Risk-benefit considerations when prescribing phosphodiesterase-5 inhibitors in children

Bibliography

• MJdel Cerro, SAbman, GDiaz, et al. A consensus approach to the classification of pediatric pulmonary hypertensive vascular disease: report from the PVRI Pediatric Taskforce, Panama 2011. Pulm Circ 2011;1(2):286-98
   PubMedGoogle Scholar
• SMoledina, AAHislop, HFoster, et al. Childhood idiopathic pulmonary arterial hypertension: a national cohort study. Heart 2010;96:1401-6
   PubMed Web of Science ®Google Scholar
• RLvan Loon, MTRoofthooft, HLHillege, et al. Pediatric pulmonary hypertension in the Netherlands. Epidemiology and characterization during the period 1991 to 2005. Circulation 2011;124:1755-64
   PubMed Web of Science ®Google Scholar
• GKovacs, ABerghold, SScheidl, et al. Pulmonary arterial pressure during rest and exercise in healthy subjects: a systematic review. Eur Respir J 2009;34:888-94
   PubMed Web of Science ®Google Scholar
• MHumbert, NWMorrell, SLArcher, et al. Cellular and molecular pathobiology of pulmonary arterial hypertension. J Amer Coll Cardiol 2004;43(12 Suppl S):13S-24S
   PubMed Web of Science ®Google Scholar
• RMBerger, MBeghetti, THumpl, et al. Clinical features of paediatric pulmonary hypertension: a registry study. Lancet 2012;379:537-46
   PubMed Web of Science ®Google Scholar
• DHeath, JEEdwards. The pathology of hypertensive pulmonary vascular disease. Circulation 1958;18:533-47
   PubMed Web of Science ®Google Scholar
• DChemla, VCastelain, PHerve, et al. Haemodynamic evaluation of pulmonary hypertension. Eur Resp J 2002;20:1314-31
   PubMed Web of Science ®Google Scholar
• NGaliè, MMHoeper, MHumbert, et al. Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Resp J 2009;34:1219-63
   PubMed Web of Science ®Google Scholar
• HAGhofrani, IHOsterloh, FGrimminger. Sildenafil: from angina to erectile dysfunction to pulmonary hypertension and beyond. Nat Rev Drug Discov 2006;5(8):689-702
   PubMed Web of Science ®Google Scholar
• AMAtz, DIWessel. Sildenafil ameliorates effects of inhaled nitric oxide withdrawal. Anaesthesiology 1999;91:307-10
   PubMed Web of Science ®Google Scholar
• DAbrams, ISchulze-Neick, AGMagee. Sildenafil as a selective pulmonary vasodilator in childhood primary pulmonary hypertension. Heart 2000;84:e4
   PubMedGoogle Scholar
• Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021845s000_RevatioTOC.cfm [Last accessed 6 January 2015]
   Google Scholar
• Available from: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022332s000ltr.pdf [Last accessed 6 January 2015]
   Google Scholar
• STakatsuki, MCalderbank, DDIvy. Initial experience with Tadalafil in Pediatric Pulmonary Arterial Hypertension. Pediatr Cardiol 2012;33:683-8
   PubMed Web of Science ®Google Scholar
• PKubes, MSuzuki, DNGranger. Nitric oxide: an endogenous modulator of leucocyte adhesion. Proc Natl Acad Sci USA 1991;88(11):4651-5
   PubMed Web of Science ®Google Scholar
• BTantini, AManes, EFiumana, et al. Antiproliferative effect of sildenafil on human pulmonary artery smooth muscle cells. Basic Res Cardiol 2005;100(2):131-8
   PubMed Web of Science ®Google Scholar
• RTSchermuly, KPKreisselmeier, HAGhofrani, et al. Chronic sildenafil treatment inhibits monocrotaline-induced pulmonary hypertension in rats. Am J Respir Crit Care Med 2004;169:39-45
   PubMed Web of Science ®Google Scholar
• TJToward, NSmith, KJBroadley. Effect of phosphodiesterase-5 inhibitor, sildenafil (Viagra), in animal models of airways disease. Am J Respir Crit Care Med 2004;169(2):227-34
   PubMed Web of Science ®Google Scholar
• Summary of product characteristics Revatio (sildenafil), electronic Medicines Compendium. Available from: http://www.medicines.org.uk/emc/medicine/17443 [Last accessed 6 January 2015]
   Google Scholar
• JLVachiery, SHuez, HGillies, et al. Safety, tolerability and pharmacokinetics of intravenous sildenafil in patients with pulmonary arterial hypertension. Br J Clin Pharmacol 2011;71:289-92
   PubMed Web of Science ®Google Scholar
• NMehrotra, MGupta, AKovar, et al. The role of pharmacokinetics and pharmacodynamics in phosphodiesterase-5 inhibitor therapy. Int J Impot Res 2007;19:253-64
   PubMed Web of Science ®Google Scholar
• RJBarst, DIvy, GGaitan, et al. A randomized, double-blind, placebo controlled, dose ranging study of oral sildenafil citrate in treatment-naive children with pulmonary arterial hypertension. Circulation 2012;125(2):324-34
   PubMed Web of Science ®Google Scholar
• MJAhsman, BCWitjes, EDWildschut, et al. Sildenafil exposure in neonates with pulmonary hypertension after administration via a nasogastric tube. Arch Dis Child Fetal Neonatal Ed 2010;95:F109-14
   PubMed Web of Science ®Google Scholar
• AMukherjee, TDombi, BWittke, et al. Population pharmacokinetics of sildenafil in term neonates: evidence of rapid maturation of metabolic clearance in the early postnatal period. Clin Pharmacol Ther 2009;85:56-63
   PubMed Web of Science ®Google Scholar
• CApitz, JTReyes, HHoltby, et al. Pharmacokinetic and hemodynamic responses to oral sildenafil during invasive testing in children with pulmonary hypertension. J Am Coll Card 2010;55:1456-62
