Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial
Diabetes is an independent risk factor for cognitive impairment. We aimed to investigate the association between the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide and cognitive impairment as an exploratory analysis within the Researching Cardiovascular Events With a Weekly Incretin in...
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| Veröffentlicht in: | Lancet neurology 2020-07, Vol.19 (7), p.582-590 |
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| creator | Cukierman-Yaffe, Tali Gerstein, Hertzel C Colhoun, Helen M Diaz, Rafael García-Pérez, Luis-Emilio Lakshmanan, Mark Bethel, Angelyn Xavier, Denis Probstfield, Jeffrey Riddle, Matthew C Rydén, Lars Atisso, Charles Messan Hall, Stephanie Rao-Melacini, Purnima Basile, Jan Cushman, William C Franek, Edward Keltai, Matyas Lanas, Fernando Leiter, Lawrence A Lopez-Jaramillo, Patricio Pirags, Valdis Pogosova, Nana Raubenheimer, Peter J Shaw, Jonathan E Sheu, Wayne H-H Temelkova-Kurktschiev, Theodora |
| description | Diabetes is an independent risk factor for cognitive impairment. We aimed to investigate the association between the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide and cognitive impairment as an exploratory analysis within the Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) trial.
REWIND is a randomised, double-blind placebo-controlled trial at 371 sites in 24 countries. We included men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m2. Participants were randomly assigned (1:1) subcutaneous injections once a week of either dulaglutide (1·5 mg) or an equal volume of matching placebo. Randomisation was done using a computer-generated code with stratification by site. Participants and all study personnel were masked to treatment allocation until the database was locked. Participants were followed up at least every 6 months for the composite primary outcome of stroke, myocardial infarction, or death from cardiovascular or unknown causes. Cognitive function was assessed at baseline and during follow-up using the Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST). We present here the exploratory primary cognitive outcome, which was the first occurrence of a follow-up score on MoCA or DSST that was 1·5 SDs or more below the baseline mean score in the participant's country. All analyses were done using an intention-to-treat approach. The REWIND trial is registered with ClinicalTrials.gov, NCT01394952.
Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were randomly assigned to either dulaglutide (n=4949) or placebo (n=4952). During median follow-up of 5·4 (IQR 5·1–5·9) years, 8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned placebo. The cognitive outcome occurred in 4·05 per 100 patient-years in participants assigned dulaglutide and 4·35 per 100 patient-years in people assigned placebo (hazard ratio [HR] 0·93, 95% CI 0·85–1·02; p=0·11). After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79–0·95; p=0·0018).
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| doi_str_mv | 10.1016/S1474-4422(20)30173-3 |
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REWIND is a randomised, double-blind placebo-controlled trial at 371 sites in 24 countries. We included men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m2. Participants were randomly assigned (1:1) subcutaneous injections once a week of either dulaglutide (1·5 mg) or an equal volume of matching placebo. Randomisation was done using a computer-generated code with stratification by site. Participants and all study personnel were masked to treatment allocation until the database was locked. Participants were followed up at least every 6 months for the composite primary outcome of stroke, myocardial infarction, or death from cardiovascular or unknown causes. Cognitive function was assessed at baseline and during follow-up using the Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST). We present here the exploratory primary cognitive outcome, which was the first occurrence of a follow-up score on MoCA or DSST that was 1·5 SDs or more below the baseline mean score in the participant's country. All analyses were done using an intention-to-treat approach. The REWIND trial is registered with ClinicalTrials.gov, NCT01394952.
Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were randomly assigned to either dulaglutide (n=4949) or placebo (n=4952). During median follow-up of 5·4 (IQR 5·1–5·9) years, 8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned placebo. The cognitive outcome occurred in 4·05 per 100 patient-years in participants assigned dulaglutide and 4·35 per 100 patient-years in people assigned placebo (hazard ratio [HR] 0·93, 95% CI 0·85–1·02; p=0·11). After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79–0·95; p=0·0018).
Long-term treatment with dulaglutide might reduce cognitive impairment in people with type 2 diabetes. Further studies of this drug focused on brain health and cognitive function are clearly indicated.
