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Effects of succinobucol (AGI-1067) after an acute coronary syndrome: a randomised, double-blind, placebo-controlled trial.

BACKGROUNDOxidative stress and inflammation are involved in the pathophysiology of atherosclerosis. Our aim was to assess the effects of the antioxidant succinobucol (AGI-1067) on cardiovascular outcomes in patients with recent acute coronary syndromes already managed with conventional treatments. M... Full description

Journal Title: Lancet (London England), May 24, 2008, Vol.371(9626), pp.1761-1768
Main Author: Tardif, Jean-Claude
Other Authors: Mcmurray, John J V , Klug, Eric , Small, Robert , Schumi, Jennifer , Choi, Jasmine , Cooper, Jim , Scott, Robert , Lewis, Eldrin F , L'Allier, Philippe L , Pfeffer, Marc A , Tardif, Jean-Claude
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: E-ISSN: 1474-547X ; DOI: 1474-547X ; DOI: 10.1016/S0140-6736(08)60763-1
Link: http://search.proquest.com/docview/70771984/?pq-origsite=primo
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title: Effects of succinobucol (AGI-1067) after an acute coronary syndrome: a randomised, double-blind, placebo-controlled trial.
format: Article
creator:
  • Tardif, Jean-Claude
  • Mcmurray, John J V
  • Klug, Eric
  • Small, Robert
  • Schumi, Jennifer
  • Choi, Jasmine
  • Cooper, Jim
  • Scott, Robert
  • Lewis, Eldrin F
  • L'Allier, Philippe L
  • Pfeffer, Marc A
  • Tardif, Jean-Claude
subjects:
  • Acute Coronary Syndrome–Complications
  • Adult–Drug Therapy
  • Aged–Adverse Effects
  • Antioxidants–Therapeutic Use
  • Cardiovascular Diseases–Etiology
  • Diabetes Mellitus, Type 2–Mortality
  • Double-Blind Method–Prevention & Control
  • Endpoint Determination–Prevention & Control
  • Female–Adverse Effects
  • Humans–Analogs & Derivatives
  • Male–Therapeutic Use
  • Middle Aged–Therapeutic Use
  • Probucol–Therapeutic Use
  • Abridged
  • Antioxidants
  • Succinobucol
  • Probucol
ispartof: Lancet (London, England), May 24, 2008, Vol.371(9626), pp.1761-1768
description: BACKGROUNDOxidative stress and inflammation are involved in the pathophysiology of atherosclerosis. Our aim was to assess the effects of the antioxidant succinobucol (AGI-1067) on cardiovascular outcomes in patients with recent acute coronary syndromes already managed with conventional treatments. METHODSAfter an acute coronary syndrome occurring 14-365 days before recruitment, 6144 patients were randomly assigned with a computer-generated randomisation list, stratified by study site, to receive succinobucol (n=3078) or placebo (n=3066) in addition to standard of care. Enrolment began in July, 2003; this event-driven trial was stopped in August, 2006, after the prespecified number of primary outcome events had occurred. The composite primary endpoint was time to first occurrence of cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, unstable angina, or coronary revascularisation. Efficacy analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00066898. FINDINGSAll randomised patients were included in the efficacy analyses. Succinobucol had no effect on the primary endpoint (530 events in succinobucol group vs 529 in placebo group; hazard ratio 1.00, 95% CI 0.89-1.13, p=0.96). The composite secondary endpoint of cardiovascular death, cardiac arrest, myocardial infarction, or stroke occurred in fewer patients in the succinobucol group than in the placebo group (207 vs 252 events; 0.81, 0.68-0.98, p=0.029). The tertiary endpoint of new-onset diabetes developed in fewer patients without diabetes at baseline in the succinobucol group than in such patients in the placebo group (30 of 1923 vs 82 of 1950 patients; 0.37, 0.24-0.56, p
language: eng
source:
identifier: E-ISSN: 1474-547X ; DOI: 1474-547X ; DOI: 10.1016/S0140-6736(08)60763-1
fulltext: fulltext
issn:
  • 1474547X
  • 1474-547X
url: Link


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titleEffects of succinobucol (AGI-1067) after an acute coronary syndrome: a randomised, double-blind, placebo-controlled trial.
