae4be7dfe2bcb420024ea865.
doi: 10.1371/currents.md.2cc69a1dae4be7dfe2bcb420024ea865.

A randomized, double-blind trial of lisinopril and losartan for the treatment of cardiomyopathy in duchenne muscular dystrophy

Hugh D Allen  1 , Kevin M Flanigan  2 , Philip T Thrush  3 , Igor Dvorchik  4 , Han Yin  4 , Charles Canter  5 , Anne M Connolly  5 , Mark Parrish  6 , Craig M McDonald  6 , Elizabeth Braunlin  7 , Steven D Colan  8 , John Day  7 , Basil Darras  9 , Jerry R Mendell  10
Affiliations

A randomized, double-blind trial of lisinopril and losartan for the treatment of cardiomyopathy in duchenne muscular dystrophy

Hugh D Allen et al. PLoS Curr. .

Erratum in

Abstract

Objectives: This study sought to compare the effectiveness and safety of an angiotensin converting enzyme inhibitor (ACE-I) (lisinopril) vs. an angiotensin receptor blocker (ARB) (losartan) for the treatment of cardiomyopathy (CM) in boys with Duchenne muscular dystrophy (DMD).

Background: Development of CM is universal in boys with DMD. ACE-I and ARB have both been suggested as effective treatment options. ARBs have been associated with skeletal muscle regeneration in a mouse model of DMD. The question of which, if either, is more effective for CM treatment in DMD remains. The purpose of this multicenter double-blind prospective study was to compare efficacy and safety of lisinopril versus losartan in the treatment of newly diagnosed CM in boys with DMD.

Methods: Echocardiographic technician inter- and intraobserver variability were tested on 2 separate days on 2 different boys with DMD CM. Results were compared with paired t-testing. Twenty-two boys with newly diagnosed DMD CM (echocardiographic ejection fraction (EF) 10% EF drop. Three boys in the aCE-I group had 3 visits, due to study funding termination. Two were withdrawn because of low EF. All their data are included in the analysis for as long as they remained in the study. Mean EF's were similar at baseline (47.5%- ACE-I, 48.4%- ARB). After 1 year each group significantly improved to 54.6% and 55.2% respectively (p=.02). There was no difference between the 2 treatment groups at 1 year.

Conclusions: Inter-observer and intra-observer reliability studies showed no differences between echocardiographers on serial examinations. EF improved equally in the two groups. There is no therapeutic difference in EF improvement between lisinopril and losartan over the one-year duration for treatment of boys with DMD-related CM.

Trial registration: ClinicalTrials.gov NCT01982695.

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Figures

Enrollment, Allocation, Follow-up, and Analysis of Trial Participants
Enrollment, Allocation, Follow-up, and Analysis of Trial Participants
Serial data for both groups. Lisinopril in red, losartan in blue.
Serial data for both groups. Lisinopril in red, losartan in blue.
EF is shown on the ordinate and time on the abscissa.
See this image and copyright information in PMC

References

    1. Allen HD, Mendell JR, and Hoffman TM. The Heart in Muscular Dystrophies; Chapter 60 in Moss and Adams’ Heart Disease in Infants, Children, and Adolescents, Including the Fetus and Young Adult, 7th Ed. Phildadelphia, Wolters Kluwer/Lippincott Williams and Wilkins, 2008.
    1. Viollet, Laurence PhD, Thrush, Philip T. MD, Flanigan ,Kevin M. MD, Mendell, Jerry R. MD, Allen, Hugh D MD. “Effects of Angiotensin-Converting Enzyme Inhibitors and/or Beta Blockers on the Cardiomyopathy in Duchenne Muscular Dystrophy”. Am J Cardiol 2012; 110(1):98-102. Epub ahead of print, 3/29/12. - PubMed
    1. Allen HD, Thrush PT, Hoffman TM, Flanigan KM, Mendell JT: Cardiac Management in Neuromuscular Disease. 2012; Phys Med Rehabil Clin N Am 23:855-68. - PubMed
    1. Duboc D, Meune C, Lerebours G, Devaux JY, Vaksmann G, Becane HM. Effect of perindopril on the onset and progression of left ventricular dysfunction in Duchenne muscular dystrophy. J Am Coll Cardiol 2005; 45: 855-857. - PubMed
    1. Hor KN, Wanasapura J, Markham LW, et al. Circumferential Strain Analysis Identifies Strata of Cardiomyopathy in Duchenne Muscular Dystrophy. A Cardiac Magnetic Resnonance Tagging Study. J Am Coll Cardiol 2009; 53: 1204-10. - PMC - PubMed

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