Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study
ObjectiveTo assess the effect of sildenafil, a phosphodiesterase type 5 inhibitor, on digital ulcer (DU) healing in systemic sclerosis (SSc).MethodsRandomised, placebo-controlled study in patients with SSc to assess the effect of sildenafil 20 mg or placebo, three times daily for 12 weeks, on ischae...
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| Veröffentlicht in: | Annals of the rheumatic diseases 2016-06, Vol.75 (6), p.1009-1015 |
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| creator | Hachulla, Eric Hatron, Pierre-Yves Carpentier, Patrick Agard, Christian Chatelus, Emmanuel Jego, Patrick Mouthon, Luc Queyrel, Viviane Fauchais, Anne-Laure Michon-Pasturel, Ulrique Jaussaud, Roland Mathian, Alexis Granel, Brigitte Diot, Elisabeth Farge-Bancel, Dominique Mekinian, Arsène Avouac, Jérôme Desmurs-Clavel, Hélène Clerson, Pierre |
| description | ObjectiveTo assess the effect of sildenafil, a phosphodiesterase type 5 inhibitor, on digital ulcer (DU) healing in systemic sclerosis (SSc).MethodsRandomised, placebo-controlled study in patients with SSc to assess the effect of sildenafil 20 mg or placebo, three times daily for 12 weeks, on ischaemic DU healing. The primary end point was the time to healing for each DU. Time to healing was compared between groups using Cox models for clustered data (two-sided tests, p=0.05).ResultsIntention-to-treat analysis involved 83 patients with a total of 192 DUs (89 in the sildenafil group and 103 in the placebo group). The HR for DU healing was 1.33 (0.88 to 2.00) (p=0.18) and 1.27 (0.85 to 1.89) (p=0.25) when adjusted for the number of DUs at entry, in favour of sildenafil. In the per protocol population, the HRs were 1.49 (0.98 to 2.28) (p=0.06) and 1.43 (0.93 to 2.19) p=0.10. The mean number of DUs per patient was lower in the sildenafil group compared with the placebo group at week (W) 8 (1.23±1.61 vs 1.79±2.40 p=0.04) and W12 (0.86±1.62 vs 1.51±2.68, p=0.01) resulting from a greater healing rate (p=0.01 at W8 and p=0.03 at W12).ConclusionsThe primary end point was not reached in intention-to-treat, partly because of an unexpectedly high healing rate in the placebo group. We found a significant decrease in the number of DUs in favour of sildenafil compared with placebo at W8 and W12, confirming a sildenafil benefit.Trial registration numberNCT01295736. |
| doi_str_mv | 10.1136/annrheumdis-2014-207001 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4893100</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1788536869</sourcerecordid><originalsourceid>FETCH-LOGICAL-b548t-9ab98cad7f53b0f4b94de7429d5c3932ddcbe921a914663ca8c454be13e0c8353</originalsourceid><addsrcrecordid>eNqNkk-P1CAYxonRuOPoV1ASL3qoQoEWPGyyGUfXZBIPumdC4e2UCS1jaTeZby9j1826Jy8Q4Pf-e3gQekPJB0pZ9dEMw9jB3DufipJQnpeaEPoErSivZD5V5ClaEUJYwVVVX6AXKR3ykUgqn6OLUiglWFmu0LRtW2-NPeHY4uSDg8G0PuA4YJ9sZ6D3Fju_95MJeA4WRtyBCX7YYz_gdErTHyLZAGNMPn3CUwf4GIyFJhY2DtMYQwCHf2w_32y2OE2zO71Ez1oTEry629fo5sv25-a62H3_-m1ztSsaweVUKNMoaY2rW8Ea0vJGcQc1L5UTlilWOmcbUCU1Kg9dMWuk5YI3QBkQK5lga3S55D3OTQ_OQu7GBH0cfW_Gk47G639fBt_pfbzVXCpGs3hr9H5J0D0Ku77a6fMdOVemSt3SzL67KzbGXzOkSfdZQQjBDBDnpGktpWCVrFRG3z5CD3EehyxFphSTpRCqylS9UDYrm0Zo7zugRJ9doB-4QJ9doBcX5MjXD-e-j_v77RkoF6DpD_-d9TfVzcMh</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1793825596</pqid></control><display><type>article</type><title>Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study</title><source>MEDLINE</source><source>BMJ Journals - NESLi2</source><creator>Hachulla, Eric ; Hatron, Pierre-Yves ; Carpentier, Patrick ; Agard, Christian ; Chatelus, Emmanuel ; Jego, Patrick ; Mouthon, Luc ; Queyrel, Viviane ; Fauchais, Anne-Laure ; Michon-Pasturel, Ulrique ; Jaussaud, Roland ; Mathian, Alexis ; Granel, Brigitte ; Diot, Elisabeth ; Farge-Bancel, Dominique ; Mekinian, Arsène ; Avouac, Jérôme ; Desmurs-Clavel, Hélène ; Clerson, Pierre</creator><creatorcontrib>Hachulla, Eric ; Hatron, Pierre-Yves ; Carpentier, Patrick ; Agard, Christian ; Chatelus, Emmanuel ; Jego, Patrick ; Mouthon, Luc ; Queyrel, Viviane ; Fauchais, Anne-Laure ; Michon-Pasturel, Ulrique ; Jaussaud, Roland ; Mathian, Alexis ; Granel, Brigitte ; Diot, Elisabeth ; Farge-Bancel, Dominique ; Mekinian, Arsène ; Avouac, Jérôme ; Desmurs-Clavel, Hélène ; Clerson, Pierre ; SEDUCE study group</creatorcontrib><description>ObjectiveTo assess the effect of sildenafil, a phosphodiesterase type 5 inhibitor, on digital ulcer (DU) healing in systemic sclerosis (SSc).MethodsRandomised, placebo-controlled study in patients with SSc to assess the effect of sildenafil 20 mg or placebo, three times daily for 12 weeks, on ischaemic DU healing. The primary end point was the time to healing for each DU. Time to healing was compared between groups using Cox models for clustered data (two-sided tests, p=0.05).ResultsIntention-to-treat analysis involved 83 patients with a total of 192 DUs (89 in the sildenafil group and 103 in the placebo group). The HR for DU healing was 1.33 (0.88 to 2.00) (p=0.18) and 1.27 (0.85 to 1.89) (p=0.25) when adjusted for the number of DUs at entry, in favour of sildenafil. In the per protocol population, the HRs were 1.49 (0.98 to 2.28) (p=0.06) and 1.43 (0.93 to 2.19) p=0.10. The mean number of DUs per patient was lower in the sildenafil group compared with the placebo group at week (W) 8 (1.23±1.61 vs 1.79±2.40 p=0.04) and W12 (0.86±1.62 vs 1.51±2.68, p=0.01) resulting from a greater healing rate (p=0.01 at W8 and p=0.03 at W12).ConclusionsThe primary end point was not reached in intention-to-treat, partly because of an unexpectedly high healing rate in the placebo group. We found a significant decrease in the number of DUs in favour of sildenafil compared with placebo at W8 and W12, confirming a sildenafil benefit.Trial registration numberNCT01295736.</description><identifier>ISSN: 0003-4967</identifier><identifier>EISSN: 1468-2060</identifier><identifier>DOI: 10.1136/annrheumdis-2014-207001</identifier><identifier>PMID: 25995322</identifier><identifier>CODEN: ARDIAO</identifier><language>eng</language><publisher>England: Elsevier Limited</publisher><subject>Adult ; Clinical and Epidemiological Research ; Double-Blind Method ; Female ; Fingers - blood supply ; Flow velocity ; Humans ; Intention to Treat Analysis ; Ischemia ; Ischemia - drug therapy ; Ischemia - etiology ; Life Sciences ; Longitudinal Studies ; Male ; Middle Aged ; Patients ; Proportional Hazards Models ; Prospective Studies ; School dropout programs ; Scleroderma ; Scleroderma, Systemic - complications ; Sildenafil Citrate - administration & dosage ; Skin Ulcer - drug therapy ; Skin Ulcer - etiology ; Survival analysis ; Time Factors ; Treatment Outcome ; Ulcers ; Vasodilator Agents - administration & dosage</subject><ispartof>Annals of the rheumatic diseases, 2016-06, Vol.75 (6), p.1009-1015</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><rights>Copyright: 2016 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><rights>Attribution</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b548t-9ab98cad7f53b0f4b94de7429d5c3932ddcbe921a914663ca8c454be13e0c8353</citedby><cites>FETCH-LOGICAL-b548t-9ab98cad7f53b0f4b94de7429d5c3932ddcbe921a914663ca8c454be13e0c8353</cites><orcidid>0000-0001-7995-8817 ; 0000-0002-2463-218X ; 0000-0001-7432-847X ; 0000-0002-1156-0607 ; 0000-0002-7653-6528 ; 0000-0002-9838-246X ; 0000-0002-7360-6527 ; 0000-0002-3874-9119 ; 0000-0003-3507-8337 ; 0000-0003-2849-3049</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://ard.bmj.com/content/75/6/1009.