Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial

Objective The aim of this work was to assess efficacy and tolerability of simvastatin plus vitamin D for migraine prevention in adults with episodic migraine. Methods We performed a randomized, double‐blind, placebo‐controlled trial with a 12‐week baseline period and 24‐week intervention period in 5...

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Veröffentlicht in:Annals of neurology 2015-12, Vol.78 (6), p.970-981
Hauptverfasser: Buettner, Catherine, Nir, Rony-Reuven, Bertisch, Suzanne M., Bernstein, Carolyn, Schain, Aaron, Mittleman, Murray A., Burstein, Rami
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container_end_page 981
container_issue 6
container_start_page 970
container_title Annals of neurology
container_volume 78
creator Buettner, Catherine
Nir, Rony-Reuven
Bertisch, Suzanne M.
Bernstein, Carolyn
Schain, Aaron
Mittleman, Murray A.
Burstein, Rami
description Objective The aim of this work was to assess efficacy and tolerability of simvastatin plus vitamin D for migraine prevention in adults with episodic migraine. Methods We performed a randomized, double‐blind, placebo‐controlled trial with a 12‐week baseline period and 24‐week intervention period in 57 adults with episodic migraine. Participants were randomly assigned to simvastatin 20 mg tablets twice‐daily plus vitamin D3 1,000 international units capsules twice‐daily or matching placebo tablets and capsules. Results Compared to placebo, participants using simvastatin plus vitamin D3 demonstrated a greater decrease in number of migraine days from the baseline period to intervention weeks 1 to 12: a change of –8.0 (interquartile range [IQR]: −15.0 to −2.0) days in the active treatment group versus +1.0 (IQR: −1.0 to + 6.0) days in the placebo group, p 
doi_str_mv 10.1002/ana.24534
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Methods We performed a randomized, double‐blind, placebo‐controlled trial with a 12‐week baseline period and 24‐week intervention period in 57 adults with episodic migraine. Participants were randomly assigned to simvastatin 20 mg tablets twice‐daily plus vitamin D3 1,000 international units capsules twice‐daily or matching placebo tablets and capsules. Results Compared to placebo, participants using simvastatin plus vitamin D3 demonstrated a greater decrease in number of migraine days from the baseline period to intervention weeks 1 to 12: a change of –8.0 (interquartile range [IQR]: −15.0 to −2.0) days in the active treatment group versus +1.0 (IQR: −1.0 to + 6.0) days in the placebo group, p &lt; 0.001; and to intervention weeks 13 to 24: a change of −9.0 (IQR: −13 to −5) days in the active group versus +3.0 (IQR: −1.0 to + 5.0) days in the placebo group, p &lt; 0.001. In the active treatment group, 8 patients (25%) experienced 50% reduction in the number of migraine days at 12 weeks and 9 (29%) at 24 weeks postrandomization. In comparison, only 1 patient (3%) in the placebo group (p = 0.03) experienced such a reduction. Adverse events were similar in both active treatment and placebo groups. Interpretation The results demonstrate that simvastatin plus vitamin D is effective for prevention of headache in adults with episodic migraine. Given statins' ability to repair endothelial dysfunction, this economical approach may also reduce the increased risk for vascular diseases among migraineurs. Ann Neurol 2015;78:970–981</description><identifier>ISSN: 0364-5134</identifier><identifier>EISSN: 1531-8249</identifier><identifier>DOI: 10.1002/ana.24534</identifier><identifier>PMID: 26418341</identifier><language>eng</language><publisher>United States: Blackwell Publishing Ltd</publisher><subject>Adult ; Cholecalciferol - administration &amp; dosage ; Cholecalciferol - adverse effects ; Cholecalciferol - pharmacology ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration &amp; dosage ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - pharmacology ; Male ; Middle Aged ; Migraine ; Migraine Disorders - prevention &amp; control ; Outcome Assessment (Health Care) ; Placebo effect ; Simvastatin - administration &amp; dosage ; Simvastatin - adverse effects ; Simvastatin - pharmacology ; Vitamin D ; Young Adult</subject><ispartof>Annals of neurology, 2015-12, Vol.78 (6), p.970-981</ispartof><rights>2015 American Neurological Association</rights><rights>2015 American Neurological Association.