A comparison of levalbuterol with racemic albuterol in the treatment of acute severe asthma exacerbations in adults
This multicenter, randomized, double-blind trial compared nebulized levalbuterol (Lev) and racemic albuterol (Rac) in the treatment of acute asthma. Adults with acute asthma exacerbations (FEV 1 20%-55% predicted) received prednisone and either Lev (1.25 mg, n = 315) or Rac (2.5 mg, n = 312). Nebuli...
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| Veröffentlicht in: | The American journal of emergency medicine 2006-05, Vol.24 (3), p.259-267 |
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| creator | Nowak, Richard Emerman, Charles Hanrahan, John P. Parsey, Merdad V. Hanania, Nicola A. Claus, Raymond Schaefer, Kendyl Baumgartner, Rudolf A. |
| description | This multicenter, randomized, double-blind trial compared nebulized levalbuterol (Lev) and racemic albuterol (Rac) in the treatment of acute asthma.
Adults with acute asthma exacerbations (FEV
1 20%-55% predicted) received prednisone and either Lev (1.25 mg, n = 315) or Rac (2.5 mg, n = 312). Nebulized treatments were administered every 20 minutes in the first hour, then every 40 minutes for 3 additional doses, then as necessary for up to 24 hours. The primary end point was time to meet discharge criteria. Secondary end points included changes in lung function and hospitalization rates. A subset of 160 patients had plasma (
S)-albuterol concentrations determined at study entry.
Time to meet discharge criteria did not differ between the 2 treatments. FEV
1 improvement was greater following Lev compared with Rac, both after dose 1 and cumulatively over the entire treatment period (dose 1 in intent to treat [ITT] group: Lev 0.50 ± 0.43 L, Rac 0.43 ± 0.37 L;
P = .02), particularly among the 60% of patients not on recent steroid therapy (dose 1: Lev 0.58 ± 0.47 L, Rac 0.44 ± 0.37 L;
P < .01), and patients whose entry (
S)-albuterol concentrations were in the highest quartile of those measured. A small and similar proportion of Lev-treated (7.0%) and Rac-treated (9.3%) patients required hospitalization (
P = .28). Among patients not on steroids, fewer Lev- than Rac-treated patients required admission (3.8% vs 9.3%,
P = .03), as was also the case for patients with high plasma (
S)-albuterol concentrations. Asthma relapses (5% in 30 days) were lower than in previous reports and did not differ between groups.
This study suggests that early, regular nebulized β
2-agonist and systemic corticosteroid therapy may reduce hospitalization and relapse rates in patients with acute severe asthma. Lev was well tolerated and compared favorably with Rac in improving airway function, particularly in those who were not on inhaled or oral corticosteroids and in those who had high plasma (
S)-albuterol concentrations at presentation. |
| doi_str_mv | 10.1016/j.ajem.2006.01.027 |
| format | Article |
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Adults with acute asthma exacerbations (FEV
1 20%-55% predicted) received prednisone and either Lev (1.25 mg, n = 315) or Rac (2.5 mg, n = 312). Nebulized treatments were administered every 20 minutes in the first hour, then every 40 minutes for 3 additional doses, then as necessary for up to 24 hours. The primary end point was time to meet discharge criteria. Secondary end points included changes in lung function and hospitalization rates. A subset of 160 patients had plasma (
S)-albuterol concentrations determined at study entry.
Time to meet discharge criteria did not differ between the 2 treatments. FEV
1 improvement was greater following Lev compared with Rac, both after dose 1 and cumulatively over the entire treatment period (dose 1 in intent to treat [ITT] group: Lev 0.50 ± 0.43 L, Rac 0.43 ± 0.37 L;
P = .02), particularly among the 60% of patients not on recent steroid therapy (dose 1: Lev 0.58 ± 0.47 L, Rac 0.44 ± 0.37 L;
P < .01), and patients whose entry (
S)-albuterol concentrations were in the highest quartile of those measured. A small and similar proportion of Lev-treated (7.0%) and Rac-treated (9.3%) patients required hospitalization (
P = .28). Among patients not on steroids, fewer Lev- than Rac-treated patients required admission (3.8% vs 9.3%,
P = .03), as was also the case for patients with high plasma (
S)-albuterol concentrations. Asthma relapses (5% in 30 days) were lower than in previous reports and did not differ between groups.
