Effects of XXXX on major coronary events in hypercholesterolaemic @entity1 (JELIS): a randomised open-label, blinded endpoint analysis.

@entity1 @entity8393 @entity7784 @entity1164 @entity583 @entity1459 @entity951 @entity453 @entity1718 @entity6817 @entity165
BACKGROUND: Epidemiological and clinical evidence suggests that an increased intake of long-chain n-3 @entity1718 protects against mortality from @entity453 . We aimed to test the hypothesis that long-term use of @entity7784 ( @entity8393 ) is effective for prevention of major coronary events in hypercholesterolaemic @entity1 in Japan who consume a large amount of fish. METHODS: 18 645 @entity1 with a total @entity165 of 6.5 mmol/L or greater were recruited from local physicians throughout Japan between 1996 and 1999. @entity1 were randomly assigned to receive either 1800 mg of @entity8393 daily with @entity6817 ( @entity8393 group; n=9326) or statin only (controls; n=9319) with a 5-year follow-up. The primary endpoint was any major coronary event, including @entity1164 , fatal and non-fatal @entity583 , and other non-fatal events including unstable @entity951 , angioplasty, stenting, or coronary artery bypass grafting. Analysis was by intention-to-treat. The study was registered at ClinicalTrials.gov, number NCT00231738. FINDINGS: At mean follow-up of 4.6 years, we detected the primary endpoint in 262 (2.8%) @entity1 in the @entity8393 group and 324 (3.5%) in controls-a 19% relative reduction in major coronary events (p=0.011). Post-treatment LDL @entity165 concentrations decreased 25%, from 4.7 mmol/L in both groups. Serum LDL @entity165 was not a significant factor in a reduction of risk for major coronary events. @entity1459 and non-fatal coronary events were also significantly reduced in the @entity8393 group. @entity1164 and coronary death did not differ between groups. In @entity1 with a history of @entity453 who were given @entity8393 treatment, major coronary events were reduced by 19% (secondary prevention subgroup: 158 [8.7%] in the @entity8393 group vs 197 [10.7%] in the control group; p=0.048). In @entity1 with no history of @entity453 , @entity8393 treatment reduced major coronary events by 18%, but this finding was not significant (104 [1.4%] in the @entity8393 group vs 127 [1.7%] in the control group; p=0.132). INTERPRETATION: @entity8393 is a promising treatment for prevention of major coronary events, and especially non-fatal coronary events, in Japanese hypercholesterolaemic @entity1 .
