Efficacy and safety of alirocumab in people with prediabetes vs those with normoglycaemia at baseline: a pooled analysis of 10 phase III ODYSSEY clinical trials
Aim To assess the lipid‐lowering efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in people with hypercholesterolaemia and prediabetes at baseline vs people with normoglycaemia at baseline in a pooled analysis of 10 ODYSSEY phase III trials. Metho...
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| Veröffentlicht in: | Diabetic medicine 2018-01, Vol.35 (1), p.121-130 |
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| creator | Leiter, L. A. Müller‐Wieland, D. Baccara‐Dinet, M. T. Letierce, A. Samuel, R. Cariou, B. |
| description | Aim
To assess the lipid‐lowering efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in people with hypercholesterolaemia and prediabetes at baseline vs people with normoglycaemia at baseline in a pooled analysis of 10 ODYSSEY phase III trials.
Methods
People classified as having prediabetes had baseline HbA1c ≥39 mmol/mol (5.7%) and |
| doi_str_mv | 10.1111/dme.13450 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5763418</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1928506559</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4430-430567ddfcc0d0bd6bcdab2043c7c86343e516c0ed0974aed99816f852a8c1b3</originalsourceid><addsrcrecordid>eNp1kc9u1DAQhy0EosvCgRdAlrjAIa2dOH_MAQm1C6xU1EN76cma2JOuKycOdrZV3oZHrbe7VICEJWsO8_mbkX-EvOXsmKdzYno85oUo2TOy4KISWSkkf04WrBZ5VrCaH5FXMd4yxnNZyJfkKG9qKXNWLMivVddZDXqmMBgaocNppr6j4GzwettDS-1AR_SjQ3pvpw0dAxoLLU4Y6V2k08bHQ2fwofc3btaAvQUKE20horMDfqJAR-8dmjQG3Bxt3A3hjI6bhND1ek0vzq4vL1fXVKcHaSNHp2DBxdfkRZcKvjnUJbn6uro6_Z6dX3xbn345z7QQBcvSLavamE5rZlhrqlYbaHMmCl3rpipEgSWvNEPDZC0AjZQNr7qmzKHRvC2W5PNeO27bHo3GYQrg1BhsD2FWHqz6uzPYjbrxd6qsk5w3SfDhIAj-5xbjpHobNToHA_ptVFzmTcmqspQJff8Peuu3If3LjqrFLpskXZKPe0oHH2PA7mkZztQudpViV4-xJ_bdn9s_kb9zTsDJHri3Duf_m9TZj9Ve-QA5GbkL</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1974879976</pqid></control><display><type>article</type><title>Efficacy and safety of alirocumab in people with prediabetes vs those with normoglycaemia at baseline: a pooled analysis of 10 phase III ODYSSEY clinical trials</title><source>MEDLINE</source><source>Wiley Journals</source><creator>Leiter, L. A. ; Müller‐Wieland, D. ; Baccara‐Dinet, M. T. ; Letierce, A. ; Samuel, R. ; Cariou, B.</creator><creatorcontrib>Leiter, L. A. ; Müller‐Wieland, D. ; Baccara‐Dinet, M. T. ; Letierce, A. ; Samuel, R. ; Cariou, B.</creatorcontrib><description>Aim
To assess the lipid‐lowering efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in people with hypercholesterolaemia and prediabetes at baseline vs people with normoglycaemia at baseline in a pooled analysis of 10 ODYSSEY phase III trials.
Methods
People classified as having prediabetes had baseline HbA1c ≥39 mmol/mol (5.7%) and <48 mmol/mol (6.5%), or two baseline fasting plasma glucose values ≥5.6 mmol/l (100 mg/dl) but no more than one fasting plasma glucose value ≥7.0 mmol/l (126 mg/dl), or had specific terms reported in their medical history; people diagnosed with diabetes at baseline were excluded, and the remainder were classified as having normoglycaemia. Participants received alirocumab or control (placebo/ezetimibe) for 24–104 weeks, with maximally tolerated statin in most cases. The primary efficacy endpoint was LDL cholesterol reductions from baseline to week 24 in the intention‐to‐treat population using the mixed‐effect model with a repeated measures approach.
