A Double‐Blind, Randomized, Controlled Trial of Lovastatin in Early‐Stage Parkinson's Disease
ABSTRACT Background Recent evidence indicates that lipophilic statins have a neuroprotective benefit in animal models of Parkinson's disease (PD). The objective of this study was to evaluate whether lovastatin has the potential to slow motor symptom progression in patients with early‐stage PD....
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| Veröffentlicht in: | Movement disorders 2021-05, Vol.36 (5), p.1229-1237 |
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| creator | Lin, Chin‐Hsien Chang, Chin‐Hao Tai, Chun‐Hwei Cheng, Mei‐Fang Chen, Yi‐Chieh Chao, Ying‐Ting Huang, Tse‐Le Yen, Ruoh‐Fang Wu, Ruey‐Meei |
| description | ABSTRACT
Background
Recent evidence indicates that lipophilic statins have a neuroprotective benefit in animal models of Parkinson's disease (PD). The objective of this study was to evaluate whether lovastatin has the potential to slow motor symptom progression in patients with early‐stage PD.
Methods
This double‐blind, randomized, placebo‐controlled trial enrolled 77 patients with early‐stage PD between May 23, 2017, and July 12, 2018, with follow‐up ending September 1, 2019. Lovastatin 80 mg/day or placebo with 1:1 randomization was administered for 48 weeks. Mean change in the parts I–III scores of the Movement Disorder Society–Unified Parkinson's Disease Rating Scale (MDS‐UPDRS), changes in the striatal dopamine uptake ratio measured by 18F‐dopa PET scan, and changes in PD medications between baseline and the week 48 visit were measured.
Results
Of the 77 randomized patients, 70 (90.9%) completed the study. There was a slightly beneficial trend of the MDS‐UPDRS motor score in the lovastatin group (−3.18 ± 5.50) compared with the placebo group (−0.50 ± 6.11); P = 0.14 adjusted for age, sex, disease duration, and baseline LEDD. Mean percentage change in the striatal 18F‐dopa uptake ratio deteriorated less in the lovastatin group than in the placebo group on the dominant side of caudate (1.2% ± 7.3% vs −7.1% ± 8.2%, P |
| doi_str_mv | 10.1002/mds.28474 |
| format | Article |
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Background
Recent evidence indicates that lipophilic statins have a neuroprotective benefit in animal models of Parkinson's disease (PD). The objective of this study was to evaluate whether lovastatin has the potential to slow motor symptom progression in patients with early‐stage PD.
Methods
This double‐blind, randomized, placebo‐controlled trial enrolled 77 patients with early‐stage PD between May 23, 2017, and July 12, 2018, with follow‐up ending September 1, 2019. Lovastatin 80 mg/day or placebo with 1:1 randomization was administered for 48 weeks. Mean change in the parts I–III scores of the Movement Disorder Society–Unified Parkinson's Disease Rating Scale (MDS‐UPDRS), changes in the striatal dopamine uptake ratio measured by 18F‐dopa PET scan, and changes in PD medications between baseline and the week 48 visit were measured.
Results
Of the 77 randomized patients, 70 (90.9%) completed the study. There was a slightly beneficial trend of the MDS‐UPDRS motor score in the lovastatin group (−3.18 ± 5.50) compared with the placebo group (−0.50 ± 6.11); P = 0.14 adjusted for age, sex, disease duration, and baseline LEDD. Mean percentage change in the striatal 18F‐dopa uptake ratio deteriorated less in the lovastatin group than in the placebo group on the dominant side of caudate (1.2% ± 7.3% vs −7.1% ± 8.2%, P < 0.01) and putamen (2.3% ± 7.1% vs −6.4% ± 8.1%, P < 0.01). We found no between‐group differences in the change in part I or part II MDS‐UPDRS scores. Lovastatin was generally well tolerated.
Conclusions
Lovastatin treatment in patients with early‐stage PD was associated with a trend of less motor symptom worsening and was well tolerated. A future larger long‐term follow‐up study is needed to confirm our findings. © 2021 International Parkinson and Movement Disorder Society</description><identifier>ISSN: 0885-3185</identifier><identifier>EISSN: 1531-8257</identifier><identifier>DOI: 10.1002/mds.28474</identifier><identifier>PMID: 33449392</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley & Sons, Inc</publisher><subject>Animal models ; Dopamine ; Double-blind studies ; Lipophilic ; Lovastatin ; Movement disorders ; Neostriatum ; Neurodegenerative diseases ; Neuroprotection ; Parkinson's disease ; Placebos ; Positron emission tomography ; Putamen ; Statins ; trial</subject><ispartof>Movement disorders, 2021-05, Vol.36 (5), p.1229-1237</ispartof><rights>2021 International Parkinson and Movement Disorder Society</rights><rights>2021 International Parkinson and Movement Disorder Society.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4194-c9f600f1bf26601f2b5256e886e0291f07e683dbe65c0da2b9850fa6a05116c03</citedby><cites>FETCH-LOGICAL-c4194-c9f600f1bf26601f2b5256e886e0291f07e683dbe65c0da2b9850fa6a05116c03</cites><orcidid>0000-0001-8566-7573</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fmds.28474$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fmds.28474$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33449392$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lin, Chin‐Hsien</creatorcontrib><creatorcontrib>Chang, Chin‐Hao</creatorcontrib><creatorcontrib>Tai, Chun‐Hwei</creatorcontrib><creatorcontrib>Cheng, Mei‐Fang</creatorcontrib><creatorcontrib>Chen, Yi‐Chieh</creatorcontrib><creatorcontrib>Chao, Ying‐Ting</creatorcontrib><creatorcontrib>Huang, Tse‐Le</creatorcontrib><creatorcontrib>Yen, Ruoh‐Fang</creatorcontrib><creatorcontrib>Wu, Ruey‐Meei</creatorcontrib><title>A Double‐Blind, Randomized, Controlled Trial of Lovastatin in Early‐Stage Parkinson's Disease</title><title>Movement disorders</title><addtitle>Mov Disord</addtitle><description>ABSTRACT
Background
Recent evidence indicates that lipophilic statins have a neuroprotective benefit in animal models of Parkinson's disease (PD). The objective of this study was to evaluate whether lovastatin has the potential to slow motor symptom progression in patients with early‐stage PD.
