Πνευμονική Υπέρταση: Μια ΚΡΙΤΙΚΗ ματιά στις κλινικές μελέτες - AMBITION. Αναστασία Ανθη
|
|
- Grace Lamb
- 6 years ago
- Views:
Transcription
1 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. «ΑΤΤΙΚΟΝ»
2 Disclosures Sponsored to attend scientific meetings, or honoraria by: Actelion Bayer MSD Galenica GSK Pfizer
3 Ambition study August 27, 2015
4 JACC, June 2009 PAH Evidence-Based Algorithm
5 JACC, June 2009 PAH Evidence-Based Algorithm
6 AMBITION A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension
7 AMBITION A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension The study was aimed to answer the question: starting PAH treatment with a combination of an ERA and a PDE5 inhibitor is better than starting on a single specific therapy (ERA or PDE5 inhibitor alone) in relationship with clinical outcome?
8 AMBITION A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension Combination therapy with Tadalafil /Ambrisentan was selected because both medicines do not have clinically relevant drug-drug interactions when co-administered have once a day dosing & target separate pathways implicated in the pathobiology of PAH
9 Study Enrollment Criteria Key enrollment criteria: WHO Group 1 Pulmonary Arterial Hypertension (PAH) IPAH/HPAH; APAH (HIV, CTD, Drugs and Toxins, repaired simple CHD) Functional Class II or III Treatment naïve Age Baseline 6MWD m Original Protocol Criteria (Intent to Treat (ITT)) PVR 240 dyn s/cm 5 PCWP or LVEDP 15 mmhg No exclusion of subjects with risk factors for left ventricular disease N. Galiè, et al. N Engl J Med 2015;373:834-44
10 Study Enrollment Criteria Key enrollment criteria: WHO Group 1 Pulmonary Arterial Hypertension (PAH) IPAH/HPAH; APAH (HIV, CTD, Drugs and Toxins, repaired simple CHD) Functional Class II or III Treatment naïve Age Baseline 6MWD m Amendment 2: To reduce likelihood of enrolling subjects with PH due to covert diastolic dysfunction Original Protocol Criteria (Intent to Treat (ITT)) PVR 240 dyn s/cm 5 PCWP or LVEDP 15 mmhg No exclusion of subjects with risk factors for left ventricular disease Amendment 2 Changes (Primary Analysis Set (PAS)) PVR 300 dyn s/cm 5 PCWP a lowered to 12 mmhg in subjects with PVR 300 but < 500 dyn s/cm5 Exclusion of subjects with 3 of the following risk factors for left ventricular disease: BMI 30 History of essential hypertension Diabetes mellitus (any type) History of significant CAD N. Galiè, et al. N Engl J Med 2015;373: a PCWP requirement maintained at 15 mmhg In subjects with PVR 500 dyn s/cm 5
11 AMBITION: An Event Driven Trial with Time to First Clinical Failure Event as Primary Endpoint Combination arm: Ambrisentan + Tadalafil PAH Patients N = 610 (n=500 PAS) Randomized 2:1:1 to Combination arm or Monotherapy arm Monotherapy Arm: Ambrisentan + Placebo OR Monotherapy Arm: Tadalafil + Placebo 105 events in PAS: primary endpoint N. Galiè, et al. N Engl J Med 2015;373:834-44