creatorTardif, Jean-Claude ; Mcmurray, John J V ; Klug, Eric ; Small, Robert ; Schumi, Jennifer ; Choi, Jasmine ; Cooper, Jim ; Scott, Robert ; Lewis, Eldrin F ; L'Allier, Philippe L ; Pfeffer, Marc A ; Tardif, Jean-Claude
contributorTardif, J C (correspondence author) ; Pfeffer, M (record owner) ; Mcmurray, J ; Klug, E ; Chaitman, B ; Alderman, E ; Fisher, L ; Rouleau, J ; Waters, D ; Cloherty, E ; Duong, C ; Lewis, E ; Mercier, R ; Solomon, S ; Anderson, T ; Arnold, J M ; Bedard, J ; Bhargava, R ; Bose, S ; Chehayeb, R ; Cohen, E ; Constance, C ; Degrace, M ; Dion, D ; Douketis, J ; Ducas, J ; Fay, D ; Fortin, C ; Gebhardt, V ; Gendreau, R ; Gin, K ; Gosselin, G ; Grandmont, D ; Hess, A ; Hui, W ; Huynh, T T ; Kouz, S ; Lai, C ; Matangi, M ; Morris, A ; Nasmith, J ; Nault, P ; Nigro, F ; Pandey, A S ; Pesant, Y ; Petrella, R ; Poirier, P ; Pouliot, J ; Quinn, B ; Quintin, I ; Rajakumar, A ; Rinfret, S ; Rupka, D ; Sabbah, E ; Savard, D ; Schampaert, E ; Sussex, B ; Syan, G ; Talbot, P ; Tardif, J C ; Timothee, J R ; Title, L ; Tremblay, G ; Vakani, M T ; Vexler, R ; Badenhorst, C ; Bedhesi, S ; Bester, F C J ; Bodenstein, W M J ; Burgess, L ; Cassel, G ; Dawood, S Y ; Ebrahim, I ; Essop, M R ; Jankelow, P ; Jeena, C P ; Ker, A M E ; King, J ; Klug, E ; Lamparelli, R ; Lloyd, E ; Mabin, T ; Moodley, R ; Naidu, R K ; Ramdass, A S ; Roux, P ; Saaiman, J A ; Sareli, P ; Sarvan, M I ; Singh, V ; Snyders, A ; Tayob, F I ; Theron, H ; Viljoen, J ; Wittmer, H ; Ahsan, A ; Batin, P ; Boon, N ; Bridges, A ; Brooksby, P ; Channer, K ; Dunn, F ; Findlay, I ; Hillis, G ; Hudson, I ; Jacob, A ; Kadr, H B ; Lip, G ; Mcmurray, J ; Murdoch, D ; Nolan, J ; Ray, S ; Schofield, P ; Shah, A ; Squire, I ; Tan, L B ; Wheeldon, N ; Abel, P ; Ackell, P ; Alexander, S ; Amkieh, A ; Anderson, J ; Andreae, G ; Ashby, C ; Bach, R ; Bank, A ; Baron, S ; Becker, J ; Bedoya, R ; Bernstein, M ; Bethala, V ; Bhalla, R ; Bilazarian, S ; Bittner, V ; Bleyer, F ; Block, P ; Bouchard, A ; Breisblatt, W ; Brockington, G ; Brown, Charles ; Brown, Christopher ; Brown, Clinton ; Carstens, J ; Chambers, J ; Changlani, M ; Chu, A ; Cole, J ; Connelly, T ; Corbelli, J C ; Corder, C N ; Coto, H A ; Denny, M ; Denys, B ; Desai, V ; Devlin, W ; Diez, J ; Dionisopoulos, P ; Doelle, G C ; Doris, J F ; Downey, W ; Dykstra, G ; East, C ; El Shahawy, M ; Ellis, J ; Fialkow, J ; Fierer, R ; Fischell, T ; Fleet, W ; Gabriel, G ; Gammon, R ; George, W ; Gilmore, R ; Glass, M ; Goldscher, D ; Goldstein, M ; Gorwit, J ; Gottlieb, D ; Goulah, R ; Griffen, J J ; Grossman, W ; Hackworth, J N ; Halpern, S ; Haque, I ; Harrison, W R ; Haskel, E ; Haught, H ; Heinsimer, J ; Hibbard, M Herlich M ; Hilton, T ; Hinchman, D ; Hodes, Z ; Ibrahim, H ; Idarraga, S ; Jackson, B ; Jerome, S ; Judy, L ; Kakavas, P ; Kassell, D ; Kelemen, M ; Kereiakes, D J ; Kerut, E K ; Kleiman, N ; Knopp, R ; Kogan, A ; Kopecky, S L ; Koren, M ; Kosinski, E J ; Kozman, H ; Kramer, J H ; Lang, J ; Lemlek, J E ; Litt, M ; Logsdon, J ; Lurie, M ; Madder, R ; Marple, R ; Massaro, J ; Mazza, J ; Mcgarvey, J ; Mcgrew, F ; Menapace, F ; Merlino, J ; Milas, J ; Miller, D ; Miller, L A ; Mirro, M J ; Mohiuddin, S ; Muhlestein, J B ; Myers, G ; Nallasivan, M ; Nash, S ; Neutel, J ; Niazi, I K ; Obryan, J P ; Ong, S ; Pasquini, J ; Pearson, A C ; Perlstein, E
