STARTS-1 and -2. Barst R, Ivy DD, et al. Circulation 2012;125:
|
|
|
- Griffin Basil Bates
- 6 years ago
- Views:
Transcription
1 STARTS-1 and -2 A randomized, double-blind,16 week placebo controlled, dose ranging, parallel group study of oral monotherapy sildenafil in treatment naive children, aged 1-17 years, with pulmonary arterial hypertension (PAH). STARTS-1 was followed by sildenafil dose extension study STARTS-2 Barst R, Ivy DD, et al. Circulation 2012;125:
2 Disclosures The University of Colorado contracts with Actelion, Gilead, Pfizer, United Therapeutics for Dr Ivy to be a consultant Investigator Initiated grants: Gilead Steering Committee: GSK / Actelion
3 STARTS-1 Study Criteria Inclusion Aged 1-17 years with PAH (WHO Group 1) IPAH, HPAH, APAH-CHD, PAH-CTD 8 kg VO 2 Peak 10 ml/kg/min and 28 ml/kg/min Exclusion Unrepaired CHD with systemic arterial oxygen saturation <88% ERA / Prostanoid / Nitrate /PDE-5 / L-arginine Barst R, Ivy DD, et al. Circulation 2012;125:
4 STARTS-1 Objectives & Endpoints Primary efficacy endpoint - Percentage change from baseline in peak VO 2 at Week 16 Secondary efficacy endpoints - Change from baseline in mean pulmonary artery pressure (mpap) - Change from baseline in pulmonary vascular resistance index (PVRI) Barst R, Ivy DD, et al. Circulation 2012;125:
5 STARTS-1 Study Design Treatment Allocation Placebo Low Dose Medium Dose High Dose Body Weight(kg) Allocation Ratio Dose Allocation Ratio Dose Allocation Ratio Dose Allocation Ratio mg 1 20 mg 2 > mg 1 20 mg 1 40 mg 1 > mg 1 40 mg 1 80 mg 1 Barst R, Ivy DD, et al. Circulation 2012;125:
6 STARTS-1 Sildenafil Study Design Placebo Placebo Screening Sildenafil Low Dose Sildenafil Low Dose Sildenafil Low Dose Sildenafil Med Dose Sildenafil Low Dose Sildenafil High Dose Randomization Day 1 Double blind Treatment phase (16 weeks; day 1 thru day 112) Screening (Can occur up to 3 weeks before randomization (-21 to -1 days) Forced Titration (1 week; day 1 thru day 7) Weeks 2-16 Follow-up (30 40 days)
7 STARTS-1 Subject Accountability 324 Screened 235 Randomised 234 Treated Placebo Low Dose Medium Dose High Dose 60 Randomised 42 Randomised 56 Randomised 77 Randomised 60 Treated 42 Treated 55 Treated 77 Treated 30 (50%) Dev Ab 28 (67%) Dev Ab 28 (50%) Dev Ab 29 (38%) Dev Ab 29 Analysed 24 Analysed 26 Analysed 27 Analysed Barst R, Ivy DD, et al. Circulation 2012;125:
8 Time to Recruit 115 Subjects Capable of Reliable Exercise Capacity Testing Screened Randomised Dev Able Patients Randomised Aug- 03 Nov- 03 Feb- 04 May- 04 Aug- 04 Nov- 04 Feb- 05 May- 05 Aug- 05 Nov- 05 Feb- 06 May- 06 Aug- 06 Nov- 06 Feb- 07 May- 07 Aug- 07 Nov- 07 Feb- 08 Barst R, Ivy DD, et al. Circulation 2012;125:
9 Disease Etiology Primary Diagnosis Placebo Sildenafil All subjects (N=234) IPAH 35% 33% APAH-CHD 65% 67% Developmentally able subjects (N=115) IPAH 33% 36% APAH-CHD 67% 64%
10 Baseline VO 2 Peak & Hemodynamics Mean (SD) Normal Values Placebo Sildenafil Low/Medium/High (Combined) V0 2 Peak, ml/kg/min (4) n=30 18 (4) n=85 mpap, mmhg CI, L/min/m PVRI, dyne.sec.cm -5.m 2 < (22) n=59 4 (2) n= (759) n=57 63 (22) n=172 3 (2) n= (1175) n=165
11 Placebo-adjusted Percent Change VO 2 Peak Low (n=24) Medium (n=26) High (n=27) Low/Med/High (n=77) p = VO 2 Peak (% change from baseline to Week 16) Comparison to Placebo (n=29) with 95% CIs Barst R, Ivy DD, et al. Circulation 2012;125:
12 Effects of Sildenafil on PVRI and mpap in Children PVRI Low (n=37) Medium (n=51) High (n=68) L/M/H (n=156) (Change from baseline to week 16) comparison to placebo (n=52) with 95% CIs (dyne s cm -5 m 2 ) mpap Low (n=39) Medium (n=55) High (n=71) L/M/H (n=165) (Change from baseline to week 16) comparison to placebo (n=56) with 95% CIs (mmhg)
13 % Change in VO 2 Peak by Etiology IPAH Low dose Med dose High dose High/Med/Low Repaired CHD Unrepaired CHD VO 2 Peak %Change from Baseline to Week 16 Comparison to Placebo with 95%CI
