Systematic Review: Representativeness of Participants in RCTs of Acetylcholinesterase Inhibitors
To determine whether there are differences in age and sex distribution and presence of comorbidities between participants included in randomized controlled trials of acetylcholinesterase inhibitors and nationwide cohort of persons with Alzheimer's disease. PubMed, Scopus and Cochrane Library da...
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| Veröffentlicht in: | PloS one 2015-05, Vol.10 (5), p.e0124500-e0124500 |
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| description | To determine whether there are differences in age and sex distribution and presence of comorbidities between participants included in randomized controlled trials of acetylcholinesterase inhibitors and nationwide cohort of persons with Alzheimer's disease.
PubMed, Scopus and Cochrane Library databases were searched for original articles from their inception to January 4, 2015. Double-blind randomized controlled trials with donepezil, rivastigmine or galantamine compared to placebo in participants with Alzheimer's disease were included. Data from a nationwide cohort of persons with clinically verified diagnoses of Alzheimer's disease was defined as a reference population.
128 full-text articles were assessed for eligibility, 31 of them fulfilled criteria. Mean age of participants in randomized controlled trials (n = 15,032) was 5.8 years lower (95% CI 5.7 to 5.9, P < 0.001), compared to the mean age of 79.7 years in the reference population with Alzheimer's disease (n = 28,093). Most of the articles did not report age distribution of participants. The proportion of women was 63.2% (9,475/14,991) in randomized controlled trials and 67.8% (19,043/28,093) (P < 0.001) in the reference population. Information on comorbidities and use of concomitant drugs were lacking or poorly reported in most articles.
There is a discrepancy between participants in randomized controlled trials of acetylcholinesterase inhibitors and real-life population with Alzheimer's disease. Participants in randomized controlled trials were significantly younger. Further, more detailed reporting of age distribution, comorbidities and concomitant drugs would be important information for clinicians when evaluating conclusions from randomized controlled trials to real-life practice. The existing recommendations of inclusion of older people should be followed to ensure safe pharmacotherapy for older people. |
| doi_str_mv | 10.1371/journal.pone.0124500 |
| format | Article |
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PubMed, Scopus and Cochrane Library databases were searched for original articles from their inception to January 4, 2015. Double-blind randomized controlled trials with donepezil, rivastigmine or galantamine compared to placebo in participants with Alzheimer's disease were included. Data from a nationwide cohort of persons with clinically verified diagnoses of Alzheimer's disease was defined as a reference population.
128 full-text articles were assessed for eligibility, 31 of them fulfilled criteria. Mean age of participants in randomized controlled trials (n = 15,032) was 5.8 years lower (95% CI 5.7 to 5.9, P < 0.001), compared to the mean age of 79.7 years in the reference population with Alzheimer's disease (n = 28,093). Most of the articles did not report age distribution of participants. The proportion of women was 63.2% (9,475/14,991) in randomized controlled trials and 67.8% (19,043/28,093) (P < 0.001) in the reference population. Information on comorbidities and use of concomitant drugs were lacking or poorly reported in most articles.
There is a discrepancy between participants in randomized controlled trials of acetylcholinesterase inhibitors and real-life population with Alzheimer's disease. Participants in randomized controlled trials were significantly younger. Further, more detailed reporting of age distribution, comorbidities and concomitant drugs would be important information for clinicians when evaluating conclusions from randomized controlled trials to real-life practice. The existing recommendations of inclusion of older people should be followed to ensure safe pharmacotherapy for older people.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0124500</identifier><identifier>PMID: 25933023</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Acetylcholinesterase ; Age ; Age composition ; Age Factors ; Aged ; Aged, 80 and over ; Alzheimer Disease - drug therapy ; Alzheimer Disease - pathology ; Alzheimer's disease ; Cholinesterase Inhibitors - therapeutic use ; Clinical trials ; Comorbidity ; Dementia ; Disease control ; Donepezil ; Drugs ; Female ; Galantamine ; Galanthamine ; Geriatrics ; Health sciences ; Humans ; Inhibitors ; Male ; Medical imaging ; Older people ; Patients ; Pharmacology ; Pharmacy ; Randomization ; Randomized Controlled Trials as Topic ; Rivastigmine ; Studies ; Systematic review ; Womens health</subject><ispartof>PloS one, 2015-05, Vol.10 (5), p.e0124500-e0124500</ispartof><rights>COPYRIGHT 2015 Public Library of Science</rights><rights>2015 Leinonen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2015 Leinonen et al 2015 Leinonen et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-be4e696a6f153bccd3207d412d1600fb3f90555472684d27240e5920b90a6a4a3</citedby><cites>FETCH-LOGICAL-c692t-be4e696a6f153bccd3207d412d1600fb3f90555472684d27240e5920b90a6a4a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4416896/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4416896/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79569,79570</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25933023$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Leinonen, Anne</creatorcontrib><creatorcontrib>Koponen, Marjaana</creatorcontrib><creatorcontrib>Hartikainen, Sirpa</creatorcontrib><title>Systematic Review: Representativeness of Participants in RCTs of Acetylcholinesterase Inhibitors</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>To determine whether there are differences in age and sex distribution and presence of comorbidities between participants included in randomized controlled trials of acetylcholinesterase inhibitors and nationwide cohort of persons with Alzheimer's disease.