This study suggests that early, regular nebulized β
2-agonist and systemic corticosteroid therapy may reduce hospitalization and relapse rates in patients with acute severe asthma. Lev was well tolerated and compared favorably with Rac in improving airway function, particularly in those who were not on inhaled or oral corticosteroids and in those who had high plasma (
S)-albuterol concentrations at presentation.</description><identifier>ISSN: 0735-6757</identifier><identifier>EISSN: 1532-8171</identifier><identifier>DOI: 10.1016/j.ajem.2006.01.027</identifier><identifier>PMID: 16635694</identifier><identifier>CODEN: AJEMEN</identifier><language>eng</language><publisher>Philadelphia, PA: Elsevier Inc</publisher><subject>Acute Disease ; Administration, Inhalation ; Adrenergic beta-Agonists - therapeutic use ; Adult ; Albuterol - therapeutic use ; Analysis of Variance ; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Asthma ; Asthma - drug therapy ; Biological and medical sciences ; Bronchodilator Agents - therapeutic use ; Chronic obstructive pulmonary disease, asthma ; Clinics ; Corticoids ; Cost control ; Double-Blind Method ; Drug dosages ; Drug therapy ; Emergency and intensive respiratory care ; Emergency medical care ; Female ; Hospitalization ; Humans ; Intensive care medicine ; Male ; Medical sciences ; Nebulizers and Vaporizers ; Pneumology ; Prednisone - therapeutic use ; Prospective Studies ; Respiratory function ; Respiratory Function Tests ; Statistics, Nonparametric ; Steroids ; Treatment Outcome</subject><ispartof>The American journal of emergency medicine, 2006-05, Vol.24 (3), p.259-267</ispartof><rights>2006 Elsevier Inc.</rights><rights>2006 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c412t-10e189783633f6858263426d024d20a1d3185ed9b7fd641edb094a895c742a473</citedby><cites>FETCH-LOGICAL-c412t-10e189783633f6858263426d024d20a1d3185ed9b7fd641edb094a895c742a473</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0735675706000441$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17791409$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16635694$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nowak, Richard</creatorcontrib><creatorcontrib>Emerman, Charles</creatorcontrib><creatorcontrib>Hanrahan, John P.</creatorcontrib><creatorcontrib>Parsey, Merdad V.</creatorcontrib><creatorcontrib>Hanania, Nicola A.</creatorcontrib><creatorcontrib>Claus, Raymond</creatorcontrib><creatorcontrib>Schaefer, Kendyl</creatorcontrib><creatorcontrib>Baumgartner, Rudolf A.</creatorcontrib><creatorcontrib>for the XOPENEX Acute Severe Asthma Study Group</creatorcontrib><creatorcontrib>XOPENEX Acute Severe Asthma Study Group</creatorcontrib><title>A comparison of levalbuterol with racemic albuterol in the treatment of acute severe asthma exacerbations in adults</title><title>The American journal of emergency medicine</title><addtitle>Am J Emerg Med</addtitle><description>This multicenter, randomized, double-blind trial compared nebulized levalbuterol (Lev) and racemic albuterol (Rac) in the treatment of acute asthma.
Adults with acute asthma exacerbations (FEV
1 20%-55% predicted) received prednisone and either Lev (1.25 mg, n = 315) or Rac (2.5 mg, n = 312). Nebulized treatments were administered every 20 minutes in the first hour, then every 40 minutes for 3 additional doses, then as necessary for up to 24 hours. The primary end point was time to meet discharge criteria. Secondary end points included changes in lung function and hospitalization rates. A subset of 160 patients had plasma (
S)-albuterol concentrations determined at study entry.
Time to meet discharge criteria did not differ between the 2 treatments. FEV
1 improvement was greater following Lev compared with Rac, both after dose 1 and cumulatively over the entire treatment period (dose 1 in intent to treat [ITT] group: Lev 0.50 ± 0.43 L, Rac 0.43 ± 0.37 L;
P = .02), particularly among the 60% of patients not on recent steroid therapy (dose 1: Lev 0.58 ± 0.47 L, Rac 0.44 ± 0.37 L;
P < .01), and patients whose entry (
S)-albuterol concentrations were in the highest quartile of those measured. A small and similar proportion of Lev-treated (7.0%) and Rac-treated (9.3%) patients required hospitalization (
P = .28). Among patients not on steroids, fewer Lev- than Rac-treated patients required admission (3.8% vs 9.3%,
P = .03), as was also the case for patients with high plasma (
S)-albuterol concentrations. Asthma relapses (5% in 30 days) were lower than in previous reports and did not differ between groups.