14 PVRI: Analysis by Etiology IPAH Low dose Med dose High dose High/Med/Low CHD unrepaired CHD repaired Ratio Comparison (Active/Placebo) with 95% CIs Low dose Medium dose High dose Combined dose
15 Patient Disposition in STARTS-1 and -2 Placebo N=60 Low Dose N=42 n=13 Placebo/Non Random N=5 Low Dose N=55 Medium Dose N=55 n=19 Medium Dose N=74 High Dose N=77 STARTS-1 n=23 High Dose N=100 STARTS-2
16 Sildenafil Dose Changes Barst RJ, et al. Eur Heart J (2012) 33 (suppl 1): 979
17 PEAK VO2 ML/KG/MIN STARTS-2: 1 Year VO 2 Peak Baseline Year Low / Low Medium / Medium High / High Placebo / Low Placebo / Medium Placebo / High
18 Kaplan-Meier Estimated Survival From Start of Sildenafil Treatment in STARTS-1 and -2 94% 93% 89% Hazard ratios for mortality were 3.50 (95% CI, ) H vs L
19 Kaplan-Meier Estimated Survival From Start of Sildenafil Treatment in STARTS-1 and -2 94% 95% Barst RJ, et al. Eur Heart J (2012) 33 (suppl 1): 979
20 Kaplan-Meier Estimated Survival From Start of Sildenafil Treatment in STARTS-1 and -2 94% 93% 84% Barst RJ, et al. Eur Heart J (2012) 33 (suppl 1): 979
21 Baseline Characteristics and Mortality 74% (26/35) of deaths were in IPAH children 74% (26/35) of the subjects who died had baseline PVRI to the median (15 Wood units m2) 69% (24/35) had mpap to the median (62 mmhg) 71% (25/35) had RAP to the median (7.0 mmhg)
22 Baseline Characteristics and Mortality 40% (14/35) were FC III/IV at baseline All deaths judged by investigator as disease related
23 Regulatory / DMC Actions May 2011: EMA approves sildenafil for pediatric use in children with PAH August 2011: STARTS DMC mandates decrease in sildenafil dose October 2011: EMA warns against use of high dose August 2012: FDA warns against use of sildenafil 1-17 y.o. high dose of Revatio had a higher risk of death than children taking a lower dose low doses of Revatio are not effective in improving exercise ability in the 16 week randomized placebo controlled trial
24 Study Limitations No control group in LT extension 26% (9/35) of patients who died withdrew from STARTS-1/-2 study and f/u treatment unknown No treatment protocol after withdrawal Death median of 147 days (9-406 days) after off study treatment
25 Conclusions Primary endpoint of STARTS-1 did not meet predefined statistical p value peak VO2 for all sildenafil treated patients vs PBO Dose-related increase in mortality observed at 3 years Survival in treatment naïve children 88-94% at 3 years on L/M/H dose sildenafil monotherapy Survival in STARTS similar to 3 year survival in 3 recent registries (UK, Netherlands, US)
Treatment of Paediatric Pulmonary Hypertension
Treatment of Paediatric Pulmonary Hypertension Dunbar Ivy, MD The Children s Hospital Heart Institute University of Colorado School of Medicine 1 Disclosures I have the following financial relationships
Comparison between adult and pediatric populations with I/HPAH and PAH-CHD in the Bologna ARCA registry
nazzareno.galie@unibo.it Comparison between adult and pediatric populations with I/HPAH and PAH-CHD in the Bologna ARCA registry Nazzareno Galiè, MD, FESC, FRCP (Hon), DIMES 2 Comprehensive clinical classification
Objectives. Disclosures Oral Therapies for Children with Pulmonary Hypertensive Vascular Disease
Disclosures Oral Therapies for Children with Pulmonary Hypertensive Vascular Disease Erika Berman Rosenzweig, MD Director, Pulmonary Hypertension Center Associate Professor of Clinical Pediatrics (in Medicine)
Πνευμονική Υπέρταση: Μια ΚΡΙΤΙΚΗ ματιά στις κλινικές μελέτες - AMBITION. Αναστασία Ανθη
Πανελλήνια Σεμινάρια Ομάδων Εργασίας 2017 k Πνευμονική Υπέρταση: Μια ΚΡΙΤΙΚΗ ματιά στις κλινικές μελέτες - AMBITION Αναστασία Ανθη Β Κλιν. Εντατικής Θεραπείας & Διακλινικό Ιατρείο Πνευμ. Υπέρτασης Π.Γ.Ν.
