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Article ; Online: Surrogate Markers for Pulmonary Hypertension May Inform Prognosis in Lung Cancer.

Forbes, Lindsay M / Gu, Sue / Badesch, David B

American journal of respiratory and critical care medicine

2021 Volume 203, Issue 10, Page(s) 1220–1221

MeSH term(s)	Biomarkers ; Humans ; Hypertension, Pulmonary/diagnosis ; Lung Neoplasms/complications ; Lung Neoplasms/diagnosis ; Prognosis
Chemical Substances	Biomarkers
Language	English
Publishing date	2021-03-30
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	1180953-x
ISSN	1535-4970 ; 0003-0805 ; 1073-449X
ISSN (online)	1535-4970
ISSN	0003-0805 ; 1073-449X
DOI	10.1164/rccm.202103-0740ED
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Article ; Online: Inference following multiple imputation for generalized additive models: an investigation of the median p-value rule with applications to the Pulmonary Hypertension Association Registry and Colorado COVID-19 hospitalization data.

Bolt, Matthew A / MaWhinney, Samantha / Pattee, Jack W / Erlandson, Kristine M / Badesch, David B / Peterson, Ryan A

BMC medical research methodology

2022 Volume 22, Issue 1, Page(s) 148

Abstract: ... The viability of these methods in pooling results from B-splines is also examined for normal outcomes ...

Abstract	Background: Missing data prove troublesome in data analysis; at best they reduce a study's statistical power and at worst they induce bias in parameter estimates. Multiple imputation via chained equations is a popular technique for dealing with missing data. However, techniques for combining and pooling results from fitted generalized additive models (GAMs) after multiple imputation have not been well explored. Methods: We simulated missing data under MCAR, MAR, and MNAR frameworks and utilized random forest and predictive mean matching imputation to investigate a variety of rules for combining GAMs after multiple imputation with binary and normally distributed outcomes. We compared multiple pooling procedures including the "D2" method, the Cauchy combination test, and the median p-value (MPV) rule. The MPV rule involves simply computing and reporting the median p-value across all imputations. Other ad hoc methods such as a mean p-value rule and a single imputation method are investigated. The viability of these methods in pooling results from B-splines is also examined for normal outcomes. An application of these various pooling techniques is then performed on two case studies, one which examines the effect of elevation on a six-minute walk distance (a normal outcome) for patients with pulmonary arterial hypertension, and the other which examines risk factors for intubation in hospitalized COVID-19 patients (a dichotomous outcome). Results: In comparison to the results from generalized additive models fit on full datasets, the median p-value rule performs as well as if not better than the other methods examined. In situations where the alternative hypothesis is true, the Cauchy combination test appears overpowered and alternative methods appear underpowered, while the median p-value rule yields results similar to those from analyses of complete data. Conclusions: For pooling results after fitting GAMs to multiply imputed datasets, the median p-value is a simple yet useful approach which balances both power to detect important associations and control of Type I errors.
MeSH term(s)	COVID-19/epidemiology ; Colorado ; Hospitalization ; Humans ; Hypertension, Pulmonary/diagnosis ; Models, Statistical ; Registries
Language	English
Publishing date	2022-05-21
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2041362-2
ISSN	1471-2288 ; 1471-2288
ISSN (online)	1471-2288
ISSN	1471-2288
DOI	10.1186/s12874-022-01613-w
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Article ; Online: Long-Term Effects of Sotatercept on Right Ventricular Function: Results From the PULSAR Study.

Gomberg-Maitland, Mardi / McLaughlin, Vallerie V / Badesch, David B / Ghofrani, Hossein-Ardeschir / Hoeper, Marius M / Humbert, Marc / Preston, Ioana R / Souza, Rogerio / Waxman, Aaron B / de Oliveira Pena, Janethe / Lu, Jonathan T / Manimaran, Solaiappan / Gibbs, J Simon R

JACC. Heart failure

2023 Volume 11, Issue 10, Page(s) 1457–1459

Language	English
Publishing date	2023-07-12
Publishing country	United States
Document type	Letter
ZDB-ID	2705621-1
ISSN	2213-1787 ; 2213-1779
ISSN (online)	2213-1787
ISSN	2213-1779
DOI	10.1016/j.jchf.2023.05.030
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Article ; Online: Inference following multiple imputation for generalized additive models

