Sildenafil and retinopathy of prematurity risk in very low birth weight infants.
OBJECTIVE
To examine the effect of sildenafil therapy on development of severe retinopathy of prematurity (ROP) requiring surgical intervention in premature infants.


METHODS
We identified premature infants who were discharged from Pediatrix Medical Group neonatal intensive care units from 2003 to 2012 and who received an ophthalmologic exam. We matched each infant exposed to sildenafil before first eye exam to three nonexposed infants using propensity scoring to control for differences in baseline infant characteristics. We evaluated the association between sildenafil exposure and development of severe ROP using conditional logistic regression.


RESULTS
Of the 57 815 infants meeting inclusion criteria, 88 were exposed to sildenafil. We matched 81/88 (92%) sildenafil-exposed with 243 nonexposed infants. There was no difference in the proportion of infants who developed severe ROP in the sildenafil-exposed vs nonexposed groups (17/81 (21%) vs 38/243 (16%), P=0.27). On adjusted analysis, there was no difference in severe ROP in the sildenafil-exposed vs nonexposed infants (odds ratio=1.46, 95% confidence interval=0.76 to 2.82, P=0.26).


CONCLUSIONS
We did not observe an association between risk of severe ROP and sildenafil exposure before first eye exam in this cohort of premature infants.
Center for Translational Science, Children's National Medical Center, Washington, DC, USA.|Division of Clinical Pharmacology, Children's National Medical Center, Washington, DC, USA.|Department of Pediatrics, McMaster University Medical Center, Hamilton, ON, Canada.
S
S
Samiee-Zafarghandy
Center for Translational Science, Children's National Medical Center, Washington, DC, USA.|Division of Clinical Pharmacology, Children's National Medical Center, Washington, DC, USA.|Intensive Care, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, The Netherlands.|Department of Paediatric Pharmacology, University Children's Hospital Basel, Basel, Switzerland.
J N
JN
van den Anker
Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
M M
MM
Laughon
Pediatrix-Obstetrix Center for Research and Education, Sunrise, FL, USA.
R H
RH
Clark
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.|Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
P B
PB
Smith
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.|Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
C P
CP
Hornik
D001997:Bronchopulmonary Dysplasia / Q000150:complications*; D003941:Diagnostic Techniques, Ophthalmological; D005260:Female; D005865:Gestational Age; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy* / Q000209:etiology; D007223:Infant; D007234:Infant, Premature; D019102:Infant, Very Low Birth Weight; D008297:Male; D008501:Medical Records, Problem-Oriented; D012178:Retinopathy of Prematurity / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D018570:Risk Assessment; D012307:Risk Factors; D000068677:Sildenafil Citrate / Q000008:administration & dosage / Q000009:adverse effects; D013223:Statistics as Topic; D014481:United States / Q000453:epidemiology; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000009:adverse effects
D014665:Vasodilator Agents; D000068677:Sildenafil Citrate