Benefit of Adding Ezetimibe to Statin Therapy on Cardiovascular Outcomes and Safety in Patients With Versus Without Diabetes Mellitus: Results From IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial)
BACKGROUND:Ezetimibe, when added to simvastatin, reduces cardiovascular events after acute coronary syndrome. We explored outcomes stratified by diabetes mellitus (DM). METHODS:In IMPROVE-IT (Improved Reduction of OutcomesVytorin Efficacy International Trial), 18 144 patients after acute coronary sy...
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creator | Giugliano, Robert P Cannon, Christopher P Blazing, Michael A Nicolau, José C Corbalán, Ramón Špinar, Jindřich Park, Jeong-Gun White, Jennifer A Bohula, Erin A Braunwald, Eugene |
description | BACKGROUND:Ezetimibe, when added to simvastatin, reduces cardiovascular events after acute coronary syndrome. We explored outcomes stratified by diabetes mellitus (DM).
METHODS:In IMPROVE-IT (Improved Reduction of OutcomesVytorin Efficacy International Trial), 18 144 patients after acute coronary syndrome with low-density lipoprotein cholesterol 50 to 125 mg/dL were randomized to 40 mg ezetimibe/simvastatin (E/S) or 40 mg placebo/simvastatin. The primary composite end point was cardiovascular death, major coronary events, and stroke. DM was a prespecified subgroup.
RESULTS:The 4933 (27%) patients with DM were more often older and female, had had a prior myocardial infarction and revascularization, and presented more frequently with non-ST segment elevation acute coronary syndrome compared with patients without DM (each P |
doi_str_mv | 10.1161/CIRCULATIONAHA.117.030950 |
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METHODS:In IMPROVE-IT (Improved Reduction of OutcomesVytorin Efficacy International Trial), 18 144 patients after acute coronary syndrome with low-density lipoprotein cholesterol 50 to 125 mg/dL were randomized to 40 mg ezetimibe/simvastatin (E/S) or 40 mg placebo/simvastatin. The primary composite end point was cardiovascular death, major coronary events, and stroke. DM was a prespecified subgroup.
RESULTS:The 4933 (27%) patients with DM were more often older and female, had had a prior myocardial infarction and revascularization, and presented more frequently with non-ST segment elevation acute coronary syndrome compared with patients without DM (each P<0.001). The median admission low-density lipoprotein cholesterol was lower among patients with DM (89 versus 97 mg/dL, P<0.001). E/S achieved a significantly lower median time-weighted average low-density lipoprotein cholesterol compared with placebo/simvastatin, irrespective of DM (DM49 versus 67 mg/dL; no DM55 versus 71 mg/dL; both P<0.001). In patients with DM, E/S reduced the 7-year Kaplan–Meier primary end point event rate by 5.5% absolute (hazard ratio, 0.85; 95% confidence interval, 0.78-0.94); in patients without DM, the absolute difference was 0.7% (hazard ratio, 0.98; 95% confidence interval, 0.91–1.04; Pint=0.02). The largest relative reductions in patients with DM were in myocardial infarction (24%) and ischemic stroke (39%). No differences in safety outcomes by treatment were present regardless of DM. When stratified further by age, patients ≥75 years of age had a 20% relative reduction in the primary end point regardless of DM (Pint=0.91), whereas patients <75 years of age with DM had greater benefit than those without (Pint=0.011). When stratified by the TIMI (Thrombolysis in Myocardial Infarction) Risk Score for Secondary Prevention, all patients with DM demonstrated benefit with E/S regardless of risk. In contrast, among patients without DM, those with a high risk score experienced a significant (18%) relative reduction in the composite of cardiovascular death, myocardial infarction, and ischemic stroke with E/S compared with placebo/simvastatin, whereas patients without DM at low or moderate risk demonstrated no benefit with the addition of ezetimibe to simvastatin (Pint =0.034).
CONCLUSIONS:In IMPROVE-IT, the benefit of adding ezetimibe to statin was enhanced in patients with DM and in high-risk patients without DM.