This study suggests that early, regular nebulized β
2-agonist and systemic corticosteroid therapy may reduce hospitalization and relapse rates in patients with acute severe asthma. Lev was well tolerated and compared favorably with Rac in improving airway function, particularly in those who were not on inhaled or oral corticosteroids and in those who had high plasma (
S)-albuterol concentrations at presentation.</description><subject>Acute Disease</subject><subject>Administration, Inhalation</subject><subject>Adrenergic beta-Agonists - therapeutic use</subject><subject>Adult</subject><subject>Albuterol - therapeutic use</subject><subject>Analysis of Variance</subject><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Asthma</subject><subject>Asthma - drug therapy</subject><subject>Biological and medical sciences</subject><subject>Bronchodilator Agents - therapeutic use</subject><subject>Chronic obstructive pulmonary disease, asthma</subject><subject>Clinics</subject><subject>Corticoids</subject><subject>Cost control</subject><subject>Double-Blind Method</subject><subject>Drug dosages</subject><subject>Drug therapy</subject><subject>Emergency and intensive respiratory care</subject><subject>Emergency medical care</subject><subject>Female</subject><subject>Hospitalization</subject><subject>Humans</subject><subject>Intensive care medicine</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Nebulizers and Vaporizers</subject><subject>Pneumology</subject><subject>Prednisone - therapeutic use</subject><subject>Prospective Studies</subject><subject>Respiratory function</subject><subject>Respiratory Function Tests</subject><subject>Statistics, Nonparametric</subject><subject>Steroids</subject><subject>Treatment Outcome</subject><issn>0735-6757</issn><issn>1532-8171</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kU2LFDEQhoMo7uzoH_AgAXFv3eark27wsix-wYIXPYd0Us2k6e6MSXpc_71pZmDAg6eCquctinoQekNJTQmVH8bajDDXjBBZE1oTpp6hHW04q1qq6HO0I4o3lVSNukG3KY2EUCoa8RLdUCl5IzuxQ-ke2zAfTfQpLDgMeIKTmfo1QwwT_u3zAUdjYfYWX9t-wfkAOEcweYYlbzljyxAnOEEEbFI-zAbDU4nG3mQflrSljFunnF6hF4OZEry-1D36-fnTj4ev1eP3L98e7h8rKyjLFSVA2061XHI-yLZpmeSCSUeYcIwY6jhtG3BdrwYnBQXXk06YtmusEswIxffo7rz3GMOvFVLWs08WpsksENakpWo72ZWH7dG7f8AxrHEpt2lKOGkJaTteKHambAwpRRj0MfrZxD8F0psQPepNiN6EaEJ1EVJCby-r134Gd41cDBTg_QUwyZppiGaxPl05pToqSFe4j2cOysdOHqJO1sNiwfkINmsX_P_u-Auj7qjb</recordid><startdate>20060501</startdate><enddate>20060501</enddate><creator>Nowak, Richard</creator><creator>Emerman, Charles</creator><creator>Hanrahan, John P.</creator><creator>Parsey, Merdad V.</creator><creator>Hanania, Nicola A.</creator><creator>Claus, Raymond</creator><creator>Schaefer, Kendyl</creator><creator>Baumgartner, Rudolf A.</creator><general>Elsevier Inc</general><general>Elsevier</general><general>Elsevier Limited</general><scope>IQODW</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>3V.</scope><scope>7RV</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20060501</creationdate><title>A comparison of levalbuterol with racemic albuterol in the treatment of acute severe asthma exacerbations in adults</title><author>Nowak, Richard ; Emerman, Charles ; Hanrahan, John P. ; Parsey, Merdad V. ; Hanania, Nicola A. ; Claus, Raymond ; Schaefer, Kendyl ; Baumgartner, Rudolf A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c412t-10e189783633f6858263426d024d20a1d3185ed9b7fd641edb094a895c742a473</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Acute Disease</topic><topic>Administration, Inhalation</topic><topic>Adrenergic beta-Agonists - therapeutic use</topic><topic>Adult</topic><topic>Albuterol - therapeutic use</topic><topic>Analysis of Variance</topic><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>Asthma</topic><topic>Asthma - drug therapy</topic><topic>Biological and medical sciences</topic><topic>Bronchodilator Agents - therapeutic use</topic><topic>Chronic obstructive pulmonary disease, asthma</topic><topic>Clinics</topic><topic>Corticoids</topic><topic>Cost control</topic><topic>Double-Blind Method</topic><topic>Drug dosages</topic><topic>Drug therapy</topic><topic>Emergency and intensive respiratory care</topic><topic>Emergency medical care</topic><topic>Female</topic><topic>Hospitalization</topic><topic>Humans</topic><topic>Intensive care medicine</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Nebulizers and Vaporizers</topic><topic>Pneumology</topic><topic>Prednisone - therapeutic use</topic><topic>Prospective Studies</topic><topic>Respiratory function</topic><topic>Respiratory Function Tests</topic><topic>Statistics, Nonparametric</topic><topic>Steroids</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nowak, Richard</creatorcontrib><creatorcontrib>Emerman, Charles</creatorcontrib><creatorcontrib>Hanrahan, John P.