Persistent Pulmonary Hypertension of the Newborn - Mattel ...

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Studies of Inhaled Prostaglandins in PulmonaryHypertension - AnimalsAuthor, yrWelte, 1993Zobel, 1995Booke, 1996Habler, 1996Habler, 1996Walmrath, 1997Krieg, 1998Ikeda, 1999Kumar, 2010PatientDrug6 dogs IPGI , INO212 piglets IPGI , 2 i.v. PGI 2 , iNO6 ewes IPGI , INO214 Healthy lambs IPGI 215 healthy lambs IPGI 2Rabbit lungINO, IPGI , IPGE 2 1 , i.v PGI 2 , i.vPGE 124 pigs INO, IPGE , 1 INO + IPGE 1Anesthetized catsINO, IPGI , 2 INO + IPGI 2 ,IPGI L2after L-NAME,Papaverine 2 mg/kgNewborn lambsIPGI 2Inhaled MilrinoneIPGI 2 + Inhaled Milrinone
Studies of Inhaled Prostaglandins in PulmonaryHypertension – Human AdultsAuthor, YearWalmrath, 1993Bein, 1994PatientDrugARDS - 3 adults IPGI , 2 i.v. PGI 21 adult IPGI 2Walmrath, 1995 12 adults IPGI 2Bein, 1996Eichelbronner, 1996Haraldsson, 1996Olschewski, 1996Walmrath, 1996Webb, 1996Van Heerden, 1996Van Heerden, 1996Haraldsson, 1998O’Hare, 1998Meyer, 1998Putensen, 1998Olschewski, 1998Olschewski, 2000Della Rocca, 20088 adults IPGI 2Exposure period 15 min16 adult with PHT INO, IPGI 29 adults with PHT IPGI 2Exposure period 10 min6 adults with PHT IPGI , 2 i.v. PGI 2, INO, Aerosolized iloprost16 adults - ARDSINO, IPGI 2– for 15 min65 yr, M, PE, PHT IPGI 2for 24 hours2 adults IPGI 25 adults, ARDS IPGI 2, INO Exposure for 30 min10 adults IPGI 2, INO for 10 minPregnant womanIPGI 215 adults with ALI IPGE 110 adults, ARDS INO, IPGE , 1 i.v PGE 1no intervention45 yr, F, PHT Aerosolized iloprost, INO19 adults with PHT Inhaled iloprost18 adults, lung transplantation IPGE 1
Page 7 and 8: It is 4 AM in the morning -------Yo
Page 9 and 10: Off Label Drug Use• FDA regulates
Page 11 and 12: Off Label Drug Use• New uses, dos
Page 13 and 14: Post-INO Era• Questionnaire to220
Page 16 and 17: Regulation of Pulmonary Vascular To
Page 18: Regulation of Pulmonary Vascular To
Page 21 and 22: PO Sildenafil• 1 st dose - 1 mg/0
Page 23 and 24: PDE-5 5 Inhibitor - Sildenafil• R
Page 25 and 26: PDE-5 5 Inhibitor - Sildenafil• P
Page 27 and 28: PDE-3 3 Inhibitor - Milrinone• Pr
Page 29 and 30: Milrinone Improves Oxygenationin Ne
Page 31 and 32: Regulation of Pulmonary Vascular To
Page 35: Regulation of Pulmonary Vascular To
Page 38 and 39: In utero exposure to PGSynthetase i
Page 40 and 41: Non-selective action:• Systemic &
Page 42 and 43: PGE 1 - Metabolism70-95%PGE 115-OH
Page 46 and 47: Studies of Inhaled Prostaglandins i
Page 48 and 49: Phase I Clinical Trial of IPGE 1 in
Page 50 and 51: Phase I Trial: Dose ResponseDoseng/
Page 52 and 53: Phase I Trial: Adverse Effects:No e
Page 54 and 55: Effect on Ductus Arteriosus• Echo
Page 56 and 57: Stability and Emitted DoseModified
Page 58 and 59: ResultsLC-MS Chromatograms Followin
Page 60 and 61: Aerosol Particle Size DistributionA
Page 62 and 63: Pharmacokinetics of IPGE 1 ?
Page 64 and 65: Nominal DoseAerosolizedRemain in de
Page 66 and 67: Aerosol Delivery Assessed by MRIExp
Page 68 and 69: Aerosol Delivery Assessed by MRI450
Page 70 and 71: Aerosol Delivery During HFOVSood et
Page 72 and 73: Preliminary Data - Conclusions• P
Page 74 and 75: Specific AimsPrimary Aims:‣ Evalu
Page 76: Challenges: RCTs in PPHN• Small n
Page 79 and 80: Thank YouDiscussion

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