ispartofLancet (London, England), May 24, 2008, Vol.371(9626), pp.1761-1768
identifier
subjectAcute Coronary Syndrome–Complications ; Adult–Drug Therapy ; Aged–Adverse Effects ; Antioxidants–Therapeutic Use ; Cardiovascular Diseases–Etiology ; Diabetes Mellitus, Type 2–Mortality ; Double-Blind Method–Prevention & Control ; Endpoint Determination–Prevention & Control ; Female–Adverse Effects ; Humans–Analogs & Derivatives ; Male–Therapeutic Use ; Middle Aged–Therapeutic Use ; Probucol–Therapeutic Use ; Abridged ; Antioxidants ; Succinobucol ; Probucol
descriptionBACKGROUNDOxidative stress and inflammation are involved in the pathophysiology of atherosclerosis. Our aim was to assess the effects of the antioxidant succinobucol (AGI-1067) on cardiovascular outcomes in patients with recent acute coronary syndromes already managed with conventional treatments. METHODSAfter an acute coronary syndrome occurring 14-365 days before recruitment, 6144 patients were randomly assigned with a computer-generated randomisation list, stratified by study site, to receive succinobucol (n=3078) or placebo (n=3066) in addition to standard of care. Enrolment began in July, 2003; this event-driven trial was stopped in August, 2006, after the prespecified number of primary outcome events had occurred. The composite primary endpoint was time to first occurrence of cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, unstable angina, or coronary revascularisation. Efficacy analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00066898. FINDINGSAll randomised patients were included in the efficacy analyses. Succinobucol had no effect on the primary endpoint (530 events in succinobucol group vs 529 in placebo group; hazard ratio 1.00, 95% CI 0.89-1.13, p=0.96). The composite secondary endpoint of cardiovascular death, cardiac arrest, myocardial infarction, or stroke occurred in fewer patients in the succinobucol group than in the placebo group (207 vs 252 events; 0.81, 0.68-0.98, p=0.029). The tertiary endpoint of new-onset diabetes developed in fewer patients without diabetes at baseline in the succinobucol group than in such patients in the placebo group (30 of 1923 vs 82 of 1950 patients; 0.37, 0.24-0.56, p<0.0001). New-onset atrial fibrillation occurred more often in the succinobucol group than in the placebo group (107 of 2818 vs 55 of 2787 patients; 1.87, 1.67-2.09, p=0.0002). Although the number of patients who reported any treatment emergent adverse event was much the same in the two groups, more patients in the succinobucol group than in the placebo group reported bleeding episodes or anaemia (32 vs 18 and 37 vs ten, respectively) as serious adverse events. Relative to treatment with placebo, succinobucol increased LDL cholesterol and systolic blood pressure, and decreased HDL cholesterol and glycated haemoglobin (p<0.0001 for all). INTERPRETATIONAlthough succinobucol had no effect on the primary endpoint, changes in the rates of other clinical outcomes-both beneficial and harmful-will need to be further assessed before succinobucol is used in patients with atherosclerosis or as an antidiabetic agent.