CLINICAL TRIAL REGISTRATION:URLhttps://www.clinicaltrials.gov. Unique identifierNCT00202878.</description><identifier>ISSN: 0009-7322</identifier><identifier>EISSN: 1524-4539</identifier><identifier>DOI: 10.1161/CIRCULATIONAHA.117.030950</identifier><identifier>PMID: 29263150</identifier><language>eng</language><publisher>United States: by the American College of Cardiology Foundation and the American Heart Association, Inc</publisher><subject>Acute Coronary Syndrome - diagnosis ; Acute Coronary Syndrome - mortality ; Acute Coronary Syndrome - therapy ; Aged ; Biomarkers - blood ; Cholesterol, LDL - blood ; Comorbidity ; Diabetes Mellitus - diagnosis ; Diabetes Mellitus - mortality ; Diabetes Mellitus - therapy ; Dyslipidemias - diagnosis ; Dyslipidemias - drug therapy ; Dyslipidemias - mortality ; Ezetimibe, Simvastatin Drug Combination - adverse effects ; Ezetimibe, Simvastatin Drug Combination - therapeutic use ; Female ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use ; Male ; Middle Aged ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome</subject><ispartof>Circulation (New York, N.Y.), 2018-04, Vol.137 (15), p.1571-1582</ispartof><rights>2018 by the American College of Cardiology Foundation and the American Heart Association, Inc.</rights><rights>2017 American Heart Association, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3010-2b5e9b9fe439bc6ff9afbfcc8c39ca71833dbcc47e18ed31be1b4a49eec4bb0f3</citedby><cites>FETCH-LOGICAL-c3010-2b5e9b9fe439bc6ff9afbfcc8c39ca71833dbcc47e18ed31be1b4a49eec4bb0f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,3687,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29263150$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Giugliano, Robert P</creatorcontrib><creatorcontrib>Cannon, Christopher P</creatorcontrib><creatorcontrib>Blazing, Michael A</creatorcontrib><creatorcontrib>Nicolau, José C</creatorcontrib><creatorcontrib>Corbalán, Ramón</creatorcontrib><creatorcontrib>Špinar, Jindřich</creatorcontrib><creatorcontrib>Park, Jeong-Gun</creatorcontrib><creatorcontrib>White, Jennifer A</creatorcontrib><creatorcontrib>Bohula, Erin A</creatorcontrib><creatorcontrib>Braunwald, Eugene</creatorcontrib><creatorcontrib>IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) Investigators</creatorcontrib><title>Benefit of Adding Ezetimibe to Statin Therapy on Cardiovascular Outcomes and Safety in Patients With Versus Without Diabetes Mellitus: Results From IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial)</title><title>Circulation (New York, N.Y.)</title><addtitle>Circulation</addtitle><description>BACKGROUND:Ezetimibe, when added to simvastatin, reduces cardiovascular events after acute coronary syndrome. We explored outcomes stratified by diabetes mellitus (DM).
METHODS:In IMPROVE-IT (Improved Reduction of OutcomesVytorin Efficacy International Trial), 18 144 patients after acute coronary syndrome with low-density lipoprotein cholesterol 50 to 125 mg/dL were randomized to 40 mg ezetimibe/simvastatin (E/S) or 40 mg placebo/simvastatin. The primary composite end point was cardiovascular death, major coronary events, and stroke. DM was a prespecified subgroup.
RESULTS:The 4933 (27%) patients with DM were more often older and female, had had a prior myocardial infarction and revascularization, and presented more frequently with non-ST segment elevation acute coronary syndrome compared with patients without DM (each P<0.001). The median admission low-density lipoprotein cholesterol was lower among patients with DM (89 versus 97 mg/dL, P<0.001). E/S achieved a significantly lower median time-weighted average low-density lipoprotein cholesterol compared with placebo/simvastatin, irrespective of DM (DM49 versus 67 mg/dL; no DM55 versus 71 mg/dL; both P<0.001). In patients with DM, E/S reduced the 7-year Kaplan–Meier primary end point event rate by 5.5% absolute (hazard ratio, 0.85; 95% confidence interval, 0.78-0.94); in patients without DM, the absolute difference was 0.7% (hazard ratio, 0.98; 95% confidence interval, 0.91–1.04; Pint=0.02). The largest relative reductions in patients with DM were in myocardial infarction (24%) and ischemic stroke (39%). No differences in safety outcomes by treatment were present regardless of DM. When stratified further by age, patients ≥75 years of age had a 20% relative reduction in the primary end point regardless of DM (Pint=0.91), whereas patients <75 years of age with DM had greater benefit than those without (Pint=0.011). When stratified by the TIMI (Thrombolysis in Myocardial Infarction) Risk Score for Secondary Prevention, all patients with DM demonstrated benefit with E/S regardless of risk. In contrast, among patients without DM, those with a high risk score experienced a significant (18%) relative reduction in the composite of cardiovascular death, myocardial infarction, and ischemic stroke with E/S compared with placebo/simvastatin, whereas patients without DM at low or moderate risk demonstrated no benefit with the addition of ezetimibe to simvastatin (Pint =0.034).
CONCLUSIONS:In IMPROVE-IT, the benefit of adding ezetimibe to statin was enhanced in patients with DM and in high-risk patients without DM.