Eli Lilly and Company.</description><identifier>ISSN: 1474-4422</identifier><identifier>EISSN: 1474-4465</identifier><identifier>DOI: 10.1016/S1474-4422(20)30173-3</identifier><language>eng</language><publisher>London: Elsevier Ltd</publisher><subject>Antidiabetics ; Cardiovascular diseases ; Cerebral infarction ; Cognitive ability ; Dementia ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; GLP-1 receptor agonists ; Glucagon ; Glucagon-like peptide 1 ; Heart attacks ; Hemoglobin ; Insulin ; Memory ; Myocardial infarction ; Peptides ; Risk factors ; Validation studies</subject><ispartof>Lancet neurology, 2020-07, Vol.19 (7), p.582-590</ispartof><rights>2020 Elsevier Ltd</rights><rights>2020. Elsevier Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c460t-9241805458849a493d24a43cd9ff2977a6c40eba1e38da7cb301b746ef6072b13</citedby><cites>FETCH-LOGICAL-c460t-9241805458849a493d24a43cd9ff2977a6c40eba1e38da7cb301b746ef6072b13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1474442220301733$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:144083948$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Cukierman-Yaffe, Tali</creatorcontrib><creatorcontrib>Gerstein, Hertzel C</creatorcontrib><creatorcontrib>Colhoun, Helen M</creatorcontrib><creatorcontrib>Diaz, Rafael</creatorcontrib><creatorcontrib>García-Pérez, Luis-Emilio</creatorcontrib><creatorcontrib>Lakshmanan, Mark</creatorcontrib><creatorcontrib>Bethel, Angelyn</creatorcontrib><creatorcontrib>Xavier, Denis</creatorcontrib><creatorcontrib>Probstfield, Jeffrey</creatorcontrib><creatorcontrib>Riddle, Matthew C</creatorcontrib><creatorcontrib>Rydén, Lars</creatorcontrib><creatorcontrib>Atisso, Charles Messan</creatorcontrib><creatorcontrib>Hall, Stephanie</creatorcontrib><creatorcontrib>Rao-Melacini, Purnima</creatorcontrib><creatorcontrib>Basile, Jan</creatorcontrib><creatorcontrib>Cushman, William C</creatorcontrib><creatorcontrib>Franek, Edward</creatorcontrib><creatorcontrib>Keltai, Matyas</creatorcontrib><creatorcontrib>Lanas, Fernando</creatorcontrib><creatorcontrib>Leiter, Lawrence A</creatorcontrib><creatorcontrib>Lopez-Jaramillo, Patricio</creatorcontrib><creatorcontrib>Pirags, Valdis</creatorcontrib><creatorcontrib>Pogosova, Nana</creatorcontrib><creatorcontrib>Raubenheimer, Peter J</creatorcontrib><creatorcontrib>Shaw, Jonathan E</creatorcontrib><creatorcontrib>Sheu, Wayne H-H</creatorcontrib><creatorcontrib>Temelkova-Kurktschiev, Theodora</creatorcontrib><title>Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial</title><title>Lancet neurology</title><description>Diabetes is an independent risk factor for cognitive impairment. We aimed to investigate the association between the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide and cognitive impairment as an exploratory analysis within the Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) trial.
REWIND is a randomised, double-blind placebo-controlled trial at 371 sites in 24 countries. We included men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m2. Participants were randomly assigned (1:1) subcutaneous injections once a week of either dulaglutide (1·5 mg) or an equal volume of matching placebo. Randomisation was done using a computer-generated code with stratification by site. Participants and all study personnel were masked to treatment allocation until the database was locked. Participants were followed up at least every 6 months for the composite primary outcome of stroke, myocardial infarction, or death from cardiovascular or unknown causes. Cognitive function was assessed at baseline and during follow-up using the Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST). We present here the exploratory primary cognitive outcome, which was the first occurrence of a follow-up score on MoCA or DSST that was 1·5 SDs or more below the baseline mean score in the participant's country. All analyses were done using an intention-to-treat approach. The REWIND trial is registered with ClinicalTrials.gov, NCT01394952.
Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were randomly assigned to either dulaglutide (n=4949) or placebo (n=4952). During median follow-up of 5·4 (IQR 5·1–5·9) years, 8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned placebo. The cognitive outcome occurred in 4·05 per 100 patient-years in participants assigned dulaglutide and 4·35 per 100 patient-years in people assigned placebo (hazard ratio [HR] 0·93, 95% CI 0·85–1·02; p=0·11). After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79–0·95; p=0·0018).
Long-term treatment with dulaglutide might reduce cognitive impairment in people with type 2 diabetes. Further studies of this drug focused on brain health and cognitive function are clearly indicated.