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0Tardif, Jean-Claude
1Mcmurray, John J V
2Klug, Eric
3Small, Robert
4Schumi, Jennifer
5Choi, Jasmine
6Cooper, Jim
7Scott, Robert
8Lewis, Eldrin F
9L'Allier, Philippe L
10Pfeffer, Marc A
titleEffects of succinobucol (AGI-1067) after an acute coronary syndrome: a randomised, double-blind, placebo-controlled trial.
descriptionBACKGROUNDOxidative stress and inflammation are involved in the pathophysiology of atherosclerosis. Our aim was to assess the effects of the antioxidant succinobucol (AGI-1067) on cardiovascular outcomes in patients with recent acute coronary syndromes already managed with conventional treatments. METHODSAfter an acute coronary syndrome occurring 14-365 days before recruitment, 6144 patients were randomly assigned with a computer-generated randomisation list, stratified by study site, to receive succinobucol (n=3078) or placebo (n=3066) in addition to standard of care. Enrolment began in July, 2003; this event-driven trial was stopped in August, 2006, after the prespecified number of primary outcome events had occurred. The composite primary endpoint was time to first occurrence of cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, unstable angina, or coronary revascularisation. Efficacy analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00066898. FINDINGSAll randomised patients were included in the efficacy analyses. Succinobucol had no effect on the primary endpoint (530 events in succinobucol group vs 529 in placebo group; hazard ratio 1.00, 95% CI 0.89-1.13, p=0.96). The composite secondary endpoint of cardiovascular death, cardiac arrest, myocardial infarction, or stroke occurred in fewer patients in the succinobucol group than in the placebo group (207 vs 252 events; 0.81, 0.68-0.98, p=0.029). The tertiary endpoint of new-onset diabetes developed in fewer patients without diabetes at baseline in the succinobucol group than in such patients in the placebo group (30 of 1923 vs 82 of 1950 patients; 0.37, 0.24-0.56, p<0.0001). New-onset atrial fibrillation occurred more often in the succinobucol group than in the placebo group (107 of 2818 vs 55 of 2787 patients; 1.87, 1.67-2.09, p=0.0002). Although the number of patients who reported any treatment emergent adverse event was much the same in the two groups, more patients in the succinobucol group than in the placebo group reported bleeding episodes or anaemia (32 vs 18 and 37 vs ten, respectively) as serious adverse events. Relative to treatment with placebo, succinobucol increased LDL cholesterol and systolic blood pressure, and decreased HDL cholesterol and glycated haemoglobin (p<0.0001 for all). INTERPRETATIONAlthough succinobucol had no effect on the primary endpoint, changes in the rates of other clinical outcomes-both beneficial and harmful-will need to be further assessed before succinobucol is used in patients with atherosclerosis or as an antidiabetic agent.
