Use of responder threshold criteria to evaluate the response to treatment in the phase III CHEST-1 study
Background In the Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase - Stimulator Trial 1 (CHEST-1) study, riociguat improved 6-minute walking distance (6MWD) vs placebo in patients with inoperable chronic thromboembolic pulmonary hypertension or persistent/recurrent pulmonary h...
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| creator | D’Armini, Andrea M., MD Ghofrani, Hossein-Ardeschir, MD Kim, Nick H., MD Mayer, Eckhard, MD, PhD Morsolini, Marco, MD, PhD Pulido-Zamudio, Tomás, MD Simonneau, Gerald, MD Wilkins, Martin R., MD Curram, John, PhD Davie, Neil, PhD Hoeper, Marius M., MD |
| description | Background In the Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase - Stimulator Trial 1 (CHEST-1) study, riociguat improved 6-minute walking distance (6MWD) vs placebo in patients with inoperable chronic thromboembolic pulmonary hypertension or persistent/recurrent pulmonary hypertension after pulmonary endarterectomy. In this study, the proportion of patients who achieved responder thresholds that correlate with improved outcome in patients with pulmonary arterial hypertension was determined at baseline and at the end of CHEST-1. Methods Patients received placebo or riociguat individually adjusted up to 2.5 mg 3 times a day for 16 weeks. Response criteria were defined as follows: 6MWD increase ≥40 m, 6MWD ≥380 m, cardiac index ≥2.5 liters/min/m2 , pulmonary vascular resistance |
| doi_str_mv | 10.1016/j.healun.2015.02.003 |
| format | Article |
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In this study, the proportion of patients who achieved responder thresholds that correlate with improved outcome in patients with pulmonary arterial hypertension was determined at baseline and at the end of CHEST-1. Methods Patients received placebo or riociguat individually adjusted up to 2.5 mg 3 times a day for 16 weeks. Response criteria were defined as follows: 6MWD increase ≥40 m, 6MWD ≥380 m, cardiac index ≥2.5 liters/min/m2 , pulmonary vascular resistance <500 dyn∙sec∙cm−5 , mixed venous oxygen saturation ≥65%, World Health Organization functional class I/II, N-terminal pro-brain natriuretic peptide <1,800 pg/ml, and right atrial pressure <8 mm Hg. Results Riociguat increased the proportion of patients with 6MWD ≥380 m, World Health Organization functional class I/II, and pulmonary vascular resistance <500 dyn∙sec∙cm−5 from 37%, 34%, and 25% at baseline to 58%, 57%, and 50% at Week 16, whereas there was little change in placebo-treated patients (6MWD ≥380 m, 43% vs 44%; World Health Organization functional class I/II, 29% vs 38%; pulmonary vascular resistance <500 dyn∙sec∙cm−5 , 27% vs 26%). Similar changes were observed for thresholds for cardiac index, mixed venous oxygen saturation, N-terminal pro-brain natriuretic peptide, and right atrial pressure. Conclusions In this exploratory analysis, riociguat increased the proportion of patients with inoperable chronic thromboembolic pulmonary hypertension or persistent/recurrent pulmonary hypertension after pulmonary endarterectomy achieving criteria defining a positive response to therapy.</description><identifier>ISSN: 1053-2498</identifier><identifier>EISSN: 1557-3117</identifier><identifier>DOI: 10.1016/j.healun.2015.02.003</identifier><identifier>PMID: 25813765</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; chronic thromboembolic pulmonary hypertension ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; Follow-Up Studies ; Humans ; Hypertension, Pulmonary - drug therapy ; Hypertension, Pulmonary - physiopathology ; Male ; Middle Aged ; Pyrazoles - administration & dosage ; Pyrimidines - administration & dosage ; responder threshold criteria ; Retrospective Studies ; riociguat ; soluble guanylate cyclase stimulator ; Surgery ; Time