CLINICAL TRIAL REGISTRATION:URLhttps://www.clinicaltrials.gov. Unique identifierNCT00202878.</description><subject>Acute Coronary Syndrome - diagnosis</subject><subject>Acute Coronary Syndrome - mortality</subject><subject>Acute Coronary Syndrome - therapy</subject><subject>Aged</subject><subject>Biomarkers - blood</subject><subject>Cholesterol, LDL - blood</subject><subject>Comorbidity</subject><subject>Diabetes Mellitus - diagnosis</subject><subject>Diabetes Mellitus - mortality</subject><subject>Diabetes Mellitus - therapy</subject><subject>Dyslipidemias - diagnosis</subject><subject>Dyslipidemias - drug therapy</subject><subject>Dyslipidemias - mortality</subject><subject>Ezetimibe, Simvastatin Drug Combination - adverse effects</subject><subject>Ezetimibe, Simvastatin Drug Combination - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>0009-7322</issn><issn>1524-4539</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkd9u0zAYxSMEYmXwCsjcjYsMO06aehIXXehYpI5OXVcuI9v5TA1JXPxnU3lf3gNP2ZC448r2p9_xOfZJkncEnxIyJR-qel3dLuebevVlfjmPs_IUU8wK_CyZkCLL07yg7HkywRiztKRZdpS8cu57PE5pWbxMjjKWTSkp8CT5fQ4DKO2RUWjetnr4hha_wOteC0DeoBvPvR7QZgeW7w_IDKjittXmjjsZOm7RKnhpenCIDy264Qr8AUXBdZTB4B36qv0ObcG6MO5N8OiT5gJ81FxB12kf3BlagwtdxC-s6VF9db1ebRdpvUEndb-35g7aSLRBeh0TxKhPrmdoe_DGRsOFUlpyeUD14MEO_IHkHdpYzbv3r5MXincO3jyux8ntxWJTXabL1ee6mi9TSTHBaSYKYIIpyCkTcqoU40ooKWeSMslLMqO0FVLmJZAZtJQIICLnOQOQuRBY0ePkZLw3Zv4ZwPmm107GR_IBTHANYSXLWZazIqJsRKU1zllQzd7qnttDQ3Dz0HLzb8txVjZjy1H79tEmiB7av8qnWiPwcQTuTRd_w_3owj3YZge887v_MPgDR---MQ</recordid><startdate>20180410</startdate><enddate>20180410</enddate><creator>Giugliano, Robert P</creator><creator>Cannon, Christopher P</creator><creator>Blazing, Michael A</creator><creator>Nicolau, José C</creator><creator>Corbalán, Ramón</creator><creator>Špinar, Jindřich</creator><creator>Park, Jeong-Gun</creator><creator>White, Jennifer A</creator><creator>Bohula, Erin A</creator><creator>Braunwald, Eugene</creator><general>by the American College of Cardiology Foundation and the American Heart Association, Inc</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>7X8</scope></search><sort><creationdate>20180410</creationdate><title>Benefit of Adding Ezetimibe to Statin Therapy on Cardiovascular Outcomes and Safety in Patients With Versus Without Diabetes Mellitus: Results From IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial)</title><author>Giugliano, Robert P ; Cannon, Christopher P ; Blazing, Michael A ; Nicolau, José C ; Corbalán, Ramón ; Špinar, Jindřich ; Park, Jeong-Gun ; White, Jennifer A ; Bohula, Erin A ; Braunwald, Eugene</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3010-2b5e9b9fe439bc6ff9afbfcc8c39ca71833dbcc47e18ed31be1b4a49eec4bb0f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Acute Coronary Syndrome - diagnosis</topic><topic>Acute Coronary Syndrome - mortality</topic><topic>Acute Coronary Syndrome - therapy</topic><topic>Aged</topic><topic>Biomarkers - blood</topic><topic>Cholesterol, LDL - blood</topic><topic>Comorbidity</topic><topic>Diabetes Mellitus - diagnosis</topic><topic>Diabetes Mellitus - mortality</topic><topic>Diabetes Mellitus - therapy</topic><topic>Dyslipidemias - diagnosis</topic><topic>Dyslipidemias - drug therapy</topic><topic>Dyslipidemias - mortality</topic><topic>Ezetimibe, Simvastatin Drug Combination - adverse effects</topic><topic>Ezetimibe, Simvastatin Drug Combination - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Giugliano, Robert P</creatorcontrib><creatorcontrib>Cannon, Christopher P</creatorcontrib><creatorcontrib>Blazing, Michael A</creatorcontrib><creatorcontrib>Nicolau, José C</creatorcontrib><creatorcontrib>Corbalán, Ramón</creatorcontrib><creatorcontrib>Špinar, Jindřich</creatorcontrib><creatorcontrib>Park, Jeong-Gun</creatorcontrib><creatorcontrib>White, Jennifer A</creatorcontrib><creatorcontrib>Bohula, Erin A</creatorcontrib><creatorcontrib>Braunwald, Eugene</creatorcontrib><creatorcontrib>IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Circulation (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Giugliano, Robert P</au><au>Cannon, Christopher P</au><au>Blazing, Michael A</au><au>Nicolau, José C</au><au>Corbalán, Ramón</au><au>Špinar, Jindřich</au><au>Park, Jeong-Gun</au><au>White, Jennifer A</au><au>Bohula, Erin A</au><au>Braunwald, Eugene</au><aucorp>IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Benefit of Adding Ezetimibe to Statin Therapy on Cardiovascular Outcomes and Safety in Patients With Versus Without Diabetes Mellitus: Results From IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial)</atitle><jtitle>Circulation (New York, N.Y.)</jtitle><addtitle>Circulation</addtitle><date>2018-04-10</date><risdate>2018</risdate><volume>137</volume><issue>15</issue><spage>1571</spage><epage>1582</epage><pages>1571-1582</pages><issn>0009-7322</issn><eissn>1524-4539</eissn><abstract>BACKGROUND:Ezetimibe, when added to simvastatin, reduces cardiovascular events after acute coronary syndrome. We explored outcomes stratified by diabetes mellitus (DM).