subject
0Acute Coronary Syndrome–Complications
1Adult–Drug Therapy
2Aged–Adverse Effects
3Antioxidants–Therapeutic Use
4Cardiovascular Diseases–Etiology
5Diabetes Mellitus, Type 2–Mortality
6Double-Blind Method–Prevention & Control
7Endpoint Determination–Prevention & Control
8Female–Adverse Effects
9Humans–Analogs & Derivatives
10Male–Therapeutic Use
11Middle Aged–Therapeutic Use
12Probucol–Therapeutic Use
13Abridged
14Antioxidants
15Succinobucol
16Probucol
17NCT00066898
18ClinicalTrials.gov
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0Tardif, J C
1Pfeffer, M
2Mcmurray, J
3Klug, E
4Chaitman, B
5Alderman, E
6Fisher, L
7Rouleau, J
8Waters, D
9Cloherty, E
10Duong, C
11Lewis, E
12Mercier, R
13Solomon, S
14Anderson, T
15Arnold, J M
16Bedard, J
17Bhargava, R
18Bose, S
19Chehayeb, R
20Cohen, E
21Constance, C
22Degrace, M
23Dion, D
24Douketis, J
25Ducas, J
26Fay, D
27Fortin, C
28Gebhardt, V
29Gendreau, R
30Gin, K
31Gosselin, G
32Grandmont, D
33Hess, A
34Hui, W
35Huynh, T T
36Kouz, S
37Lai, C
38Matangi, M
39Morris, A
40Nasmith, J
41Nault, P
42Nigro, F
43Pandey, A S
44Pesant, Y
45Petrella, R
46Poirier, P
47Pouliot, J
48Quinn, B
49Quintin, I
50Rajakumar, A
51Rinfret, S
52Rupka, D
53Sabbah, E
54Savard, D
55Schampaert, E
56Sussex, B
57Syan, G
58Talbot, P
59Timothee, J R
60Title, L
61Tremblay, G
62Vakani, M T
63Vexler, R
64Badenhorst, C
65Bedhesi, S
66Bester, F C J
67Bodenstein, W M J
68Burgess, L
69Cassel, G
70Dawood, S Y
71Ebrahim, I
72Essop, M R
73Jankelow, P
74Jeena, C P
75Ker, A M E
76King, J
77Lamparelli, R
78Lloyd, E
79Mabin, T
80Moodley, R
81Naidu, R K
82Ramdass, A S
83Roux, P
84Saaiman, J A
85Sareli, P
86Sarvan, M I
87Singh, V
88Snyders, A
89Tayob, F I
90Theron, H
91Viljoen, J
92Wittmer, H
93Ahsan, A
94Batin, P
95Boon, N
96Bridges, A
97Brooksby, P
98Channer, K
99Dunn, F
100...
startdate20080524
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citationpf 1761 pt 1768 vol 371 issue 9626
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titleEffects of succinobucol (AGI-1067) after an acute coronary syndrome: a randomised, double-blind, placebo-controlled trial.
authorTardif, Jean-Claude ; Mcmurray, John J V ; Klug, Eric ; Small, Robert ; Schumi, Jennifer ; Choi, Jasmine ; Cooper, Jim ; Scott, Robert ; Lewis, Eldrin F ; L'Allier, Philippe L ; Pfeffer, Marc A ; Tardif, Jean-Claude
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1Adult–Drug Therapy
2Aged–Adverse Effects
3Antioxidants–Therapeutic Use
4Cardiovascular Diseases–Etiology
5Diabetes Mellitus, Type 2–Mortality
6Double-Blind Method–Prevention & Control
7Endpoint Determination–Prevention & Control
8Female–Adverse Effects
9Humans–Analogs & Derivatives
10Male–Therapeutic Use
11Middle Aged–Therapeutic Use
12Probucol–Therapeutic Use
13Abridged
14Antioxidants
15Succinobucol
16Probucol
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1Mcmurray, John J V
2Klug, Eric
3Small, Robert
4Schumi, Jennifer
5Choi, Jasmine
6Cooper, Jim
7Scott, Robert
8Lewis, Eldrin F
9L'Allier, Philippe L
10Pfeffer, Marc A
11Tardif, J C
12Pfeffer, M
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14Klug, E
15Chaitman, B
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18Rouleau, J
19Waters, D
20Cloherty, E
21Duong, C
22Lewis, E
23Mercier, R
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25Anderson, T
26Arnold, J M
27Bedard, J
28Bhargava, R
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30Chehayeb, R
31Cohen, E
32Constance, C
33Degrace, M
34Dion, D
35Douketis, J
36Ducas, J
37Fay, D
38Fortin, C
39Gebhardt, V
40Gendreau, R
41Gin, K
42Gosselin, G
43Grandmont, D
44Hess, A
45Hui, W
46Huynh, T T
47Kouz, S
48Lai, C
49Matangi, M
50Morris, A
51Nasmith, J
52Nault, P
53Nigro, F
54Pandey, A S
55Pesant, Y
56Petrella, R
57Poirier, P
58Pouliot, J
59Quinn, B
60Quintin, I
61Rajakumar, A
62Rinfret, S
63Rupka, D
64Sabbah, E
65Savard, D
66Schampaert, E
67Sussex, B
68Syan, G
69Talbot, P
70Timothee, J R
71Title, L