Results
Reductions in LDL cholesterol from baseline to week 24 with alirocumab were 44.0–61.8% (prediabetes group) and 45.8–59.5% (normoglycaemia group). In both subgroups, LDL cholesterol reductions were generally similar in those with and without baseline triglycerides ≥1.7 mmol/l (150 mg/dl). Alirocumab was not associated with changes in HbA1c or fasting plasma glucose over time in either subgroup (up to 24 months' follow‐up). Adverse event rates were generally similar in those with and without prediabetes.
Conclusions
Over a mean follow‐up of 24–104 weeks, alirocumab treatment resulted in significant LDL cholesterol reductions from baseline that were similar in participants with prediabetes and those with normoglycaemia at baseline, with no effect on glycaemia and a safety profile similar to that of the control.
What's new?
With statins being associated with an increased risk of diabetes (especially in individuals with risk factors for diabetes) and recent studies linking PCSK9 to glucose homeostasis, there is much interest in whether PCSK9 inhibitors affect diabetes risk.
We assessed the efficacy/safety of alirocumab, a PCSK9 inhibitor, vs control over a mean follow‐up of 24–104 weeks in people with hypercholesterolaemia and prediabetes vs people with normoglycaemia at baseline from 10 ODYSSEY phase III trials.
Our findings show alirocumab is generally well tolerated and significantly reduced LDL cholesterol levels to similar extents in individuals with prediabetes and those with normoglycaemia without any changes in measures of glycaemic control.</description><identifier>ISSN: 0742-3071</identifier><identifier>EISSN: 1464-5491</identifier><identifier>DOI: 10.1111/dme.13450</identifier><identifier>PMID: 28799203</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Adult ; Aged ; Antibodies, Monoclonal - therapeutic use ; Antibodies, Monoclonal, Humanized ; Anticholesteremic Agents - therapeutic use ; Blood glucose ; Blood Glucose - metabolism ; Case-Control Studies ; Cholesterol ; Cholesterol, LDL - metabolism ; Clinical trials ; Clinical Trials, Phase III as Topic ; Diabetes ; Diabetes mellitus ; Double-Blind Method ; Fasting ; Female ; Glucose ; Glycated Hemoglobin - metabolism ; Homeostasis ; Humans ; Hypercholesterolemia - complications ; Hypercholesterolemia - drug therapy ; Hypercholesterolemia - metabolism ; Kexin ; Laboratory testing ; Low density lipoprotein ; Male ; Middle Aged ; Monoclonal antibodies ; Motivation ; Prediabetic State - complications ; Prediabetic State - metabolism ; Proprotein convertases ; Randomized Controlled Trials as Topic ; Research: Treatment ; Safety ; Statins ; Subtilisin ; Treatment Outcome ; Triglycerides ; Triglycerides - metabolism</subject><ispartof>Diabetic medicine, 2018-01, Vol.35 (1), p.121-130</ispartof><rights>2017 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK</rights><rights>2017 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.</rights><rights>Diabetic Medicine © 2018 Diabetes UK</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4430-430567ddfcc0d0bd6bcdab2043c7c86343e516c0ed0974aed99816f852a8c1b3</citedby><cites>FETCH-LOGICAL-c4430-430567ddfcc0d0bd6bcdab2043c7c86343e516c0ed0974aed99816f852a8c1b3</cites><orcidid>0000-0002-1040-6229</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fdme.13450$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdme.13450$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28799203$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Leiter, L. A.</creatorcontrib><creatorcontrib>Müller‐Wieland, D.</creatorcontrib><creatorcontrib>Baccara‐Dinet, M. T.</creatorcontrib><creatorcontrib>Letierce, A.</creatorcontrib><creatorcontrib>Samuel, R.</creatorcontrib><creatorcontrib>Cariou, B.</creatorcontrib><title>Efficacy and safety of alirocumab in people with prediabetes vs those with normoglycaemia at baseline: a pooled analysis of 10 phase III ODYSSEY clinical trials</title><title>Diabetic medicine</title><addtitle>Diabet Med</addtitle><description>Aim
To assess the lipid‐lowering efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in people with hypercholesterolaemia and prediabetes at baseline vs people with normoglycaemia at baseline in a pooled analysis of 10 ODYSSEY phase III trials.