Disclosures. Inhaled Therapy in Pediatric Pulmonary Hypertension. Inhaled Prostacyclin: Rationale. Outline
Disclosures Inhaled Therapy in Pediatric Pulmonary Hypertension The University of Colorado receives fees for Dr Ivy to be a consultant for Actelion, Gilead, Lilly, Pfizer, and United Therapeutics Dunbar
Therapeutic approaches in P(A)H and the new ESC Guidelines
Therapeutic approaches in P(A)H and the new ESC Guidelines Jean-Luc Vachiéry, FESC Head Pulmonary Vascular Diseases and Heart Failure Clinic Hôpital Universitaire Erasme Université Libre de Bruxelles Belgium
IV PGI2 vs. Inhaled PGI2 in chronic lung disease
Inhaled Therapies for PAH Erika Berman Rosenzweig, MD Associate Professor of Clinical Pediatrics (in Medicine) Director, Pulmonary Hypertension Center Columbia University Medical Center Disclosures Has
Prognostic value of echocardiographic parameters in patients with pulmonary arterial hypertension (PAH) treated with targeted therapies
Prognostic value of echocardiographic parameters in patients with pulmonary arterial hypertension (PAH) treated with targeted therapies E. Beciani, M. Palazzini, C. Bachetti, F. Sgro, E. Conficoni, E.
THERAPEUTICS IN PULMONARY ARTERIAL HYPERTENSION Evidences & Guidelines
THERAPEUTICS IN PULMONARY ARTERIAL HYPERTENSION Evidences & Guidelines Vu Nang Phuc, MD Dinh Duc Huy, MD Pham Nguyen Vinh, MD, PhD, FACC Tam Duc Cardiology Hospital Faculty Disclosure No conflict of interest
The Sildenafil Controversy
The Sildenafil Controversy Chronology European Development Revatio (Sildenafil) Orphan Drug designation: 03.12.2003 & 27.02.2007 Paediatric Investigation Plan: 17.03.2010 Marketing Authorisation in EU:
PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See United States Package Insert (USPI)
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
Role of Combination PAH Therapies
Role of Combination PAH Therapies Ronald J. Oudiz, MD, FACP, FACC Associate Professor of Medicine, David Geffen School of Medicine at UCLA Director, Liu Center for Pulmonary Hypertension Los Angeles Biomedical
Progress in PAH. Gerald Simonneau
Progress in PAH Gerald Simonneau National Reference center for Pulmonary Hypertension Bicetre University Hospital, INSERM U 999 Paris-Sud University Le Kremlin Bicêtre France Clinical Classification of
Effective Strategies and Clinical Updates in Pulmonary Arterial Hypertension
Effective Strategies and Clinical Updates in Pulmonary Arterial Hypertension Hap Farber Director, Pulmonary Hypertension Center Boston University School of Medicine Disclosures 1) Honoria: Actelion, Gilead,
MACITENTAN DEVELOPMENT IN CHILDREN WITH PULMONARY HYPERTENSION (PAH)
MACITENTAN DEVELOPMENT IN CHILDREN WITH PULMONARY HYPERTENSION (PAH) ORPHAN DRUG AND RARE DISEASE 11 MAY 2017 Catherine Lesage, MD, Pediatrics Program Head, Actelion Copyright AGENDA Pulmonary Arterial
The Case of Lucia Nazzareno Galiè, M.D.
The Case of Lucia Nazzareno Galiè, M.D. DIMES Disclosures Consulting fees and research support from Actelion Pharmaceuticals Ltd, Bayer HealthCare, Eli Lilly and Co, GlaxoSmithKline and Pfizer Ltd Clinical
SATELLITE SYMPOSIUM OF MSD. sgc Stimulation for the treatment of PH. Real life management of PAH: case presentation
SATELLITE SYMPOSIUM OF MSD sgc Stimulation for the treatment of PH Real life management of PAH: case presentation Eftychia Demerouti MD, MSc, PhD Cardiologist Onassis Cardiac Surgery Center Conflict of
Anjali Vaidya, MD, FACC, FASE, FACP Associate Director, Pulmonary Hypertension, Right Heart Failure, Pulmonary Thromboendarterectomy Program Advanced
Anjali Vaidya, MD, FACC, FASE, FACP Associate Director, Pulmonary Hypertension, Right Heart Failure, Pulmonary Thromboendarterectomy Program Advanced Heart Failure & Cardiac Transplant Temple University
*Division of Pulmonary, Sleep, and Critical Care Medicine, Rhode Island Hospital, Alpert Medical School of Brown University, Providence, RI, USA
The Relationship between NO Pathway Biomarkers and Response to Riociguat in the RESPITE Study of Patients with PAH Not Reaching Treatment Goals with Phosphodiesterase 5 Inhibitors James R Klinger,* Raymond
ACCP PAH Medical Therapy Guidelines: 2007 Update. David Badesch, MD University of Colorado School of Medicine Denver, CO
ACCP PAH Medical Therapy Guidelines: 2007 Update David Badesch, MD University of Colorado School of Medicine Denver, CO Disclosure of Commercial Interest Dr. Badesch has received grant/research support
The Case of Marco Nazzareno Galiè, M.D.
