Simvastatin as a novel therapeutic agent for venous ulcers: a randomized, double-blind, placebo-controlled trial
Summary Background Although the standard treatment for venous ulcers is compression, drugs may be used as adjunctive therapy. Simvastatin has shown potential wound‐healing properties; however, no studies have investigated its use in venous ulcers. Objectives To assess the efficacy and safety of simv...
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| Veröffentlicht in: | British journal of dermatology (1951) 2014-05, Vol.170 (5), p.1151-1157 |
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| container_title | British journal of dermatology (1951) |
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| creator | Evangelista, M.T.P. Casintahan, M.F.A. Villafuerte, L.L. |
| description | Summary
Background
Although the standard treatment for venous ulcers is compression, drugs may be used as adjunctive therapy. Simvastatin has shown potential wound‐healing properties; however, no studies have investigated its use in venous ulcers.
Objectives
To assess the efficacy and safety of simvastatin in venous ulcer healing when combined with standard treatment for ulcers.
Methods
This was a randomized, double‐blind, placebo‐controlled trial. Outcome measures were the proportion of healed ulcers, healing time, total surface area healed and Dermatology Life Quality Index (DLQI) scores.
Results
Sixty‐six patients were randomized into two groups: a simvastatin (n = 32) and a control (n = 34) group. Among ulcers ≤ 5 cm, 100% were healed in the simvastatin group, and 50% were healed in the control group [relative risk (RR) 0·10, 95% confidence interval (CI) 0·0141–0·707]. The average healing times for ulcers ≤ 5 cm were 6·89 ± 0·78 weeks and 8·40 ± 1·13 weeks for the simvastatin and control groups, respectively (P 5 cm, 67% closed in the simvastatin group, with a mean healing time of 9·17 ± 1·07 weeks. No ulcers of this size closed in the control group (RR 0·33, 95% CI 0·132–0·840). The simvastatin group had lower DLQI scores (P |
| doi_str_mv | 10.1111/bjd.12883 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1526732934</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1526732934</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4283-47bfb45a7722530cf7b5b0b9b1735f81472baa99e53018347ede6db275fa90773</originalsourceid><addsrcrecordid>eNp1kE1v1DAQhi0EotvCgT-AfEGiEmn9EcdJb1DY8rGCAyAkLpbtTMDFiYPtLJRfj2G35cRcrJGfmdH7IPSAkhNa6tRc9ieUtS2_hVaUN6JilPPbaEUIkRXpGn6ADlO6JIRyIshddMBqQZqW1ys0v3fjVqess5uwTljjKWzB4_wVop5hyc5i_QWmjIcQ8RamsCS8eAsxnRU46qkPo_sF_RPch8V4qIx3U-lmry2YUNkw5Ri8hx7n6LS_h-4M2ie4v3-P0Mf1iw_nL6vNu4tX5083la1Zy6tamsHUQkvJmODEDtIIQ0xnqORiaGktmdG666B80pJEQg9Nb5gUg-6IlPwIPd7tnWP4vkDKanTJgvd6gpJBUcEayVnH64Ie71AbQ0oRBjVHN-p4pShRfwSrIlj9FVzYh_u1ixmhvyGvjRbg0R7QyWo_FEPWpX9cKwSjLSnc6Y774Txc_f-ievb6-fXpajfhUoafNxM6flMliRTq09sLtW7l5o34vFaE_waWM6Dc</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1526732934</pqid></control><display><type>article</type><title>Simvastatin as a novel therapeutic agent for venous ulcers: a randomized, double-blind, placebo-controlled trial</title><source>MEDLINE</source><source>Access via Wiley Online Library</source><source>Oxford University Press Journals All Titles (1996-Current)</source><creator>Evangelista, M.T.P. ; Casintahan, M.F.A. ; Villafuerte, L.L.</creator><creatorcontrib>Evangelista, M.T.P. ; Casintahan, M.F.A. ; Villafuerte, L.L.</creatorcontrib><description>Summary
Background
Although the standard treatment for venous ulcers is compression, drugs may be used as adjunctive therapy. Simvastatin has shown potential wound‐healing properties; however, no studies have investigated its use in venous ulcers.