12 AMBITION: An Event Driven Trial with Time to First Clinical Failure Event as Primary Endpoint Combination arm: Ambrisentan + Tadalafil PAH Patients N = 610 (n=500 PAS) Randomized 2:1:1 to Combination arm or Monotherapy arm Monotherapy Arm: Ambrisentan + Placebo OR Monotherapy Arm: Tadalafil + Placebo 105 events in PAS: primary endpoint Following the first event, subjects could receive blinded combination therapy, and remained in the study N. Galiè, et al. N Engl J Med 2015;373:834-44
13 Primary End Point: Clinical Failure Event Time (days) to first clinical failure event of PAH, defined as: Death (all-cause) or Hospitalization for worsening PAH* >15% decrease from baseline in 6MWD # and WHO functional class III or IV symptoms # or Disease progression* or Unsatisfactory long-term clinical response* * CEAC adjudicated Receiving 1 dose of treatment and being in the study 6 months and A decrease from baseline in 6MWD # and WHO functional class III symptoms for 6 months or longer At 2 clinic visits separated by 6 months # At 2 consecutive post-baseline visits separated by 14 days N. Galiè, et al. N Engl J Med 2015;373:834-44
14 Baseline Characteristics Characteristic Combination Therapy (n=253) Pooled Monotherapy Ambrisentan monotherapy (n=126) Tadalafil Monotherapy (n=121) (n=247) Age, y, mean ± SD 54.5 ± ± ± ±15.2 Female sex, n (%) 188 (74) 200 (81) 100 (79) 100 (83) Race/Race combinations, n (%) White 232 (92) 212 (86) 106 (85) 106 (88) African American / African Heritage 10 (4) 24 (10) 13 (10) 11 (9) Asian 5 (2) 7 (3) 4 (3) 3 (2) Other 6 (2) 3 (1) 3 (2) 1 (1) Region, n (%) North America 116 (46) 112 (45) 51 (41) 61 (50) Europe 129 (51) 128 (52) 72 (57) 56 (46) Asia Pacific 8 (3) 7 (3) 3 (2) 4 (3) N. Galiè, et al. N Engl J Med 2015;373:834-44
15 Baseline Characteristics Characteristic Combination Therapy (n=253) Pooled Monotherapy (n=247) Ambrisentan Monotherapy (n=126) Tadalafil Monotherapy (n=121) PAH classification, n (%) Idiopathic Heritable Associated with CTD Associated with CHD Associated with HIV Associated with drug use or toxin 127 (50) 7 (3) 103 (41) 5 (2) 5 (2) 6 (2) 138 (56) 7 (3) 84 (34) 4 (2) 4 (2) 10 (4) 72 (57) 3 (2) 44 (35) 1 (1) 2 (2) 4 (3) 66 (55) 4 (3) 40 (33) 3 (3) 2 (2) 6 (5) exposure Concomitant calcium channel 77 (30) 79 (32) 37 (29) 42 (35) blockers, n (%) No history of PAH therapy, n (%) 242 (96) 235 (96) 120 (97) 115 (95) Time from diagnosis to first study drug administration, days, median N. Galiè, et al. N Engl J Med 2015;373:834-44
16 Baseline Characteristics Characteristic Combination Therapy (n=253) Pooled Monotherapy (n=247) Ambrisentan monotherapy (n=126) Tadalafil Monotherapy (n=121) Baseline Who Functional Class II 76 (30%) 79 (32%) 38 (30%) 41 (34%) III 177 (70%) 168 (68%) 88 (70%) 80 (66%) Baseline 6MWD (m) ± SD (87.9) (91.8) (92.3) (91.6) Hemodynamic variables RAP, mm Hg, mean ± SD 7.7 ± ± ± ± 4.8 PAP, mm Hg, mean ± SD 48.1 ± ± ± ± 12.6 PCWP, mm Hg, mean ± SD 8.4 ± ± ± ± 3.5 CI, L/min/m 2, mean ± SD 2.41 ± ± ± ± 0.77 PVR, dyne.sec/cm 5, mean ± SD ± ± ± ± Time on study medication to FAV, ± NA ± ± days, mean ± SD N. Galiè, et al. N Engl J Med 2015;373:834-44
17 Upfront combination therapy with ambrisentan/tadalafil reduced the risk of clinical failure Primary Endpoint: Time to First Clinical Failure Event (PrimaryAnalysis Set) 50% Risk Reduction 95% CIs (using log-log transform method) are presented for each treatment group at weeks 4, 8, 16, 24, and then every 12 weeks up to week 96. N. Galiè, et al. N Engl J Med 2015;373:834-44