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5404-36edf4257794fd1ffa19d825fff16873030215f3932f60421b4b2d95a14ce9a03</citedby><cites>FETCH-LOGICAL-c5404-36edf4257794fd1ffa19d825fff16873030215f3932f60421b4b2d95a14ce9a03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fana.24534$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fana.24534$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26418341$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Buettner, Catherine</creatorcontrib><creatorcontrib>Nir, Rony-Reuven</creatorcontrib><creatorcontrib>Bertisch, Suzanne M.</creatorcontrib><creatorcontrib>Bernstein, Carolyn</creatorcontrib><creatorcontrib>Schain, Aaron</creatorcontrib><creatorcontrib>Mittleman, Murray A.</creatorcontrib><creatorcontrib>Burstein, Rami</creatorcontrib><title>Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial</title><title>Annals of neurology</title><addtitle>Ann Neurol</addtitle><description>Objective The aim of this work was to assess efficacy and tolerability of simvastatin plus vitamin D for migraine prevention in adults with episodic migraine. Methods We performed a randomized, double‐blind, placebo‐controlled trial with a 12‐week baseline period and 24‐week intervention period in 57 adults with episodic migraine. Participants were randomly assigned to simvastatin 20 mg tablets twice‐daily plus vitamin D3 1,000 international units capsules twice‐daily or matching placebo tablets and capsules. Results Compared to placebo, participants using simvastatin plus vitamin D3 demonstrated a greater decrease in number of migraine days from the baseline period to intervention weeks 1 to 12: a change of –8.0 (interquartile range [IQR]: −15.0 to −2.0) days in the active treatment group versus +1.0 (IQR: −1.0 to + 6.0) days in the placebo group, p &lt; 0.001; and to intervention weeks 13 to 24: a change of −9.0 (IQR: −13 to −5) days in the active group versus +3.0 (IQR: −1.0 to + 5.0) days in the placebo group, p &lt; 0.001. In the active treatment group, 8 patients (25%) experienced 50% reduction in the number of migraine days at 12 weeks and 9 (29%) at 24 weeks postrandomization. In comparison, only 1 patient (3%) in the placebo group (p = 0.03) experienced such a reduction. Adverse events were similar in both active treatment and placebo groups. Interpretation The results demonstrate that simvastatin plus vitamin D is effective for prevention of headache in adults with episodic migraine. Given statins' ability to repair endothelial dysfunction, this economical approach may also reduce the increased risk for vascular diseases among migraineurs. Ann Neurol 2015;78:970–981</description><subject>Adult</subject><subject>Cholecalciferol - administration &amp; dosage</subject><subject>Cholecalciferol - adverse effects</subject><subject>Cholecalciferol - pharmacology</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration &amp; dosage</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - pharmacology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Migraine</subject><subject>Migraine Disorders - prevention &amp; control</subject><subject>Outcome Assessment (Health Care)</subject><subject>Placebo effect</subject><subject>Simvastatin - administration &amp; dosage</subject><subject>Simvastatin - adverse effects</subject><subject>Simvastatin - pharmacology</subject><subject>Vitamin D</subject><subject>Young Adult</subject><issn>0364-5134</issn><issn>1531-8249</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkV1rFDEUhkNR2rX1wj8gAW8qOO3J94wXhbVqW1gqUj_Am5CdSWrqTLIms6v11xu77aKC4E0SyHMezjkvQo8IHBAAemiCOaBcML6FJkQwUtWUN_fQBJjklSCM76AHOV8BQCMJbKMdKjmpGScT9PbCDyuTRzP6gE3o8MqPZijvl9jFhAd_mYwPFi-SXdkw-hie4ylOhYyD_2G7Z7iNYUyx722Hx-RNv4fuO9Nn-_D23kXvX796d3xazd6cnB1PZ1UrOPCKSds5ToVSDXcdcc6QpqupcM4RWSsGDCgRjjWMOgmckjmf064RhvDWNgbYLjpaexfL-WC7tnSXTK8XyQ8mXetovP7zJ_jP-jKuNFdECCGLYP9WkOLXpc2jHnxubd-bYOMya6KUlJJzYP-BSqhrJYQq6JO_0Ku4TKFsolBCgYByFOrpmmpTzDlZt-mbgP6VqS6Z6ptMC_v490E35F2IBThcA998b6__bdLT8-mdslpX-Dza75sKk75oqZgS-uP5iZ59uChrUp_0C_YTMZO5GA</recordid><startdate>201512</startdate><enddate>201512</enddate><creator>Buettner, Catherine</creator><creator>Nir, Rony-Reuven</creator><creator>Bertisch, Suzanne M.