PubMed, Scopus and Cochrane Library databases were searched for original articles from their inception to January 4, 2015. Double-blind randomized controlled trials with donepezil, rivastigmine or galantamine compared to placebo in participants with Alzheimer's disease were included. Data from a nationwide cohort of persons with clinically verified diagnoses of Alzheimer's disease was defined as a reference population.
128 full-text articles were assessed for eligibility, 31 of them fulfilled criteria. Mean age of participants in randomized controlled trials (n = 15,032) was 5.8 years lower (95% CI 5.7 to 5.9, P < 0.001), compared to the mean age of 79.7 years in the reference population with Alzheimer's disease (n = 28,093). Most of the articles did not report age distribution of participants. The proportion of women was 63.2% (9,475/14,991) in randomized controlled trials and 67.8% (19,043/28,093) (P < 0.001) in the reference population. Information on comorbidities and use of concomitant drugs were lacking or poorly reported in most articles.
There is a discrepancy between participants in randomized controlled trials of acetylcholinesterase inhibitors and real-life population with Alzheimer's disease. Participants in randomized controlled trials were significantly younger. Further, more detailed reporting of age distribution, comorbidities and concomitant drugs would be important information for clinicians when evaluating conclusions from randomized controlled trials to real-life practice. The existing recommendations of inclusion of older people should be followed to ensure safe pharmacotherapy for older people.</description><subject>Acetylcholinesterase</subject><subject>Age</subject><subject>Age composition</subject><subject>Age Factors</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Alzheimer Disease - drug therapy</subject><subject>Alzheimer Disease - pathology</subject><subject>Alzheimer's disease</subject><subject>Cholinesterase Inhibitors - therapeutic use</subject><subject>Clinical trials</subject><subject>Comorbidity</subject><subject>Dementia</subject><subject>Disease control</subject><subject>Donepezil</subject><subject>Drugs</subject><subject>Female</subject><subject>Galantamine</subject><subject>Galanthamine</subject><subject>Geriatrics</subject><subject>Health sciences</subject><subject>Humans</subject><subject>Inhibitors</subject><subject>Male</subject><subject>Medical imaging</subject><subject>Older people</subject><subject>Patients</subject><subject>Pharmacology</subject><subject>Pharmacy</subject><subject>Randomization</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Rivastigmine</subject><subject>Studies</subject><subject>Systematic review</subject><subject>Womens health</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><sourceid>DOA</sourceid><recordid>eNqNk11v0zAUhiMEYmPwDxBEQkJw0eLvJFwgVRUflSYNdYNb4zgnras07myn0H-P22ZTg3aBLMXWyXNe-7z2SZKXGI0xzfCHle1cq5rxxrYwRpgwjtCj5BwXlIwEQfTxyfoseeb9CiFOcyGeJmeEF5QiQs-TX9c7H2CtgtHpHLYGfn-M88aBhzbE6BZa8D61dfpduQiZjWqDT02bzqc3h_hEQ9g1emkbE9EATnlIZ-3SlCZY558nT2rVeHjRzxfJjy-fb6bfRpdXX2fTyeVIi4KEUQkMRCGUqDGnpdYVJSirGCYVFgjVJa0LxDlnGRE5q0hGGAJeEFQWSAnFFL1IXh91N431sjfHSyyyTDCWcxyJ2ZGorFrJjTNr5XbSKiMPAesW8lBiA7KAsq4yqsuCYIYqkWckfnLNuYh6GkWtT_1uXbmGSkeznGoGosM_rVnKhd1KxrDICxEF3vUCzt520Te5Nl5D06gWbHc8d57Hg2cRffMP-nB1PbVQsQDT1jbuq_eicsIIzSnP0Z4aP0DFUcHa6PiSahPjg4T3g4TIBPgTFqrzXs6u5__PXv0csm9P2CWoJiy9bbpgbOuHIDuC2lnvHdT3JmMk941w54bcN4LsGyGmvTq9oPuku5dP_wKT2QJ5</recordid><startdate>20150501</startdate><enddate>20150501</enddate><creator>Leinonen, Anne</creator><creator>Koponen, Marjaana</creator><creator>Hartikainen, Sirpa</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><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>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PIMPY</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQGLB</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20150501</creationdate><title>Systematic Review: Representativeness of Participants in RCTs of Acetylcholinesterase Inhibitors</title><author>Leinonen, Anne ; Koponen, Marjaana ; Hartikainen, Sirpa</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-be4e696a6f153bccd3207d412d1600fb3f90555472684d27240e5920b90a6a4a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Acetylcholinesterase</topic><topic>Age</topic><topic>Age composition</topic><topic>Age Factors</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Alzheimer Disease - drug therapy</topic><topic>Alzheimer Disease - pathology</topic><topic>Alzheimer's disease</topic><topic>Cholinesterase Inhibitors - therapeutic use</topic><topic>Clinical