Methods
This double‐blind, randomized, placebo‐controlled trial enrolled 77 patients with early‐stage PD between May 23, 2017, and July 12, 2018, with follow‐up ending September 1, 2019. Lovastatin 80 mg/day or placebo with 1:1 randomization was administered for 48 weeks. Mean change in the parts I–III scores of the Movement Disorder Society–Unified Parkinson's Disease Rating Scale (MDS‐UPDRS), changes in the striatal dopamine uptake ratio measured by 18F‐dopa PET scan, and changes in PD medications between baseline and the week 48 visit were measured.
Results
Of the 77 randomized patients, 70 (90.9%) completed the study. There was a slightly beneficial trend of the MDS‐UPDRS motor score in the lovastatin group (−3.18 ± 5.50) compared with the placebo group (−0.50 ± 6.11); P = 0.14 adjusted for age, sex, disease duration, and baseline LEDD. Mean percentage change in the striatal 18F‐dopa uptake ratio deteriorated less in the lovastatin group than in the placebo group on the dominant side of caudate (1.2% ± 7.3% vs −7.1% ± 8.2%, P < 0.01) and putamen (2.3% ± 7.1% vs −6.4% ± 8.1%, P < 0.01). We found no between‐group differences in the change in part I or part II MDS‐UPDRS scores. Lovastatin was generally well tolerated.
Conclusions
Lovastatin treatment in patients with early‐stage PD was associated with a trend of less motor symptom worsening and was well tolerated. A future larger long‐term follow‐up study is needed to confirm our findings. © 2021 International Parkinson and Movement Disorder Society</description><subject>Animal models</subject><subject>Dopamine</subject><subject>Double-blind studies</subject><subject>Lipophilic</subject><subject>Lovastatin</subject><subject>Movement disorders</subject><subject>Neostriatum</subject><subject>Neurodegenerative diseases</subject><subject>Neuroprotection</subject><subject>Parkinson's disease</subject><subject>Placebos</subject><subject>Positron emission tomography</subject><subject>Putamen</subject><subject>Statins</subject><subject>trial</subject><issn>0885-3185</issn><issn>1531-8257</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp1kMtq3DAUQEVIaSZpF_mBYMgiKdTJlWzJ8jKdSR8wpSWPtZDtq6BEtiaS3TJd9RP6jf2Sqpmki0BBcLU493A5hOxTOKEA7LTv4gmTZVVukRnlBc0l49U2mYGUPC-o5DtkN8ZbAEo5FS_JTlGUZV3UbEb0WbbwU-Pw989f75wdurfZhR4639sfmP5zP4zBO4dddhWsdpk32dJ_03HUox2y9M51cOu0fDnqG8y-6nBnh-iHo5gtbEQd8RV5YbSL-Ppx7pHr9-dX84_58suHT_OzZd6WtC7ztjYCwNDGMCGAGtZwxgVKKRBYTQ1UKGTRNSh4C51mTS05GC00cEpFC8UeOd54V8HfTxhH1dvYonN6QD9FxcpKcllzVib08Bl666cwpOsU46ziVQ1Vlag3G6oNPsaARq2C7XVYKwrqb3eVuquH7ok9eDROTY_dP_IpdAJON8B363D9f5P6vLjcKP8A_OGMbw</recordid><startdate>202105</startdate><enddate>202105</enddate><creator>Lin, Chin‐Hsien</creator><creator>Chang, Chin‐Hao</creator><creator>Tai, Chun‐Hwei</creator><creator>Cheng, Mei‐Fang</creator><creator>Chen, Yi‐Chieh</creator><creator>Chao, Ying‐Ting</creator><creator>Huang, Tse‐Le</creator><creator>Yen, Ruoh‐Fang</creator><creator>Wu, Ruey‐Meei</creator><general>John Wiley & Sons, Inc</general><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TK</scope><scope>8FD</scope><scope>FR3</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-8566-7573</orcidid></search><sort><creationdate>202105</creationdate><title>A Double‐Blind, Randomized, Controlled Trial of Lovastatin in Early‐Stage Parkinson's Disease</title><author>Lin, Chin‐Hsien ; Chang, Chin‐Hao ; Tai, Chun‐Hwei ; Cheng, Mei‐Fang ; Chen, Yi‐Chieh ; Chao, Ying‐Ting ; Huang, Tse‐Le ; Yen, Ruoh‐Fang ; Wu, Ruey‐Meei</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4194-c9f600f1bf26601f2b5256e886e0291f07e683dbe65c0da2b9850fa6a05116c03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Animal models</topic><topic>Dopamine</topic><topic>Double-blind studies</topic><topic>Lipophilic</topic><topic>Lovastatin</topic><topic>Movement disorders</topic><topic>Neostriatum</topic><topic>Neurodegenerative