Stabilization of Early Duchenne Cardiomyopathy With Aldosterone Inhibition: Results of the Multicenter AIDMD Trial
Background Duchenne muscular dystrophy incurs nearly universal dilated cardiomyopathy by the third decade of life, preceded by myocardial damage and impaired left ventricular strain by cardiac magnetic resonance. It has been shown that (1) mineralocorticoid receptor antagonist therapy with spironola...
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| Published in | Journal of the American Heart Association Vol. 8; no. 19; p. e013501 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
John Wiley and Sons Inc
01.10.2019
Wiley |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2047-9980 2047-9980 |
| DOI | 10.1161/JAHA.119.013501 |
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| Abstract | Background Duchenne muscular dystrophy incurs nearly universal dilated cardiomyopathy by the third decade of life, preceded by myocardial damage and impaired left ventricular strain by cardiac magnetic resonance. It has been shown that (1) mineralocorticoid receptor antagonist therapy with spironolactone attenuated damage while maintaining function when given early in a mouse model and (2) low-dose eplerenone stabilized left ventricular strain in boys with Duchenne muscular dystrophy and evident myocardial damage but preserved ejection fraction. We hypothesized that moderate-dose spironolactone versus eplerenone would provide similar cardioprotection in this first head-to-head randomized trial of available mineralocorticoid receptor antagonists, the AIDMD (Aldosterone Inhibition in Duchenne Muscular Dystrophy) trial. Methods and Results This was a multicenter, double-blind, randomized, noninferiority trial. Subjects were randomized to eplerenone, 50 mg, or spironolactone, 50 mg, orally once daily for 12 months. The primary outcome was change in left ventricular systolic strain at 12 months. Among 52 enrolled male subjects, aged 14 (interquartile range, 12-18) years, spironolactone was noninferior to eplerenone (∆strain, 0.4 [interquartile range, -0.4 to 0.6] versus 0.2 [interquartile range, -0.2 to 0.7];
=0.542). Renal and pulmonary function remained stable in both groups, and no subjects experienced serious hyperkalemia. Infrequent adverse events included gynecomastia in one subject in the spironolactone arm and facial rash in one subject in the eplerenone arm. Conclusions In boys with Duchenne muscular dystrophy and preserved left ventricular ejection fraction, spironolactone added to background therapy is noninferior to eplerenone in preserving contractile function. These findings support early mineralocorticoid receptor antagonist therapy as effective and safe in a genetic disease with high cardiomyopathy risk. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02354352. |
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| AbstractList | Background Duchenne muscular dystrophy incurs nearly universal dilated cardiomyopathy by the third decade of life, preceded by myocardial damage and impaired left ventricular strain by cardiac magnetic resonance. It has been shown that (1) mineralocorticoid receptor antagonist therapy with spironolactone attenuated damage while maintaining function when given early in a mouse model and (2) low-dose eplerenone stabilized left ventricular strain in boys with Duchenne muscular dystrophy and evident myocardial damage but preserved ejection fraction. We hypothesized that moderate-dose spironolactone versus eplerenone would provide similar cardioprotection in this first head-to-head randomized trial of available mineralocorticoid receptor antagonists, the AIDMD (Aldosterone Inhibition in Duchenne Muscular Dystrophy) trial. Methods and Results This was a multicenter, double-blind, randomized, noninferiority trial. Subjects were randomized to eplerenone, 50 mg, or spironolactone, 50 mg, orally once daily for 12 months. The primary outcome was change in left ventricular systolic strain at 12 months. Among 52 enrolled male subjects, aged 14 (interquartile range, 12-18) years, spironolactone was noninferior to eplerenone (∆strain, 0.4 [interquartile range, -0.4 to 0.6] versus 0.2 [interquartile range, -0.2 to 0.7]; P=0.542). Renal and pulmonary function remained stable in both groups, and no subjects experienced serious hyperkalemia. Infrequent adverse events included gynecomastia in one subject in the spironolactone arm and facial rash in one subject in the eplerenone arm. Conclusions In boys with Duchenne muscular dystrophy and preserved left ventricular ejection fraction, spironolactone added to background therapy is noninferior to eplerenone in preserving contractile function. These findings support early mineralocorticoid receptor antagonist therapy as effective and safe in a genetic disease with high cardiomyopathy risk. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02354352.Background Duchenne muscular dystrophy incurs nearly universal dilated cardiomyopathy by the third decade of life, preceded by myocardial damage and impaired left ventricular strain by cardiac magnetic resonance. It has been shown that (1) mineralocorticoid receptor antagonist therapy with spironolactone attenuated damage while maintaining function when given early in a mouse model and (2) low-dose eplerenone stabilized left ventricular strain in boys with Duchenne muscular dystrophy and evident myocardial damage but preserved ejection fraction. We hypothesized that moderate-dose spironolactone versus eplerenone would provide similar cardioprotection in this first head-to-head randomized trial of available mineralocorticoid receptor antagonists, the AIDMD (Aldosterone Inhibition in Duchenne Muscular Dystrophy) trial. Methods and Results This was a multicenter, double-blind, randomized, noninferiority trial. Subjects were randomized to eplerenone, 50 mg, or spironolactone, 50 mg, orally once daily for 12 months. The primary outcome was change in left ventricular systolic strain at 12 months. Among 52 enrolled male subjects, aged 14 (interquartile range, 12-18) years, spironolactone was noninferior to eplerenone (∆strain, 0.4 [interquartile range, -0.4 to 0.6] versus 0.2 [interquartile range, -0.2 to 0.7]; P=0.542). Renal and pulmonary function remained stable in both groups, and no subjects experienced serious hyperkalemia. Infrequent adverse events included gynecomastia in one subject in the spironolactone arm and facial rash in one subject in the eplerenone arm. Conclusions In boys with Duchenne muscular dystrophy and preserved left ventricular ejection fraction, spironolactone added to background therapy is noninferior to eplerenone in preserving contractile function. These findings support early mineralocorticoid receptor antagonist therapy as effective and safe in a genetic disease with high cardiomyopathy risk. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02354352. Background Duchenne muscular dystrophy incurs nearly universal dilated cardiomyopathy by the third decade of life, preceded by myocardial damage and impaired left ventricular strain by cardiac magnetic resonance. It has been shown that (1) mineralocorticoid receptor antagonist therapy with spironolactone attenuated damage while maintaining function when given early in a mouse model and (2) low-dose eplerenone stabilized left ventricular strain in boys with Duchenne muscular dystrophy and evident myocardial damage but preserved ejection fraction. We hypothesized that moderate-dose spironolactone versus eplerenone would provide similar cardioprotection in this first head-to-head randomized trial of available mineralocorticoid receptor antagonists, the AIDMD (Aldosterone Inhibition in Duchenne Muscular Dystrophy) trial. Methods and Results This was a multicenter, double-blind, randomized, noninferiority trial. Subjects were randomized to eplerenone, 50 mg, or spironolactone, 50 mg, orally once daily for 12 months. The primary outcome was change in left ventricular systolic strain at 12 months. Among 52 enrolled male subjects, aged 14 (interquartile range, 12-18) years, spironolactone was noninferior to eplerenone (∆strain, 0.4 [interquartile range, -0.4 to 0.6] versus 0.2 [interquartile range, -0.2 to 0.7]; =0.542). Renal and pulmonary function remained stable in both groups, and no subjects experienced serious hyperkalemia. Infrequent adverse events included gynecomastia in one subject in the spironolactone arm and facial rash in one subject in the eplerenone arm. Conclusions In boys with Duchenne muscular dystrophy and preserved left ventricular ejection fraction, spironolactone added to background therapy is noninferior to eplerenone in preserving contractile function. These findings support early mineralocorticoid receptor antagonist therapy as effective and safe in a genetic disease with high cardiomyopathy risk. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02354352. Background Duchenne muscular dystrophy incurs nearly universal dilated cardiomyopathy by the third decade of life, preceded by myocardial damage and impaired left ventricular strain by cardiac magnetic resonance. It has been shown that (1) mineralocorticoid receptor antagonist therapy with spironolactone attenuated damage while maintaining function when given early in a mouse model and (2) low‐dose eplerenone stabilized left ventricular strain in boys with Duchenne muscular dystrophy and evident myocardial damage but preserved ejection fraction. We hypothesized that moderate‐dose spironolactone versus eplerenone would provide similar cardioprotection in this first head‐to‐head randomized trial of available mineralocorticoid receptor antagonists, the AIDMD (Aldosterone Inhibition in Duchenne Muscular Dystrophy) trial. Methods and Results This was a multicenter, double‐blind, randomized, noninferiority trial. Subjects were randomized to eplerenone, 50 mg, or spironolactone, 50 mg, orally once daily for 12 months. The primary outcome was change in left ventricular systolic strain at 12 months. Among 52 enrolled male subjects, aged 14 (interquartile range, 12–18) years, spironolactone was noninferior to eplerenone (∆strain, 0.4 [interquartile range, −0.4 to 0.6] versus 0.2 [interquartile range, −0.2 to 0.7]; P=0.542). Renal and pulmonary function remained stable in both groups, and no subjects experienced serious hyperkalemia. Infrequent adverse events included gynecomastia in one subject in the spironolactone arm and facial rash in one subject in the eplerenone arm. Conclusions In boys with Duchenne muscular dystrophy and preserved left ventricular ejection fraction, spironolactone added to background therapy is noninferior to eplerenone in preserving contractile function. These findings support early mineralocorticoid receptor antagonist therapy as effective and safe in a genetic disease with high cardiomyopathy risk. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02354352. |