Objectives
To assess the efficacy and safety of simvastatin in venous ulcer healing when combined with standard treatment for ulcers.
Methods
This was a randomized, double‐blind, placebo‐controlled trial. Outcome measures were the proportion of healed ulcers, healing time, total surface area healed and Dermatology Life Quality Index (DLQI) scores.
Results
Sixty‐six patients were randomized into two groups: a simvastatin (n = 32) and a control (n = 34) group. Among ulcers ≤ 5 cm, 100% were healed in the simvastatin group, and 50% were healed in the control group [relative risk (RR) 0·10, 95% confidence interval (CI) 0·0141–0·707]. The average healing times for ulcers ≤ 5 cm were 6·89 ± 0·78 weeks and 8·40 ± 1·13 weeks for the simvastatin and control groups, respectively (P < 0·001). Among ulcers > 5 cm, 67% closed in the simvastatin group, with a mean healing time of 9·17 ± 1·07 weeks. No ulcers of this size closed in the control group (RR 0·33, 95% CI 0·132–0·840). The simvastatin group had lower DLQI scores (P < 0·001) post‐treatment. No adverse effects were documented.
Conclusions
Simvastatin 40 mg daily, in addition to standard wound care and compression, is associated with a significant improvement in healing rate and time, as well as an improved patient quality of life when compared with placebo in the management of venous ulcers.
What's already known about this topic?
The standard treatment for venous ulcers is compression therapy, but drugs may be used as adjunctive therapy to accelerate the healing process.
Statins are cholesterol‐lowering drugs that may also have pleiotropic effects, which accelerate wound healing. However, supporting evidence for this is mainly from animal studies.
There are no previous studies investigating the use of statins for venous ulcers.
What does this study add?
This is the first study to investigate the use of statins (simvastatin 40 mg daily) in venous ulcer healing.
This randomized, double‐blind, placebo‐controlled trial showed that simvastatin, in addition to standard wound care and compression, is associated with a significant improvement in healing rate and time, as well as an improved patient quality of life when compared with placebo in the management of venous ulcers. No adverse effects were documented.</description><identifier>ISSN: 0007-0963</identifier><identifier>EISSN: 1365-2133</identifier><identifier>DOI: 10.1111/bjd.12883</identifier><identifier>PMID: 24506834</identifier><identifier>CODEN: BJDEAZ</identifier><language>eng</language><publisher>Oxford: Blackwell Publishing Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Biological and medical sciences ; Cardiovascular Agents - administration & dosage ; Dermatologic Agents - administration & dosage ; Dermatology ; Double-Blind Method ; Female ; Humans ; Male ; Medical sciences ; Middle Aged ; Simvastatin - administration & dosage ; Treatment Outcome ; Varicose Ulcer - drug therapy ; Wound Healing - drug effects ; Young Adult</subject><ispartof>British journal of dermatology (1951), 2014-05, Vol.170 (5), p.1151-1157</ispartof><rights>2014 British Association of Dermatologists</rights><rights>2015 INIST-CNRS</rights><rights>2014 British Association of Dermatologists.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4283-47bfb45a7722530cf7b5b0b9b1735f81472baa99e53018347ede6db275fa90773</citedby><cites>FETCH-LOGICAL-c4283-47bfb45a7722530cf7b5b0b9b1735f81472baa99e53018347ede6db275fa90773</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbjd.12883$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbjd.12883$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28552180$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24506834$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Evangelista, M.T.P.</creatorcontrib><creatorcontrib>Casintahan, M.F.A.</creatorcontrib><creatorcontrib>Villafuerte, L.L.</creatorcontrib><title>Simvastatin as a novel therapeutic agent for venous ulcers: a randomized, double-blind, placebo-controlled trial</title><title>British journal of dermatology (1951)</title><addtitle>Br J Dermatol</addtitle><description>Summary
Background
Although the standard treatment for venous ulcers is compression, drugs may be used as adjunctive therapy. Simvastatin has shown potential wound‐healing properties; however, no studies have investigated its use in venous ulcers.
Objectives
To assess the efficacy and safety of simvastatin in venous ulcer healing when combined with standard treatment for ulcers.
Methods
This was a randomized, double‐blind, placebo‐controlled trial. Outcome measures were the proportion of healed ulcers, healing time, total surface area healed and Dermatology Life Quality Index (DLQI) scores.