18 First Adjudicated Clinical Failure by Subgroups Pooled Monotherapy CONFIDENTIAL N. Galiè, et al. N Engl J Med 2015;373:834-44
19 NT-proBNP: change from baseline to week 24 and treatment differences Ratio of NT-proBNP (pg/ml) to BASELINE Treatment ratios to COMBO Week 24 Combo vs pooled mono p< Combo vs ambrisentan mono p= Combo vs tadalafil mono p< Vertical bars represent 95% CIs. Graph is a mixed models repeated measures (MMRM) analysis adjusted for baseline aetiology of PAH (IPAH/HPAH vs non-ipah), WHO FC (II vs III) and baseline, with no imputation for missing data. N. Galiè, et al. N Engl J Med 2015;373:834-44
20 6MWD: change from baseline to week 24 and treatment differences Median change in 6MWD (m) from baseline Median treatment difference with COMBO (m) Week 24 Combination: +49.0m Pooled mono: +23.8m Ambrisentan mono: +27.0m Tadalafil mono: +22.7m Vertical bars represent 95% CIs. Stratified Wilcoxon Rank Sum analysis. Worst rank scores were used for missing data following death or adjudicated hospitalisation; otherwise, LOCF imputation was used. N. Galiè, et al. N Engl J Med 2015;373:834-44
21 WHO FC change at week 24 Combination therapy (n=253) Pooled monotherapy (n=247) Ambrisentan monotherapy (n=126) Tadalafil monotherapy (n=121) Baseline WHO FC, observed, n II 76 (30%) 79 (32%) 38 (30%) 41 (34%) III 177 (70%) 168 (68%) 88 (70%) 80 (66%) Week 24 WHO FC, observed, n Improved 89 (38%) 80 (36%) 41 (38%) 39 (35%) No change 138 (59%) 133 ( 60%) 63 (58%) 70 (63%) Deteriorated 6 (3%) 7 (3%) 5 (5%) 2 (2%) Week 24 WHO FC, imputed*, n Improved 94 (37%) 81 (33%) 42 (34%) 39 (33%) No change 146 (58%) 147 (60%) 73 (59%) 74 (62%) Deteriorated 12 (5%) 16 (7%) 9 (7%) 7 (6%) p value *Worst case imputation (0) was used for missing data following death or adjudicated hospitalisation; otherwise, LOCF imputation was used. Baseline data have not been used for imputation. p value from CMH tests stratified by baseline aetiology of PAH (IPAH/HPAH vs non-ipah) and WHO FC (II vs III). N. Galiè, et al. N Engl J Med 2015;373:834-44
22 Only adverse events on randomised treatment, with onset between first dose of study drug and last dose+30 days are shown Adverse Events ( 15% in COMB) AE Term n, (%) COMB (n=253) AMB Mono (n=126) TAD Mono (n=121) Any AE 247 (98%) 120 (95%) 114 (94%) Oedema peripheral 115 (45%) 41 (33%) 34 (28%) Headache 107 (42%) 41 (33%) 42 (35%) Nasal congestion 54 (21%) 19 (15%) 15 (12%) Diarrhoea 50 (20%) 29 (23%) 23 (19%) Dizziness 50 (20%) 24 (19%) 14 (12%) Dyspnoea 44 (17%) 22 (17%) 20 (17%) Nausea 43 (17%) 18 (14%) 20 (17%) Cough 40 (16%) 14 (11%) 21 (17%) Flushing 38 (15%) 18 (14%) 11 (9%) Anemia 37 (15%) 8 (6%) 14 (12%) Nasopharyngitis 37 (15%) 26 (21%) 18 (15%) Pain in extremity 37 (15%) 14 (11%) 18 (15%) Syncope 13 (5%) 7 (6%) 10 (8%)
23 Initial combination therapy with ambrisentan & tadalafil in CTD-PAH: subgroup analysis from the AMBITION trial Coghlan JG, et al. Ann Rheum Dis 2016;0:1 9.