</creatorcontrib><creatorcontrib>Parsey, Merdad V.</creatorcontrib><creatorcontrib>Hanania, Nicola A.</creatorcontrib><creatorcontrib>Claus, Raymond</creatorcontrib><creatorcontrib>Schaefer, Kendyl</creatorcontrib><creatorcontrib>Baumgartner, Rudolf A.</creatorcontrib><creatorcontrib>for the XOPENEX Acute Severe Asthma Study Group</creatorcontrib><creatorcontrib>XOPENEX Acute Severe Asthma Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>The American journal of emergency medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nowak, Richard</au><au>Emerman, Charles</au><au>Hanrahan, John P.</au><au>Parsey, Merdad V.</au><au>Hanania, Nicola A.</au><au>Claus, Raymond</au><au>Schaefer, Kendyl</au><au>Baumgartner, Rudolf A.</au><aucorp>for the XOPENEX Acute Severe Asthma Study Group</aucorp><aucorp>XOPENEX Acute Severe Asthma Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A comparison of levalbuterol with racemic albuterol in the treatment of acute severe asthma exacerbations in adults</atitle><jtitle>The American journal of emergency medicine</jtitle><addtitle>Am J Emerg Med</addtitle><date>2006-05-01</date><risdate>2006</risdate><volume>24</volume><issue>3</issue><spage>259</spage><epage>267</epage><pages>259-267</pages><issn>0735-6757</issn><eissn>1532-8171</eissn><coden>AJEMEN</coden><abstract>This multicenter, randomized, double-blind trial compared nebulized levalbuterol (Lev) and racemic albuterol (Rac) in the treatment of acute asthma.
Adults with acute asthma exacerbations (FEV
1 20%-55% predicted) received prednisone and either Lev (1.25 mg, n = 315) or Rac (2.5 mg, n = 312). Nebulized treatments were administered every 20 minutes in the first hour, then every 40 minutes for 3 additional doses, then as necessary for up to 24 hours. The primary end point was time to meet discharge criteria. Secondary end points included changes in lung function and hospitalization rates. A subset of 160 patients had plasma (
S)-albuterol concentrations determined at study entry.
Time to meet discharge criteria did not differ between the 2 treatments. FEV
1 improvement was greater following Lev compared with Rac, both after dose 1 and cumulatively over the entire treatment period (dose 1 in intent to treat [ITT] group: Lev 0.50 ± 0.43 L, Rac 0.43 ± 0.37 L;
P = .02), particularly among the 60% of patients not on recent steroid therapy (dose 1: Lev 0.58 ± 0.47 L, Rac 0.44 ± 0.37 L;
P < .01), and patients whose entry (
S)-albuterol concentrations were in the highest quartile of those measured. A small and similar proportion of Lev-treated (7.0%) and Rac-treated (9.3%) patients required hospitalization (
P = .28). Among patients not on steroids, fewer Lev- than Rac-treated patients required admission (3.8% vs 9.3%,
P = .03), as was also the case for patients with high plasma (
S)-albuterol concentrations. Asthma relapses (5% in 30 days) were lower than in previous reports and did not differ between groups.
This study suggests that early, regular nebulized β
2-agonist and systemic corticosteroid therapy may reduce hospitalization and relapse rates in patients with acute severe asthma. Lev was well tolerated and compared favorably with Rac in improving airway function, particularly in those who were not on inhaled or oral corticosteroids and in those who had high plasma (
S)-albuterol concentrations at presentation.</abstract><cop>Philadelphia, PA</cop><pub>Elsevier Inc</pub><pmid>16635694</pmid><doi>10.1016/j.ajem.2006.01.027</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | The American journal of emergency medicine, 2006-05, Vol.24 (3), p.259-267 |
| issn | 0735-6757 1532-8171 |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Acute Disease Administration, Inhalation Adrenergic beta-Agonists - therapeutic use Adult Albuterol - therapeutic use Analysis of Variance Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Asthma Asthma - drug therapy Biological and medical sciences Bronchodilator Agents - therapeutic use Chronic obstructive pulmonary disease, asthma Clinics Corticoids Cost control Double-Blind Method Drug dosages Drug therapy Emergency and intensive respiratory care Emergency medical care Female Hospitalization Humans Intensive care medicine Male Medical sciences Nebulizers and Vaporizers Pneumology Prednisone - therapeutic use Prospective Studies Respiratory function Respiratory Function Tests Statistics, Nonparametric Steroids Treatment Outcome |
| title | A comparison of levalbuterol with racemic albuterol in the treatment of acute severe asthma exacerbations in adults |
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