   PubMed Web of Science ®Google Scholar
• GBurgess, HHoogkamer, LCollings, et al. Mutual pharmacokinetic interactions between steady-state bosentan and sildenafil. Eur J Clin Pharmacol 2008;64:43-50
   PubMed Web of Science ®Google Scholar
• Summary of product characteristics Adcirca® (tadalafil), electronic Medicines Compendium. Available from: https://www.medicines.org.uk/emc/medicine/23886 [Last accessed 6 January 2015]
   Google Scholar
• AAKaratza, ABush, AGMagee. Safety and efficacy of Sildenafil therapy in children with pulmonary hypertension. Int J Cardiol 2005;100:267-73
   PubMed Web of Science ®Google Scholar
• THumpl, JTReyes, HHoltby, et al. Beneficial effect of oral sildenafil therapy on childhood pulmonary arterial hypertension: twelve-month clinical trial of a single-drug, open-label, pilot study. Circulation 2005;111:3274-80
   PubMed Web of Science ®Google Scholar
• THumpl, JTReyes, SErickson, et al. Sildenafil therapy for neonatal and childhood pulmonary hypertensive vascular disease. Cardiol Young 2010;21:187-93
   PubMed Web of Science ®Google Scholar
• PNamachivayam, UTheilen, WWButt, et al. Sildenafil prevents rebound pulmonary hypertension after withdrawal of nitric oxide in children. Am J Respir Crit Care Med 2006;174:1043-7
   Web of Science ®Google Scholar
• RJBarst, MBeghetti, TPulido, et al. STARTS-2: long-term survival with oral Sildenafil monotherapy in treatment-naive pediatric pulmonary arterial hypertension. Circulation 2014;129:1914-23
   PubMed Web of Science ®Google Scholar
• DMMaxey, DDIvy, MTOgawa, et al. Food and drug (FDA) postmarket reported effects and adverse events associated with pulmonary hypertension therapy in pediatric patients. Pediatr Cardiol 2013;34:1628-36
   PubMed Web of Science ®Google Scholar
• Drug Safety and Availability. FDA Drug Safety Communication: FDA recommends against use of Revatio (sildenafil) in children with pulmonary hypertension. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm317123.htm [Last accessed 6 January 2015]
   Google Scholar
• European Medicines Agency assessment report on Revatio. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000638/WC500107804.pdf [Last accessed 6 January 2015]
   Google Scholar
• SHAbman, JPKinsella, EBRosenzweig, et al. Pediatric pulmonary hypertension network. Am J Respir Crit Care Med 2013;187:572-5
   PubMed Web of Science ®Google Scholar
• FDA Drug Safety Communication: FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm390876.htm [Last accessed 6 January 2015]
   Google Scholar
• AVassalos, EPeng, DYoung, et al. Pre-operative sildenafil and pulmonary endothelial-related complications following cardiopulmonary bypass: a randomised trial in children undergoing cardiac surgery. Anaesthesia 2011;66:472-80
   PubMed Web of Science ®Google Scholar
• RGiordano, GPalma, VPoli, et al. First experience with sildenafil after Fontan operation: short-term outcomes. J Cardiovasc Med 2013. [Epub ahead of print]
   Google Scholar
• KLunze, NGilbert, SMebus, et al. First experience with an oral combination therapy using bosentan and sildenafil for pulmonary arterial hypertension. Eur J Clin Invest 2006;36(Suppl 3):32-8
   PubMedGoogle Scholar
• JMDouwes, MTRoofthooft, RLVan Loon, et al. Sildenafil add-on therapy in paediatric pulmonary arterial hypertension, experiences of a national referral centre. Heart 2014;100:224-30
   PubMed Web of Science ®Google Scholar
• MRSabri, EBeheshtian. Comparison of the therapeutic and side effects of tadalafil and sildenafil in children and adolescents with pulmonary arterial hypertension. Pediatr Cardiol 2014;35:699-704
   PubMed Web of Science ®Google Scholar
• JFinsterer, CStöllberger. The heart in human dystrophinopathies. Cardiology 2003;99:1-19
   PubMed Web of Science ®Google Scholar
• KBushby, FMuntoni, JPBourke. 107th ENMC international workshop: The management of cardiac involvement in muscular dystrophy and myotonic dystrophy. 7th-9th June 2002, Naarden, the Netherlands. Neuromuscul Disord 2003;13:166-72
   PubMedGoogle Scholar
• CMAdamo, DFDai, JMPercival, et al. Sildenafil reverses cardiac dysfunction in the mdx mouse model of Duchenne muscular dystrophy. PNAS 2010;107:19079-83
   PubMed Web of Science ®Google Scholar
• MDNelson, FRader, XTang, et al. PDE5 inhibition alleviates functional muscle ischemia in boys with Duchenne muscular dystrophy. Neurology 2014;82(23):2085-91
   PubMed Web of Science ®Google Scholar
• CTKlodell, TEMorey, EBLobato, et al. Effect of sildenafil on pulmonary artery pressure, systemic pressure, and nitric oxide utilization in patients with left ventricular assist devices. Ann Thorac Surg 2007;83:68-71
   PubMed Web of Science ®Google Scholar
• DJGoldberg, BFrench, MGMcBride, et al. Impact of oral sildenafil on exercise performance in children and young adults after the fontan operation. A randomized, double-blind, placebo-controlled, crossover trial. Circulation 2011;123:1185-93
   PubMed Web of Science ®Google Scholar