Methods
People classified as having prediabetes had baseline HbA1c ≥39 mmol/mol (5.7%) and <48 mmol/mol (6.5%), or two baseline fasting plasma glucose values ≥5.6 mmol/l (100 mg/dl) but no more than one fasting plasma glucose value ≥7.0 mmol/l (126 mg/dl), or had specific terms reported in their medical history; people diagnosed with diabetes at baseline were excluded, and the remainder were classified as having normoglycaemia. Participants received alirocumab or control (placebo/ezetimibe) for 24–104 weeks, with maximally tolerated statin in most cases. The primary efficacy endpoint was LDL cholesterol reductions from baseline to week 24 in the intention‐to‐treat population using the mixed‐effect model with a repeated measures approach.
Results
Reductions in LDL cholesterol from baseline to week 24 with alirocumab were 44.0–61.8% (prediabetes group) and 45.8–59.5% (normoglycaemia group). In both subgroups, LDL cholesterol reductions were generally similar in those with and without baseline triglycerides ≥1.7 mmol/l (150 mg/dl). Alirocumab was not associated with changes in HbA1c or fasting plasma glucose over time in either subgroup (up to 24 months' follow‐up). Adverse event rates were generally similar in those with and without prediabetes.
Conclusions
Over a mean follow‐up of 24–104 weeks, alirocumab treatment resulted in significant LDL cholesterol reductions from baseline that were similar in participants with prediabetes and those with normoglycaemia at baseline, with no effect on glycaemia and a safety profile similar to that of the control.
What's new?
With statins being associated with an increased risk of diabetes (especially in individuals with risk factors for diabetes) and recent studies linking PCSK9 to glucose homeostasis, there is much interest in whether PCSK9 inhibitors affect diabetes risk.
We assessed the efficacy/safety of alirocumab, a PCSK9 inhibitor, vs control over a mean follow‐up of 24–104 weeks in people with hypercholesterolaemia and prediabetes vs people with normoglycaemia at baseline from 10 ODYSSEY phase III trials.
Our findings show alirocumab is generally well tolerated and significantly reduced LDL cholesterol levels to similar extents in individuals with prediabetes and those with normoglycaemia without any changes in measures of glycaemic control.</description><subject>Adult</subject><subject>Aged</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Anticholesteremic Agents - therapeutic use</subject><subject>Blood glucose</subject><subject>Blood Glucose - metabolism</subject><subject>Case-Control Studies</subject><subject>Cholesterol</subject><subject>Cholesterol, LDL - metabolism</subject><subject>Clinical trials</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Double-Blind Method</subject><subject>Fasting</subject><subject>Female</subject><subject>Glucose</subject><subject>Glycated Hemoglobin - metabolism</subject><subject>Homeostasis</subject><subject>Humans</subject><subject>Hypercholesterolemia - complications</subject><subject>Hypercholesterolemia - drug therapy</subject><subject>Hypercholesterolemia - metabolism</subject><subject>Kexin</subject><subject>Laboratory testing</subject><subject>Low density lipoprotein</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Monoclonal antibodies</subject><subject>Motivation</subject><subject>Prediabetic State - complications</subject><subject>Prediabetic State - metabolism</subject><subject>Proprotein convertases</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Research: Treatment</subject><subject>Safety</subject><subject>Statins</subject><subject>Subtilisin</subject><subject>Treatment Outcome</subject><subject>Triglycerides</subject><subject>Triglycerides - metabolism</subject><issn>0742-3071</issn><issn>1464-5491</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp1kc9u1DAQhy0EosvCgRdAlrjAIa2dOH_MAQm1C6xU1EN76cma2JOuKycOdrZV3oZHrbe7VICEJWsO8_mbkX-EvOXsmKdzYno85oUo2TOy4KISWSkkf04WrBZ5VrCaH5FXMd4yxnNZyJfkKG9qKXNWLMivVddZDXqmMBgaocNppr6j4GzwettDS-1AR_SjQ3pvpw0dAxoLLU4Y6V2k08bHQ2fwofc3btaAvQUKE20horMDfqJAR-8dmjQG3Bxt3A3hjI6bhND1ek0vzq4vL1fXVKcHaSNHp2DBxdfkRZcKvjnUJbn6uro6_Z6dX3xbn345z7QQBcvSLavamE5rZlhrqlYbaHMmCl3rpipEgSWvNEPDZC0AjZQNr7qmzKHRvC2W5PNeO27bHo3GYQrg1BhsD2FWHqz6uzPYjbrxd6qsk5w3SfDhIAj-5xbjpHobNToHA_ptVFzmTcmqspQJff8Peuu3If3LjqrFLpskXZKPe0oHH2PA7mkZztQudpViV4-xJ_bdn9s_kb9zTsDJHri3Duf_m9TZj9Ve-QA5GbkL</recordid><startdate>201801</startdate><enddate>201801</enddate><creator>Leiter, L. A.