The Case of Marco Nazzareno Galiè, M.D. DIMES Disclosures Consulting fees and research support from Actelion Pharmaceuticals Ltd, Bayer HealthCare, Eli Lilly and Co, GlaxoSmithKline and Pfizer Ltd Clinical
The US REVEAL Registry
Pulmonary Hypertension: Lessons from Contemporary Registries The US REVEAL Registry ESC August 30, 2010 Dave Badesch, MD University of Colorado Disclosures Dr. Badesch has received grant/research support
Raymond L. Benza, MD, a Mardi Gomberg-Maitland, MD, MSc, b Robert Naeije, MD, PhD, c Carl P. Arneson, MStat, d and Irene M.
http://www.jhltonline.org Prognostic factors associated with increased survival in patients with pulmonary arterial hypertension treated with subcutaneous treprostinil in randomized, placebo-controlled
Effects of Long-Term Bosentan in Children With Pulmonary Arterial Hypertension
Journal of the American College of Cardiology Vol. 46, No. 4, 2005 2005 by the American College of Cardiology Foundation ISSN 0735-1097/05/$30.00 Published by Elsevier Inc. doi:10.1016/j.jacc.2005.01.066
Therapy Update: ERAs. Review of Mechanism. Disclosure Statements. Outline. Disclosure: Research support from United Therapeutics
1 Therapy Update: ERAs Disclosure Statements Disclosure: Research support from United Therapeutics Most of the medications discussed in this presentation are off-label usage Nidhy Varghese, MD Pulmonary
Intravenous Therapies for Pulmonary Hypertensive Vascular Disease. Intravenous Treatment for PAH: Past, Present and Future 3/10/2012
Intravenous Therapies for Pulmonary Hypertensive Vascular Disease Robyn J Barst MD Professor Emeritus Columbia University New York, NY March 1 th 212 Presented By: Erika Berman Rosenzweig, MD Dr. Robyn
Congenital Heart Disease. STARTS-2 Long-Term Survival With Oral Sildenafil Monotherapy in Treatment-Naive Pediatric Pulmonary Arterial Hypertension
Congenital Heart Disease STARTS-2 Long-Term Survival With Oral Sildenafil Monotherapy in Treatment-Naive Pediatric Pulmonary Arterial Hypertension Robyn J. Barst, MD ; Maurice Beghetti, MD; Tomas Pulido,
Nuovi approcci terapeutici nel trattamento dell ipertensione arteriosa polmonare in pediatria
Nuovi approcci terapeutici nel trattamento dell ipertensione arteriosa polmonare in pediatria Alessandro Rimini Dipartimento Cardiovascolare IRCCS G.Gaslini-Genova XLI CONGRESSO NAZIONALE della SOCIETÀ
Real-world experience with riociguat in CTEPH
Real-world experience with riociguat in CTEPH Matthias Held Center of Pulmonary Hypertension and Pulmonary Vascular Disease, Medical Mission Hospital, Würzburg, Germany Tuesday, 29 September ERS International
Paediatric PAH in the current era
Paediatric PAH in the current era Dunbar Ivy, MD The Children s Hospital Heart Institute University of Colorado School of Medicine Paediatric PAH in the current era & A Gap Analysis Dunbar Ivy, MD The
Cardiac Catheterization is Unnecessary in the Evaluation of Patients with Pulmonary Hypertension: CON
Cardiac Catheterization is Unnecessary in the Evaluation of Patients with Pulmonary Hypertension: CON Dunbar Ivy, MD The Children s s Hospital Heart Institute 1 Diagnostic Evaluation: Right Heart Cardiac
National Horizon Scanning Centre. Oral and inhaled treprostinil for pulmonary arterial hypertension: NYHA class III. April 2008
Oral and inhaled treprostinil for pulmonary arterial hypertension: NYHA class April 2008 This technology summary is based on information available at the time of research and a limited literature search.