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://ard.bmj.com/content/75/6/1009.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>114,115,230,314,776,780,881,3183,23550,27901,27902,77569,77600</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25995322$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://amu.hal.science/hal-01466199$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Hachulla, Eric</creatorcontrib><creatorcontrib>Hatron, Pierre-Yves</creatorcontrib><creatorcontrib>Carpentier, Patrick</creatorcontrib><creatorcontrib>Agard, Christian</creatorcontrib><creatorcontrib>Chatelus, Emmanuel</creatorcontrib><creatorcontrib>Jego, Patrick</creatorcontrib><creatorcontrib>Mouthon, Luc</creatorcontrib><creatorcontrib>Queyrel, Viviane</creatorcontrib><creatorcontrib>Fauchais, Anne-Laure</creatorcontrib><creatorcontrib>Michon-Pasturel, Ulrique</creatorcontrib><creatorcontrib>Jaussaud, Roland</creatorcontrib><creatorcontrib>Mathian, Alexis</creatorcontrib><creatorcontrib>Granel, Brigitte</creatorcontrib><creatorcontrib>Diot, Elisabeth</creatorcontrib><creatorcontrib>Farge-Bancel, Dominique</creatorcontrib><creatorcontrib>Mekinian, Arsène</creatorcontrib><creatorcontrib>Avouac, Jérôme</creatorcontrib><creatorcontrib>Desmurs-Clavel, Hélène</creatorcontrib><creatorcontrib>Clerson, Pierre</creatorcontrib><creatorcontrib>SEDUCE study group</creatorcontrib><title>Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study</title><title>Annals of the rheumatic diseases</title><addtitle>Ann Rheum Dis</addtitle><description>ObjectiveTo assess the effect of sildenafil, a phosphodiesterase type 5 inhibitor, on digital ulcer (DU) healing in systemic sclerosis (SSc).MethodsRandomised, placebo-controlled study in patients with SSc to assess the effect of sildenafil 20 mg or placebo, three times daily for 12 weeks, on ischaemic DU healing. The primary end point was the time to healing for each DU. Time to healing was compared between groups using Cox models for clustered data (two-sided tests, p=0.05).ResultsIntention-to-treat analysis involved 83 patients with a total of 192 DUs (89 in the sildenafil group and 103 in the placebo group). The HR for DU healing was 1.33 (0.88 to 2.00) (p=0.18) and 1.27 (0.85 to 1.89) (p=0.25) when adjusted for the number of DUs at entry, in favour of sildenafil. In the per protocol population, the HRs were 1.49 (0.98 to 2.28) (p=0.06) and 1.43 (0.93 to 2.19) p=0.10. The mean number of DUs per patient was lower in the sildenafil group compared with the placebo group at week (W) 8 (1.23±1.61 vs 1.79±2.40 p=0.04) and W12 (0.86±1.62 vs 1.51±2.68, p=0.01) resulting from a greater healing rate (p=0.01 at W8 and p=0.03 at W12).ConclusionsThe primary end point was not reached in intention-to-treat, partly because of an unexpectedly high healing rate in the placebo group. We found a significant decrease in the number of DUs in favour of sildenafil compared with placebo at W8 and W12, confirming a sildenafil benefit.Trial registration numberNCT01295736.