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A 52-week placebo-controlled trial of evolocumab in hyperlipidemia.

BACKGROUNDEvolocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduced low-density lipoprotein (LDL) cholesterol levels in phase 2 studies. We conducted a phase 3 trial to evaluate the safety and efficacy of 52 weeks of treatment with e... Full description

Journal Title: The New England journal of medicine May 8, 2014, Vol.370(19), pp.1809-1819
Main Author: Blom, Dirk J
Other Authors: Hala, Tomas , Bolognese, Michael , Lillestol, Michael J , Toth, Phillip D , Burgess, Lesley , Ceska, Richard , Roth, Eli , Koren, Michael J , Ballantyne, Christie M , Monsalvo, Maria Laura , Tsirtsonis, Kate , Kim, Jae B , Scott, Rob , Wasserman, Scott M , Stein, Evan A , Blom, Dirk J
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: E-ISSN: 1533-4406 ; DOI: 1533-4406 ; DOI: 10.1056/NEJMoa1316222
Link: http://search.proquest.com/docview/1523405745/?pq-origsite=primo
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title: A 52-week placebo-controlled trial of evolocumab in hyperlipidemia.
format: Article
creator:
  • Blom, Dirk J
  • Hala, Tomas
  • Bolognese, Michael
  • Lillestol, Michael J
  • Toth, Phillip D
  • Burgess, Lesley
  • Ceska, Richard
  • Roth, Eli
  • Koren, Michael J
  • Ballantyne, Christie M
  • Monsalvo, Maria Laura
  • Tsirtsonis, Kate
  • Kim, Jae B
  • Scott, Rob
  • Wasserman, Scott M
  • Stein, Evan A
  • Blom, Dirk J
subjects:
  • Adult–Adverse Effects
  • Aged–Therapeutic Use
  • Antibodies, Monoclonal–Therapeutic Use
  • Atorvastatin Calcium–Blood
  • Azetidines–Therapeutic Use
  • Cholesterol, LDL–Therapeutic Use
  • Combined Modality Therapy–Diet Therapy
  • Double-Blind Method–Drug Therapy
  • Ezetimibe–Antagonists & Inhibitors
  • Female–Immunology
  • Heptanoic Acids–Therapeutic Use
  • Humans–Immunology
  • Hydroxymethylglutaryl-Coa Reductase Inhibitors–Immunology
  • Hyperlipidemias–Immunology
  • Least-Squares Analysis–Immunology
  • Male–Immunology
  • Middle Aged–Immunology
  • Proprotein Convertase 9–Immunology
  • Proprotein Convertases–Immunology
  • Pyrroles–Immunology
  • Serine Endopeptidases–Immunology
  • Abridged
  • Antibodies, Monoclonal
  • Azetidines
  • Cholesterol, LDL
  • Heptanoic Acids
  • Hydroxymethylglutaryl-Coa Reductase Inhibitors
  • Pyrroles
  • Atorvastatin Calcium
  • Pcsk9 Protein, Human
  • Proprotein Convertase 9
  • Proprotein Convertases
  • Serine Endopeptidases
  • Ezetimibe
  • Evolocumab
ispartof: The New England journal of medicine, May 8, 2014, Vol.370(19), pp.1809-1819
description: BACKGROUNDEvolocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduced low-density lipoprotein (LDL) cholesterol levels in phase 2 studies. We conducted a phase 3 trial to evaluate the safety and efficacy of 52 weeks of treatment with evolocumab. METHODSWe stratified patients with hyperlipidemia according to the risk categories outlined by the Adult Treatment Panel III of the National Cholesterol Education Program. On the basis of this classification, patients were started on background lipid-lowering therapy with diet alone or diet plus atorvastatin at a dose of 10 mg daily, atorvastatin at a dose of 80 mg daily, or atorvastatin at a dose of 80 mg daily plus ezetimibe at a dose of 10 mg daily, for a run-in period of 4 to 12 weeks. Patients with an LDL cholesterol level of 75 mg per deciliter (1.9 mmol per liter) or higher were then randomly assigned in a 2:1 ratio to receive either evolocumab (420 mg) or placebo every 4 weeks. The primary end point was the percent change from baseline in LDL cholesterol, as measured by means of ultracentrifugation, at week 52. RESULTSAmong the 901 patients included in the primary analysis, the overall least-squares mean (±SE) reduction in LDL cholesterol from baseline in the evolocumab group, taking into account the change in the placebo group, was 57.0±2.1% (P
language: eng
source:
identifier: E-ISSN: 1533-4406 ; DOI: 1533-4406 ; DOI: 10.1056/NEJMoa1316222
fulltext: fulltext
issn:
  • 15334406
  • 1533-4406
url: Link


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titleA 52-week placebo-controlled trial of evolocumab in hyperlipidemia.