</creator><creator>Müller‐Wieland, D.</creator><creator>Baccara‐Dinet, M. T.</creator><creator>Letierce, A.</creator><creator>Samuel, R.</creator><creator>Cariou, B.</creator><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</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>7T5</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-1040-6229</orcidid></search><sort><creationdate>201801</creationdate><title>Efficacy and safety of alirocumab in people with prediabetes vs those with normoglycaemia at baseline: a pooled analysis of 10 phase III ODYSSEY clinical trials</title><author>Leiter, L. A. ; Müller‐Wieland, D. ; Baccara‐Dinet, M. T. ; Letierce, A. ; Samuel, R. ; Cariou, B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4430-430567ddfcc0d0bd6bcdab2043c7c86343e516c0ed0974aed99816f852a8c1b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Antibodies, Monoclonal, Humanized</topic><topic>Anticholesteremic Agents - therapeutic use</topic><topic>Blood glucose</topic><topic>Blood Glucose - metabolism</topic><topic>Case-Control Studies</topic><topic>Cholesterol</topic><topic>Cholesterol, LDL - metabolism</topic><topic>Clinical trials</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Double-Blind Method</topic><topic>Fasting</topic><topic>Female</topic><topic>Glucose</topic><topic>Glycated Hemoglobin - metabolism</topic><topic>Homeostasis</topic><topic>Humans</topic><topic>Hypercholesterolemia - complications</topic><topic>Hypercholesterolemia - drug therapy</topic><topic>Hypercholesterolemia - metabolism</topic><topic>Kexin</topic><topic>Laboratory testing</topic><topic>Low density lipoprotein</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Monoclonal antibodies</topic><topic>Motivation</topic><topic>Prediabetic State - complications</topic><topic>Prediabetic State - metabolism</topic><topic>Proprotein convertases</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Research: Treatment</topic><topic>Safety</topic><topic>Statins</topic><topic>Subtilisin</topic><topic>Treatment Outcome</topic><topic>Triglycerides</topic><topic>Triglycerides - metabolism</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Leiter, L. A.</creatorcontrib><creatorcontrib>Müller‐Wieland, D.</creatorcontrib><creatorcontrib>Baccara‐Dinet, M. T.</creatorcontrib><creatorcontrib>Letierce, A.</creatorcontrib><creatorcontrib>Samuel, R.</creatorcontrib><creatorcontrib>Cariou, B.</creatorcontrib><collection>Wiley-Blackwell Open Access Titles</collection><collection>Wiley Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Diabetic medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Leiter, L. A.</au><au>Müller‐Wieland, D.</au><au>Baccara‐Dinet, M. T.</au><au>Letierce, A.</au><au>Samuel, R.</au><au>Cariou, B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of alirocumab in people with prediabetes vs those with normoglycaemia at baseline: a pooled analysis of 10 phase III ODYSSEY clinical trials</atitle><jtitle>Diabetic medicine</jtitle><addtitle>Diabet Med</addtitle><date>2018-01</date><risdate>2018</risdate><volume>35</volume><issue>1</issue><spage>121</spage><epage>130</epage><pages>121-130</pages><issn>0742-3071</issn><eissn>1464-5491</eissn><abstract>Aim
To assess the lipid‐lowering efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in people with hypercholesterolaemia and prediabetes at baseline vs people with normoglycaemia at baseline in a pooled analysis of 10 ODYSSEY phase III trials.