Results
Sixty‐six patients were randomized into two groups: a simvastatin (n = 32) and a control (n = 34) group. Among ulcers ≤ 5 cm, 100% were healed in the simvastatin group, and 50% were healed in the control group [relative risk (RR) 0·10, 95% confidence interval (CI) 0·0141–0·707]. The average healing times for ulcers ≤ 5 cm were 6·89 ± 0·78 weeks and 8·40 ± 1·13 weeks for the simvastatin and control groups, respectively (P < 0·001). Among ulcers > 5 cm, 67% closed in the simvastatin group, with a mean healing time of 9·17 ± 1·07 weeks. No ulcers of this size closed in the control group (RR 0·33, 95% CI 0·132–0·840). The simvastatin group had lower DLQI scores (P < 0·001) post‐treatment. No adverse effects were documented.
Conclusions
Simvastatin 40 mg daily, in addition to standard wound care and compression, is associated with a significant improvement in healing rate and time, as well as an improved patient quality of life when compared with placebo in the management of venous ulcers.
What's already known about this topic?
The standard treatment for venous ulcers is compression therapy, but drugs may be used as adjunctive therapy to accelerate the healing process.
Statins are cholesterol‐lowering drugs that may also have pleiotropic effects, which accelerate wound healing. However, supporting evidence for this is mainly from animal studies.
There are no previous studies investigating the use of statins for venous ulcers.
What does this study add?
This is the first study to investigate the use of statins (simvastatin 40 mg daily) in venous ulcer healing.
This randomized, double‐blind, placebo‐controlled trial showed that simvastatin, in addition to standard wound care and compression, is associated with a significant improvement in healing rate and time, as well as an improved patient quality of life when compared with placebo in the management of venous ulcers. No adverse effects were documented.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biological and medical sciences</subject><subject>Cardiovascular Agents - administration & dosage</subject><subject>Dermatologic Agents - administration & dosage</subject><subject>Dermatology</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Simvastatin - administration & dosage</subject><subject>Treatment Outcome</subject><subject>Varicose Ulcer - drug therapy</subject><subject>Wound Healing - drug effects</subject><subject>Young Adult</subject><issn>0007-0963</issn><issn>1365-2133</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kE1v1DAQhi0EotvCgT-AfEGiEmn9EcdJb1DY8rGCAyAkLpbtTMDFiYPtLJRfj2G35cRcrJGfmdH7IPSAkhNa6tRc9ieUtS2_hVaUN6JilPPbaEUIkRXpGn6ADlO6JIRyIshddMBqQZqW1ys0v3fjVqess5uwTljjKWzB4_wVop5hyc5i_QWmjIcQ8RamsCS8eAsxnRU46qkPo_sF_RPch8V4qIx3U-lmry2YUNkw5Ri8hx7n6LS_h-4M2ie4v3-P0Mf1iw_nL6vNu4tX5083la1Zy6tamsHUQkvJmODEDtIIQ0xnqORiaGktmdG666B80pJEQg9Nb5gUg-6IlPwIPd7tnWP4vkDKanTJgvd6gpJBUcEayVnH64Ie71AbQ0oRBjVHN-p4pShRfwSrIlj9FVzYh_u1ixmhvyGvjRbg0R7QyWo_FEPWpX9cKwSjLSnc6Y774Txc_f-ievb6-fXpajfhUoafNxM6flMliRTq09sLtW7l5o34vFaE_waWM6Dc</recordid><startdate>201405</startdate><enddate>201405</enddate><creator>Evangelista, M.T.P.</creator><creator>Casintahan, M.F.A.</creator><creator>Villafuerte, L.L.</creator><general>Blackwell Publishing Ltd</general><general>Wiley-Blackwell</general><scope>BSCLL</scope><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>7X8</scope></search><sort><creationdate>201405</creationdate><title>Simvastatin as a novel therapeutic agent for venous ulcers: a randomized, double-blind, placebo-controlled trial</title><author>Evangelista, M.T.P. ; Casintahan, M.F.A. ; Villafuerte, L.L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4283-47bfb45a7722530cf7b5b0b9b1735f81472baa99e53018347ede6db275fa90773</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biological and medical sciences</topic><topic>Cardiovascular Agents - administration & dosage</topic><topic>Dermatologic Agents - administration & dosage</topic><topic>Dermatology</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Simvastatin - administration & dosage</topic><topic>Treatment Outcome</topic><topic>Varicose Ulcer - drug therapy</topic><topic>Wound Healing - drug effects</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Evangelista, M.T.P.