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. STUDY DESIGN: We identified premature infants who were discharged from Pediatrix Medical Group neonatal intensive care units from 2003–2012 and who received an ophthalmologic exam. We matched each infant exposed to sildenafil prior to first eye exam to three non-exposed 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. RESULT: Of the 57815 infants meeting inclusion criteria, 88 were exposed to sildenafil. We matched 81/88 (92%) sildenafil-exposed with 243 non-exposed infants. There was no difference in the proportion of infants who developed severe ROP in the sildenafil-exposed vs. non-exposed 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 versus non-exposed infants (odds ratio=1.46, 95% confidence interval=0.76–2.82, P=0.26). CONCLUSION: We did not observe an association between risk of severe ROP and sildenafil exposure prior to first eye exam in this cohort of premature infants.