creatorBlom, Dirk J ; Hala, Tomas ; Bolognese, Michael ; Lillestol, Michael J ; Toth, Phillip D ; Burgess, Lesley ; Ceska, Richard ; Roth, Eli ; Koren, Michael J ; Ballantyne, Christie M ; Monsalvo, Maria Laura ; Tsirtsonis, Kate ; Kim, Jae B ; Scott, Rob ; Wasserman, Scott M ; Stein, Evan A ; Blom, Dirk J
contributorArya, Ktut (correspondence author) ; Mckeirnan, Maureen (record owner) ; Sullivan, David ; Watts, Gerald ; Paulweber, Bernhard ; Cornelli, Koenraad ; De Meulemeester, Marc ; Mortelmans, Jaak ; Vanriet, Didier ; Bergeron, Jean ; Dzongowski, Peter ; Gupta, Anil ; Henein, Sam ; Lasko, Ben ; Powell, Calvin ; Adamkova, Vera ; Cermak, Ondrej ; Ceska, Richard ; Charvat, Jiri ; Hala, Tomas ; Hamouz, Zdenek ; Macha, Jan ; Rosolova, Hana ; Smejkalova, Olga ; Spinar, Jindrich ; Vojacek, Jan ; Krogsaa, Annesofie ; Storgaard Nedergaard, Bettina ; Wermuth, Susanne ; Bajnok, Laszlo ; Farsang, Csaba ; Forster, Tamas ; Laszlo, Zoltan ; Lupkovics, Geza ; Papp, Andras ; Szakal, Imre ; Zsom, Marianna ; Blom, Dirk ; Burgess, Lesley ; Coetzee, Kathleen ; Ebrahim, Iftikhar ; Lombaard, Johannes ; Middlemost, Shirley ; Naidoo, Visvakuren ; Pillay, Somasundram ; Arslanian, Armen ; Ballantyne, Christie ; Bays, Harold ; Beasley, Richard ; Bolognese, Michael ; Brazg, Ronald ; Connery, Lisa ; Elinoff, Victor ; Harper, Wayne ; Hoekstra, John ; Huehnergarth, Kier ; Huling, Randall ; Kivitz, Alan ; Koren, Michael ; Lillestol, Michael ; Lipetz, Robert ; Makam, Sashi ; Marx, Phyllis ; Nakhle, Samer ; Oh, Jung ; Pleskow, Warren ; Rankin, Bruce ; Remler, Robert ; Rhee, Margaret ; Ries, Daniel ; Roth, Eli ; Rubino, John ; Saway, William ; Schramm, Rashmi ; Strout, Cynthia ; Toth, Phillip ; Turner, Traci ; Watkins, Larry ; Weiss, Robert ; Wenker, Matthew ; Williams, Hayes ; Hennekens, Charles H ; Andreotti, Felicita ; Baigent, Colin ; Brown, W Virgil ; Davis, Barry ; Wiviott, Stephen D ; Turner, Traci ; Tarr, William E ; Tarr, William E ; Tarr, William E
ispartofThe New England journal of medicine, May 8, 2014, Vol.370(19), pp.1809-1819
identifier
subjectAdult–Adverse Effects ; Aged–Therapeutic Use ; Antibodies, Monoclonal–Therapeutic Use ; Atorvastatin Calcium–Blood ; Azetidines–Therapeutic Use ; Cholesterol, LDL–Therapeutic Use ; Combined Modality Therapy–Diet Therapy ; Double-Blind Method–Drug Therapy ; Ezetimibe–Antagonists & Inhibitors ; Female–Immunology ; Heptanoic Acids–Therapeutic Use ; Humans–Immunology ; Hydroxymethylglutaryl-Coa Reductase Inhibitors–Immunology ; Hyperlipidemias–Immunology ; Least-Squares Analysis–Immunology ; Male–Immunology ; Middle Aged–Immunology ; Proprotein Convertase 9–Immunology ; Proprotein Convertases–Immunology ; Pyrroles–Immunology ; Serine Endopeptidases–Immunology ; Abridged ; Antibodies, Monoclonal ; Azetidines ; Cholesterol, LDL ; Heptanoic Acids ; Hydroxymethylglutaryl-Coa Reductase Inhibitors ; Pyrroles ; Atorvastatin Calcium ; Pcsk9 Protein, Human ; Proprotein Convertase 9 ; Proprotein Convertases ; Serine Endopeptidases ; Ezetimibe ; Evolocumab
descriptionBACKGROUNDEvolocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduced low-density lipoprotein (LDL) cholesterol levels in phase 2 studies. We conducted a phase 3 trial to evaluate the safety and efficacy of 52 weeks of treatment with evolocumab. METHODSWe stratified patients with hyperlipidemia according to the risk categories outlined by the Adult Treatment Panel III of the National Cholesterol Education Program. On the basis of this classification, patients were started on background lipid-lowering therapy with diet alone or diet plus atorvastatin at a dose of 10 mg daily, atorvastatin at a dose of 80 mg daily, or atorvastatin at a dose of 80 mg daily plus ezetimibe at a dose of 10 mg daily, for a run-in period of 4 to 12 weeks. Patients with an LDL cholesterol level of 75 mg per deciliter (1.9 mmol per liter) or higher were then randomly assigned in a 2:1 ratio to receive either evolocumab (420 mg) or placebo every 4 weeks. The primary end point was the percent change from baseline in LDL cholesterol, as measured by means of ultracentrifugation, at week 52. RESULTSAmong the 901 patients included in the primary analysis, the overall least-squares mean (±SE) reduction in LDL cholesterol from baseline in the evolocumab group, taking into account the change in the placebo group, was 57.0±2.1% (P<0.001). The mean reduction was 55.7±4.2% among patients who underwent background therapy with diet alone, 61.6±2.6% among those who received 10 mg of atorvastatin, 56.8±5.3% among those who received 80 mg of atorvastatin, and 48.5±5.2% among those who received a combination of 80 mg of atorvastatin and 10 mg of ezetimibe (P<0.001 for all comparisons). Evolocumab treatment also significantly reduced levels of apolipoprotein B, non-high-density lipoprotein cholesterol, lipoprotein(a), and triglycerides. The most common adverse events were nasopharyngitis, upper respiratory tract infection, influenza, and back pain. CONCLUSIONSAt 52 weeks, evolocumab added to diet alone, to low-dose atorvastatin, or to high-dose atorvastatin with or without ezetimibe significantly reduced LDL cholesterol levels in patients with a range of cardiovascular risks. (Funded by Amgen; DESCARTES ClinicalTrials.gov number, NCT01516879.).
