cardiovascular prevention | versus placebo or control No demonstrated result for efficacy | 4 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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Eritsland, 1996 | Omacor vs control | | | all cause death 1.23 [0.43; 3.51] stroke (fatal & non fatal) 0.69 [0.16; 3.07] cardiovascular events 1.16 [0.55; 2.43] | GISSI-P, 1999 | Omacor vs control | all cause death 0.86 [0.77; 0.97] cardiovascular events 0.89 [0.80; 1.00] | | cancer (new or death) 1.06 [0.84; 1.34] stroke (fatal & non fatal) 1.19 [0.88; 1.61] | Johansen, 1999 | Omacor vs placebo | | | all cause death 0.33 [0.03; 3.18] cardiovascular events 0.33 [0.03; 3.18] | Nilsen, 2001 | Omacor vs placebo | | | all cause death 1.00 [0.45; 2.24] cancer (new or death) ∞ [NaN; ∞] cardiovascular events 1.04 [0.82; 1.33] |
Trial | Treatments | Patients | Method |
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Eritsland, 1996 | Omacor capsules, 4/d (3.3g EPA + DHA daily) (n=317) vs. no treatment (n=293) | people admitted for coronary bypass grafting | open Parallel groups Sample size: 317/293 Primary endpoint: FU duration: 12 months | GISSI-P, 1999 | Omacor gelatine capsules, 1/d (0.9g/d EPA + DHA daily) (n=5665) vs. no treatment (n=5668) | people with recent myocardial infarction | open Parallel groups Sample size: 5665/5668 Primary endpoint: death, stroke, MI FU duration: median 40 months | Johansen, 1999 | Omacor capsules, 6/d (5g EPA + DHA daily) (n=250) vs. placebo (corn oil capsules, 6/d) (n=250) | people about to undergo elective coronary angioplasty | double blind Parallel groups Sample size: 250/250 Primary endpoint: restenosis FU duration: 6.5 months | Nilsen, 2001 | Omacor capsules 4/d (3.5g EPA + DHA) (n=150) vs. placebo (corn oil capsules, 4/d) (n=150) | people with acute myocardial infarction 4-8 days agoe/pj | double-blind Parallel groups Sample size: 150/150 Primary endpoint: CV events FU duration: 24 months |
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