</description><subject>Adult</subject><subject>Clinical and Epidemiological Research</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Fingers - blood supply</subject><subject>Flow velocity</subject><subject>Humans</subject><subject>Intention to Treat Analysis</subject><subject>Ischemia</subject><subject>Ischemia - drug therapy</subject><subject>Ischemia - etiology</subject><subject>Life Sciences</subject><subject>Longitudinal Studies</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Patients</subject><subject>Proportional Hazards Models</subject><subject>Prospective Studies</subject><subject>School dropout programs</subject><subject>Scleroderma</subject><subject>Scleroderma, Systemic - complications</subject><subject>Sildenafil Citrate - administration & dosage</subject><subject>Skin Ulcer - drug therapy</subject><subject>Skin Ulcer - etiology</subject><subject>Survival analysis</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Ulcers</subject><subject>Vasodilator Agents - administration & dosage</subject><issn>0003-4967</issn><issn>1468-2060</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNkk-P1CAYxonRuOPoV1ASL3qoQoEWPGyyGUfXZBIPumdC4e2UCS1jaTeZby9j1826Jy8Q4Pf-e3gQekPJB0pZ9dEMw9jB3DufipJQnpeaEPoErSivZD5V5ClaEUJYwVVVX6AXKR3ykUgqn6OLUiglWFmu0LRtW2-NPeHY4uSDg8G0PuA4YJ9sZ6D3Fju_95MJeA4WRtyBCX7YYz_gdErTHyLZAGNMPn3CUwf4GIyFJhY2DtMYQwCHf2w_32y2OE2zO71Ez1oTEry629fo5sv25-a62H3_-m1ztSsaweVUKNMoaY2rW8Ea0vJGcQc1L5UTlilWOmcbUCU1Kg9dMWuk5YI3QBkQK5lga3S55D3OTQ_OQu7GBH0cfW_Gk47G639fBt_pfbzVXCpGs3hr9H5J0D0Ku77a6fMdOVemSt3SzL67KzbGXzOkSfdZQQjBDBDnpGktpWCVrFRG3z5CD3EehyxFphSTpRCqylS9UDYrm0Zo7zugRJ9doB-4QJ9doBcX5MjXD-e-j_v77RkoF6DpD_-d9TfVzcMh</recordid><startdate>20160601</startdate><enddate>20160601</enddate><creator>Hachulla, Eric</creator><creator>Hatron, Pierre-Yves</creator><creator>Carpentier, Patrick</creator><creator>Agard, Christian</creator><creator>Chatelus, Emmanuel</creator><creator>Jego, Patrick</creator><creator>Mouthon, Luc</creator><creator>Queyrel, Viviane</creator><creator>Fauchais, Anne-Laure</creator><creator>Michon-Pasturel, Ulrique</creator><creator>Jaussaud, Roland</creator><creator>Mathian, Alexis</creator><creator>Granel, Brigitte</creator><creator>Diot, Elisabeth</creator><creator>Farge-Bancel, Dominique</creator><creator>Mekinian, Arsène</creator><creator>Avouac, Jérôme</creator><creator>Desmurs-Clavel, Hélène</creator><creator>Clerson, Pierre</creator><general>Elsevier Limited</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</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>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>M7P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-7995-8817</orcidid><orcidid>https://orcid.org/0000-0002-2463-218X</orcidid><orcidid>https://orcid.org/0000-0001-7432-847X</orcidid><orcidid>https://orcid.org/0000-0002-1156-0607</orcidid><orcidid>https://orcid.org/0000-0002-7653-6528</orcidid><orcidid>https://orcid.org/0000-0002-9838-246X</orcidid><orcidid>https://orcid.org/0000-0002-7360-6527</orcidid><orcidid>https://orcid.org/0000-0002-3874-9119</orcidid><orcidid>https://orcid.org/0000-0003-3507-8337</orcidid><orcidid>https://orcid.org/0000-0003-2849-3049</orcidid></search><sort><creationdate>20160601</creationdate><title>Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study</title><author>Hachulla, Eric ; Hatron, Pierre-Yves ; Carpentier, Patrick ; Agard, Christian ; Chatelus, Emmanuel ; Jego, Patrick ; Mouthon, Luc ; Queyrel, Viviane ; Fauchais, Anne-Laure ; Michon-Pasturel, Ulrique ; Jaussaud, Roland ; Mathian, Alexis ; Granel, Brigitte ; Diot, Elisabeth ; Farge-Bancel, Dominique ; Mekinian, Arsène ; Avouac, Jérôme ; Desmurs-Clavel, Hélène ; Clerson, Pierre</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b548t-9ab98cad7f53b0f4b94de7429d5c3932ddcbe921a914663ca8c454be13e0c8353</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Clinical and Epidemiological Research</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Fingers - blood supply</topic><topic>Flow velocity</topic><topic>Humans</topic><topic>Intention to Treat Analysis</topic><topic>Ischemia</topic><topic>Ischemia - drug therapy</topic><topic>Ischemia - etiology</topic><topic>Life Sciences</topic><topic>Longitudinal Studies</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Patients</topic><topic>Proportional Hazards Models</topic><topic>Prospective Studies</topic><topic>School dropout programs</topic><topic>Scleroderma</topic><topic>Scleroderma, Systemic - complications</topic><topic>Sildenafil Citrate - administration & dosage</topic><topic>Skin Ulcer - drug therapy</topic><topic>Skin Ulcer - etiology</topic><topic>Survival analysis</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Ulcers</topic><topic>Vasodilator Agents - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hachulla, Eric</creatorcontrib><creatorcontrib>Hatron, Pierre-Yves</creatorcontrib><creatorcontrib>Carpentier, Patrick</creatorcontrib><creatorcontrib>Agard, Christian</creatorcontrib><creatorcontrib>Chatelus, Emmanuel</creatorcontrib><creatorcontrib>Jego, Patrick</creatorcontrib><creatorcontrib>Mouthon, Luc</creatorcontrib><creatorcontrib>Queyrel, Viviane</creatorcontrib><creatorcontrib>Fauchais, Anne-Laure</creatorcontrib><creatorcontrib>Michon-Pasturel, Ulrique</creatorcontrib><creatorcontrib>Jaussaud, Roland</creatorcontrib><creatorcontrib>Mathian, Alexis</creatorcontrib><creatorcontrib>Granel, Brigitte</creatorcontrib><creatorcontrib>Diot, Elisabeth</creatorcontrib><creatorcontrib>Farge-Bancel, Dominique</creatorcontrib><creatorcontrib>Mekinian, Arsène</creatorcontrib><creatorcontrib>Avouac, Jérôme</creatorcontrib><creatorcontrib>Desmurs-Clavel, Hélène</creatorcontrib><creatorcontrib>Clerson, Pierre</creatorcontrib><creatorcontrib>SEDUCE study group</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals: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>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>BMJ Journals</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>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>Biological Science Database</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 China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Annals of the rheumatic diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hachulla, Eric</au><au>Hatron, Pierre-Yves</au><au>Carpentier, Patrick</au><au>Agard, Christian</au><au>Chatelus, Emmanuel</au><au>Jego, Patrick</au><au>Mouthon, Luc</au><au>Queyrel, Viviane</au><au>Fauchais, Anne-Laure</au><au>Michon-Pasturel, Ulrique</au><au>Jaussaud, Roland</au><au>Mathian, Alexis</au><au>Granel, Brigitte</au><au>Diot, Elisabeth</au><au>Farge-Bancel, Dominique</au><au>Mekinian, Arsène</au><au>Avouac, Jérôme</au><au>Desmurs-Clavel, Hélène</au><au>Clerson, Pierre</au><aucorp>SEDUCE study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study</atitle><jtitle>Annals of the rheumatic diseases</jtitle><addtitle>Ann Rheum Dis</addtitle><date>2016-06-01</date><risdate>2016</risdate><volume>75</volume><issue>6</issue><spage>1009</spage><epage>1015</epage><pages>1009-1015</pages><issn>0003-4967</issn><eissn>1468-2060</eissn><coden>ARDIAO</coden><abstract>ObjectiveTo assess the effect of sildenafil, a phosphodiesterase type 5 inhibitor, on digital ulcer (DU) healing in systemic sclerosis (SSc).MethodsRandomised, placebo-controlled