| Author | Cardona, Andrea Cripe, Linda H. Hor, Kan N. Halnon, Nancy Smart, Suzanne Raman, Subha V. Auerbach, Scott R. Mazur, Wojciech Saeed, Ibrahim M. Puchalski, Michael D. Truong, Uyen Markham, Larry Soslow, Jonathan H. McCarthy, Beth Statland, Jeffrey M. He, Xin Kissel, John T. |
| AuthorAffiliation | 8 University of Colorado Denver CO 4 Department of Epidemiology and Biostatistics University of Maryland College Park MD 11 Department of Neurology Ohio State University Columbus OH 5 University of California, Los Angeles Los Angeles CA 7 University of Utah Salt Lake City UT 1 Ohio State University Wexner Medical Center Columbus OH 2 Nationwide Children's Hospital Columbus OH 6 Vanderbilt University Medical Center Nashville TN 3 The Christ Hospital Heart and Vascular Center Cincinnati OH 9 Saint Luke's Mid America Heart Institute Kansas City MO 10 University of Kansas Medical Center Kansas City MO |
| AuthorAffiliation_xml | – name: 2 Nationwide Children's Hospital Columbus OH – name: 5 University of California, Los Angeles Los Angeles CA – name: 11 Department of Neurology Ohio State University Columbus OH – name: 6 Vanderbilt University Medical Center Nashville TN – name: 3 The Christ Hospital Heart and Vascular Center Cincinnati OH – name: 1 Ohio State University Wexner Medical Center Columbus OH – name: 4 Department of Epidemiology and Biostatistics University of Maryland College Park MD – name: 7 University of Utah Salt Lake City UT – name: 8 University of Colorado Denver CO – name: 9 Saint Luke's Mid America Heart Institute Kansas City MO – name: 10 University of Kansas Medical Center Kansas City MO |
| Author_xml | – sequence: 1 givenname: Subha V. surname: Raman fullname: Raman, Subha V. – sequence: 2 givenname: Kan N. surname: Hor fullname: Hor, Kan N. – sequence: 3 givenname: Wojciech surname: Mazur fullname: Mazur, Wojciech – sequence: 4 givenname: Andrea surname: Cardona fullname: Cardona, Andrea – sequence: 5 givenname: Xin surname: He fullname: He, Xin – sequence: 6 givenname: Nancy surname: Halnon fullname: Halnon, Nancy – sequence: 7 givenname: Larry surname: Markham fullname: Markham, Larry – sequence: 8 givenname: Jonathan H. surname: Soslow fullname: Soslow, Jonathan H. – sequence: 9 givenname: Michael D. surname: Puchalski fullname: Puchalski, Michael D. – sequence: 10 givenname: Scott R. surname: Auerbach fullname: Auerbach, Scott R. – sequence: 11 givenname: Uyen surname: Truong fullname: Truong, Uyen – sequence: 12 givenname: Suzanne surname: Smart fullname: Smart, Suzanne – sequence: 13 givenname: Beth surname: McCarthy fullname: McCarthy, Beth – sequence: 14 givenname: Ibrahim M. surname: Saeed fullname: Saeed, Ibrahim M. – sequence: 15 givenname: Jeffrey M. surname: Statland fullname: Statland, Jeffrey M. – sequence: 16 givenname: John T. surname: Kissel fullname: Kissel, John T. – sequence: 17 givenname: Linda H. surname: Cripe fullname: Cripe, Linda H. |
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| Keywords | magnetic resonance imaging cardiomyopathy mineralocorticoid receptor antagonist Duchenne muscular dystrophy aldosterone |
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| Snippet | Background Duchenne muscular dystrophy incurs nearly universal dilated cardiomyopathy by the third decade of life, preceded by myocardial damage and impaired... |
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| SubjectTerms | Adolescent aldosterone Cardiomyopathies - diagnostic imaging Cardiomyopathies - drug therapy Cardiomyopathies - etiology Cardiomyopathies - physiopathology cardiomyopathy Child Double-Blind Method Duchenne muscular dystrophy Eplerenone - administration & dosage Eplerenone - adverse effects Humans magnetic resonance imaging Magnetic Resonance Imaging, Cine Male mineralocorticoid receptor antagonist Mineralocorticoid Receptor Antagonists - administration & dosage Mineralocorticoid Receptor Antagonists - adverse effects Muscular Dystrophy, Duchenne - complications Muscular Dystrophy, Duchenne - diagnosis Myocardial Contraction - drug effects Original Research Spironolactone - administration & dosage Spironolactone - adverse effects Stroke Volume - drug effects Time Factors Treatment Outcome United States Ventricular Function, Left - drug effects Young Adult |
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| Title | Stabilization of Early Duchenne Cardiomyopathy With Aldosterone Inhibition: Results of the Multicenter AIDMD Trial |
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