National Horizon Scanning Centre. Tadalafil for pulmonary arterial hypertension. October 2007
Tadalafil for pulmonary arterial hypertension October 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a
Paediatric Pulmonary Arterial Hypertension (PAH)
Paediatric Pulmonary Arterial Hypertension (PAH) Regulators perspective on a Global challenge EMA FDA HC paediatric PAH workshop 12 th June 2017 Cécile Ollivier European Medicines Agency Science and Innovation
Pulmonary Hypertension Associated with Congenital Heart Disease. Amiram Nir Hadassah, Jerusalem
Pulmonary Hypertension Associated with Congenital Heart Disease Amiram Nir Hadassah, Jerusalem Disclosure Honoraria - Actelion Research grants form Actelion The Nice Classification (2013) Blok et al. Expert
Updates in Pulmonary Hypertension Pharmacotherapy. Ziad Sadik PharmD BCPS
Updates in Pulmonary Hypertension Pharmacotherapy Ziad Sadik PharmD BCPS Disclosure Information I have no financial relationship to disclose AND I will not discuss off label use and/or investigational
Clinical History. CHD-PAH Case: Physical Exam. Clinical History. To Repair or not to Repair?
CHD-PAH Case: To Repair or not to Repair? Erika Berman Rosenzweig, MD Columbia University, College of Physicians and Surgeons Clinical History 18 year old female had been previously well, but new murmur
In focus The paediatric PAH population Clinicians Perspectives
In focus The paediatric PAH population Clinicians Perspectives Maurice Beghetti Pediatric Cardiology University Children s Hospital HUG and CHUV Pulmonary Hypertension Program HUG Centre Universitaire
Pulmonary arterial hypertension. Pulmonary arterial hypertension: newer therapies. Definition of PH 12/18/16. WHO Group classification of PH
Pulmonary arterial hypertension Pulmonary arterial hypertension: newer therapies Ramona L. Doyle, MD Clinical Professor of Medicine, UCSF Attending Physician UCSF PH Clinic Definition and classification
Paediatric addendum to CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension
5 December 2011 EMA/CHMP/213972/2010 Committee for Medicinal Products for Human use (CHMP) Paediatric addendum to CHMP guideline on the clinical investigations of medicinal products for the treatment of
Pulmonary Hypertension: Follow-up in adolescence and adults
Pulmonary Hypertension: Follow-up in adolescence and adults Helmut Baumgartner Westfälische Wilhelms-Universität Münster Adult Congenital and Valvular Heart Disease Center University of Muenster Germany
Pharmacy Management Drug Policy
SUBJECT: Pulmonary Arterial Hypertension (PAH) POLICY NUMBER: Pharmacy-42 Clinical criteria used to make utilization review decisions are based on credible scientific evidence published in peer reviewed
Functional Class Improvement and 3-Year Survival Outcomes in Patients With Pulmonary Arterial Hypertension in the REVEAL Registry
CHEST Original Research PULMONARY VASCULAR DISEASE Functional Class Improvement and 3-Year Survival Outcomes in Patients With Pulmonary Arterial Hypertension in the REVEAL Registry Robyn J. Barst, MD ;
Pulmonary hypertension; does gender matter?
Pulmonary hypertension; does gender matter? Nazzareno Galiè Istituto di Cardiologia Università di Bologna nazzareno.galie@unibo.it Galiè N et al. European Heart Journal (2009) 30, 2493 2537 Pulmonary Hypertension
MANAGEMENT CALL TO DISCUSS LONGER-TERM IMPROVEMENTS IN KIDNEY FUNCTION WITH BARDOXOLONE
MANAGEMENT CALL TO DISCUSS LONGER-TERM IMPROVEMENTS IN KIDNEY FUNCTION WITH BARDOXOLONE Introduction Substantial body of prior CKD clinical data characterizes Bard s unique profile Bard has demonstrated
Functional class in children
Functional class in children WHO-FC versus Panama Pediatric FC Astrid E Lammers Paediatric Cardiology, Münster University Hospital Astrid.Lammers@ukmuenster.de Disclosures Consulting activity for Actelion
Pulmonary Arterial Hypertension Drug Prior Authorization Protocol
Pulmonary Arterial Hypertension Drug Prior Authorization Protocol Line of Business: Medicaid P&T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review
Φαρµακοθεραπεία στη Πνευµονική Αρτηριακή Υπέρταση: Αρχική ή διαδοχική συνδυαστική θεραπεία
37 ο Πανελλήνιο Καρδιολογικό Συνέδριο Αθήνα, Οκτώβριος 2016 k Φαρµακοθεραπεία στη Πνευµονική Αρτηριακή Υπέρταση: Αρχική ή διαδοχική συνδυαστική θεραπεία Αναστασία Ανθη Β Κλιν. Εντατικής Θεραπείας & Διακλινικό