Matthew A. Bolt / Samantha MaWhinney / Jack W. Pattee / Kristine M. Erlandson / David B. Badesch / Ryan A. Peterson

BMC Medical Research Methodology, Vol 22, Iss 1, Pp 1-

an investigation of the median p-value rule with applications to the Pulmonary Hypertension Association Registry and Colorado COVID-19 hospitalization data

2022 Volume 14

Abstract: ... The viability of these methods in pooling results from B-splines is also examined for normal outcomes ...

Abstract	Abstract Background Missing data prove troublesome in data analysis; at best they reduce a study’s statistical power and at worst they induce bias in parameter estimates. Multiple imputation via chained equations is a popular technique for dealing with missing data. However, techniques for combining and pooling results from fitted generalized additive models (GAMs) after multiple imputation have not been well explored. Methods We simulated missing data under MCAR, MAR, and MNAR frameworks and utilized random forest and predictive mean matching imputation to investigate a variety of rules for combining GAMs after multiple imputation with binary and normally distributed outcomes. We compared multiple pooling procedures including the “D2” method, the Cauchy combination test, and the median p-value (MPV) rule. The MPV rule involves simply computing and reporting the median p-value across all imputations. Other ad hoc methods such as a mean p-value rule and a single imputation method are investigated. The viability of these methods in pooling results from B-splines is also examined for normal outcomes. An application of these various pooling techniques is then performed on two case studies, one which examines the effect of elevation on a six-minute walk distance (a normal outcome) for patients with pulmonary arterial hypertension, and the other which examines risk factors for intubation in hospitalized COVID-19 patients (a dichotomous outcome). Results In comparison to the results from generalized additive models fit on full datasets, the median p-value rule performs as well as if not better than the other methods examined. In situations where the alternative hypothesis is true, the Cauchy combination test appears overpowered and alternative methods appear underpowered, while the median p-value rule yields results similar to those from analyses of complete data. Conclusions For pooling results after fitting GAMs to multiply imputed datasets, the median p-value is a simple yet useful approach which balances both power ...
Keywords	Missing data ; Pooling results ; Simulation study ; Splines ; Elevation ; Pulmonary arterial hypertension ; Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2022-05-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Sildenafil for COPD: a randomized crossover trial.

Bull, Todd / Badesch, David B

COPD

2012 Volume 9, Issue 3, Page(s) 211–212

MeSH term(s)	Exercise Test/drug effects ; Female ; Humans ; Male ; Oxygen Consumption/drug effects ; Piperazines/therapeutic use ; Pulmonary Disease, Chronic Obstructive/complications ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Purines/therapeutic use ; Sildenafil Citrate ; Sulfones/therapeutic use ; Vasodilator Agents/therapeutic use
Chemical Substances	Piperazines ; Purines ; Sulfones ; Vasodilator Agents ; Sildenafil Citrate (BW9B0ZE037)
Language	English
Publishing date	2012-06
Publishing country	England
Document type	Comment ; Editorial
ZDB-ID	2171107-0
ISSN	1541-2563 ; 1541-2555
ISSN (online)	1541-2563
ISSN	1541-2555
DOI	10.3109/15412555.2012.683966
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Article ; Online: Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension.

Humbert, Marc / McLaughlin, Vallerie / Gibbs, J Simon R / Gomberg-Maitland, Mardi / Hoeper, Marius M / Preston, Ioana R / Souza, Rogerio / Waxman, Aaron B / Ghofrani, Hossein-Ardeschir / Escribano Subias, Pilar / Feldman, Jeremy / Meyer, Gisela / Montani, David / Olsson, Karen M / Manimaran, Solaiappan / de Oliveira Pena, Janethe / Badesch, David B

The European respiratory journal

2023 Volume 61, Issue 1

Abstract: Background: In participants with pulmonary arterial hypertension, 24 weeks of sotatercept resulted in a significantly greater reduction from baseline in pulmonary vascular resistance than placebo. This report characterises the longer-term safety and ... ...

