See also:

GISSI-P study, 1999
	download pdf: Omacor | omega-3 fatty acids for cardiovascular prevention

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)

Trials register #

NA

• . 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
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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 | Hubmed | Fulltext

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