Oral Therapies for Pulmonary Arterial Hypertension
Oral Therapies for Pulmonary Arterial Hypertension Leslie Wooten, PharmD PGY2 Internal Medicine Pharmacy Resident University of Cincinnati Medical Center April 30 th, 2018 Objectives Pharmacist Objectives
Scottish Medicines Consortium
Scottish Medicines Consortium sildenafil, 20mg (as citrate) tablets (Revatio ) No. (596/10) Pfizer Ltd 15 January 2010 The Scottish Medicines Consortium (SMC) has completed its assessment of the above
2017 UnitedHealthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2020-10 Program Prior Authorization/Medical Necessity PAH Agents Medication Adcirca (tadalafil), Adempas (riociguat), Letairis
Where are we now in the longterm. of PAH and CTEPH? Hits and misses of medical treatment. Hap Farber Boston University School of Medicine, Boston, USA
Where are we now in the longterm management of PAH and CTEPH? Hits and misses of medical treatment Hap Farber Boston University School of Medicine, Boston, USA Monday, 28 September ERS International Congress
Tadalafil for the Treatment of Pulmonary Arterial Hypertension
Journal of the American College of Cardiology Vol. 60, No. 8, 2012 2012 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00 Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jacc.2012.05.004
Review Report. Epoprostenol ACT 1.5 mg. Actelion Pharmaceuticals Japan Ltd. Date of Application March 04, 2016 Dosage Form/Strength
Review Report January 18, 2017 Pharmaceuticals and Medical Devices Agency The following are the results of the review of the following pharmaceutical product submitted for marketing approval conducted
Management of Pulmonary Arterial Hypertension: Evolution in Management
Management of Pulmonary Arterial Hypertension: Evolution in Management Stephen C. Mathai, MD MHS The Johns Hopkins Pulmonary Hypertension Program Assistant Professor of Medicine Johns Hopkins University
Role of pulmonary vasodilators in the Fontan setting. Michael Cheung Melbourne
Role of pulmonary vasodilators in the Fontan setting Michael Cheung Melbourne Fontan circuit Low resistance to adequate pulmonary blood flow is critical Central PA anatomy (size and distortion) Intrapulmonary
PADN-5 Trial. Pulmonary artery denervation significantly increases 6-minute walk distance for patients with CpcPH: The PADN-5 Study
PADN-5 PADN-5 Trial Pulmonary artery denervation significantly increases 6-minute walk distance for patients with CpcPH: The PADN-5 Study Shao-Liang Chen, MD Hang Zhang, Juan Zhang, Mengxuan Chen, Dujiang
Chronic Thromboembolic Pulmonary Hypertention CTEPH
Chronic Thromboembolic Pulmonary Hypertention CTEPH Medical Management Otto Schoch, Prof. Dr. Klinik für Pneumologie und Schlafmedizin Kantonsspital St.Gallen CTEPH: Medical Management Diagnostic aspects
Sildenafil Citrate Powder. Sildenafil citrate powder. Description. Section: Prescription Drugs Effective Date: January 1, 2016
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.06.15 Subject: Sildenafil Citrate Powder Page: 1 of 6 Last Review Date: December 3, 2015 Sildenafil Citrate
Managing Multiple Oral Medications
Managing Multiple Oral Medications Chris Archer-Chicko, MSN, CRNP PENN Presbyterian Medical Center Arlene Schiro,, CRNP Massachusetts General Hospital Mary Bartlett, CRNP Winthrop University Hospital PH
Registry to Evaluate Early and Long-Term PAH Disease Management. Transforming PAH Experience Into Knowledge
Registry to Evaluate Early and Long-Term PAH Disease Management Transforming PAH Experience Into Knowledge Protocol and Goals of the REVEAL Registry Robyn J. Barst, MD REVEAL Study Objectives To characterize
4/14/2010. Pulmonary Hypertension: An Update. Tim Williamson, MD, FCCP. University of Kansas Hospital. Normal Physiology
Pulmonary Hypertension: An Update Tim Williamson, MD, FCCP Director, Pulmonary Vascular Program University of Kansas Hospital Normal Physiology 1 Pulmonary Perfusion 101 High Pressure Low Pressure Pulmonary
PULMONARY ARTERIAL HYPERTENSION AGENTS
Approvable Criteria: PULMONARY ARTERIAL HYPERTENSION AGENTS Brand Name Generic Name Length of Authorization Adcirca tadalafil Calendar Year Adempas riociguat Calendar Year Flolan epoprostenol sodium Calendar