study in patients with SSc to assess the effect of sildenafil 20 mg or placebo, three times daily for 12 weeks, on ischaemic DU healing. The primary end point was the time to healing for each DU. Time to healing was compared between groups using Cox models for clustered data (two-sided tests, p=0.05).ResultsIntention-to-treat analysis involved 83 patients with a total of 192 DUs (89 in the sildenafil group and 103 in the placebo group). The HR for DU healing was 1.33 (0.88 to 2.00) (p=0.18) and 1.27 (0.85 to 1.89) (p=0.25) when adjusted for the number of DUs at entry, in favour of sildenafil. In the per protocol population, the HRs were 1.49 (0.98 to 2.28) (p=0.06) and 1.43 (0.93 to 2.19) p=0.10. The mean number of DUs per patient was lower in the sildenafil group compared with the placebo group at week (W) 8 (1.23±1.61 vs 1.79±2.40 p=0.04) and W12 (0.86±1.62 vs 1.51±2.68, p=0.01) resulting from a greater healing rate (p=0.01 at W8 and p=0.03 at W12).ConclusionsThe primary end point was not reached in intention-to-treat, partly because of an unexpectedly high healing rate in the placebo group. We found a significant decrease in the number of DUs in favour of sildenafil compared with placebo at W8 and W12, confirming a sildenafil benefit.Trial registration numberNCT01295736.</abstract><cop>England</cop><pub>Elsevier Limited</pub><pmid>25995322</pmid><doi>10.1136/annrheumdis-2014-207001</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-7995-8817</orcidid><orcidid>https://orcid.org/0000-0002-2463-218X</orcidid><orcidid>https://orcid.org/0000-0001-7432-847X</orcidid><orcidid>https://orcid.org/0000-0002-1156-0607</orcidid><orcidid>https://orcid.org/0000-0002-7653-6528</orcidid><orcidid>https://orcid.org/0000-0002-9838-246X</orcidid><orcidid>https://orcid.org/0000-0002-7360-6527</orcidid><orcidid>https://orcid.org/0000-0002-3874-9119</orcidid><orcidid>https://orcid.org/0000-0003-3507-8337</orcidid><orcidid>https://orcid.org/0000-0003-2849-3049</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0003-4967 |
| ispartof | Annals of the rheumatic diseases, 2016-06, Vol.75 (6), p.1009-1015 |
| issn | 0003-4967 1468-2060 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4893100 |
| source | MEDLINE; BMJ Journals - NESLi2 |
| subjects | Adult Clinical and Epidemiological Research Double-Blind Method Female Fingers - blood supply Flow velocity Humans Intention to Treat Analysis Ischemia Ischemia - drug therapy Ischemia - etiology Life Sciences Longitudinal Studies Male Middle Aged Patients Proportional Hazards Models Prospective Studies School dropout programs Scleroderma Scleroderma, Systemic - complications Sildenafil Citrate - administration & dosage Skin Ulcer - drug therapy Skin Ulcer - etiology Survival analysis Time Factors Treatment Outcome Ulcers Vasodilator Agents - administration & dosage |
| title | Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-15T06%3A56%3A48IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy%20of%20sildenafil%20on%20ischaemic%20digital%20ulcer%20healing%20in%20systemic%20sclerosis:%20the%20placebo-controlled%20SEDUCE%20study&rft.jtitle=Annals%20of%20the%20rheumatic%20diseases&rft.au=Hachulla,%20Eric&rft.aucorp=SEDUCE%20study%20group&rft.date=2016-06-01&rft.volume=75&rft.issue=6&rft.spage=1009&rft.epage=1015&rft.pages=1009-1015&rft.issn=0003-4967&rft.eissn=1468-2060&rft.coden=ARDIAO&rft_id=info:doi/10.1136/annrheumdis-2014-207001&rft_dat=%3Cproquest_pubme%3E1788536869%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1793825596&rft_id=info:pmid/25995322&rfr_iscdi=true |