Abstract	Background: In participants with pulmonary arterial hypertension, 24 weeks of sotatercept resulted in a significantly greater reduction from baseline in pulmonary vascular resistance than placebo. This report characterises the longer-term safety and efficacy of sotatercept in the PULSAR open-label extension. We report cumulative safety, and efficacy at months 18-24, for all participants treated with sotatercept. Methods: PULSAR was a phase 2, randomised, double-blind, placebo-controlled study followed by an open-label extension, which evaluated sotatercept on top of background pulmonary arterial hypertension therapy in adults. Participants originally randomised to placebo were re-randomised 1:1 to sotatercept 0.3 or 0.7 mg·kg Results: Of 106 participants enrolled in the PULSAR study, 97 continued into the extension period. Serious treatment-emergent adverse events were reported in 32 (30.8%) participants; 10 (9.6%) reported treatment-emergent adverse events leading to study discontinuation. Three (2.9%) participants died, none considered related to study drug. The placebo-crossed group demonstrated significant improvement across primary and secondary endpoints and clinical efficacy was maintained in the continued-sotatercept group. Conclusion: These results support the longer-term safety and durability of clinical benefit of sotatercept for pulmonary arterial hypertension.
MeSH term(s)	Adult ; Humans ; Pulmonary Arterial Hypertension ; DEAE-Dextran ; Treatment Outcome ; Familial Primary Pulmonary Hypertension ; Double-Blind Method
Chemical Substances	ACE-011 ; DEAE-Dextran (9015-73-0)
Language	English
Publishing date	2023-01-06
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639359-7
ISSN	1399-3003 ; 0903-1936
ISSN (online)	1399-3003
ISSN	0903-1936
DOI	10.1183/13993003.01347-2022
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Zs.A 2322: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Mortality in Pulmonary Arterial Hypertension in the Modern Era: Early Insights From the Pulmonary Hypertension Association Registry.

Chang, Kevin Y / Duval, Sue / Badesch, David B / Bull, Todd M / Chakinala, Murali M / De Marco, Teresa / Frantz, Robert P / Hemnes, Anna / Mathai, Stephen C / Rosenzweig, Erika Berman / Ryan, John J / Thenappan, Thenappan

Journal of the American Heart Association

2022 Volume 11, Issue 9, Page(s) e024969

Abstract: Background Current mortality data for pulmonary arterial hypertension (PAH) in the United States are based on registries that enrolled patients prior to 2010. We sought to determine mortality in PAH in the modern era using the PHAR (Pulmonary ... ...

Abstract	Background Current mortality data for pulmonary arterial hypertension (PAH) in the United States are based on registries that enrolled patients prior to 2010. We sought to determine mortality in PAH in the modern era using the PHAR (Pulmonary Hypertension Association Registry). Methods and Results We identified all adult patients with PAH enrolled in the PHAR between September 2015 and September 2020 (N=935). We used Kaplan-Meier survival analysis and Cox proportional hazards models to assess mortality at 1, 2, and 3 years. Patients were stratified based on disease severity by 3 validated risk scores. In treatment-naïve patients, we compared survival based on initial treatment strategy. The median age was 56 years (44-68 years), and 76% were women. Of the 935 patients, 483 (52%) were ≤6 months from PAH diagnosis. There were 121 deaths (12.9%) during a median follow-up time of 489 days (281-812 days). The 1-, 2-, and 3-year mortality was 8% (95% CI, 6%-10%), 16% (95% CI, 13%-19%), and 21% (95% CI, 17%-25%), respectively. When stratified into low-, intermediate-, and high-risk PAH, the mortality at 1, 2, and 3 years was 1%, 4% to 6%, and 7% to 11% for low risk; 7% to 8%, 11% to 16%, and 18% to 20% for intermediate risk; and 12% to 19%, 22% to 38%, and 28% to 55% for high risk, respectively. In treatment-naïve patients, initial combination therapy was associated with better 1-year survival (adjusted hazard ratio, 0.43 [95% CI, 0.19-0.95];
MeSH term(s)	Adult ; Familial Primary Pulmonary Hypertension ; Female ; Humans ; Hypertension, Pulmonary ; Male ; Middle Aged ; Proportional Hazards Models ; Pulmonary Arterial Hypertension/diagnosis ; Registries ; Survival Rate ; United States/epidemiology
Language	English
Publishing date	2022-04-27
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2653953-6
ISSN	2047-9980 ; 2047-9980
ISSN (online)	2047-9980
ISSN	2047-9980
DOI	10.1161/JAHA.121.024969
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Article ; Online: Effects of sotatercept on haemodynamics and right heart function: analysis of the STELLAR trial.