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0Blom, Dirk J
1Hala, Tomas
2Bolognese, Michael
3Lillestol, Michael J
4Toth, Phillip D
5Burgess, Lesley
6Ceska, Richard
7Roth, Eli
8Koren, Michael J
9Ballantyne, Christie M
10Monsalvo, Maria Laura
11Tsirtsonis, Kate
12Kim, Jae B
13Scott, Rob
14Wasserman, Scott M
15Stein, Evan A
titleA 52-week placebo-controlled trial of evolocumab in hyperlipidemia.
descriptionBACKGROUNDEvolocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduced low-density lipoprotein (LDL) cholesterol levels in phase 2 studies. We conducted a phase 3 trial to evaluate the safety and efficacy of 52 weeks of treatment with evolocumab. METHODSWe stratified patients with hyperlipidemia according to the risk categories outlined by the Adult Treatment Panel III of the National Cholesterol Education Program. On the basis of this classification, patients were started on background lipid-lowering therapy with diet alone or diet plus atorvastatin at a dose of 10 mg daily, atorvastatin at a dose of 80 mg daily, or atorvastatin at a dose of 80 mg daily plus ezetimibe at a dose of 10 mg daily, for a run-in period of 4 to 12 weeks. Patients with an LDL cholesterol level of 75 mg per deciliter (1.9 mmol per liter) or higher were then randomly assigned in a 2:1 ratio to receive either evolocumab (420 mg) or placebo every 4 weeks. The primary end point was the percent change from baseline in LDL cholesterol, as measured by means of ultracentrifugation, at week 52. RESULTSAmong the 901 patients included in the primary analysis, the overall least-squares mean (±SE) reduction in LDL cholesterol from baseline in the evolocumab group, taking into account the change in the placebo group, was 57.0±2.1% (P<0.001). The mean reduction was 55.7±4.2% among patients who underwent background therapy with diet alone, 61.6±2.6% among those who received 10 mg of atorvastatin, 56.8±5.3% among those who received 80 mg of atorvastatin, and 48.5±5.2% among those who received a combination of 80 mg of atorvastatin and 10 mg of ezetimibe (P<0.001 for all comparisons). Evolocumab treatment also significantly reduced levels of apolipoprotein B, non-high-density lipoprotein cholesterol, lipoprotein(a), and triglycerides. The most common adverse events were nasopharyngitis, upper respiratory tract infection, influenza, and back pain. CONCLUSIONSAt 52 weeks, evolocumab added to diet alone, to low-dose atorvastatin, or to high-dose atorvastatin with or without ezetimibe significantly reduced LDL cholesterol levels in patients with a range of cardiovascular risks. (Funded by Amgen; DESCARTES ClinicalTrials.gov number, NCT01516879.).
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0Adult–Adverse Effects
1Aged–Therapeutic Use
2Antibodies, Monoclonal–Therapeutic Use
3Atorvastatin Calcium–Blood
4Azetidines–Therapeutic Use
5Cholesterol, LDL–Therapeutic Use
6Combined Modality Therapy–Diet Therapy
7Double-Blind Method–Drug Therapy
8Ezetimibe–Antagonists & Inhibitors
9Female–Immunology
10Heptanoic Acids–Therapeutic Use
11Humans–Immunology
12Hydroxymethylglutaryl-Coa Reductase Inhibitors–Immunology
13Hyperlipidemias–Immunology
14Least-Squares Analysis–Immunology