Eli Lilly and Company.</description><subject>Antidiabetics</subject><subject>Cardiovascular diseases</subject><subject>Cerebral infarction</subject><subject>Cognitive ability</subject><subject>Dementia</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>GLP-1 receptor agonists</subject><subject>Glucagon</subject><subject>Glucagon-like peptide 1</subject><subject>Heart attacks</subject><subject>Hemoglobin</subject><subject>Insulin</subject><subject>Memory</subject><subject>Myocardial infarction</subject><subject>Peptides</subject><subject>Risk factors</subject><subject>Validation 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Rafael ; García-Pérez, Luis-Emilio ; Lakshmanan, Mark ; Bethel, Angelyn ; Xavier, Denis ; Probstfield, Jeffrey ; Riddle, Matthew C ; Rydén, Lars ; Atisso, Charles Messan ; Hall, Stephanie ; Rao-Melacini, Purnima ; Basile, Jan ; Cushman, William C ; Franek, Edward ; Keltai, Matyas ; Lanas, Fernando ; Leiter, Lawrence A ; Lopez-Jaramillo, Patricio ; Pirags, Valdis ; Pogosova, Nana ; Raubenheimer, Peter J ; Shaw, Jonathan E ; Sheu, Wayne H-H ; Temelkova-Kurktschiev, Theodora</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c460t-9241805458849a493d24a43cd9ff2977a6c40eba1e38da7cb301b746ef6072b13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Antidiabetics</topic><topic>Cardiovascular diseases</topic><topic>Cerebral infarction</topic><topic>Cognitive ability</topic><topic>Dementia</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin 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Tali</au><au>Gerstein, Hertzel C</au><au>Colhoun, Helen M</au><au>Diaz, Rafael</au><au>García-Pérez, Luis-Emilio</au><au>Lakshmanan, Mark</au><au>Bethel, Angelyn</au><au>Xavier, Denis</au><au>Probstfield, Jeffrey</au><au>Riddle, Matthew C</au><au>Rydén, Lars</au><au>Atisso, Charles Messan</au><au>Hall, Stephanie</au><au>Rao-Melacini, Purnima</au><au>Basile, Jan</au><au>Cushman, William C</au><au>Franek, Edward</au><au>Keltai, Matyas</au><au>Lanas, Fernando</au><au>Leiter, Lawrence A</au><au>Lopez-Jaramillo, Patricio</au><au>Pirags, Valdis</au><au>Pogosova, Nana</au><au>Raubenheimer, Peter J</au><au>Shaw, Jonathan E</au><au>Sheu, Wayne H-H</au><au>Temelkova-Kurktschiev, Theodora</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial</atitle><jtitle>Lancet neurology</jtitle><date>2020-07-01</date><risdate>2020</risdate><volume>19</volume><issue>7</issue><spage>582</spage><epage>590</epage><pages>582-590</pages><issn>1474-4422</issn><eissn>1474-4465</eissn><abstract>Diabetes is an independent risk factor for cognitive impairment. We aimed to investigate the association between the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide and cognitive impairment as an exploratory analysis within the Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) trial.
REWIND is a randomised, double-blind placebo-controlled trial at 371 sites in 24 countries. We included men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m2. Participants were randomly assigned (1:1) subcutaneous injections once a week of either dulaglutide (1·5 mg) or an equal volume of matching placebo. Randomisation was done using a computer-generated code with stratification by site. Participants and all study personnel were masked to treatment allocation until the database was locked. Participants were followed up at least every 6 months for the composite primary outcome of stroke, myocardial infarction, or death from cardiovascular or unknown causes. Cognitive function was assessed at baseline and during follow-up using the Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST). We present here the exploratory primary cognitive outcome, which was the first occurrence of a follow-up score on MoCA or DSST that was 1·5 SDs or more below the baseline mean score in the participant's country. All analyses were done using an intention-to-treat approach. The REWIND trial is registered with ClinicalTrials.gov, NCT01394952.
Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were randomly assigned to either dulaglutide (n=4949) or placebo (n=4952). During median follow-up of 5·4 (IQR 5·1–5·9) years, 8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned placebo. The cognitive outcome occurred in 4·05 per 100 patient-years in participants assigned dulaglutide and 4·35 per 100 patient-years in people assigned placebo (hazard ratio [HR] 0·93, 95% CI 0·85–1·02; p=0·11). After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79–0·95; p=0·0018).
Long-term treatment with dulaglutide might reduce cognitive impairment in people with type 2 diabetes. Further studies of this drug focused on brain health and cognitive function are clearly indicated.
Eli Lilly and Company.</abstract><cop>London</cop><pub>Elsevier Ltd</pub><doi>10.1016/S1474-4422(20)30173-3</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1474-4422 |
| ispartof | Lancet neurology, 2020-07, Vol.19 (7), p.582-590 |
| issn | 1474-4422 1474-4465 |
| language | eng |
| recordid | cdi_swepub_primary_oai_swepub_ki_se_470351 |
| source | Elsevier ScienceDirect Journals |
| subjects | Antidiabetics Cardiovascular diseases Cerebral infarction Cognitive ability Dementia Diabetes Diabetes mellitus (non-insulin dependent) GLP-1 receptor agonists Glucagon Glucagon-like peptide 1 Heart attacks Hemoglobin Insulin Memory Myocardial infarction Peptides Risk factors Validation studies |
| title | Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-04T03%3A19%3A02IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_swepu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Effect%20of%20dulaglutide%20on%20cognitive%20impairment%20in%20type%202%20diabetes:%20an%20exploratory%20analysis%20of%20the%20REWIND%20trial&rft.jtitle=Lancet%20neurology&rft.au=Cukierman-Yaffe,%20Tali&rft.date=2020-07-01&rft.volume=19&rft.issue=7&rft.spage=582&rft.epage=590&rft.pages=582-590&rft.issn=1474-4422&rft.eissn=1474-4465&rft_id=info:doi/10.1016/S1474-4422(20)30173-3&rft_dat=%3Cproquest_swepu%3E2415303200%3C/proquest_swepu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2424891061&rft_id=info:pmid/&rft_els_id=S1474442220301733&rfr_iscdi=true |