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Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease.

BACKGROUNDPatients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol leve... Full description

Journal Title: The New England journal of medicine September 28, 2017, Vol.377(13), pp.1217-1227
Main Author: Bowman, Louise
Other Authors: Hopewell, Jemma C , Chen, Fang , Wallendszus, Karl , Stevens, William , Collins, Rory , Wiviott, Stephen D , Cannon, Christopher P , Braunwald, Eugene , Sammons, Emily , Landray, Martin J , Bowman, Louise
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: E-ISSN: 1533-4406 ; DOI: 1533-4406 ; DOI: 10.1056/NEJMoa1706444
Link: http://search.proquest.com/docview/1933606973/?pq-origsite=primo
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title: Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease.
format: Article
creator:
  • Bowman, Louise
  • Hopewell, Jemma C
  • Chen, Fang
  • Wallendszus, Karl
  • Stevens, William
  • Collins, Rory
  • Wiviott, Stephen D
  • Cannon, Christopher P
  • Braunwald, Eugene
  • Sammons, Emily
  • Landray, Martin J
  • Bowman, Louise
subjects:
  • Aged–Adverse Effects
  • Anticholesteremic Agents–Therapeutic Use
  • Atherosclerosis–Complications
  • Cholesterol–Drug Therapy
  • Cholesterol Ester Transfer Proteins–Blood
  • Coronary Disease–Antagonists & Inhibitors
  • Double-Blind Method–Epidemiology
  • Drug Therapy, Combination–Mortality
  • Female–Prevention & Control
  • Humans–Therapeutic Use
  • Hydroxymethylglutaryl-Coa Reductase Inhibitors–Adverse Effects
  • Incidence–Therapeutic Use
  • Kaplan-Meier Estimate–Therapeutic Use
  • Male–Therapeutic Use
  • Medication Adherence–Therapeutic Use
  • Middle Aged–Therapeutic Use
  • Oxazolidinones–Therapeutic Use
  • Abridged
  • Anticholesteremic Agents
  • Cetp Protein, Human
  • Cholesterol Ester Transfer Proteins
  • Hydroxymethylglutaryl-Coa Reductase Inhibitors
  • Oxazolidinones
  • Cholesterol
  • Anacetrapib
ispartof: The New England journal of medicine, September 28, 2017, Vol.377(13), pp.1217-1227
description: BACKGROUNDPatients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODSWe conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTSDuring the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONSAmong patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .).
language: eng
source:
identifier: E-ISSN: 1533-4406 ; DOI: 1533-4406 ; DOI: 10.1056/NEJMoa1706444
fulltext: fulltext
issn:
  • 15334406
  • 1533-4406
url: Link


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titleEffects of Anacetrapib in Patients with Atherosclerotic Vascular Disease.
creatorBowman, Louise ; Hopewell, Jemma C ; Chen, Fang ; Wallendszus, Karl ; Stevens, William ; Collins, Rory ; Wiviott, Stephen D ; Cannon, Christopher P ; Braunwald, Eugene ; Sammons, Emily ; Landray, Martin J ; Bowman, Louise
contributorJiang, L (correspondence author) ; Armitage, J (record owner) ; Haynes, R ; Maggioni, A P ; Angermann, C E ; Ertl, G ; Wanner, C ; Pedersen, T ; Goto, S ; Teramoto, T ; Baigent, C ; Barter, P ; Chen, Y ; Chen, Z ; Gray, A ; Mihaylova, B ; Sleight, P ; Tobert, J ; Blaustein, R ; Delucca, P ; Mitchel, Y ; van Leijenhorst, G ; Sandercock, P ; Demets, D ; Kjekshus, J ; Neuberger, J ; Tonkin, A ; Emberson, J ; Granger, C ; Colhoun, H ; Barton, J ; Bray, C ; Dayanandan, R ; Knott, C ; Lay, M ; Murphy, K ; Wincott, E ; Achiri, P ; Barry, S ; Bateman, S ; Brewster, A ; Briggs, S ; Brown, R ; Burke, A ; Butler, E ; Cobb, L ; Collet, A ; Crowther, J ; Cureton, L ; Danesh-Pour, S ; Fathers, S ; Fletcher, L ; Frederick, K ; Gordon, T ; Gray, M ; Heineman, J ; Howard, S ; Jackson, D ; Lam, N ; Lee, R ; Machin, O ; Madgwick, Z ; Matthewson, M ; Nolan, J ; Nunn, M ; Panicker, A ; Pank, L ; Pearson-Burton, E ; Pickworth, S ; Qiao, Y ; Radley, A ; Roby, K ; Sayer, J ; Shah, S ; Taylor, K ; Thorne, H ; Timadjer, A ; Vandenberg, K ; Wickman, M ; Willett, M ; Woods, J ; Yu, H ; Aung, T ; Bulbulia, R ; Clarke, R ; Herrington, W ; Judge, P ; Lewis, D ; Llewellyn-Bennett, R ; Mafham, M ; Preiss, D ; Reith, C ; Storey, B ; Tomson, J ; Waters, E ; Baxter, A ; Goodenough, R ; Ait-Sadi, R ; Arnold, M ; Barton, I ; Berry, C ; Blower, G ; Booth, J ; Brown, E ; Bu, Y ; Cleverley, P ; Coates, G ; Cox, J ; Craig, M ; Cui, G ; Dalton, P ; Danel, L ; Daniels, C ; Dawe, C ; Field, A ; Gilbert, S ; Harding, P ; Jayne, K ; Kurien, R ; Lancaster, G ; Maskill, A ; Mcdougall, A ; Mostefai, Y ; Mulay, S ; Munday, A ; Murawska, A ; Prajapati, N ; Ramesh, S ; Reid, R ; Syed, S ; Todd, H ; Young, A ; Zhu, W ; Parish, S ; Valdes-Marquez, E ; Hill, M ; Clark, S ; Emmens, K ; Mcclean, G ; Radley, M ; Wintour, J ; Allworth, M ; Beneat, A-M ; Bird, C ; Boggs, L ; Casey, A ; Chavagnon, T ; Chung, K ; Chung, R ; Cockram, L ; Cox, R ; Douglas, J ; Finnegan, L ; French, H ; Goodwin, N ; Gordon, A ; Gordon, J ; Guest, C ; Hazim, S ; Hill, J ; Hrusecka, R ; Lacey, M ; Luker, N ; Mulligan, S ; Obrero, M E ; Plunkett, N ; Sansom, L ; Shellard, R ; Taylor, J ; Taylor, P ; Tyler, J ; Weaving, L ; Wheeler, J ; Williams, T ; Yeung, M ; Beebe, S ; Bowsher-Brown, K ; Dabrowski, J ; Henderson, J ; James, J ; Lochhead, H ; Toghill, V ; Wright, L ; Young, L ; Hundei, W ; Liu, J ; Qu, J ; Zhang, H ; Dai, H ; Feng, F ; Hou, L ; Li, J ; Ma, L ; Niu, S ; Tang, R ; Wang, S ; Wei, X ; Xie, M ; Yan, X ; Yang, M ; Zhang, Y ; Zhang, L ; Zhang, A ; Zhang, S ; Zhao, L ; Zhong, H ; Chen, L ; Gao, Y ; Li, L ; Yang, H ; Zhang, J ; Brenner, S ; Heldmann, M ; Kraus, B ; Meyer, B ; Fajardo-Moser, M ; Hartner, C ; Knoppe, A ; Pop-Marschall, D ; Renner, J ; Saemann, U ; Fabbri, G ; Lorimer, A ; Lucci, D ; Bartolomei Mecatti, B ; Ceseri, M ; Baldini, E ; Benoni, S ; Bianchini, F ; Ferruzzi, P ; Miccoli, M ; Musio, S ; Ramani, F ; Gorini, M ; Orsini, G ; Kato, E ; Tawara, K ; Tomita, A
ispartofThe New England journal of medicine, September 28, 2017, Vol.377(13), pp.1217-1227
identifier
subjectAged–Adverse Effects ; Anticholesteremic Agents–Therapeutic Use ; Atherosclerosis–Complications ; Cholesterol–Drug Therapy ; Cholesterol Ester Transfer Proteins–Blood ; Coronary Disease–Antagonists & Inhibitors ; Double-Blind Method–Epidemiology ; Drug Therapy, Combination–Mortality ; Female–Prevention & Control ; Humans–Therapeutic Use ; Hydroxymethylglutaryl-Coa Reductase Inhibitors–Adverse Effects ; Incidence–Therapeutic Use ; Kaplan-Meier Estimate–Therapeutic Use ; Male–Therapeutic Use ; Medication Adherence–Therapeutic Use ; Middle Aged–Therapeutic Use ; Oxazolidinones–Therapeutic Use ; Abridged ; Anticholesteremic Agents ; Cetp Protein, Human ; Cholesterol Ester Transfer Proteins ; Hydroxymethylglutaryl-Coa Reductase Inhibitors ; Oxazolidinones ; Cholesterol ; Anacetrapib
descriptionBACKGROUNDPatients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODSWe conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTSDuring the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONSAmong patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .).