What is controversial in adult congenital heart disease
What is controversial in adult congenital heart disease Gerhard-Paul Diller Adult Congenital Heart Center and Center for Pulmonary Hypertension, Royal Brompton Hospital, London, UK, National Heart Institute,
Inhaled sodium nitrite in pulmonary hypertension associated with heart failure with preserved ejection fraction
Inhaled sodium nitrite in pulmonary hypertension associated with heart failure with preserved ejection fraction 4th Annual Pulmonary Hypertension Drug Discovery and Development Symposium July -, 7 Berlin,
Updates on Pulmonary Hypertension Treatment
Updates on Pulmonary Hypertension Treatment Dane Mellgren, PharmD PGY-1 Pharmacy Practice Resident Hennepin County Medical Center 04/27/18 Disclosure I have no disclosures to be made regarding the content
Pulmonary Arterial Hypertension: The Approach to Management in 2019
Pulmonary Arterial Hypertension: The Approach to Management in 2019 Munir S. Janmohamed M.D. FACC Medical Director Mechanical Circulatory Support/Heart Failure Program Mercy General Hospital/Mercy Medical
Increasing knowledge about the pathophysiology
Eur Respir Rev 27; 16: 12, 13 18 DOI: 1.1183/95918.124 CopyrightßERSJ Ltd 27 Dual endothelin receptor antagonism: setting standards in PAH M. Humbert ABSTRACT: Endothelin (ET) has emerged as a key mediator
Pulmonary Hypertension: When to Initiate Advanced Therapy. Jonathan D. Rich, MD Associate Professor of Medicine Northwestern University
Pulmonary Hypertension: When to Initiate Advanced Therapy Jonathan D. Rich, MD Associate Professor of Medicine Northwestern University Disclosures Medtronic, Abbott: Consultant Hemodynamic Definition of
Advances in Pharmacotherapy of PAH
24 th Annual Advances in Heart Disease Advances in Pharmacotherapy of PAH Gabriel Gregoratos, MD 12/14/2007 UCSF Cardiology 1 Faculty Disclosure Statement for Gabriel Gregoratos, MD Nothing to disclose
Pulmonary Hypertension in 2012
Pulmonary Hypertension in 2012 Evan Brittain, MD December 7, 2012 Kingston, Jamaica VanderbiltHeart.com Disclosures None VanderbiltHeart.com Outline Definition and Classification of PH Hemodynamics of
Corporate Update January 2018
Corporate Update January 2018 Tenax Strategic Update Specialty pharmaceutical company focused on search, development, and commercialization of drugs that address diseases with high unmet medical need Shift
EMA/FDA/Health Canada Workshop on Paediatric PAH
EMA/FDA/Health Canada Workshop on Paediatric PAH Industry Perspective Date: 12/06/2017 * Version: FINAL Industry perspective on partnering with academia and agencies in drug development for children with
Drug Class Monograph. Policy/Criteria:
Drug Class Monograph Class: Pulmonary Arterial Hypertension Agents Drugs: Adcirca (tadalafil), Adempas (riociguat), Flolan (epoprostenol), Letairis (ambrisentan), Opsumit (macitentan), Orenitram (treprostinil),
Contreversies in the management of PH What is controversial in treatment?
Contreversies in the management of PH What is controversial in treatment? Service de Pneumologie et Réanimation National reference center for pulmonary hypertension Université Paris Sud Hôpital Antoine
Clinical Worsening as Composite Study End Point in Pediatric Pulmonary Arterial Hypertension
[ Original Research Pulmonary Vascular Disease ] Clinical Worsening as Composite Study End Point in Pediatric Pulmonary Arterial Hypertension Mark-Jan Ploegstra, MD ; Sanne Arjaans, BSc ; Willemijn M.
Pulmonary vasodilators in Fontan Patients
Pulmonary vasodilators in Fontan Patients Maurice Beghetti Pediatric Cardiology University Children s Hospital HUG and CHUV Pulmonary Hypertension Program HUG Centre Universitaire Romand de Cardiologie
Combination therapy in the treatment of pulmonary arterial hypertension 2015 update
Journal of Rare Cardiovascular Diseases 2015; 2 (4): 103 107 www.jrcd.eu REVIEW ARTICLE Rare diseases of pulmonary circulation Combination therapy in the treatment of pulmonary arterial hypertension 2015
1. Phosphodiesterase Type 5 Enzyme Inhibitors: Sildenafil (Revatio), Tadalafil (Adcirca)
This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutic
PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI.