Factors ; Treatment Outcome ; treatment response ; Vascular Resistance ; Ventricular Function, Right - drug effects ; Ventricular Function, Right - physiology ; Ventricular Pressure - drug effects ; Ventricular Pressure - physiology ; Young Adult</subject><ispartof>The Journal of heart and lung transplantation, 2015-03, Vol.34 (3), p.348-355</ispartof><rights>The Authors</rights><rights>2015 The Authors</rights><rights>Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c463t-9205303a81c73bc6e1c067a255f389bc8c856a6f35e1955c6cfd677dedb438ac3</citedby><cites>FETCH-LOGICAL-c463t-9205303a81c73bc6e1c067a255f389bc8c856a6f35e1955c6cfd677dedb438ac3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.healun.2015.02.003$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,778,782,3539,27907,27908,45978</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25813765$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>D’Armini, Andrea M., MD</creatorcontrib><creatorcontrib>Ghofrani, Hossein-Ardeschir, MD</creatorcontrib><creatorcontrib>Kim, Nick H., MD</creatorcontrib><creatorcontrib>Mayer, Eckhard, MD, PhD</creatorcontrib><creatorcontrib>Morsolini, Marco, MD, PhD</creatorcontrib><creatorcontrib>Pulido-Zamudio, Tomás, MD</creatorcontrib><creatorcontrib>Simonneau, Gerald, MD</creatorcontrib><creatorcontrib>Wilkins, Martin R., MD</creatorcontrib><creatorcontrib>Curram, John, PhD</creatorcontrib><creatorcontrib>Davie, Neil, PhD</creatorcontrib><creatorcontrib>Hoeper, Marius M., MD</creatorcontrib><title>Use of responder threshold criteria to evaluate the response to treatment in the phase III CHEST-1 study</title><title>The Journal of heart and lung transplantation</title><addtitle>J Heart Lung Transplant</addtitle><description>Background In the Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase - Stimulator Trial 1 (CHEST-1) study, riociguat improved 6-minute walking distance (6MWD) vs placebo in patients with inoperable chronic thromboembolic pulmonary hypertension or persistent/recurrent pulmonary hypertension after pulmonary endarterectomy. In this study, the proportion of patients who achieved responder thresholds that correlate with improved outcome in patients with pulmonary arterial hypertension was determined at baseline and at the end of CHEST-1. Methods Patients received placebo or riociguat individually adjusted up to 2.5 mg 3 times a day for 16 weeks. Response criteria were defined as follows: 6MWD increase ≥40 m, 6MWD ≥380 m, cardiac index ≥2.5 liters/min/m2 , pulmonary vascular resistance <500 dyn∙sec∙cm−5 , mixed venous oxygen saturation ≥65%, World Health Organization functional class I/II, N-terminal pro-brain natriuretic peptide <1,800 pg/ml, and right atrial pressure <8 mm Hg. Results Riociguat increased the proportion of patients with 6MWD ≥380 m, World Health Organization functional class I/II, and pulmonary vascular resistance <500 dyn∙sec∙cm−5 from 37%, 34%, and 25% at baseline to 58%, 57%, and 50% at Week 16, whereas there was little change in placebo-treated patients (6MWD ≥380 m, 43% vs 44%; World Health Organization functional class I/II, 29% vs 38%; pulmonary vascular resistance <500 dyn∙sec∙cm−5 , 27% vs 26%). Similar changes were observed for thresholds for cardiac index, mixed venous oxygen saturation, N-terminal pro-brain natriuretic peptide, and right atrial pressure. Conclusions In this exploratory analysis, riociguat increased the proportion of patients with inoperable chronic thromboembolic pulmonary hypertension or persistent/recurrent pulmonary hypertension after pulmonary endarterectomy achieving criteria defining a positive response to therapy.