The Journal of Pediatrics
Volume 157, Issue 2 , Pages 282-287 , August 2010

The Efficacy and Safety of the Novel Aldosterone Antagonist Eplerenone in Children with Hypertension: A Randomized, Double-Blind, Dose-Response Study

  • Jennifer S. Li, MD, MHS

      Affiliations

    • Division of Pediatric Cardiology and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC
    • Corresponding Author InformationReprint requests: Jennifer S. Li MD, MHS, Box 3090, Duke University Medical Center, Durham, NC 27710.
    • ,
  • Joseph T. Flynn, MD, MS

      Affiliations

    • Division of Nephrology, Seattle Children's Hospital, Seattle, WA
    • ,
  • Ronald Portman, MD

      Affiliations

    • Bristol-Myers Squibb, Princeton, NJ
    • ,
  • Ira Davis, MD

      Affiliations

    • Baxter Healthcare, McGaw Park, IL
    • ,
  • Masayo Ogawa, MD

      Affiliations

    • Pfizer Global Research and Development, New London, CT
    • New York, NY
    • ,
  • Harry Shi, MA

      Affiliations

    • Pfizer Global Research and Development, New London, CT
    • New York, NY
    • ,
  • Milton L. Pressler, MD

      Affiliations

    • Pfizer Global Research and Development, New London, CT
    • New York, NY

Received 7 October 2009 ,Revised 29 December 2009 ,Accepted 22 February 2010.

References 

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  7. Weinberger MH, Roniker B, Krause SL, Weiss RJ. Eplerenone, a selective aldosterone blocker, in mild-to-moderate hypertension. Am J Hypertens. 2002;15:709–716
  8. Krum H, Nolly H, Workman D, He W, Roniker B, Krause S, et al. Efficacy of eplerenone added to renin-angiotensin blockade in hypertensive patients. Hypertension. 2002;40:117–239
  9. National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004;114(Suppl):555–576
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  11. Struthers A, Krum H, Williams GH. A comparison of the aldosterone-blocking agents eplerenone and spironolactone. Clin Cardiol. 2008;31:153–158
  12. Flack JM, Oparil S, Pratt JH, Roniker B, Garthwaite S, Kleiman JH, et al. Efficacy and tolerability of eplerenone and losartan in hypertensive black and white patients. J Am Coll Cardiol. 2003;41:1148–1155
  13. Epstein M, Williams GH, Weinberger M, Lewin A, Krause S, Mukherjee R, et al. Selective aldosterone blockade with eplerenone reduces albuminuria in patients with type 2 diabetes. Clin J Am Soc Nephrol. 2006;1:940–951
  14. Pitt B, Reichek N, Willenbrock R, Zannad F, Phillips RA, Roniker B, et al. Effects of eplerenone, enalapril, and eplerenone/enalapril in patients with essential hypertension and left ventricular hypertrophy: the 4E-Left Ventricular Hypertrophy Study. Circulation. 2003;108:1831–1838
  15. Burgess ED, Lacourciere Y, Ruilope-Urioste LM, Oparil S, Kleiman JH, Krause S, et al. Long-term safety and efficacy of the selective aldosterone blocker eplerenone in patients with essential hypertension. Clin Ther. 2003;25:2388–2404
  16. Sorof JM. Prevalence and consequence of systolic hypertension in children. Am J Hypertens. 2002;15(2 Pt 2):57S–60S
  17. Pasquali SK, Sanders SP, Li JS. Oral antihypertensive trial design and analysis under the pediatric exclusivity provision. Am Heart J. 2002;144:608–614
  18. Ge RS, Dong Q, Sottas CM, Latif SA, Morris DJ, Hardy MP. Stimulation of testosterone production in rat Leydig cells by aldosterone is mineralocorticoid receptor mediated. Mol Cell Endocrinol. 2005;243:35–42
  19. de Gasparo M, Whitebread SE, Preiswerk G, Jeunemaître X, Corvol P, Ménard J. Antialdosterones: incidence and prevention of sexual side effects. J Steroid Biochem. 1989;32(1B):223–227
  20. Guo C, Ricchiuti V, Lian BQ, Yao TM, Coutinho P, Romero JR, et al. Mineralocorticoid receptor blockade reverses obesity-related changes in expression of adiponectin, peroxisome proliferator-activated receptor-gamma, and proinflammatory adipokines. Circulation. 2008;117:2253–2261
  21. Takeda Y. Effects of epleternone, a selective mineralocorticoid receptor antagonist, on clinical and experimental salt-sensitive hypertension. Hypertens Res. 2009;32:321–324

 Funded by Pfizer, Inc. J.L. is a consultant to Pfizer, Inc and Sanofi-Aventis. J.F. is a consultant to Pfizer, Inc, Gilead Sciences, Inc, Shire Pharmaceuticals, and Novartis Pharmaceuticals. M.P., M.O., and H.S. were employees of Pfizer, Inc during the study. The other authors declare no conflicts of interest.

 Registered at clinicaltrials.gov (NCT10014589).

PII: S0022-3476(10)00166-6

doi: 10.1016/j.jpeds.2010.02.042

The Journal of Pediatrics
Volume 157, Issue 2 , Pages 282-287 , August 2010

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