24 Initial combination therapy with ambrisentan & tadalafil and mortality in pts with PAH: a secondary analysis of the results from the AMBITION study Hoeper MM et al. Lancet Respir Med 2016
25 Initial combination therapy with ambrisentan & tadalafil and mortality in pts with PAH: a secondary analysis of the results from the AMBITION study Hoeper MM et al. Lancet Respir Med 2016
26 Initial combination therapy with ambrisentan & tadalafil and mortality in pts with PAH: a secondary analysis of the results from the AMBITION study Initial combination therapy might be associated with a survival advantage compared with initial monotherapy in pts with newly diagnosed PAH This hypothesis needs to be addressed in future studies Hoeper MM et al. Lancet Respir Med 2016
27 Evidence based treatment algorithm for PAH patients PH guidelines 2015
28 Evidence based treatment algorithm for PAH patients Initial monotherapy Initial oral combination PH guidelines 2015
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
More informationTherapeutic 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
More informationPulmonary Arterial Hypertension RELATED TO CONNECTIVE TISSUE DISORDER The strategy of INITIAL COMBINATION THERAPY
Pulmonary Arterial Hypertension RELATED TO CONNECTIVE TISSUE DISORDER The strategy of INITIAL COMBINATION THERAPY Eftychia Demerouti MD, MSc, PhD Cardiologist Onassis Cardiac Surgery Center None related
More informationEffective 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,
More informationProgress 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
More informationSATELLITE 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
More informationThe 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
More informationSTARTS-1 and -2. Barst R, Ivy DD, et al. Circulation 2012;125:
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
More informationThe 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
More informationComparison 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
More informationContreversies 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
More informationPFIZER 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.
More informationTHERAPEUTICS 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
More information*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
More informationMACITENTAN 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
More informationReal-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
More informationPulmonary 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
More informationRole 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
More informationDisclosures. 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
More informationThe 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
More informationACCP 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
More informationScottish 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
More informationChronic 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
More informationTherapy 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
More informationTadalafil 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
More informationClinical Commissioning Policy: Selexipag for treating pulmonary arterial hypertension (all ages)
Clinical Commissioning Policy: Selexipag for treating pulmonary arterial hypertension (all ages) NHS England Reference: 170065P 1 NHS England INFORMATION READER BOX Directorate Medical Operations and Information
More informationΘεραπεία με βάση τη βαρύτητα ή εξαρχής επιθετική συνδυαστική θεραπεία. Φραντζέσκα Φραντζεσκάκη Πνευμονολόγος-Εντατικολόγος ΠΓΝ «ΑΤΤΙΚΟΝ»
Θεραπεία με βάση τη βαρύτητα ή εξαρχής επιθετική συνδυαστική θεραπεία Φραντζέσκα Φραντζεσκάκη Πνευμονολόγος-Εντατικολόγος ΠΓΝ «ΑΤΤΙΚΟΝ» S.Gaine and V.McLaughlin, Eur Respi Rev 2017;26 Ultimate goal of
More informationProtocol. This trial protocol has been provided by the authors to give readers additional information about their work.
Protocol This trial protocol has been provided by the authors to give readers additional information about their work. Protocol for: Galiè N, Barberà JA, Frost AE, et al. Initial use of ambrisentan plus
More informationCase Presentation : Pulmonary Hypertension: Diagnosis and Imaging
Case Presentation 9.40-11.20: Pulmonary Hypertension: Diagnosis and Imaging Eftychia Demerouti MD, MSc, PhD Cardiologist Onassis Cardiac Surgery Center Conflicts of interest Consulting fees and fees for
More informationPrognostic 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.
More informationUpdate in Pulmonary Arterial Hypertension
Update in Pulmonary Arterial Hypertension Michael J Sanley, MD April 12, 2018 Disclosures I have nothing to disclose 2 1 Case Presentation 67 yo male with atrial fibrillation, CLL on IVIG, presents with
More informationMedical Management of CTEPH: What is its role?