72Tremblay, G
73Vakani, M T
74Vexler, R
75Badenhorst, C
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9Cloherty, E
10Duong, C
11Lewis, E
12Mercier, R
13Solomon, S
14Anderson, T
15Arnold, J M
16Bedard, J
17Bhargava, R
18Bose, S
19Chehayeb, R
20Cohen, E
21Constance, C
22DeGrace, M
23Dion, D
24Douketis, J
25Ducas, J
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57Syan, G
58Talbot, P
59Timothee, J R
60Title, L
61Tremblay, G
62Vakani, M T
63Vexler, R
64Badenhorst, C
65Bedhesi, S
66Bester, F C J
67Bodenstein, W M J
68Burgess, L
69Cassel, G
70Dawood, S Y
71Ebrahim, I
72Essop, M R
73Jankelow, P
74Jeena, C P
75Ker, A M E
76King, J
77Lamparelli, R
78Lloyd, E
79Mabin, T
80Moodley, R
81Naidu, R K
82Ramdass, A S
83Roux, P
84Saaiman, J A
85Sareli, P
86Sarvan, M I
87Singh, V
88Snyders, A
89Tayob, F I
90Theron, H
91Viljoen, J
92Wittmer, H
93Ahsan, A
94Batin, P
95Boon, N
96Bridges, A
97Brooksby, P
98Channer, K
99Dunn, F
100...
atitleEffects of succinobucol (AGI-1067) after an acute coronary syndrome: a randomised, double-blind, placebo-controlled trial.
jtitleLancet (London, England)
risdate20080524
volume371
issue9626
spage1761
epage1768
pages1761-1768
eissn1474-547X
formatjournal
genrearticle
ristypeJOUR
abstractBACKGROUNDOxidative stress and inflammation are involved in the pathophysiology of atherosclerosis. Our aim was to assess the effects of the antioxidant succinobucol (AGI-1067) on cardiovascular outcomes in patients with recent acute coronary syndromes already managed with conventional treatments. METHODSAfter an acute coronary syndrome occurring 14-365 days before recruitment, 6144 patients were randomly assigned with a computer-generated randomisation list, stratified by study site, to receive succinobucol (n=3078) or placebo (n=3066) in addition to standard of care. Enrolment began in July, 2003; this event-driven trial was stopped in August, 2006, after the prespecified number of primary outcome events had occurred. The composite primary endpoint was time to first occurrence of cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, unstable angina, or coronary revascularisation. Efficacy analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00066898. FINDINGSAll randomised patients were included in the efficacy analyses. Succinobucol had no effect on the primary endpoint (530 events in succinobucol group vs 529 in placebo group; hazard ratio 1.00, 95% CI 0.89-1.13, p=0.96). The composite secondary endpoint of cardiovascular death, cardiac arrest, myocardial infarction, or stroke occurred in fewer patients in the succinobucol group than in the placebo group (207 vs 252 events; 0.81, 0.68-0.98, p=0.029). The tertiary endpoint of new-onset diabetes developed in fewer patients without diabetes at baseline in the succinobucol group than in such patients in the placebo group (30 of 1923 vs 82 of 1950 patients; 0.37, 0.24-0.56, p<0.0001). New-onset atrial fibrillation occurred more often in the succinobucol group than in the placebo group (107 of 2818 vs 55 of 2787 patients; 1.87, 1.67-2.09, p=0.0002). Although the number of patients who reported any treatment emergent adverse event was much the same in the two groups, more patients in the succinobucol group than in the placebo group reported bleeding episodes or anaemia (32 vs 18 and 37 vs ten, respectively) as serious adverse events. Relative to treatment with placebo, succinobucol increased LDL cholesterol and systolic blood pressure, and decreased HDL cholesterol and glycated haemoglobin (p<0.0001 for all). INTERPRETATIONAlthough succinobucol had no effect on the primary endpoint, changes in the rates of other clinical outcomes-both beneficial and harmful-will need to be further assessed before succinobucol is used in patients with atherosclerosis or as an antidiabetic agent.
doi10.1016/S0140-6736(08)60763-1
urlhttp://search.proquest.com/docview/70771984/
issn01406736
date2008-05-24