Souza, Rogerio / Badesch, David B / Ghofrani, H Ardeschir / Gibbs, J Simon R / Gomberg-Maitland, Mardi / McLaughlin, Vallerie V / Preston, Ioana R / Waxman, Aaron B / Grünig, Ekkehard / Kopeć, Grzegorz / Meyer, Gisela / Olsson, Karen M / Rosenkranz, Stephan / Lin, Jianxin / Johnson-Levonas, Amy O / de Oliveira Pena, Janethe / Humbert, Marc / Hoeper, Marius M

The European respiratory journal

2023 Volume 62, Issue 3

Abstract: Background: In the phase 3 STELLAR trial, sotatercept, an investigational first-in-class activin signalling inhibitor, demonstrated beneficial effects on 6-min walk distance and additional efficacy endpoints in pre-treated participants with pulmonary ... ...

Abstract	Background: In the phase 3 STELLAR trial, sotatercept, an investigational first-in-class activin signalling inhibitor, demonstrated beneficial effects on 6-min walk distance and additional efficacy endpoints in pre-treated participants with pulmonary arterial hypertension (PAH). Methods: This Results: Relative to placebo, treatment with sotatercept led to significant (all p<0.0001 except where noted) improvements from baseline in mean pulmonary artery (PA) pressure (-13.9 mmHg), pulmonary vascular resistance (-254.8 dyn·s·cm Conclusion: In pre-treated patients with PAH, sotatercept demonstrated substantial improvements in PA pressures, PA compliance, PA-RV coupling and right heart function.
MeSH term(s)	Humans ; Hemodynamics ; Heart ; Recombinant Fusion Proteins/therapeutic use ; Cardiac Catheterization ; Familial Primary Pulmonary Hypertension
Chemical Substances	ACE-011 ; Recombinant Fusion Proteins
Language	English
Publishing date	2023-09-21
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639359-7
ISSN	1399-3003 ; 0903-1936
ISSN (online)	1399-3003
ISSN	0903-1936
DOI	10.1183/13993003.01107-2023
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Zs.A 2322: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Anticoagulation in Pulmonary Arterial Hypertension.

Robinson, Jeffrey C / Pugliese, Steven C / Fox, Daniel L / Badesch, David B

Current hypertension reports

2016 Volume 18, Issue 6, Page(s) 47

Abstract: Pulmonary arterial hypertension (PAH) is characterized by molecular and pathologic alteration to the pulmonary circulation, resulting in increased pulmonary vascular resistance, right ventricular failure, and eventual death. Pharmacologic treatment of ... ...

Abstract	Pulmonary arterial hypertension (PAH) is characterized by molecular and pathologic alteration to the pulmonary circulation, resulting in increased pulmonary vascular resistance, right ventricular failure, and eventual death. Pharmacologic treatment of PAH consists of use of a multitude of pulmonary vasodilators, sometimes in combination. PAH has been associated with increased thrombosis and disrupted coagulation and fibrinolysis, making anticoagulation an attractive and frequently employed therapeutic modality. Observational studies have provided some insight into the therapeutic potential of anticoagulation in idiopathic PAH, but there is a distinct lack of well-controlled prospective trials. Due to the conflicting evidence, there is a large amount of heterogeneity in the application of therapeutic anticoagulation in PAH and further well-controlled prospective trials are needed to clarify its role in treating PAH.
MeSH term(s)	Anticoagulants/pharmacology ; Blood Coagulation/drug effects ; Disease Management ; Humans ; Hypertension, Pulmonary/blood ; Hypertension, Pulmonary/complications ; Hypertension, Pulmonary/drug therapy ; Thrombosis/etiology ; Thrombosis/prevention & control
Chemical Substances	Anticoagulants
Language	English
Publishing date	2016-06
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2057367-4
ISSN	1534-3111 ; 1522-6417
ISSN (online)	1534-3111
ISSN	1522-6417
DOI	10.1007/s11906-016-0657-2
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Zs.A 5522: Show issues

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Article ; Online: Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension.

