Conference: 2011 PH Professional Network Symposium
Release Date: 09.22.2011
Presentation Type: Abstracts
S. Walker, MS, CRNP1; B.D. Hanna, MD, PhD1; H. Meluskey, BS, BSN, RN1; E. Ramsey, PharmD2; S. Dubey,MD1
1. Division of Cardiology, The Children's Hospital of Philadelphia and University of Pennsylvania, School of Medicine, Philadelphia, PA
2. Department of Pharmacy, The Children's Hospital of Philadelphia and University of Pennsylvania, School of Medicine, Philadelphia, PA
BACKGROUND: Sildenafil reduces pulmonary artery pressure and right heart failure in pediatric pulmonary hypertension. The Cochrane Review (Kanthapillai P, et al: The Cochrane Library 2009) highlighted a lack of data regarding the sildenafil pediatric safety profile.
PURPOSE: This study reports the frequency and severity of adverse effects with pediatric Sildenafil use.
MATERIALS AND METHODS: Retrospective data from a convenience sample of 228 pediatric patients, ages 0 - 18 years, with exposure to oral sildenafil (02/10/04 to 10/27/10) included Dana Point Classification, age at and duration of sildenafil exposure, reason for not attaining the target dose or stopping sildenafil and adverse events (cardiovascular, pulmonary, GI, neurologic, skin, urologic and lab values).
RESULTS: During a patient exposure of 317 patient-years there were no life threatening or life altering events from sildenafil. The dose was highest in infants where the side effect frequency was lowest. The target dose was not reached in 55 subjects: 40 had therapeutic effect maintained at a lower dose; 9 died; 6 had side effects (1: priapism; 1: headache; 4: hypotension, exacerbated by, but not caused by sildenafil). Cessation of sildenafil occurred in 113 subjects: 59 improved; 8 switched to another therapy; 36 died, 5 had side effects (2: priapism; 1: headache; 1: hypotension, 1: hypotension and abdominal pain), 2 patients had hemoptysis from pulmonary vein stenosis, and 3 did not adhere to the treatment. An additional 8 patients had side effects which resolved with time without change in care (3: priapism; 2: diarrhea; 1: abdominal pain; 2: flushing).
CONCLUSION: From this extensive record review, we conclude that a goal sildenafil dose of 6 mg/kg/day (max 60 mg/day) is safe in pediatric patients aged from birth to 18 years and with Dana Point Classifications of 1.1, 1.4 and 3.7. We did not study other classifications. This study did not study the efficacy of sildenafil to treat pediatric pulmonary hypertension signs or symptoms.