Medical Management of CTEPH: What is its role? Nick H. Kim, MD University of California, San Diego Disclosures Consultant/Speakers Bureau: Actelion, Bayer Healthcare Research Support: Aires, Gilead Sciences,
More informationPulmonary 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
More information22nd 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
More informationOral 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
More informationClinical Commissioning Policy: Selexipag in the treatment of Pulmonary Arterial Hypertension
Clinical Commissioning Policy: Selexipag in the treatment of Pulmonary Arterial Hypertension Reference: NHS England: 16017/P NHS England INFORMATION READER BOX Directorate Medical Operations and Information
More informationTreatment 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
More informationPulmonary Arterial Hypertension - Overview
Pulmonary Arterial Hypertension - Overview J. Shaun Smith, MD Co-Director, Pulmonary Vascular Disease Program Assistant Professor of Medicine Division of Pulmonary, Critical Care and Sleep Medicine The
More informationPulmonary Arterial Hypertension - Overview
Pulmonary Arterial Hypertension - Overview J. Shaun Smith, MD Co-Director, Pulmonary Vascular Disease Program Assistant Professor of Medicine Division of Pulmonary, Critical Care and Sleep Medicine The
More informationApproach to Pulmonary Hypertension in the Hospital
Approach to Pulmonary Hypertension in the Hospital Todd M Bull MD Professor of Medicine Director Pulmonary Vascular Disease Center Director Center for Lungs and Breathing Division of Pulmonary Sciences
More informationCombination 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
More informationClinical Science Working Group 6: Diagnosis & Assessment of PAH. Co-chairs: David B. Badesch, MD Marius M. Hoeper, MD. Working Group 6 Members
Clinical Science Working Group 6: Diagnosis & Assessment of PAH Co-chairs: David B. Badesch, MD Marius M. Hoeper, MD Working Group 6 Members Harm Jan Bogaard, Robin Condliffe, Robert Frantz, Dinesh Khanna,
More informationPulmonary Hypertension. Pulmonary Arterial Hypertension Diagnosis, Impact and Outcomes
Pulmonary Hypertension Pulmonary Arterial Hypertension Diagnosis, Impact and Outcomes Pulmonary Arterial Hypertension Disease of small pulmonary arteries Characteristic changes Medial hypertrophy Intimal
More informationUpdates 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
More informationIV 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
More informationJ. Gerry Coghlan 1 Richard Channick. Nazzareno Galiè 5 Hossein-Ardeschir Ghofrani. Irene M. Lang 10 Vallerie McLaughlin
Am J Cardiovasc Drugs (2018) 18:37 47 https://doi.org/10.1007/s40256-017-0262-z ORIGINAL RESEARCH ARTICLE Targeting the Prostacyclin Pathway with in Patients with Pulmonary Arterial Hypertension Receiving
More informationReal life management of CTEPH: patient case
2 nd International Congress on cardiovascular imaging in clinical practice k Real life management of CTEPH: patient case Anastasia Anthi Pulmonary Hypertension Clinic, Attikon University Hospital, Athens
More informationClinical Commissioning Policy Proposition: Selexipag in the treatment of Pulmonary Arterial Hypertension
Clinical Commissioning Policy Proposition: Selexipag in the treatment of Pulmonary Arterial Hypertension Reference: NHS England A11X04/01 Information Reader Box (IRB) to be inserted on inside front cover
More informationCONUNDRUMS 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
More informationΠνευμονική υπέρταση: Τα 10 πιο σημαντικά κενά και παραλείψεις των Κατευθυντήριων Οδηγιών του 2015
Πνευμονική υπέρταση: Τα 10 πιο σημαντικά κενά και παραλείψεις των Κατευθυντήριων Οδηγιών του 2015 Γεωργία Γ. Πίτσιου, MD, MSc, PhD Πνευμονολόγος- Εντατικολόγος Επίκουρη Καθηγήτρια Ιατρική Σχολή ΑΠΘ Γ.Ν.