Methods
People classified as having prediabetes had baseline HbA1c ≥39 mmol/mol (5.7%) and <48 mmol/mol (6.5%), or two baseline fasting plasma glucose values ≥5.6 mmol/l (100 mg/dl) but no more than one fasting plasma glucose value ≥7.0 mmol/l (126 mg/dl), or had specific terms reported in their medical history; people diagnosed with diabetes at baseline were excluded, and the remainder were classified as having normoglycaemia. Participants received alirocumab or control (placebo/ezetimibe) for 24–104 weeks, with maximally tolerated statin in most cases. The primary efficacy endpoint was LDL cholesterol reductions from baseline to week 24 in the intention‐to‐treat population using the mixed‐effect model with a repeated measures approach.
Results
Reductions in LDL cholesterol from baseline to week 24 with alirocumab were 44.0–61.8% (prediabetes group) and 45.8–59.5% (normoglycaemia group). In both subgroups, LDL cholesterol reductions were generally similar in those with and without baseline triglycerides ≥1.7 mmol/l (150 mg/dl). Alirocumab was not associated with changes in HbA1c or fasting plasma glucose over time in either subgroup (up to 24 months' follow‐up). Adverse event rates were generally similar in those with and without prediabetes.
Conclusions
Over a mean follow‐up of 24–104 weeks, alirocumab treatment resulted in significant LDL cholesterol reductions from baseline that were similar in participants with prediabetes and those with normoglycaemia at baseline, with no effect on glycaemia and a safety profile similar to that of the control.
What's new?
With statins being associated with an increased risk of diabetes (especially in individuals with risk factors for diabetes) and recent studies linking PCSK9 to glucose homeostasis, there is much interest in whether PCSK9 inhibitors affect diabetes risk.
We assessed the efficacy/safety of alirocumab, a PCSK9 inhibitor, vs control over a mean follow‐up of 24–104 weeks in people with hypercholesterolaemia and prediabetes vs people with normoglycaemia at baseline from 10 ODYSSEY phase III trials.
Our findings show alirocumab is generally well tolerated and significantly reduced LDL cholesterol levels to similar extents in individuals with prediabetes and those with normoglycaemia without any changes in measures of glycaemic control.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>28799203</pmid><doi>10.1111/dme.13450</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-1040-6229</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Diabetic medicine, 2018-01, Vol.35 (1), p.121-130 |
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| source | MEDLINE; Wiley Journals |
| subjects | Adult Aged Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized Anticholesteremic Agents - therapeutic use Blood glucose Blood Glucose - metabolism Case-Control Studies Cholesterol Cholesterol, LDL - metabolism Clinical trials Clinical Trials, Phase III as Topic Diabetes Diabetes mellitus Double-Blind Method Fasting Female Glucose Glycated Hemoglobin - metabolism Homeostasis Humans Hypercholesterolemia - complications Hypercholesterolemia - drug therapy Hypercholesterolemia - metabolism Kexin Laboratory testing Low density lipoprotein Male Middle Aged Monoclonal antibodies Motivation Prediabetic State - complications Prediabetic State - metabolism Proprotein convertases Randomized Controlled Trials as Topic Research: Treatment Safety Statins Subtilisin Treatment Outcome Triglycerides Triglycerides - metabolism |
| title | Efficacy and safety of alirocumab in people with prediabetes vs those with normoglycaemia at baseline: a pooled analysis of 10 phase III ODYSSEY clinical trials |
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