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>chronic thromboembolic pulmonary hypertension</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Hypertension, Pulmonary - drug therapy</subject><subject>Hypertension, Pulmonary - physiopathology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pyrazoles - administration & dosage</subject><subject>Pyrimidines - administration & dosage</subject><subject>responder threshold criteria</subject><subject>Retrospective Studies</subject><subject>riociguat</subject><subject>soluble guanylate cyclase stimulator</subject><subject>Surgery</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>treatment response</subject><subject>Vascular Resistance</subject><subject>Ventricular Function, Right - drug effects</subject><subject>Ventricular Function, Right - physiology</subject><subject>Ventricular Pressure - drug effects</subject><subject>Ventricular Pressure - physiology</subject><subject>Young Adult</subject><issn>1053-2498</issn><issn>1557-3117</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU1rGzEQhkVoadK0_yAEHXvZrT5WH74UikkaQ6CHJGchS7OsnPXKkbQB__vItZtDLz1p4H3fmdEzCF1R0lJC5fdNO4Ad56llhIqWsJYQfoYuqBCq4ZSqD7UmgjesW-hz9DnnDSGEccE-oXMmNOVKigs0PGXAsccJ8i5OHhIuQ62HOHrsUiiQgsUlYnits2yBKsPJXINVKAls2cJUcJj-iLvBVmW1WuHl3c3DY0NxLrPff0Efeztm-Hp6L9HT7c3j8q65__1rtfx537hO8tIsWN2ZcKupU3ztJFBHpLJMiJ7rxdppp4W0sucC6EIIJ13vpVIe_Lrj2jp-ib4d--5SfJkhF7MN2cE42gninA2VUvFOCS2qtTtaXYo5J-jNLoWtTXtDiTkwNhtzZGwOjA1hpjKusevThHm9Bf8e-gu1Gn4cDVD_-RogmewCTA58SOCK8TH8b8K_DdwYpuDs-Ax7yJs4p6kyNNTkGjAPhzsfzkwFoUQSzd8ADaWjnQ</recordid><startdate>20150301</startdate><enddate>20150301</enddate><creator>D’Armini, Andrea M., MD</creator><creator>Ghofrani, Hossein-Ardeschir, MD</creator><creator>Kim, Nick H., MD</creator><creator>Mayer, Eckhard, MD, PhD</creator><creator>Morsolini, Marco, MD, PhD</creator><creator>Pulido-Zamudio, Tomás, MD</creator><creator>Simonneau, Gerald, MD</creator><creator>Wilkins, Martin R., MD</creator><creator>Curram, John, PhD</creator><creator>Davie, Neil, PhD</creator><creator>Hoeper, Marius M., MD</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20150301</creationdate><title>Use of responder threshold criteria to evaluate the response to treatment in the phase III CHEST-1 study</title><author>D’Armini, Andrea M., MD ; Ghofrani, Hossein-Ardeschir, MD ; Kim, Nick H., MD ; Mayer, Eckhard, MD, PhD ; Morsolini, Marco, MD, PhD ; Pulido-Zamudio, Tomás, MD ; Simonneau, Gerald, MD ; Wilkins, Martin R., MD ; Curram, John, PhD ; Davie, Neil, PhD ; Hoeper, Marius M., MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c463t-9205303a81c73bc6e1c067a255f389bc8c856a6f35e1955c6cfd677dedb438ac3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>chronic thromboembolic pulmonary hypertension</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Hypertension, Pulmonary - drug therapy</topic><topic>Hypertension, Pulmonary - physiopathology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pyrazoles - administration & dosage</topic><topic>Pyrimidines - administration & dosage</topic><topic>responder threshold criteria</topic><topic>Retrospective Studies</topic><topic>riociguat</topic><topic>soluble guanylate cyclase stimulator</topic><topic>Surgery</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>treatment response</topic><topic>Vascular Resistance</topic><topic>Ventricular Function, Right - drug effects</topic><topic>Ventricular Function, Right - physiology</topic><topic>Ventricular Pressure - drug effects</topic><topic>Ventricular Pressure - physiology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>D’Armini, Andrea M., MD</creatorcontrib><creatorcontrib>Ghofrani, Hossein-Ardeschir, MD</creatorcontrib><creatorcontrib>Kim, Nick H., MD</creatorcontrib><creatorcontrib>Mayer, Eckhard, MD, PhD</creatorcontrib><creatorcontrib>Morsolini, Marco, MD, PhD</creatorcontrib><creatorcontrib>Pulido-Zamudio, Tomás, MD</creatorcontrib><creatorcontrib>Simonneau, Gerald, MD</creatorcontrib><creatorcontrib>Wilkins, Martin R., MD</creatorcontrib><creatorcontrib>Curram, John, PhD</creatorcontrib><creatorcontrib>Davie, Neil, PhD</creatorcontrib><creatorcontrib>Hoeper, Marius