More informationLa terapia dell ipertensione arteriosa polmonare oggi
La terapia dell ipertensione arteriosa polmonare oggi PneumoTrieste 2017 Trieste 3 5 Aprile 2017 Sergio Harari U.O. di Pneumologia e UTIR Servizio di Emodinamica e Fisiopatologia Respiratoria Ospedale
More informationLatest 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
More informationGalie 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,
More informationDECLARATION OF CONFLICT OF INTEREST
DECLARATION OF CONFLICT OF INTEREST ESC Congress 2011 Pathophysiology of HFPEF Vascular Remodeling & Pulmonary Hypertension Carolyn S.P. Lam MBBS, MRCP, MS Case Presentation 81 yo woman with dyspnoea &
More informationClass 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
More informationManaging 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
More informationVOLIBRIS PRODUCT INFORMATION
VOLIBRIS PRODUCT INFORMATION (ambrisentan) 5 mg and 10 mg tablets TERATOGENICITY VOLIBRIS may cause birth defects and is contraindicated in pregnancy (see Contraindications). NAME OF THE MEDICINE Ambrisentan
More informationPulmonary 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
More informationFinal Appraisal Report: GlaxoSmithKline. Advice No: 2508 April Recommendation of AWMSG
Final Appraisal Report: Ambrisentan (Volibris ) for pulmonary arterial hypertension GlaxoSmithKline Advice No: 2508 April 2009 Recommendation of AWMSG Ambrisentan (Volibris ) is recommended for use within
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Health Technology Appraisal. Drugs for the treatment of pulmonary arterial hypertension
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Health Technology Appraisal Drugs for the treatment of Draft remit / appraisal objective: Draft scope To appraise the clinical and cost effectiveness
More informationWhere 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
More informationPULMONARY HYPERTENSION RESPIRATORY & CRITICAL CARE CONFERENCE APRIL 21, 2016 LAURA G. HOOPER
PULMONARY HYPERTENSION RESPIRATORY & CRITICAL CARE CONFERENCE APRIL 21, 2016 LAURA G. HOOPER OUTLINE Brief review of WHO Group Classification Scheme Subgroups we ll focus on: WHO Group I Pulmonary Arterial
More informationGSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationPulmonary Hypertension: We have come a Long Way
Pulmonary Hypertension: We have come a Long Way Shelley Shapiro M.D. Ph.D Pulmonary Hypertension Program 9001.01 1 2 Disclosures Grant Support Gilead, United Therapeutics, Actelion, GeNO, Medtonics, Bellerphon,
More informationSelexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension
Eur Respir J 2012; 40: 874 880 DOI: 10.1183/09031936.00137511 CopyrightßERS 2012 : an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension Gérald Simonneau*,
More informationΔΙΑΓΝΩΣΗ ΚΑΙ ΘΕΡΑΠΕΙΑ ΤΗΣ ΧΡΟΝΙΑΣ ΘΡΟΜΒΟΕΜΒΟΛΙΚΗΣ ΥΠΕΡΤΑΣΗΣ (CTEPH)
Aristotle University of Thessaloniki Cardiology Clinic, AHEPA Hospital ΔΙΑΓΝΩΣΗ ΚΑΙ ΘΕΡΑΠΕΙΑ ΤΗΣ ΧΡΟΝΙΑΣ ΘΡΟΜΒΟΕΜΒΟΛΙΚΗΣ ΥΠΕΡΤΑΣΗΣ (CTEPH) Charalampos I. Karvounis, MD Professor of Cardiology Aristotle
More informationNational 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
More informationFunctional 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 ;
More informationPulmonary 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
More informationPulmonary 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
More information4/14/2010. 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
More informationBeyond a single pathway: combination therapy in pulmonary arterial hypertension
REVIEW PULMONARY ARTERIAL HYPERTENSION Beyond a single pathway: combination therapy in pulmonary arterial hypertension Olivier Sitbon 1,2,3 and Sean Gaine 4 Affiliations: 1 Univ. Paris-Sud, Université
More informationClinical Trial Synopsis TL-OPI-518, NCT#
Clinical Trial Synopsis, NCT# 00225264 Title of Study: A Double-Blind, Randomized, Comparator-Controlled Study in Subjects With Type 2 Diabetes Mellitus Comparing the Effects of Pioglitazone HCl vs Glimepiride
More informationDr.Fayez EL Shaer Consultant cardiologist Assistant professor of cardiology KKUH
Pulmonary Hypertension in patients with Heart Failure with Preserved Ejection Fraction Dr.Fayez EL Shaer Consultant cardiologist Assistant professor of cardiology KKUH Recent evaluation of available data
More informationMulticenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) Long Term Outcomes
Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with (MOMENTUM 3) Long Term Outcomes Mandeep R. Mehra, MD, Daniel J. Goldstein, MD, Nir Uriel, MD, Joseph