15Male–Immunology
16Middle Aged–Immunology
17Proprotein Convertase 9–Immunology
18Proprotein Convertases–Immunology
19Pyrroles–Immunology
20Serine Endopeptidases–Immunology
21Abridged
22Antibodies, Monoclonal
23Azetidines
24Cholesterol, LDL
25Heptanoic Acids
26Hydroxymethylglutaryl-Coa Reductase Inhibitors
27Pyrroles
28Atorvastatin Calcium
29Pcsk9 Protein, Human
30Proprotein Convertase 9
31Proprotein Convertases
32Serine Endopeptidases
33Ezetimibe
34Evolocumab
35NCT01516879
36ClinicalTrials.gov
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1Mckeirnan, Maureen
2Sullivan, David
3Watts, Gerald
4Paulweber, Bernhard
5Cornelli, Koenraad
6De Meulemeester, Marc
7Mortelmans, Jaak
8Vanriet, Didier
9Bergeron, Jean
10Dzongowski, Peter
11Gupta, Anil
12Henein, Sam
13Lasko, Ben
14Powell, Calvin
15Adamkova, Vera
16Cermak, Ondrej
17Ceska, Richard
18Charvat, Jiri
19Hala, Tomas
20Hamouz, Zdenek
21Macha, Jan
22Rosolova, Hana
23Smejkalova, Olga
24Spinar, Jindrich
25Vojacek, Jan
26Krogsaa, Annesofie
27Storgaard Nedergaard, Bettina
28Wermuth, Susanne
29Bajnok, Laszlo
30Farsang, Csaba
31Forster, Tamas
32Laszlo, Zoltan
33Lupkovics, Geza
34Papp, Andras
35Szakal, Imre
36Zsom, Marianna
37Blom, Dirk
38Burgess, Lesley
39Coetzee, Kathleen
40Ebrahim, Iftikhar
41Lombaard, Johannes
42Middlemost, Shirley
43Naidoo, Visvakuren
44Pillay, Somasundram
45Arslanian, Armen
46Ballantyne, Christie
47Bays, Harold
48Beasley, Richard
49Bolognese, Michael
50Brazg, Ronald
51Connery, Lisa
52Elinoff, Victor
53Harper, Wayne
54Hoekstra, John
55Huehnergarth, Kier
56Huling, Randall
57Kivitz, Alan
58Koren, Michael
59Lillestol, Michael
60Lipetz, Robert
61Makam, Sashi
62Marx, Phyllis
63Nakhle, Samer
64Oh, Jung
65Pleskow, Warren
66Rankin, Bruce
67Remler, Robert
68Rhee, Margaret
69Ries, Daniel
70Roth, Eli
71Rubino, John
72Saway, William
73Schramm, Rashmi
74Strout, Cynthia
75Toth, Phillip
76Turner, Traci
77Watkins, Larry
78Weiss, Robert
79Wenker, Matthew
80Williams, Hayes
81Hennekens, Charles H
82Andreotti, Felicita
83Baigent, Colin
84Brown, W Virgil
85Davis, Barry
86Wiviott, Stephen D
87Tarr, William E
startdate20140508
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citationpf 1809 pt 1819 vol 370 issue 19
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titleA 52-week placebo-controlled trial of evolocumab in hyperlipidemia.
authorBlom, Dirk J ; Hala, Tomas ; Bolognese, Michael ; Lillestol, Michael J ; Toth, Phillip D ; Burgess, Lesley ; Ceska, Richard ; Roth, Eli ; Koren, Michael J ; Ballantyne, Christie M ; Monsalvo, Maria Laura ; Tsirtsonis, Kate ; Kim, Jae B ; Scott, Rob ; Wasserman, Scott M ; Stein, Evan A ; Blom, Dirk J
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topic
0Adult–Adverse Effects
1Aged–Therapeutic Use
2Antibodies, Monoclonal–Therapeutic Use
3Atorvastatin Calcium–Blood
4Azetidines–Therapeutic Use
5Cholesterol, LDL–Therapeutic Use
6Combined Modality Therapy–Diet Therapy
7Double-Blind Method–Drug Therapy
8Ezetimibe–Antagonists & Inhibitors
9Female–Immunology
10Heptanoic Acids–Therapeutic Use
11Humans–Immunology
12Hydroxymethylglutaryl-Coa Reductase Inhibitors–Immunology
13Hyperlipidemias–Immunology
14Least-Squares Analysis–Immunology
