Intravenous sildenafil in the treatment of neonates with ... - NCBI

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Intravenous sildenafil in the treatment of neonates with ... - NCBI
Steinhorn RH(1), Kinsella JP, Pierce C, Butrous G, Dilleen M, Oakes M, Wessel DL. ... OBJECTIVE: To evaluate the safety of intravenous (IV) sildenafil, an inhibitor of cyclic ... Purines/pharmacokinetics; Sildenafil Citrate; Sulfones/ administration ...

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Iv sildenafil was well tolerated, and acute and sustained improvements in oxygenation were noted in those neonates who received the higher infusion doses. Ultimately, these factors lead to increased pulmonary vascular resistance with secondarily increased pulmonary arterial pressures. Specifically, no binds to and activates guanylyl cyclase in vascular smooth muscle cells.

Over the course of the next several decades survival rates improved, with reported 1-, 3-, and 5-year survival rates from the 1950s to 1990s of 66, 52, and 35, respectively. In contrast, these subgroups are uncommon in children, accounting for less than 2 of all cases in the multinational tracking outcomes and practice in pediatric pulmonary hypertension registry where 57 of pah cases were identified as having idiopathic or familial pah, while 38 had pah associated with congenital heart disease. The mean absolute bioavailability for the tablet is 41 (range 2563) and the recommended intravenous dose is half that of the oral dose.

Historical data indicate that pah outcomes among children have been quite poor, with survival rates beyond 1 and 7 years in 1965 having been reported as 37 and 0, respectively. The primary outcome measure was percent change in peak oxygen consumption in all patients receiving sildenafil combined versus placebo, with exercise testing being performed in all patients able to exercise reliably. Non-commercial uses of the work are permitted without any further permission from dove medical press limited, provided the work is properly attributed.

Compared to epoprostenol alone, subjects also receiving sildenafil demonstrated increased 6-minute walk distance (28. Historically, there have been very few rigorous clinical trials of pah therapies in children. The results of this analysis demonstrated a 43 reduction in all-cause mortality, as well as a 61 reduction in hospitalizations in patients undergoing targeted pharmacologic treatment of pah compared to patients receiving placebo.

Accordingly, new agents to treat pediatric pulmonary hypertension have been identified as a high priority for study by the us food and drug administration (fda) and are listed on the best pharmaceuticals for childrens act (bpca) priority list of needs in pediatric therapeutics. Patients with idiopathic pah demonstrated greater improvements than patients with associated pah but these improvements did not reach statistical significance for either of these subgroups (note it is likely that these subgroup analyses were underpowered). Older children and adolescents typically present with excessive fatigue, exercise intolerance, syncope or near syncope, and occasionally chest pain.

Seven neonates were enrolled before developing the need for ino. Even relatively smaller and easier to conduct pharmacokineticpharmacodynamic studies have been limited in this population and instead dosing, safety, and efficacy of drugs have been extrapolated from adult trials. Bpca created incentives for studying on-patent drugs in children, most notably, a potential 6-month patent extension. In younger children and in those with associated intracardiac shunts, pulmonary arterial pressures alone may inaccurately represent severity of disease. After completion of the initial 6 weeks of therapy, each participant then crossed over to the alternative therapy to complete an additional 6 weeks of therapy.


Safety and tolerability considerations in the use of sildenafil for ...


Dec 15, 2015 ... Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. ... Steinhorn RH, Kinsella JP, Pierce C, et al. Intravenous sildenafil in the treatment of neonates with persistent pulmonary hypertension. J Pediatr.

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Sildenafil in Infants and Children - MDPI
Jul 24, 2017 ... Sildenafil (or other PDE5 inhibitors) and possibly intravenous ..... sildenafil citrate in treatment-naive children with pulmonary arterial hypertension. ... Steinhorn, R.H.; Kinsella, J.P.; Pierce, C.; Butrous, G.; Dilleen, M.; Oakes, M.; ...
Steinhorn Intravenous Sildenafil Viagra For Sale Perhaps the most notable sildenafil trials conducted in the adult population are the double-blinded, placebo-controlled sildenafil use in pah study, or sildenafil use in pulmonary arterial hypertension (super)-1 study, and its extension study, Additionally. Even relatively smaller and easier to conduct pharmacokineticpharmacodynamic studies have been limited in this population and instead dosing, safety, and efficacy of drugs have been extrapolated from adult trials, Patients affected with pah often present with nonspecific symptoms, which can make clinical diagnosis difficult.
  • Intravenous sildenafil in the treatment of neonates with ... - F1000


    By combining the sildenafil dose groups, the authors were able to reduce the sample size and treatment effect size on which to base the study. The recommended dosing interval is three times a day (tid) with maximum plasma concentrations observed within 30120 minutes (median 60 minutes) of oral dosing in the fasted state. Bpca created incentives for studying on-patent drugs in children, most notably, a potential 6-month patent extension. Historically, there have been very few rigorous clinical trials of pah therapies in children. Here we will review the clinical presentation, diagnosis, and natural history of pah and then summarize available data on safety and efficacy of sildenafil in adults and children.

    Older children and adolescents typically present with excessive fatigue, exercise intolerance, syncope or near syncope, and occasionally chest pain. After 3 years of treatment, a total of 37 patients had died, 26 of which remained on sildenafil monotherapy at the time of death. There are several noninvasive methods to estimate pulmonary artery pressures, including echocardiography and cardiac magnetic resonance imaging. In a retrospective cohort from the netherlands, the reported annual incidence was 3. Patients affected with pah often present with nonspecific symptoms, which can make clinical diagnosis difficult, sometimes leading to delays in diagnosis.

    Administered dosages varied by weight for patients 45 kg, the dosing groups mirrored those used in the super-1 trials in adults (10, 40, and 80 mg for low-, medium-, and highdose groups, respectively). When pulmonary vascular resistance and pressures are significantly elevated, right ventricular dysfunction ensues with associated low cardiac output. Among infants and younger children, the clinical presentation of pah may consist of failure to thrive, tachypnea, or symptoms of compromised cardiac output such as feeding intolerance. These changes include development of a vasomotor imbalance favoring pulmonary vasoconstriction, inflammation, and remodeling of the vessel walls. Most notably, medications with hypotensive effects have the potential to induce severe hypotension when administered in combination with sildenafil. The financial gains associated with patent extension are potentially very significant and so industry sponsors have been willing to invest substantially in pediatric clinical trials. Department of pediatrics, northwestern university feinberg school of medicine and childrens memorial hospital, chicago, il 60614, usa. Perhaps the most notable sildenafil trials conducted in the adult population are the double-blinded, placebo-controlled sildenafil use in pah study, or sildenafil use in pulmonary arterial hypertension (super)-1 study, and its extension study, super-2. Ci 975 m), for sildenafil tid doses of 20, 40, or 80 mg, respectively. Sildenafil is a phosphodiesterase type-5 inhibitor approved for treatment of pulmonary arterial hypertension (pah) in adults.

    Dec 3, 2009 ... F1000Prime Recommended Article: Intravenous sildenafil in the treatment of ... Ajizian S: F1000Prime Recommendation of [Steinhorn RH et al., ...

    Pulmonary hypertension in neonates: sildenafil | Guidance and ... - NICE

    Mar 29, 2016 ... In a dose‑escalation study of intravenous sildenafil in 36 neonates with ... of intravenous sildenafil in neonates with PPHN (Steinhorn et al.
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