Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: A double-blind, randomized, placebo-controlled trial
Identifieur interne : 00B788 ( Main/Exploration ); précédent : 00B787; suivant : 00B789Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: A double-blind, randomized, placebo-controlled trial
Auteurs : Gerald Simonneau [France, États-Unis, Italie, Belgique, Australie] ; Robyn J. Barst ; Nazzareno Galie ; Robert Naeije ; Stuart Rich ; Robert C. Bourge ; Anne Keogh ; Ronald Oudiz ; Adaani Frost ; Shelmer D. Blackburn ; James W. Crow ; Lewis J. RubinSource :
- American journal of respiratory and critical care medicine [ 1073-449X ] ; 2002.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
Pulmonary arterial hypertension is a life-threatening disease for which continuous intravenous prostacyclin has proven to be effective. However, this treatment requires a permanent central venous catheter with the associated risk of serious complications such as sepsis, thromboembolism, or syncope. Treprostinil, a stable prostacyclin analogue, can be administered by a continuous subcutaneous infusion, avoiding these risks. We conducted a 12-week, double-blind, placebo-controlled multicenter trial in 470 patients with pulmonary arterial hypertension, either primary or associated with connective tissue disease or congenital systemic-to-pulmonary shunts. Exercise capacity improved with treprostinil and was unchanged with placebo; the between treatment group difference in median six-minute walking distance was 16 m (p = 0.006). Improvement in exercise capacity was greater in the sicker patients and was dose-related, but independent of disease etiology. Concomitantly, treprostinil significantly improved indices of dyspnea, signs and symptoms of pulmonary hypertension, and hemodynamics. The most common side effect attributed to treprostinil was infusion site pain (85%) leading to premature discontinuation from the study in 8% of patients. Three patients in the treprostinil treatment group presented with an episode of gastrointestinal hemorrhage. We conclude that chronic subcutaneous infusion of treprostinil is an effective treatment with an acceptable safety profile in patients with pulmonary arterial hypertension.
Affiliations:
- Australie, Belgique, France, Italie, États-Unis
- Alabama, Californie, Caroline du Nord, Illinois, Nouvelle-Galles du Sud, Région de Bruxelles-Capitale, Texas, État de New York
- Bruxelles, Sydney
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Barst</name></author><author><name sortKey="Galie, Nazzareno" sort="Galie, Nazzareno" uniqKey="Galie N" first="Nazzareno" last="Galie">Nazzareno Galie</name></author><author><name sortKey="Naeije, Robert" sort="Naeije, Robert" uniqKey="Naeije R" first="Robert" last="Naeije">Robert Naeije</name></author><author><name sortKey="Rich, Stuart" sort="Rich, Stuart" uniqKey="Rich S" first="Stuart" last="Rich">Stuart Rich</name></author><author><name sortKey="Bourge, Robert C" sort="Bourge, Robert C" uniqKey="Bourge R" first="Robert C." last="Bourge">Robert C. Bourge</name></author><author><name sortKey="Keogh, Anne" sort="Keogh, Anne" uniqKey="Keogh A" first="Anne" last="Keogh">Anne Keogh</name></author><author><name sortKey="Oudiz, Ronald" sort="Oudiz, Ronald" uniqKey="Oudiz R" first="Ronald" last="Oudiz">Ronald Oudiz</name></author><author><name sortKey="Frost, Adaani" sort="Frost, Adaani" uniqKey="Frost A" first="Adaani" last="Frost">Adaani Frost</name></author><author><name sortKey="Blackburn, Shelmer D" sort="Blackburn, Shelmer D" uniqKey="Blackburn S" first="Shelmer D." last="Blackburn">Shelmer D. Blackburn</name></author><author><name sortKey="Crow, James W" sort="Crow, James W" uniqKey="Crow J" first="James W." last="Crow">James W. Crow</name></author><author><name sortKey="Rubin, Lewis J" sort="Rubin, Lewis J" uniqKey="Rubin L" first="Lewis J." last="Rubin">Lewis J. Rubin</name></author></analytic><series><title level="j" type="main">American journal of respiratory and critical care medicine</title><title level="j" type="abbreviated">Am. j. respir. crit. care med.</title><idno type="ISSN">1073-449X</idno><imprint><date when="2002">2002</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">American journal of respiratory and critical care medicine</title><title level="j" type="abbreviated">Am. j. respir. crit. care med.