</creatorcontrib><creatorcontrib>Casintahan, M.F.A.</creatorcontrib><creatorcontrib>Villafuerte, L.L.</creatorcontrib><collection>Istex</collection><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>MEDLINE - Academic</collection><jtitle>British journal of dermatology (1951)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Evangelista, M.T.P.</au><au>Casintahan, M.F.A.</au><au>Villafuerte, L.L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Simvastatin as a novel therapeutic agent for venous ulcers: a randomized, double-blind, placebo-controlled trial</atitle><jtitle>British journal of dermatology (1951)</jtitle><addtitle>Br J Dermatol</addtitle><date>2014-05</date><risdate>2014</risdate><volume>170</volume><issue>5</issue><spage>1151</spage><epage>1157</epage><pages>1151-1157</pages><issn>0007-0963</issn><eissn>1365-2133</eissn><coden>BJDEAZ</coden><abstract>Summary
Background
Although the standard treatment for venous ulcers is compression, drugs may be used as adjunctive therapy. Simvastatin has shown potential wound‐healing properties; however, no studies have investigated its use in venous ulcers.
Objectives
To assess the efficacy and safety of simvastatin in venous ulcer healing when combined with standard treatment for ulcers.
Methods
This was a randomized, double‐blind, placebo‐controlled trial. Outcome measures were the proportion of healed ulcers, healing time, total surface area healed and Dermatology Life Quality Index (DLQI) scores.
Results
Sixty‐six patients were randomized into two groups: a simvastatin (n = 32) and a control (n = 34) group. Among ulcers ≤ 5 cm, 100% were healed in the simvastatin group, and 50% were healed in the control group [relative risk (RR) 0·10, 95% confidence interval (CI) 0·0141–0·707]. The average healing times for ulcers ≤ 5 cm were 6·89 ± 0·78 weeks and 8·40 ± 1·13 weeks for the simvastatin and control groups, respectively (P < 0·001). Among ulcers > 5 cm, 67% closed in the simvastatin group, with a mean healing time of 9·17 ± 1·07 weeks. No ulcers of this size closed in the control group (RR 0·33, 95% CI 0·132–0·840). The simvastatin group had lower DLQI scores (P < 0·001) post‐treatment. No adverse effects were documented.
Conclusions
Simvastatin 40 mg daily, in addition to standard wound care and compression, is associated with a significant improvement in healing rate and time, as well as an improved patient quality of life when compared with placebo in the management of venous ulcers.
What's already known about this topic?
The standard treatment for venous ulcers is compression therapy, but drugs may be used as adjunctive therapy to accelerate the healing process.
Statins are cholesterol‐lowering drugs that may also have pleiotropic effects, which accelerate wound healing. However, supporting evidence for this is mainly from animal studies.
There are no previous studies investigating the use of statins for venous ulcers.
What does this study add?
This is the first study to investigate the use of statins (simvastatin 40 mg daily) in venous ulcer healing.
This randomized, double‐blind, placebo‐controlled trial showed that simvastatin, in addition to standard wound care and compression, is associated with a significant improvement in healing rate and time, as well as an improved patient quality of life when compared with placebo in the management of venous ulcers. No adverse effects were documented.</abstract><cop>Oxford</cop><pub>Blackwell Publishing Ltd</pub><pmid>24506834</pmid><doi>10.1111/bjd.12883</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Aged Aged, 80 and over Biological and medical sciences Cardiovascular Agents - administration & dosage Dermatologic Agents - administration & dosage Dermatology Double-Blind Method Female Humans Male Medical sciences Middle Aged Simvastatin - administration & dosage Treatment Outcome Varicose Ulcer - drug therapy Wound Healing - drug effects Young Adult |
| title | Simvastatin as a novel therapeutic agent for venous ulcers: a randomized, double-blind, placebo-controlled trial |
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