Related trials
Risk and Prevention Study, 2013 - omega-3 Fatty acids vs placebo
ALPHA OMEGA (ALA), 2010 - alpha-linolenic acid vs placebo
ALPHA OMEGA (EPA DHA), 2010 - omega-3 Fatty acids vs placebo
OMEGA, 2009 - omega-3 Fatty acids vs control
GISSI HF fatty acid, 2008 - omega-3 fatty acids vs placebo
Burr (DART 2), 2003 - diet vs control
Bemelmans, 2002 - fish oil vs control
Maresta, 2002 - Esapent vs placebo
Nilsen, 2001 - Omacor vs placebo
Brox, 2001 - fish oil vs control
Terano, 1999 - fish oil vs control
von Schacky, 1999 - fish oil vs placebo
Malaguarnera, 1999 - fish oil vs control
GISSI-P, 1999 - Omacor vs control
Johansen, 1999 - Omacor vs placebo
Sirtori, 1998 - Esapent vs placebo
Dehmer, 1998 - MaxEPA vs control
Almallah, 1998 - fish oil vs placebo
Singh, 1997 - MaxEPA vs placebo
Katan, 1997 - fish oil vs control
Lorenz-Meyer, 1996 - fish oil vs placebo
Loeschke, 1996 - fish oil vs placebo
Belluzzi, 1996 - PurEPA vs placebo
Rossing, 1996 - Eskisol vs placebo
Eritsland, 1996 - Omacor vs control
See also:
All cardiovascular prevention clinical trials
All clinical trials of omega-3 fatty acids
All clinical trials of Omacor
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|
Treatments
Studied treatment |
Omacor gelatine capsules, 1/d (0.9g/d EPA + DHA daily)
|
Control treatment |
no treatment
|
Patients
Patients |
people with recent myocardial infarction |
Baseline characteristics |
global risk of bias |
Medium or high |
|
Method and design
Randomized effectives |
5665 / 5668 (studied vs. control) |
Design |
Parallel groups |
Blinding |
open |
Follow-up duration |
median 40 months |
Lost to follow-up |
?/5665, ?/5658 |
Geographic area |
Italy |
Primary endpoint |
death, stroke, MI |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
All cause death
477 / 5665
554 / 5658
0,86 [0,77;0,97]
Cancer
142 / 5665
134 / 5658
1,06 [0,84;1,34]
cardiovascular events
556 / 5665
621 / 5658
0,89 [0,80;1,00]
stroke (fatal and non fatal)
92 / 5665
77 / 5658
1,19 [0,88;1,61]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
All cause death
|
477 / 5665 (8,4%) |
554 / 5658 (9,8%) |
0,86 |
[0,77;0,97] |
|
|
Cancer
|
142 / 5665 (2,5%) |
134 / 5658 (2,4%) |
1,06 |
[0,84;1,34] |
|
|
cardiovascular events
|
556 / 5665 (9,8%) |
621 / 5658 (11,0%) |
0,89 |
[0,80;1,00] |
|
|
stroke (fatal and non fatal)
|
92 / 5665 (1,6%) |
77 / 5658 (1,4%) |
1,19 |
[0,88;1,61] |
|
|
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
All cause death |
8,42% |
9,79% |
-13,7‰
|
Cancer |
2,51% |
2,37% |
1,4‰
|
cardiovascular events |
9,81% |
10,98% |
-11,6‰
|
stroke (fatal and non fatal) |
1,62% |
1,36% |
2,6‰
|
Meta-analysis of all similar trials:
omega-3 fatty acids in cardiovascular prevention for all type of patients
omega-3 fatty acids in cardiovascular prevention for patients at high risk
Reference(s)
-
.
Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico..
Lancet 1999 Aug 7;354:447-55
Pubmed
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Hubmed
| Fulltext
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Marchioli R, Barzi F, Bomba E, Chieffo C, Di Gregorio D, Di Mascio R, Franzosi MG, Geraci E, Levantesi G, Maggioni AP, Mantini L, Marfisi RM, Mastrogiuseppe G, Mininni N, Nicolosi GL, Santini M, Schweiger C, Tavazzi L, Tognoni G, Tucci C, Valagussa F.
Early protection against sudden death by n-3 polyunsaturated fatty acids after myocardial infarction: time-course analysis of the results of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI)-Prevenzione..
Circulation 2002 Apr 23;105:1897-903
Pubmed
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Hubmed
| Fulltext
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