15Male–Immunology
16Middle Aged–Immunology
17Proprotein Convertase 9–Immunology
18Proprotein Convertases–Immunology
19Pyrroles–Immunology
20Serine Endopeptidases–Immunology
21Abridged
22Antibodies, Monoclonal
23Azetidines
24Cholesterol, LDL
25Heptanoic Acids
26Hydroxymethylglutaryl-Coa Reductase Inhibitors
27Pyrroles
28Atorvastatin Calcium
29Pcsk9 Protein, Human
30Proprotein Convertase 9
31Proprotein Convertases
32Serine Endopeptidases
33Ezetimibe
34Evolocumab
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0Blom, Dirk J
1Hala, Tomas
2Bolognese, Michael
3Lillestol, Michael J
4Toth, Phillip D
5Burgess, Lesley
6Ceska, Richard
7Roth, Eli
8Koren, Michael J
9Ballantyne, Christie M
10Monsalvo, Maria Laura
11Tsirtsonis, Kate
12Kim, Jae B
13Scott, Rob
14Wasserman, Scott M
15Stein, Evan A
16Arya, Ktut
17Mckeirnan, Maureen
18Sullivan, David
19Watts, Gerald
20Paulweber, Bernhard
21Cornelli, Koenraad
22De Meulemeester, Marc
23Mortelmans, Jaak
24Vanriet, Didier
25Bergeron, Jean
26Dzongowski, Peter
27Gupta, Anil
28Henein, Sam
29Lasko, Ben
30Powell, Calvin
31Adamkova, Vera
32Cermak, Ondrej
33Charvat, Jiri
34Hamouz, Zdenek
35Macha, Jan
36Rosolova, Hana
37Smejkalova, Olga
38Spinar, Jindrich
39Vojacek, Jan
40Krogsaa, Annesofie
41Storgaard Nedergaard, Bettina
42Wermuth, Susanne
43Bajnok, Laszlo
44Farsang, Csaba
45Forster, Tamas
46Laszlo, Zoltan
47Lupkovics, Geza
48Papp, Andras
49Szakal, Imre
50Zsom, Marianna
51Blom, Dirk
52Coetzee, Kathleen
53Ebrahim, Iftikhar
54Lombaard, Johannes
55Middlemost, Shirley
56Naidoo, Visvakuren
57Pillay, Somasundram
58Arslanian, Armen
59Ballantyne, Christie
60Bays, Harold
61Beasley, Richard
62Brazg, Ronald
63Connery, Lisa
64Elinoff, Victor
65Harper, Wayne
66Hoekstra, John
67Huehnergarth, Kier
68Huling, Randall
69Kivitz, Alan
70Koren, Michael
71Lillestol, Michael
72Lipetz, Robert
73Makam, Sashi
74Marx, Phyllis
75Nakhle, Samer
76Oh, Jung
77Pleskow, Warren
78Rankin, Bruce
79Remler, Robert
80Rhee, Margaret
81Ries, Daniel
82Rubino, John
83Saway, William
84Schramm, Rashmi
85Strout, Cynthia
86Toth, Phillip
87Turner, Traci
88Watkins, Larry
89Weiss, Robert
90Wenker, Matthew
91Williams, Hayes
92Hennekens, Charles H
93Andreotti, Felicita
94Baigent, Colin
95Brown, W Virgil
96Davis, Barry
97Wiviott, Stephen D
98Tarr, William E
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7Mortelmans, Jaak
8Vanriet, Didier
9Bergeron, Jean
10Dzongowski, Peter
11Gupta, Anil
12Henein, Sam
13Lasko, Ben
14Powell, Calvin
15Adamkova, Vera
16Cermak, Ondrej
17Ceska, Richard
18Charvat, Jiri
19Hala, Tomas
20Hamouz, Zdenek
21Macha, Jan
22Rosolova, Hana
23Smejkalova, Olga
24Spinar, Jindrich
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26Krogsaa, Annesofie
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28Wermuth, Susanne
29Bajnok, Laszlo
30Farsang, Csaba
31Forster, Tamas
32Laszlo, Zoltan
33Lupkovics, Geza
34Papp, Andras
35Szakal, Imre
36Zsom, Marianna
37Blom, Dirk
38Burgess, Lesley
39Coetzee, Kathleen
40Ebrahim, Iftikhar
41Lombaard, Johannes
42Middlemost, Shirley
43Naidoo, Visvakuren
44Pillay, Somasundram
45Arslanian, Armen
46Ballantyne, Christie
47Bays, Harold
48Beasley, Richard
49Bolognese, Michael
50Brazg, Ronald
51Connery, Lisa
52Elinoff, Victor