More informationRisk populations moving to screening programs
Risk populations moving to screening programs Maurice Beghetti Pediatric Cardiology University Children s Hospital HUG and CHUV Pulmonary Hypertension Program HUG Centre Universitaire Romand de Cardiologie
More informationAnjali 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
More information1. 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
More informationPulmonary 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,
More informationPulmonary Hypertension: Definition and Unmet Needs
Heart Failure Center Hadassah University Hospital Pulmonary Hypertension: Definition and Unmet Needs Israel Gotsman The Heart Failure Center Hadassah University Hospital I DO NOT have a financial interest/
More informationAdvances 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
More informationINSPIRE: A Phase 3 Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861 in Pulmonary Arterial Hypertension (PAH)
INSPIRE: A Phase 3 Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861 in Pulmonary Arterial Hypertension (PAH) N. S. Hill; J. P. Feldman; S. Sahay; D. J. Levine; R. F. Roscigno;
More informationELIGIBILITY CRITERIA FOR PULMONARY ARTERIAL HYPERTENSION THERAPY
ELIGIBILITY CRITERIA FOR PULMONARY ARTERIAL HYPERTENSION THERAPY Contents Eligibility criteria for Pulmonary Arterial Hypertension therapy...2-6 Initial Application for funding of Pulmonary Arterial Hypertension
More informationClinical Trial Synopsis TL-OPI-516, NCT#
Clinical Trial Synopsis, NCT#00225277 Title of Study: A Double-Blind, Randomized, Comparator-Controlled Study in Subjects With Type 2 Diabetes Mellitus Comparing the Effects of Pioglitazone HCl Versus
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationPulmonary 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
More information6 min Walking Test: η σημασία του στην κλινική πράξη Καρακώστας Γεώργιος
6 min Walking Test: η σημασία του στην κλινική πράξη Καρακώστας Γεώργιος Διευθυντής Καρδιολογικής Κλινικής, Γ.Ν. Κιλκίς Definition The 6 minute walking test (6MWT) is a sub-maximal exercise test used to
More informationCorporate 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
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION Macitentan (Opsumit Actelion Pharmaceuticals Canada Inc.) Indication: Pulmonary Arterial Hypertension Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that
More informationPulmonary arterial hypertension (PAH) is
Eur Respir Rev 21; 19: 118, 314 32 DOI: 1.1183/95918.781 CopyrightßERS 21 REVIEW Early intervention in pulmonary arterial hypertension associated with systemic sclerosis: an essential component of disease
More informationRiociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2)
ORIGINAL ARTICLE PULMONARY VASCULAR DISEASES Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study () Lewis J. Rubin 1, Nazzareno Galiè 2, Friedrich Grimminger 3,4,
More informationNavigating the identification, diagnosis and management of pulmonary hypertension using the updated ESC/ERS guidelines
Navigating the identification, diagnosis and management of pulmonary hypertension using the updated ESC/ERS guidelines Host: Marc Humbert Speaker: Simon Gibbs Marc HUMBERT, MD, PhD Professor of Respiratory
More informationUpdates 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
More informationRisk Stratification in Pulmonary Hypertension and Pregnancy
Risk Stratification in Pulmonary Hypertension and Pregnancy Dr Robin Condliffe Pulmonary Vascular Disease Unit Royal Hallamshire Hospital Sheffield United Kingdom Conflicts of Interest Honorararia Actelion,
More informationNational 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.
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT
European Medicines Agency London, 18 December 2008 Doc. Ref. EMEA/CHMP/EWP/356954/2008 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT CHMP GUIDELINE ON THE CLINICAL INVESTIGATIONS OF MEDICINAL
More informationEpoprostenol and pulmonary arterial hypertension: 20 years of clinical experience
REVIEW PULMONARY ARTERIAL HYPERTENSION Epoprostenol and pulmonary arterial hypertension: 20 years of clinical experience Olivier Sitbon 1,2,3 and Anton Vonk Noordegraaf 4 Affiliations: 1 Universite Paris-Sud,
More informationRaymond 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
More informationPulmonary Hypertension: Another Use for Viagra
Pulmonary Hypertension: Another Use for Viagra Kathleen Tong, MD Director, Heart Failure Program Assistant Clinical Professor University of California, Davis Disclosures I have no financial conflicts A
More information