</title><idno type="ISSN">1073-449X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Analog</term><term>Arterial pressure</term><term>Exploration</term><term>Hemodynamics</term><term>Human</term><term>Prostaglandin</term><term>Pulmonary hypertension</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Hypertension artérielle pulmonaire</term><term>Analogue</term><term>Prostaglandine</term><term>Pression artérielle</term><term>Hémodynamique</term><term>Traitement</term><term>Exploration</term><term>Homme</term><term>Tréprostinil</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Pulmonary arterial hypertension is a life-threatening disease for which continuous intravenous prostacyclin has proven to be effective. However, this treatment requires a permanent central venous catheter with the associated risk of serious complications such as sepsis, thromboembolism, or syncope. Treprostinil, a stable prostacyclin analogue, can be administered by a continuous subcutaneous infusion, avoiding these risks. We conducted a 12-week, double-blind, placebo-controlled multicenter trial in 470 patients with pulmonary arterial hypertension, either primary or associated with connective tissue disease or congenital systemic-to-pulmonary shunts. Exercise capacity improved with treprostinil and was unchanged with placebo; the between treatment group difference in median six-minute walking distance was 16 m (p = 0.006). Improvement in exercise capacity was greater in the sicker patients and was dose-related, but independent of disease etiology. Concomitantly, treprostinil significantly improved indices of dyspnea, signs and symptoms of pulmonary hypertension, and hemodynamics. The most common side effect attributed to treprostinil was infusion site pain (85%) leading to premature discontinuation from the study in 8% of patients. Three patients in the treprostinil treatment group presented with an episode of gastrointestinal hemorrhage. We conclude that chronic subcutaneous infusion of treprostinil is an effective treatment with an acceptable safety profile in patients with pulmonary arterial hypertension.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Belgique</li><li>France</li><li>Italie</li><li>États-Unis</li></country><region><li>Alabama</li><li>Californie</li><li>Caroline du Nord</li><li>Illinois</li><li>Nouvelle-Galles du Sud</li><li>Région de Bruxelles-Capitale</li><li>Texas</li><li>État de New York</li></region><settlement><li>Bruxelles</li><li>Sydney</li></settlement></list><tree><noCountry><name sortKey="Barst, Robyn J" sort="Barst, Robyn J" uniqKey="Barst R" first="Robyn J." last="Barst">Robyn J. Barst</name><name sortKey="Blackburn, Shelmer D" sort="Blackburn, Shelmer D" uniqKey="Blackburn S" first="Shelmer D." last="Blackburn">Shelmer D. Blackburn</name><name sortKey="Bourge, Robert C" sort="Bourge, Robert C" uniqKey="Bourge R" first="Robert C." last="Bourge">Robert C. Bourge</name><name sortKey="Crow, James W" sort="Crow, James W" uniqKey="Crow J" first="James W." last="Crow">James W. Crow</name><name sortKey="Frost, Adaani" sort="Frost, Adaani" uniqKey="Frost A" first="Adaani" last="Frost">Adaani Frost</name><name sortKey="Galie, Nazzareno" sort="Galie, Nazzareno" uniqKey="Galie N" first="Nazzareno" last="Galie">Nazzareno Galie</name><name sortKey="Keogh, Anne" sort="Keogh, Anne" uniqKey="Keogh A" first="Anne" last="Keogh">Anne Keogh</name><name sortKey="Naeije, Robert" sort="Naeije, Robert" uniqKey="Naeije R" first="Robert" last="Naeije">Robert Naeije</name><name sortKey="Oudiz, Ronald" sort="Oudiz, Ronald" uniqKey="Oudiz R" first="Ronald" last="Oudiz">Ronald Oudiz</name><name sortKey="Rich, Stuart" sort="Rich, Stuart" uniqKey="Rich S" first="Stuart" last="Rich">Stuart Rich</name><name sortKey="Rubin, Lewis J" sort="Rubin, Lewis J" uniqKey="Rubin L" first="Lewis J." last="Rubin">Lewis J. Rubin</name></noCountry><country name="France"><noRegion><name sortKey="Simonneau, Gerald" sort="Simonneau, Gerald" uniqKey="Simonneau G" first="Gerald" last="Simonneau">Gerald Simonneau</name></noRegion></country><country name="États-Unis"><region name="État de New York"><name sortKey="Simonneau, Gerald" sort="Simonneau, Gerald" uniqKey="Simonneau G" first="Gerald" last="Simonneau">Gerald Simonneau</name></region><name sortKey="Simonneau, Gerald" sort="Simonneau, Gerald" uniqKey="Simonneau G" first="Gerald" last="Simonneau">Gerald Simonneau</name><name sortKey="Simonneau, Gerald" sort="Simonneau, Gerald" uniqKey="Simonneau G" first="Gerald" last="Simonneau">Gerald Simonneau</name><name sortKey="Simonneau, Gerald" sort="Simonneau, Gerald" uniqKey="Simonneau G" first="Gerald" last="Simonneau">Gerald Simonneau</name><name sortKey="Simonneau, Gerald" sort="Simonneau, Gerald" uniqKey="Simonneau G" first="Gerald" last="Simonneau">Gerald Simonneau</name><name sortKey="Simonneau, Gerald" sort="Simonneau, Gerald" uniqKey="Simonneau G" first="Gerald" last="Simonneau">Gerald Simonneau</name><name sortKey="Simonneau, Gerald" sort="Simonneau, Gerald" uniqKey="Simonneau G" first="Gerald" last="Simonneau">Gerald Simonneau</name></country><country name="Italie"><noRegion><name sortKey="Simonneau, Gerald" sort="Simonneau, Gerald" uniqKey="Simonneau G" first="Gerald" last="Simonneau">Gerald Simonneau</name></noRegion></country><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Simonneau, Gerald" sort="Simonneau, Gerald" uniqKey="Simonneau G" first="Gerald" last="Simonneau">Gerald Simonneau</name></region></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Simonneau, Gerald" sort="Simonneau, Gerald" uniqKey="Simonneau G" first="Gerald" last="Simonneau">Gerald Simonneau</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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