53Harper, Wayne
54Hoekstra, John
55Huehnergarth, Kier
56Huling, Randall
57Kivitz, Alan
58Koren, Michael
59Lillestol, Michael
60Lipetz, Robert
61Makam, Sashi
62Marx, Phyllis
63Nakhle, Samer
64Oh, Jung
65Pleskow, Warren
66Rankin, Bruce
67Remler, Robert
68Rhee, Margaret
69Ries, Daniel
70Roth, Eli
71Rubino, John
72Saway, William
73Schramm, Rashmi
74Strout, Cynthia
75Toth, Phillip
76Turner, Traci
77Watkins, Larry
78Weiss, Robert
79Wenker, Matthew
80Williams, Hayes
81Hennekens, Charles H
82Andreotti, Felicita
83Baigent, Colin
84Brown, W Virgil
85Davis, Barry
86Wiviott, Stephen D
87Tarr, William E
atitleA 52-week placebo-controlled trial of evolocumab in hyperlipidemia.
jtitleThe New England journal of medicine
risdate20140508
volume370
issue19
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genrearticle
ristypeJOUR
abstractBACKGROUNDEvolocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduced low-density lipoprotein (LDL) cholesterol levels in phase 2 studies. We conducted a phase 3 trial to evaluate the safety and efficacy of 52 weeks of treatment with evolocumab. METHODSWe stratified patients with hyperlipidemia according to the risk categories outlined by the Adult Treatment Panel III of the National Cholesterol Education Program. On the basis of this classification, patients were started on background lipid-lowering therapy with diet alone or diet plus atorvastatin at a dose of 10 mg daily, atorvastatin at a dose of 80 mg daily, or atorvastatin at a dose of 80 mg daily plus ezetimibe at a dose of 10 mg daily, for a run-in period of 4 to 12 weeks. Patients with an LDL cholesterol level of 75 mg per deciliter (1.9 mmol per liter) or higher were then randomly assigned in a 2:1 ratio to receive either evolocumab (420 mg) or placebo every 4 weeks. The primary end point was the percent change from baseline in LDL cholesterol, as measured by means of ultracentrifugation, at week 52. RESULTSAmong the 901 patients included in the primary analysis, the overall least-squares mean (±SE) reduction in LDL cholesterol from baseline in the evolocumab group, taking into account the change in the placebo group, was 57.0±2.1% (P<0.001). The mean reduction was 55.7±4.2% among patients who underwent background therapy with diet alone, 61.6±2.6% among those who received 10 mg of atorvastatin, 56.8±5.3% among those who received 80 mg of atorvastatin, and 48.5±5.2% among those who received a combination of 80 mg of atorvastatin and 10 mg of ezetimibe (P<0.001 for all comparisons). Evolocumab treatment also significantly reduced levels of apolipoprotein B, non-high-density lipoprotein cholesterol, lipoprotein(a), and triglycerides. The most common adverse events were nasopharyngitis, upper respiratory tract infection, influenza, and back pain. CONCLUSIONSAt 52 weeks, evolocumab added to diet alone, to low-dose atorvastatin, or to high-dose atorvastatin with or without ezetimibe significantly reduced LDL cholesterol levels in patients with a range of cardiovascular risks. (Funded by Amgen; DESCARTES ClinicalTrials.gov number, NCT01516879.).
doi10.1056/NEJMoa1316222
urlhttp://search.proquest.com/docview/1523405745/
issn00284793
date2014-05-08