M., MD</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>The Journal of heart and lung transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>D’Armini, Andrea M., MD</au><au>Ghofrani, Hossein-Ardeschir, MD</au><au>Kim, Nick H., MD</au><au>Mayer, Eckhard, MD, PhD</au><au>Morsolini, Marco, MD, PhD</au><au>Pulido-Zamudio, Tomás, MD</au><au>Simonneau, Gerald, MD</au><au>Wilkins, Martin R., MD</au><au>Curram, John, PhD</au><au>Davie, Neil, PhD</au><au>Hoeper, Marius M., MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Use of responder threshold criteria to evaluate the response to treatment in the phase III CHEST-1 study</atitle><jtitle>The Journal of heart and lung transplantation</jtitle><addtitle>J Heart Lung Transplant</addtitle><date>2015-03-01</date><risdate>2015</risdate><volume>34</volume><issue>3</issue><spage>348</spage><epage>355</epage><pages>348-355</pages><issn>1053-2498</issn><eissn>1557-3117</eissn><abstract>Background In the Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase - Stimulator Trial 1 (CHEST-1) study, riociguat improved 6-minute walking distance (6MWD) vs placebo in patients with inoperable chronic thromboembolic pulmonary hypertension or persistent/recurrent pulmonary hypertension after pulmonary endarterectomy. In this study, the proportion of patients who achieved responder thresholds that correlate with improved outcome in patients with pulmonary arterial hypertension was determined at baseline and at the end of CHEST-1. Methods Patients received placebo or riociguat individually adjusted up to 2.5 mg 3 times a day for 16 weeks. Response criteria were defined as follows: 6MWD increase ≥40 m, 6MWD ≥380 m, cardiac index ≥2.5 liters/min/m2 , pulmonary vascular resistance <500 dyn∙sec∙cm−5 , mixed venous oxygen saturation ≥65%, World Health Organization functional class I/II, N-terminal pro-brain natriuretic peptide <1,800 pg/ml, and right atrial pressure <8 mm Hg. Results Riociguat increased the proportion of patients with 6MWD ≥380 m, World Health Organization functional class I/II, and pulmonary vascular resistance <500 dyn∙sec∙cm−5 from 37%, 34%, and 25% at baseline to 58%, 57%, and 50% at Week 16, whereas there was little change in placebo-treated patients (6MWD ≥380 m, 43% vs 44%; World Health Organization functional class I/II, 29% vs 38%; pulmonary vascular resistance <500 dyn∙sec∙cm−5 , 27% vs 26%). Similar changes were observed for thresholds for cardiac index, mixed venous oxygen saturation, N-terminal pro-brain natriuretic peptide, and right atrial pressure. Conclusions In this exploratory analysis, riociguat increased the proportion of patients with inoperable chronic thromboembolic pulmonary hypertension or persistent/recurrent pulmonary hypertension after pulmonary endarterectomy achieving criteria defining a positive response to therapy.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>25813765</pmid><doi>10.1016/j.healun.2015.02.003</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Aged Aged, 80 and over chronic thromboembolic pulmonary hypertension Dose-Response Relationship, Drug Double-Blind Method Female Follow-Up Studies Humans Hypertension, Pulmonary - drug therapy Hypertension, Pulmonary - physiopathology Male Middle Aged Pyrazoles - administration & dosage Pyrimidines - administration & dosage responder threshold criteria Retrospective Studies riociguat soluble guanylate cyclase stimulator Surgery Time Factors Treatment Outcome treatment response Vascular Resistance Ventricular Function, Right - drug effects Ventricular Function, Right - physiology Ventricular Pressure - drug effects Ventricular Pressure - physiology Young Adult |
| title | Use of responder threshold criteria to evaluate the response to treatment in the phase III CHEST-1 study |
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