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
CDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION Macitentan (Opsumit Actelion Pharmaceuticals Canada Inc.) Indication: Pulmonary Arterial Hypertension Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that
STARTS-2: Long-Term Survival With Oral Sildenafil Monotherapy in. Treatment-Naïve Pediatric Pulmonary Arterial Hypertension
STARTS-2: Long-Term Survival With Oral Sildenafil Monotherapy in Treatment-Naïve Pediatric Pulmonary Arterial Hypertension Running title: Barst et al.; STARTS-2 Long-Term Sildenafil in Pediatric PAH Downloaded
CONUNDRUMS IN PULMONARY ARTERIAL HYPERTENSION
CONUNDRUMS IN PULMONARY ARTERIAL HYPERTENSION MOHAMMED RAFIQUE ESSOP MILPARK HOSPITAL and UNIVERSITY OF THE WITWATERSRAND POINTS FOR DISCUSSION What is the pathogenetic mechanism of PAH? Importance of
EXTRAPOLATION CHALLENGES IN PEDIATRIC PAH
EXTRAPOLATION CHALLENGES IN PEDIATRIC PAH Possible solutions for a feasible, global study M. Bacchi, A. Morganti, P. Cornelisse, J. Bolognese, C. Lesage, A. Kümmel, P. Nilsson Copyright 2016 Actelion Pharmaceuticals
Galie N, Benza R, Rubin LJ, Hoeper MM, Jansa P, Kusic-Pajic A, Simonneau G
Bosentan improves hemodynamics and delays time to clinical worsening in patients with mildly symptomatic pulmonary arterial hypertension: Results of the EARLY study Galie N, Benza R, Rubin LJ, Hoeper MM,
Latest Results from Clinical Trials (MAESTRO)
EuroGUCH 2018 & 11 th Advanced Symposium on ACHD Munster April 2018 Latest Results from Clinical Trials (MAESTRO) Michael A Gatzoulis Adult Congenital Heart Centre & National Centre for Pulmonary Hypertension
22nd Annual Heart Failure 2018 an Update on Therapy. Pulmonary Arterial Hypertension: Contemporary Approach to Treatment
22nd Annual Heart Failure 2018 an Update on Therapy Pulmonary Arterial Hypertension: Contemporary Approach to Treatment Ronald J. Oudiz, MD, FACP, FACC, FCCP Professor of Medicine The David Geffen School
Precision medicine and personalising therapy in pulmonary hypertension: seeing the light from the dawn of a new era.
1. Eur Respir Rev. 2018 Apr 13;27(148). pii: 180004. doi: 10.1183/16000617.0004-2018. Print 2018 Jun 30. Precision medicine and personalising therapy in pulmonary hypertension: seeing the light from the
Pulmonary Arterial Hypertension (PAH): Emerging Therapeutic Strategies
Pulmonary Arterial Hypertension (PAH): Emerging Therapeutic Strategies Nick H. Kim, M.D. Clinical Professor of Medicine Director, Pulmonary Vascular Medicine Clinical Service Chief, PCCSM La Jolla Pulmonary,
A pulmonary vascular resistance of 8 Woods units per meter squared defines operablity in congenital heart disease
A pulmonary vascular resistance of 8 Woods units per meter squared defines operablity in congenital heart disease RMF Berger Beatrix Children s Hospital University Medical Center Groningen The Netherlands
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Tadalafil (Adcirca), Sildenafil citrate (Revatio) Reference Number: CP.CPA.72 Effective Date: 11.16.16 Last Review Date: 08.17 Line of Business: Medicaid Medi-Cal Revision Log See Important
Clinical and hemodynamic benefit of macitentan and riociguat upfront combination in patients with pulmonary arterial hypertension
Research Article Clinical and hemodynamic benefit of macitentan and riociguat upfront combination in patients with pulmonary arterial hypertension Roxana Sulica 1, Swathi Sangli 2, Aloke Chakravarti 3
Inhaled Nitric Oxide Beyond the Evidence- Children
Critical Care Canada Forum, Toronto 2014 Inhaled Nitric Oxide Beyond the Evidence- Children Ian Adatia, Pediatric Pulmonary Hypertension Service and Cardiac Intensive Care Unit, Stollery Children s Hospital,
Clinical Policy: Macitentan (Opsumit) Reference Number: ERX.SPMN.88
Clinical Policy: (Opsumit) Reference Number: ERX.SPMN.88 Effective Date: 07/16 Last Review Date: 06/16 Coding Implications Revision Log See Important Reminder at the end of this policy for important regulatory
Untreated idiopathic pulmonary arterial hypertension
Congenital Heart Disease Outcomes in Children With Idiopathic Pulmonary Arterial Hypertension Delphine Yung, MD; Allison C. Widlitz, MS, PA; Erika Berman Rosenzweig, MD; Diane Kerstein, MD; Greg Maislin,
Class Update with New Drug Evaluation: Drugs for Pulmonary Arterial Hypertension
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119