Am J Perinatol 2010; 27(8): 655-662
DOI: 10.1055/s-0030-1249762
© Thieme Medical Publishers

Digoxin Immune Fab Treatment for Severe Preeclampsia

C. David Adair1 , 2 , Vardaman M. Buckalew3 , Steven W. Graves4 , Garrett K. Lam5 , Donna D. Johnson6 , George Saade7 , David F. Lewis8 , Christopher Robinson6 , Theodore M. Danoff9 , Nikhil Chauhan10 , Moana Hopoate-Sitake4 , Kathy B. Porter11 , Rachel G. Humphrey12 , Kenneth F. Trofatter13 , Erol Amon14 , Suzanne Ward15 , Lizbeth Kennedy16 , Lorrie Mason17 , J. Andrew Johnston2
  • 1University of Tennessee, Chattanooga, Tennessee
  • 2Glenveigh Research, Chattanooga, Tennessee
  • 3Wake Forest University School of Medicine, Winston-Salem, North Carolina
  • 4Brigham Young University, Provo, Utah
  • 5Phoenix Perinatal Associates, Phoenix, Arizona
  • 6Medical University of South Carolina, Charleston, South Carolina
  • 7University of Texas Medical Branch, Galveston, Texas
  • 8Louisiana State University Medical Center, Shreveport, Louisiana
  • 9GlaxoSmithKline, King of Prussia, Pennsylvania
  • 10Protherics, London, United Kingdom
  • 11University of South Alabama, Mobile, Alabama
  • 12Winnie Palmer Hospital, Orlando Florida
  • 13Greenville Hospital System, Greenville, South Carolina
  • 14St. Louis University, St. Louis, Missouri
  • 15Protherics, Nashville, Tennessee
  • 16Regional Neonatal Specialists, Chattanooga, Tennessee
  • 17Regional Obstetrical Consultatns, Chattanooga, Tennessee
Further Information

Publication History

Publication Date:
15 March 2010 (online)

ABSTRACT

We evaluated the efficacy, safety, and biological mechanisms of digoxin immune Fab (DIF) treatment of severe preeclampsia. Fifty-one severe preeclamptic patients were randomized in double-blind fashion to DIF (n = 24) or placebo (n = 27) for 48 hours. Primary outcomes were change in creatinine clearance (CrCl) at 24 to 48 hours and antihypertensive drug use. Serum sodium pump inhibition, a sequela of endogenous digitalis-like factors (EDLF), was also assessed. CrCl in DIF subjects was essentially unchanged from baseline versus a decrease with placebo (−3 ± 10 and −34 ± 10 mL/min, respectively, p = 0.02). Antihypertensive use was similar between treatments (46 and 52%, respectively, p = 0.7). Serum sodium pump inhibition was decreased with DIF compared with placebo at 24 hours after treatment initiation (least squares mean difference, 19 percentage points, p = 0.03). DIF appeared to be well tolerated. These results suggest DIF prevents a decline in renal function in severe preeclampsia by neutralizing EDLF. Sodium pump inhibition was significantly improved. Further research is warranted.

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C David Adair M.D. 

Professor, University of Tennessee, Chairman, Glenveigh Research

401 Chestnut Street, Suite 230, Chattanooga, TN 37402

Email: David.Adair@Glenveigh.com