Outcomes in idiopathic pulmonary fibrosis: A meta-analysis from placebo controlled trials
Summary Background Most data on outcomes in Idiopathic Pulmonary Fibrosis (IPF) pre-dates current guidelines. Data on rates of infection is sparse; the effect of low-dose corticosteroids and disease severity is unknown. Methods We identified randomised-controlled trials of IPF and analysed rates of...
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| Veröffentlicht in: | Respiratory medicine 2014-02, Vol.108 (2), p.376-387 |
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| description | Summary Background Most data on outcomes in Idiopathic Pulmonary Fibrosis (IPF) pre-dates current guidelines. Data on rates of infection is sparse; the effect of low-dose corticosteroids and disease severity is unknown. Methods We identified randomised-controlled trials of IPF and analysed rates of mortality, lower respiratory tract infections (LRTIs), IPF progression and acute exacerbations from the placebo arms. We standardised event rates and compared differences using incidence rate ratios (IRRs) between subgroups according to disease severity or use of low-dose immunosuppression. Results Mortality was lower in trials that recruited patients with mild-moderate disease severities only, as compared to trials where patients with severe disease were allowed (188.6 vs 78.6 deaths per 1000 patient/years, IRR 0.30–0.59, p |
| doi_str_mv | 10.1016/j.rmed.2013.11.007 |
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Data on rates of infection is sparse; the effect of low-dose corticosteroids and disease severity is unknown. Methods We identified randomised-controlled trials of IPF and analysed rates of mortality, lower respiratory tract infections (LRTIs), IPF progression and acute exacerbations from the placebo arms. We standardised event rates and compared differences using incidence rate ratios (IRRs) between subgroups according to disease severity or use of low-dose immunosuppression. Results Mortality was lower in trials that recruited patients with mild-moderate disease severities only, as compared to trials where patients with severe disease were allowed (188.6 vs 78.6 deaths per 1000 patient/years, IRR 0.30–0.59, p < 0.0001). No statistical difference was seen between trials permitting and excluding low-dose prednisolone use. LRTIs were found to be commoner in trials allowing low dose prednisolone use compared with those that did not (227.1 vs 63.4 infections per 1000 patient/years. IRR 2.56–5.13, p < 0.0001), and were less frequent in trials excluding patients with severe disease (153.9 vs 257.8 infections per 1000 patient/years, IRR 0.45–0.81, p = 0.0003). Acute exacerbations occurred less frequently in trials excluding severe disease (28.2 vs 122.9 exacerbations per 1000 patient/years, IRR 0.11–0.55, p < 0.0001). There was no difference between groups in rates of IPF progression. Conclusion Mortality is heterogeneous and dependent on entry criteria. Infection rates were high, both with and without immunosuppression, and were higher in severe disease. Consideration should be given to alternative outcomes to mortality in future IPF trials if severe disease is excluded.</description><identifier>ISSN: 0954-6111</identifier><identifier>EISSN: 1532-3064</identifier><identifier>DOI: 10.1016/j.rmed.2013.11.007</identifier><identifier>PMID: 24440032</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Aged ; Bias ; Clinical trials ; Confidence intervals ; Disease ; Disease Progression ; Drug therapy ; Humans ; Idiopathic pulmonary fibrosis ; Idiopathic Pulmonary Fibrosis - drug therapy ; Idiopathic Pulmonary Fibrosis - mortality ; Immunosuppressive Agents - adverse effects ; Infections ; Lung diseases, interstitial ; Meta-analysis ; Mortality ; Pneumonia ; Pulmonary fibrosis ; Pulmonary/Respiratory ; Randomized Controlled Trials as Topic ; Respiratory Tract Infections - chemically induced ; Studies ; Treatment Outcome</subject><ispartof>Respiratory medicine, 2014-02, Vol.108 (2), p.376-387</ispartof><rights>Elsevier Ltd</rights><rights>2013 Elsevier Ltd</rights><rights>Copyright © 2013 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Feb 