diseases</topic><topic>Neuroprotection</topic><topic>Parkinson's disease</topic><topic>Placebos</topic><topic>Positron emission tomography</topic><topic>Putamen</topic><topic>Statins</topic><topic>trial</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lin, Chin‐Hsien</creatorcontrib><creatorcontrib>Chang, Chin‐Hao</creatorcontrib><creatorcontrib>Tai, Chun‐Hwei</creatorcontrib><creatorcontrib>Cheng, Mei‐Fang</creatorcontrib><creatorcontrib>Chen, Yi‐Chieh</creatorcontrib><creatorcontrib>Chao, Ying‐Ting</creatorcontrib><creatorcontrib>Huang, Tse‐Le</creatorcontrib><creatorcontrib>Yen, Ruoh‐Fang</creatorcontrib><creatorcontrib>Wu, Ruey‐Meei</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Movement disorders</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lin, Chin‐Hsien</au><au>Chang, Chin‐Hao</au><au>Tai, Chun‐Hwei</au><au>Cheng, Mei‐Fang</au><au>Chen, Yi‐Chieh</au><au>Chao, Ying‐Ting</au><au>Huang, Tse‐Le</au><au>Yen, Ruoh‐Fang</au><au>Wu, Ruey‐Meei</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Double‐Blind, Randomized, Controlled Trial of Lovastatin in Early‐Stage Parkinson's Disease</atitle><jtitle>Movement disorders</jtitle><addtitle>Mov Disord</addtitle><date>2021-05</date><risdate>2021</risdate><volume>36</volume><issue>5</issue><spage>1229</spage><epage>1237</epage><pages>1229-1237</pages><issn>0885-3185</issn><eissn>1531-8257</eissn><abstract>ABSTRACT
Background
Recent evidence indicates that lipophilic statins have a neuroprotective benefit in animal models of Parkinson's disease (PD). The objective of this study was to evaluate whether lovastatin has the potential to slow motor symptom progression in patients with early‐stage PD.
Methods
This double‐blind, randomized, placebo‐controlled trial enrolled 77 patients with early‐stage PD between May 23, 2017, and July 12, 2018, with follow‐up ending September 1, 2019. Lovastatin 80 mg/day or placebo with 1:1 randomization was administered for 48 weeks. Mean change in the parts I–III scores of the Movement Disorder Society–Unified Parkinson's Disease Rating Scale (MDS‐UPDRS), changes in the striatal dopamine uptake ratio measured by 18F‐dopa PET scan, and changes in PD medications between baseline and the week 48 visit were measured.
Results
Of the 77 randomized patients, 70 (90.9%) completed the study. There was a slightly beneficial trend of the MDS‐UPDRS motor score in the lovastatin group (−3.18 ± 5.50) compared with the placebo group (−0.50 ± 6.11); P = 0.14 adjusted for age, sex, disease duration, and baseline LEDD. Mean percentage change in the striatal 18F‐dopa uptake ratio deteriorated less in the lovastatin group than in the placebo group on the dominant side of caudate (1.2% ± 7.3% vs −7.1% ± 8.2%, P < 0.01) and putamen (2.3% ± 7.1% vs −6.4% ± 8.1%, P < 0.01). We found no between‐group differences in the change in part I or part II MDS‐UPDRS scores. Lovastatin was generally well tolerated.
Conclusions
Lovastatin treatment in patients with early‐stage PD was associated with a trend of less motor symptom worsening and was well tolerated. A future larger long‐term follow‐up study is needed to confirm our findings. © 2021 International Parkinson and Movement Disorder Society</abstract><cop>Hoboken, USA</cop><pub>John Wiley & Sons, Inc</pub><pmid>33449392</pmid><doi>10.1002/mds.28474</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-8566-7573</orcidid></addata></record> |
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| source | Wiley Online Library Journals Frontfile Complete |
| subjects | Animal models Dopamine Double-blind studies Lipophilic Lovastatin Movement disorders Neostriatum Neurodegenerative diseases Neuroprotection Parkinson's disease Placebos Positron emission tomography Putamen Statins trial |
| title | A Double‐Blind, Randomized, Controlled Trial of Lovastatin in Early‐Stage Parkinson's Disease |
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