The New England journal of medicine

2023 Volume 388, Issue 16, Page(s) 1478–1490

Abstract: ... terminal pro-B-type natriuretic peptide level, improvement in WHO functional class, time to death or ...

Abstract	Background: Pulmonary arterial hypertension is a progressive disease involving proliferative remodeling of the pulmonary vessels. Despite therapeutic advances, the disease-associated morbidity and mortality remain high. Sotatercept is a fusion protein that traps activins and growth differentiation factors involved in pulmonary arterial hypertension. Methods: We conducted a multicenter, double-blind, phase 3 trial in which adults with pulmonary arterial hypertension (World Health Organization [WHO] functional class II or III) who were receiving stable background therapy were randomly assigned in a 1:1 ratio to receive subcutaneous sotatercept (starting dose, 0.3 mg per kilogram of body weight; target dose, 0.7 mg per kilogram) or placebo every 3 weeks. The primary end point was the change from baseline at week 24 in the 6-minute walk distance. Nine secondary end points, tested hierarchically in the following order, were multicomponent improvement, change in pulmonary vascular resistance, change in N-terminal pro-B-type natriuretic peptide level, improvement in WHO functional class, time to death or clinical worsening, French risk score, and changes in the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Physical Impacts, Cardiopulmonary Symptoms, and Cognitive/Emotional Impacts domain scores; all were assessed at week 24 except time to death or clinical worsening, which was assessed when the last patient completed the week 24 visit. Results: A total of 163 patients were assigned to receive sotatercept and 160 to receive placebo. The median change from baseline at week 24 in the 6-minute walk distance was 34.4 m (95% confidence interval [CI], 33.0 to 35.5) in the sotatercept group and 1.0 m (95% CI, -0.3 to 3.5) in the placebo group. The Hodges-Lehmann estimate of the difference between the sotatercept and placebo groups in the change from baseline at week 24 in the 6-minute walk distance was 40.8 m (95% CI, 27.5 to 54.1; P<0.001). The first eight secondary end points were significantly improved with sotatercept as compared with placebo, whereas the PAH-SYMPACT Cognitive/Emotional Impacts domain score was not. Adverse events that occurred more frequently with sotatercept than with placebo included epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure. Conclusions: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).
MeSH term(s)	Adult ; Humans ; Double-Blind Method ; Hypertension, Pulmonary/drug therapy ; Pulmonary Arterial Hypertension/diagnosis ; Pulmonary Arterial Hypertension/drug therapy ; Recombinant Fusion Proteins/administration & dosage ; Recombinant Fusion Proteins/adverse effects ; Recombinant Fusion Proteins/pharmacology ; Recombinant Fusion Proteins/therapeutic use ; Treatment Outcome ; Vascular Resistance/drug effects ; Injections, Subcutaneous ; Walk Test ; Exercise Tolerance/drug effects ; Cardiovascular Agents/administration & dosage ; Cardiovascular Agents/adverse effects ; Cardiovascular Agents/pharmacology ; Cardiovascular Agents/therapeutic use ; Respiratory System Agents/administration & dosage ; Respiratory System Agents/adverse effects ; Respiratory System Agents/pharmacology ; Respiratory System Agents/therapeutic use
Chemical Substances	ACE-011 ; Recombinant Fusion Proteins ; Cardiovascular Agents ; Respiratory System Agents
Language	English
Publishing date	2023-03-06
Publishing country	United States
Document type	Randomized Controlled Trial ; Clinical Trial, Phase III ; Multicenter Study ; Journal Article
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2213558
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