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0Bowman, Louise
1Hopewell, Jemma C
2Chen, Fang
3Wallendszus, Karl
4Stevens, William
5Collins, Rory
6Wiviott, Stephen D
7Cannon, Christopher P
8Braunwald, Eugene
9Sammons, Emily
10Landray, Martin J
titleEffects of Anacetrapib in Patients with Atherosclerotic Vascular Disease.
descriptionBACKGROUNDPatients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODSWe conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTSDuring the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONSAmong patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .).
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0Aged–Adverse Effects
1Anticholesteremic Agents–Therapeutic Use
2Atherosclerosis–Complications
3Cholesterol–Drug Therapy
4Cholesterol Ester Transfer Proteins–Blood
5Coronary Disease–Antagonists & Inhibitors
6Double-Blind Method–Epidemiology
7Drug Therapy, Combination–Mortality
8Female–Prevention & Control
9Humans–Therapeutic Use
10Hydroxymethylglutaryl-Coa Reductase Inhibitors–Adverse Effects
11Incidence–Therapeutic Use
12Kaplan-Meier Estimate–Therapeutic Use
13Male–Therapeutic Use
14Medication Adherence–Therapeutic Use
15Middle Aged–Therapeutic Use
16Oxazolidinones–Therapeutic Use
17Abridged
18Anticholesteremic Agents
19Cetp Protein, Human
20Cholesterol Ester Transfer Proteins
21Hydroxymethylglutaryl-Coa Reductase Inhibitors
22Oxazolidinones
23Cholesterol
24Anacetrapib
25ISRCTN48678192
262010-023467-18
27NCT01252953
28ISRCTN
29EudraCT
30ClinicalTrials.gov
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0Jiang, L
1Armitage, J
2Haynes, R
3Maggioni, A P
4Angermann, C E
5Ertl, G
6Wanner, C
7Pedersen, T
8Goto, S
9Teramoto, T
10Baigent, C
11Barter, P
12Chen, Y
13Chen, Z
14Gray, A
15Mihaylova, B
16Sleight, P
17Tobert, J
18Blaustein, R
19Delucca, P
20Mitchel, Y
21van Leijenhorst, G
22Sandercock, P
23Demets, D
24Kjekshus, J
25Neuberger, J
26Tonkin, A
27Emberson, J
28Granger, C
29Colhoun, H
30Barton, J
31Bray, C
32Dayanandan, R
33Knott, C
34Lay, M
35Murphy, K
36Wincott, E
37Achiri, P
38Barry, S
39Bateman, S
40Brewster, A
41Briggs, S
42Brown, R
43Burke, A
44Butler, E
45Cobb, L
46Collet, A
47Crowther, J
48Cureton, L
49Danesh-Pour, S
50Fathers, S
51Fletcher, L
52Frederick, K
53Gordon, T
54Gray, M
55Heineman, J
56Howard, S
57Jackson, D
58Lam, N
59Lee, R
60Machin, O
61Madgwick, Z
62Matthewson, M
63Nolan, J
64Nunn, M
65Panicker, A
66Pank, L
67Pearson-Burton, E
68Pickworth, S
69Qiao, Y
70Radley, A
71Roby, K
72Sayer, J
73Shah, S
74Taylor, K
75Thorne, H
76Timadjer, A
77Vandenberg, K
78Wickman, M
79Willett, M
80Woods, J
81Yu, H
82Aung, T
83Bulbulia, R
84Clarke, R
85Herrington, W
86Judge, P
87Lewis, D
88Llewellyn-Bennett, R
89Mafham, M
90Preiss, D
91Reith, C
92Storey, B
93Tomson, J
94Waters, E
95Baxter, A
96Goodenough, R
97Ait-Sadi, R
98Arnold, M
99Barton, I
100...
startdate20170928
enddate20170928
citationpf 1217 pt 1227 vol 377 issue 13
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titleEffects of Anacetrapib in Patients with Atherosclerotic Vascular Disease.