trials</topic><topic>Comorbidity</topic><topic>Dementia</topic><topic>Disease control</topic><topic>Donepezil</topic><topic>Drugs</topic><topic>Female</topic><topic>Galantamine</topic><topic>Galanthamine</topic><topic>Geriatrics</topic><topic>Health sciences</topic><topic>Humans</topic><topic>Inhibitors</topic><topic>Male</topic><topic>Medical imaging</topic><topic>Older people</topic><topic>Patients</topic><topic>Pharmacology</topic><topic>Pharmacy</topic><topic>Randomization</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Rivastigmine</topic><topic>Studies</topic><topic>Systematic review</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Leinonen, Anne</creatorcontrib><creatorcontrib>Koponen, Marjaana</creatorcontrib><creatorcontrib>Hartikainen, Sirpa</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: Opposing Viewpoints</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Ecology Abstracts</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Meteorological & Geoastrophysical Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Agricultural Science Collection</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology 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>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>Advanced Technologies & Aerospace Collection</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Meteorological & Geoastrophysical Abstracts - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Leinonen, Anne</au><au>Koponen, Marjaana</au><au>Hartikainen, Sirpa</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Systematic Review: Representativeness of Participants in RCTs of Acetylcholinesterase Inhibitors</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2015-05-01</date><risdate>2015</risdate><volume>10</volume><issue>5</issue><spage>e0124500</spage><epage>e0124500</epage><pages>e0124500-e0124500</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>To determine whether there are differences in age and sex distribution and presence of comorbidities between participants included in randomized controlled trials of acetylcholinesterase inhibitors and nationwide cohort of persons with Alzheimer's disease.
PubMed, Scopus and Cochrane Library databases were searched for original articles from their inception to January 4, 2015. Double-blind randomized controlled trials with donepezil, rivastigmine or galantamine compared to placebo in participants with Alzheimer's disease were included. Data from a nationwide cohort of persons with clinically verified diagnoses of Alzheimer's disease was defined as a reference population.
128 full-text articles were assessed for eligibility, 31 of them fulfilled criteria. Mean age of participants in randomized controlled trials (n = 15,032) was 5.8 years lower (95% CI 5.7 to 5.9, P < 0.001), compared to the mean age of 79.7 years in the reference population with Alzheimer's disease (n = 28,093). Most of the articles did not report age distribution of participants. The proportion of women was 63.2% (9,475/14,991) in randomized controlled trials and 67.8% (19,043/28,093) (P < 0.001) in the reference population. Information on comorbidities and use of concomitant drugs were lacking or poorly reported in most articles.
There is a discrepancy between participants in randomized controlled trials of acetylcholinesterase inhibitors and real-life population with Alzheimer's disease. Participants in randomized controlled trials were significantly younger. Further, more detailed reporting of age distribution, comorbidities and concomitant drugs would be important information for clinicians when evaluating conclusions from randomized controlled trials to real-life practice. The existing recommendations of inclusion of older people should be followed to ensure safe pharmacotherapy for older people.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>25933023</pmid><doi>10.1371/journal.pone.0124500</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Acetylcholinesterase Age Age composition Age Factors Aged Aged, 80 and over Alzheimer Disease - drug therapy Alzheimer Disease - pathology Alzheimer's disease Cholinesterase Inhibitors - therapeutic use Clinical trials Comorbidity Dementia Disease control Donepezil Drugs Female Galantamine Galanthamine Geriatrics Health sciences Humans Inhibitors Male Medical imaging Older people Patients Pharmacology Pharmacy Randomization Randomized Controlled Trials as Topic Rivastigmine Studies Systematic review Womens health |
| title | Systematic Review: Representativeness of Participants in RCTs of Acetylcholinesterase Inhibitors |
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