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c549t-90ceddfecac69c4afdfcc6dd681c43d301ca7354e49f73a97069d88cecba9a73</citedby><cites>FETCH-LOGICAL-c549t-90ceddfecac69c4afdfcc6dd681c43d301ca7354e49f73a97069d88cecba9a73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0954611113004484$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,65309</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24440032$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Atkins, C.P</creatorcontrib><creatorcontrib>Loke, Y.K</creatorcontrib><creatorcontrib>Wilson, A.M</creatorcontrib><title>Outcomes in idiopathic pulmonary fibrosis: A meta-analysis from placebo controlled trials</title><title>Respiratory medicine</title><addtitle>Respir Med</addtitle><description>Summary Background Most data on outcomes in Idiopathic Pulmonary Fibrosis (IPF) pre-dates current guidelines. Data on rates of infection is sparse; the effect of low-dose corticosteroids and disease severity is unknown. Methods We identified randomised-controlled trials of IPF and analysed rates of mortality, lower respiratory tract infections (LRTIs), IPF progression and acute exacerbations from the placebo arms. We standardised event rates and compared differences using incidence rate ratios (IRRs) between subgroups according to disease severity or use of low-dose immunosuppression. Results Mortality was lower in trials that recruited patients with mild-moderate disease severities only, as compared to trials where patients with severe disease were allowed (188.6 vs 78.6 deaths per 1000 patient/years, IRR 0.30–0.59, p < 0.0001). No statistical difference was seen between trials permitting and excluding low-dose prednisolone use. LRTIs were found to be commoner in trials allowing low dose prednisolone use compared with those that did not (227.1 vs 63.4 infections per 1000 patient/years. IRR 2.56–5.13, p < 0.0001), and were less frequent in trials excluding patients with severe disease (153.9 vs 257.8 infections per 1000 patient/years, IRR 0.45–0.81, p = 0.0003). Acute exacerbations occurred less frequently in trials excluding severe disease (28.2 vs 122.9 exacerbations per 1000 patient/years, IRR 0.11–0.55, p < 0.0001). There was no difference between groups in rates of IPF progression. Conclusion Mortality is heterogeneous and dependent on entry criteria. Infection rates were high, both with and without immunosuppression, and were higher in severe disease. Consideration should be given to alternative outcomes to mortality in future IPF trials if severe disease is excluded.</description><subject>Aged</subject><subject>Bias</subject><subject>Clinical trials</subject><subject>Confidence intervals</subject><subject>Disease</subject><subject>Disease Progression</subject><subject>Drug therapy</subject><subject>Humans</subject><subject>Idiopathic pulmonary fibrosis</subject><subject>Idiopathic Pulmonary Fibrosis - drug therapy</subject><subject>Idiopathic Pulmonary Fibrosis - mortality</subject><subject>Immunosuppressive Agents - adverse effects</subject><subject>Infections</subject><subject>Lung diseases, interstitial</subject><subject>Meta-analysis</subject><subject>Mortality</subject><subject>Pneumonia</subject><subject>Pulmonary fibrosis</subject><subject>Pulmonary/Respiratory</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Respiratory Tract Infections - chemically induced</subject><subject>Studies</subject><subject>Treatment Outcome</subject><issn>0954-6111</issn><issn>1532-3064</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kUFrFDEUx4Modlv9Ah4k4MXLjC-T7MxGpFCKVaHQg714CtmXN5g1MxmTGWG_vRm2RejB04Pk9_7w_z3G3gioBYj2w6FOA7m6ASFrIWqA7hnbiK1sKgmtes42oLeqaoUQZ-w85wMAaKXgJTtrVJkgmw37cbfMGAfK3I_cOx8nO__0yKclDHG06ch7v08x-_yRX_GBZlvZ0YZjeeB9igOfgkXaR45xnFMMgRyfk7chv2Iv-jLo9cO8YPc3n--vv1a3d1--XV_dVrhVeq40IDnXE1psNSrbux6xda7dCVTSSRBoO7lVpHTfSas7aLXb7ZBwb3X5uWDvT7FTir8XyrMZfEYKwY4Ul2yE0lrIkiYL-u4JeohLKm0K1SrVdUq3olDNicJSOyfqzZT8UEwYAWb1bg5m9W5W70YIU7yXpbcP0ct-_XtceRRdgE8ngIqKP56SyehpLN19IpyNi_7_-ZdP1jH40aMNv-hI-V8PkxsD5vt6-fXwQgIotVPyL47SqhA</recordid><startdate>20140201</startdate><enddate>20140201</enddate><creator>Atkins, C.P</creator><creator>Loke, Y.K</creator><creator>Wilson, A.M</creator><general>Elsevier Ltd</general><general>Elsevier Limited</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>7U9</scope><scope>ASE</scope><scope>FPQ</scope><scope>H94</scope><scope>K6X</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20140201</creationdate><title>Outcomes in idiopathic pulmonary fibrosis: A meta-analysis from placebo controlled trials</title><author>Atkins, C.P ; Loke, Y.K ; Wilson, A.M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c549t-90ceddfecac69c4afdfcc6dd681c43d301ca7354e49f73a97069d88cecba9a73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Aged</topic><topic>Bias</topic><topic>Clinical trials</topic><topic>Confidence intervals</topic><topic>Disease</topic><topic>Disease Progression</topic><topic>Drug therapy</topic><topic>Humans</topic><topic>Idiopathic pulmonary fibrosis</topic><topic>Idiopathic Pulmonary Fibrosis - drug therapy</topic><topic>Idiopathic Pulmonary Fibrosis - mortality</topic><topic>Immunosuppressive Agents - adverse effects</topic><topic>Infections</topic><topic>Lung diseases, interstitial</topic><topic>Meta-analysis</topic><topic>Mortality</topic><topic>Pneumonia</topic><topic>Pulmonary fibrosis</topic><topic>Pulmonary/Respiratory</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Respiratory Tract Infections - chemically induced</topic><topic>Studies</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Atkins, C.P</creatorcontrib><creatorcontrib>Loke, Y.K</creatorcontrib><creatorcontrib>Wilson, A.M</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>Virology and AIDS Abstracts</collection><collection>British Nursing Index</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>British Nursing Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Respiratory medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Atkins, C.P</au><au>Loke, Y.K</au><au>Wilson, A.M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Outcomes in idiopathic pulmonary fibrosis: A meta-analysis from placebo controlled trials</atitle><jtitle>Respiratory medicine</jtitle><addtitle>Respir Med</addtitle><date>2014-02-01</date><risdate>2014</risdate><volume>108</volume><issue>2</issue><spage>376</spage><epage>387</epage><pages>376-387</pages><issn>0954-6111</issn><eissn>1532-3064</eissn><abstract>Summary Background Most data on outcomes in Idiopathic Pulmonary Fibrosis (IPF) pre-dates current guidelines. Data on rates of infection is sparse; the effect of low-dose corticosteroids and disease severity is unknown. Methods We identified randomised-controlled trials of IPF and analysed rates of mortality, lower respiratory tract infections (LRTIs), IPF progression and acute exacerbations from the placebo arms. We standardised event rates and compared differences using incidence rate ratios (IRRs) between subgroups according to disease severity or use of low-dose immunosuppression. Results Mortality was lower in trials that recruited patients with mild-moderate disease severities only, as compared to trials where patients with severe disease were allowed (188.6 vs 78.6 deaths per 1000 patient/years, IRR 0.30–0.59, p < 0.0001). No statistical difference was seen between trials permitting and excluding low-dose prednisolone use. LRTIs were found to be commoner in trials allowing low dose prednisolone use compared with those that did not (227.1 vs 63.4 infections per 1000 patient/years. IRR 2.56–5.13, p < 0.0001), and were less frequent in trials excluding patients with severe disease (153.9 vs 257.8 infections per 1000 patient/years, IRR 0.45–0.81, p = 0.0003). Acute exacerbations occurred less frequently in trials excluding severe disease (28.2 vs 122.9 exacerbations per 1000 patient/years, IRR 0.11–0.55, p < 0.0001). There was no difference between groups in rates of IPF progression. Conclusion Mortality is heterogeneous and dependent on entry criteria. Infection rates were high, both with and without immunosuppression, and were higher in severe disease. Consideration should be given to alternative outcomes to mortality in future IPF trials if severe disease is excluded.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>24440032</pmid><doi>10.1016/j.rmed.2013.11.007</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Bias Clinical trials Confidence intervals Disease Disease Progression Drug therapy Humans Idiopathic pulmonary fibrosis Idiopathic Pulmonary Fibrosis - drug therapy Idiopathic Pulmonary Fibrosis - mortality Immunosuppressive Agents - adverse effects Infections Lung diseases, interstitial Meta-analysis Mortality Pneumonia Pulmonary fibrosis Pulmonary/Respiratory Randomized Controlled Trials as Topic Respiratory Tract Infections - chemically induced Studies Treatment Outcome |
| title | Outcomes in idiopathic pulmonary fibrosis: A meta-analysis from placebo controlled trials |
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