title: Digoxin antibody fragment, antigen binding (Fab), treatment of preeclampsia in women with endogenous digitalis-like factor: a secondary analysis of the DEEP Trial.
abstract: OBJECTIVE
  Endogenous digitalis-like factors (EDLFs) are elevated in women with preeclampsia, and the use of an anti-digoxin antibody Fab (DIF) in women with preeclampsia who were remote from term reduced maternal blood pressure and preserved renal function. The objective was to determine whether DIF treatment in women with severe preeclampsia in association with positive EDLFs in maternal serum improves maternal-perinatal outcomes.
  
  
  METHODS
  This was a planned secondary analysis from a randomized, placebo-controlled, double-blind study of DIF in women with severe preeclampsia with positive EDLF status that was managed expectantly between 23 weeks 5 days and 34 weeks' gestation (19 women received placebo, and 17 women received DIF). Primary outcome variables were a change in creatinine clearance and the use of antihypertensives. Secondary outcomes were maternal and perinatal complications.
  
  
  RESULTS
  Women with positive EDLFs who received DIF had an attenuated decline in creatinine clearance from baseline compared with placebo (-4.5 ± 12.9 vs -53.2 ± 12.6 mL/min; P = .005). In this same group, the use of antihypertensives (the other primary outcome) was lower but not significantly so (41% vs 63%; P = .12). However, women who were treated with DIF had a lower rate of pulmonary edema (1/17 vs 6/19 women; P = .035) and lower rates of neonatal intraventricular hemorrhage (DIF: 0/17 women vs placebo: 5/19 women; P = .015).
  
  
  CONCLUSIONS
  In women with severe preeclampsia who were remote from term who were EDLF positive, the use of DIF was associated with improved maternal and neonatal outcome. These findings suggest the need for a large multicenter trial that would evaluate the benefits of DIF in the treatment of women with severe preeclampsia who are remote from term and with positive EDLF status.
authors.affiliation: Department of Obstetrics and Gynecology, University of Tennessee School of Medicine, Chattanooga, TN, USA.
authors.forename: Garrett K
authors.initials: GK
authors.lastname: Lam
authors.forename: Moana
authors.initials: M
authors.lastname: Hopoate-Sitake
authors.forename: C David
authors.initials: CD
authors.lastname: Adair
authors.forename: Vardaman M
authors.initials: VM
authors.lastname: Buckalew
authors.forename: Donna D
authors.initials: DD
authors.lastname: Johnson
authors.forename: David F
authors.initials: DF
authors.lastname: Lewis
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Robinson
authors.forename: George R
authors.initials: GR
authors.lastname: Saade
authors.forename: Steven W
authors.initials: SW
authors.lastname: Graves
mesh_terms: D000328:Adult; D000959:Antihypertensive Agents / Q000627:therapeutic use; D002298:Cardenolides / Q000097:blood*; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D007231:Infant, Newborn; D011225:Pre-Eclampsia / Q000097:blood / Q000188:drug therapy*; D011247:Pregnancy; D012503:Saponins / Q000097:blood*
chemical_list: D000959:Antihypertensive Agents; D002298:Cardenolides; D007140:Immunoglobulin Fab Fragments; D012503:Saponins; C050199:digoxin antibodies Fab fragments; C034504:digoxin-like factors; D003404:Creatinine
keywords: DEEP Trial; Digibind; creatinine clearance; intraventricular hemorrhage; pulmonary edema; sodium pump