</creator><creator>Bernstein, Carolyn</creator><creator>Schain, Aaron</creator><creator>Mittleman, Murray A.</creator><creator>Burstein, Rami</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</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>7TK</scope><scope>7U7</scope><scope>C1K</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201512</creationdate><title>Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial</title><author>Buettner, Catherine ; Nir, Rony-Reuven ; Bertisch, Suzanne M. ; Bernstein, Carolyn ; Schain, Aaron ; Mittleman, Murray A. ; Burstein, Rami</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5404-36edf4257794fd1ffa19d825fff16873030215f3932f60421b4b2d95a14ce9a03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Cholecalciferol - administration &amp; dosage</topic><topic>Cholecalciferol - adverse effects</topic><topic>Cholecalciferol - pharmacology</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Humans</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration &amp; dosage</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - pharmacology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Migraine</topic><topic>Migraine Disorders - prevention &amp; control</topic><topic>Outcome Assessment (Health Care)</topic><topic>Placebo effect</topic><topic>Simvastatin - administration &amp; dosage</topic><topic>Simvastatin - adverse effects</topic><topic>Simvastatin - pharmacology</topic><topic>Vitamin D</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Buettner, Catherine</creatorcontrib><creatorcontrib>Nir, Rony-Reuven</creatorcontrib><creatorcontrib>Bertisch, Suzanne M.</creatorcontrib><creatorcontrib>Bernstein, Carolyn</creatorcontrib><creatorcontrib>Schain, Aaron</creatorcontrib><creatorcontrib>Mittleman, Murray A.</creatorcontrib><creatorcontrib>Burstein, Rami</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest Health &amp; 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In the active treatment group, 8 patients (25%) experienced 50% reduction in the number of migraine days at 12 weeks and 9 (29%) at 24 weeks postrandomization. In comparison, only 1 patient (3%) in the placebo group (p = 0.03) experienced such a reduction. Adverse events were similar in both active treatment and placebo groups. Interpretation The results demonstrate that simvastatin plus vitamin D is effective for prevention of headache in adults with episodic migraine. Given statins' ability to repair endothelial dysfunction, this economical approach may also reduce the increased risk for vascular diseases among migraineurs. Ann Neurol 2015;78:970–981</abstract><cop>United States</cop><pub>Blackwell Publishing Ltd</pub><pmid>26418341</pmid><doi>10.1002/ana.24534</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record>
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subjects Adult
Cholecalciferol - administration & dosage
Cholecalciferol - adverse effects
Cholecalciferol - pharmacology
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage
Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects
Hydroxymethylglutaryl-CoA Reductase Inhibitors - pharmacology
Male
Middle Aged
Migraine
Migraine Disorders - prevention & control
Outcome Assessment (Health Care)
Placebo effect
Simvastatin - administration & dosage
Simvastatin - adverse effects
Simvastatin - pharmacology
Vitamin D
Young Adult
title Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial
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