METHODS:In IMPROVE-IT (Improved Reduction of OutcomesVytorin Efficacy International Trial), 18 144 patients after acute coronary syndrome with low-density lipoprotein cholesterol 50 to 125 mg/dL were randomized to 40 mg ezetimibe/simvastatin (E/S) or 40 mg placebo/simvastatin. The primary composite end point was cardiovascular death, major coronary events, and stroke. DM was a prespecified subgroup.
RESULTS:The 4933 (27%) patients with DM were more often older and female, had had a prior myocardial infarction and revascularization, and presented more frequently with non-ST segment elevation acute coronary syndrome compared with patients without DM (each P<0.001). The median admission low-density lipoprotein cholesterol was lower among patients with DM (89 versus 97 mg/dL, P<0.001). E/S achieved a significantly lower median time-weighted average low-density lipoprotein cholesterol compared with placebo/simvastatin, irrespective of DM (DM49 versus 67 mg/dL; no DM55 versus 71 mg/dL; both P<0.001). In patients with DM, E/S reduced the 7-year Kaplan–Meier primary end point event rate by 5.5% absolute (hazard ratio, 0.85; 95% confidence interval, 0.78-0.94); in patients without DM, the absolute difference was 0.7% (hazard ratio, 0.98; 95% confidence interval, 0.91–1.04; Pint=0.02). The largest relative reductions in patients with DM were in myocardial infarction (24%) and ischemic stroke (39%). No differences in safety outcomes by treatment were present regardless of DM. When stratified further by age, patients ≥75 years of age had a 20% relative reduction in the primary end point regardless of DM (Pint=0.91), whereas patients <75 years of age with DM had greater benefit than those without (Pint=0.011). When stratified by the TIMI (Thrombolysis in Myocardial Infarction) Risk Score for Secondary Prevention, all patients with DM demonstrated benefit with E/S regardless of risk. In contrast, among patients without DM, those with a high risk score experienced a significant (18%) relative reduction in the composite of cardiovascular death, myocardial infarction, and ischemic stroke with E/S compared with placebo/simvastatin, whereas patients without DM at low or moderate risk demonstrated no benefit with the addition of ezetimibe to simvastatin (Pint =0.034).
CONCLUSIONS:In IMPROVE-IT, the benefit of adding ezetimibe to statin was enhanced in patients with DM and in high-risk patients without DM.
CLINICAL TRIAL REGISTRATION:URLhttps://www.clinicaltrials.gov. Unique identifierNCT00202878.</abstract><cop>United States</cop><pub>by the American College of Cardiology Foundation and the American Heart Association, Inc</pub><pmid>29263150</pmid><doi>10.1161/CIRCULATIONAHA.117.030950</doi><tpages>12</tpages></addata></record> |
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subjects | Acute Coronary Syndrome - diagnosis Acute Coronary Syndrome - mortality Acute Coronary Syndrome - therapy Aged Biomarkers - blood Cholesterol, LDL - blood Comorbidity Diabetes Mellitus - diagnosis Diabetes Mellitus - mortality Diabetes Mellitus - therapy Dyslipidemias - diagnosis Dyslipidemias - drug therapy Dyslipidemias - mortality Ezetimibe, Simvastatin Drug Combination - adverse effects Ezetimibe, Simvastatin Drug Combination - therapeutic use Female Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Male Middle Aged Risk Assessment Risk Factors Time Factors Treatment Outcome |
title | Benefit of Adding Ezetimibe to Statin Therapy on Cardiovascular Outcomes and Safety in Patients With Versus Without Diabetes Mellitus: Results From IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) |
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