authorBowman, Louise ; Hopewell, Jemma C ; Chen, Fang ; Wallendszus, Karl ; Stevens, William ; Collins, Rory ; Wiviott, Stephen D ; Cannon, Christopher P ; Braunwald, Eugene ; Sammons, Emily ; Landray, Martin J ; Bowman, Louise
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0Aged–Adverse Effects
1Anticholesteremic Agents–Therapeutic Use
2Atherosclerosis–Complications
3Cholesterol–Drug Therapy
4Cholesterol Ester Transfer Proteins–Blood
5Coronary Disease–Antagonists & Inhibitors
6Double-Blind Method–Epidemiology
7Drug Therapy, Combination–Mortality
8Female–Prevention & Control
9Humans–Therapeutic Use
10Hydroxymethylglutaryl-Coa Reductase Inhibitors–Adverse Effects
11Incidence–Therapeutic Use
12Kaplan-Meier Estimate–Therapeutic Use
13Male–Therapeutic Use
14Medication Adherence–Therapeutic Use
15Middle Aged–Therapeutic Use
16Oxazolidinones–Therapeutic Use
17Abridged
18Anticholesteremic Agents
19Cetp Protein, Human
20Cholesterol Ester Transfer Proteins
21Hydroxymethylglutaryl-Coa Reductase Inhibitors
22Oxazolidinones
23Cholesterol
24Anacetrapib
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3ProQuest SciTech Collection
4Biological Science Database
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9Biological Science Index (ProQuest)
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0Bowman, Louise
1Hopewell, Jemma C
2Chen, Fang
3Wallendszus, Karl
4Stevens, William
5Collins, Rory
6Wiviott, Stephen D
7Cannon, Christopher P
8Braunwald, Eugene
9Sammons, Emily
10Landray, Martin J
11Jiang, L
12Armitage, J
13Haynes, R
14Maggioni, A P
15Angermann, C E
16Ertl, G
17Wanner, C
18Pedersen, T
19Goto, S
20Teramoto, T
21Baigent, C
22Barter, P
23Chen, Y
24Chen, Z
25Gray, A
26Mihaylova, B
27Sleight, P
28Tobert, J
29Blaustein, R
30Delucca, P
31Mitchel, Y
32van Leijenhorst, G
33Sandercock, P
34Demets, D
35Kjekshus, J
36Neuberger, J
37Tonkin, A
38Emberson, J
39Granger, C
40Colhoun, H
41Barton, J
42Bray, C
43Dayanandan, R
44Knott, C
45Lay, M
46Murphy, K
47Wincott, E
48Achiri, P
49Barry, S
50Bateman, S
51Brewster, A
52Briggs, S
53Brown, R
54Burke, A
55Butler, E
56Cobb, L
57Collet, A
58Crowther, J
59Cureton, L
60Danesh-Pour, S
61Fathers, S
62Fletcher, L
63Frederick, K
64Gordon, T
65Gray, M
66Heineman, J
67Howard, S
68Jackson, D
69Lam, N
70Lee, R
71Machin, O
72Madgwick, Z
73Matthewson, M
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88Vandenberg, K
89Wickman, M
90Willett, M
91Woods, J
92Yu, H
93Aung, T
94Bulbulia, R
95Clarke, R
96Herrington, W
97Judge, P
98Lewis, D
99Llewellyn-Bennett, R
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9Teramoto, T
10Baigent, C
11Barter, P
12Chen, Y
13Chen, Z
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16Sleight, P
17Tobert, J
18Blaustein, R
19DeLucca, P
20Mitchel, Y
21van Leijenhorst, G
22Sandercock, P
23DeMets, D
24Kjekshus, J
25Neuberger, J
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28Granger, C
29Colhoun, H
30Barton, J
31Bray, C
32Dayanandan, R
33Knott, C
34Lay, M
35Murphy, K
36Wincott, E
37Achiri, P
38Barry, S
39Bateman, S
40Brewster, A
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45Cobb, L
46Collet, A
47Crowther, J
48Cureton, L
49Danesh-Pour, S
50Fathers, S
51Fletcher, L
52Frederick, K
53Gordon, T
54Gray, M
55Heineman, J
56Howard, S
57Jackson, D
58Lam, N
59Lee, R
60Machin, O
61Madgwick, Z
62Matthewson, M
63Nolan, J
64Nunn, M
65Panicker, A
66Pank, L
67Pearson-Burton, E
68Pickworth, S
69Qiao, Y
70Radley, A
71Roby, K
72Sayer, J
73Shah, S
74Taylor, K
75Thorne, H
76Timadjer, A
77Vandenberg, K
78Wickman, M
79Willett, M
80Woods, J
81Yu, H
82Aung, T
83Bulbulia, R
84Clarke, R
85Herrington, W
86Judge, P
87Lewis, D
88Llewellyn-Bennett, R
89Mafham, M
90Preiss, D
91Reith, C
92Storey, B
93Tomson, J
94Waters, E
95Baxter, A
96Goodenough, R
97Ait-Sadi, R
98Arnold, M
99Barton, I
100...
atitleEffects of Anacetrapib in Patients with Atherosclerotic Vascular Disease.
jtitleThe New England journal of medicine
risdate20170928
volume377
issue13
spage1217
epage1227
pages1217-1227
eissn1533-4406
formatjournal
genrearticle
ristypeJOUR
abstractBACKGROUNDPatients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODSWe conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTSDuring the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONSAmong patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .).
doi10.1056/NEJMoa1706444
urlhttp://search.proquest.com/docview/1933606973/
issn00284793
date2017-09-28