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Table 2 Effect of Epadel on Risk of Major Coronary Eventsa in JELIS and JELIS Substudies

From: Prescription omega-3 fatty acid products containing highly purified eicosapentaenoic acid (EPA)

Analysis Group

Cohort

N

HR (95% CI)

P Value

Reference

JELIS

All patients

18,645

0.81 (0.69–0.95)

0.011

Yokoyama, 2007 [36]

Impaired glucose metabolismb

All patients

4565

0.78 (0.60–0.998)

0.048

Oikawa, 2009 [46]

Peripheral artery disease

All patients

223

0.44 (0.19–0.97)

0.041

Ishikawa, 2010 [47]

JELIS

1° prevention

14,981

0.82 (0.63–1.06)

0.132

Yokoyama, 2007 [36]

TG ≥150 mg/dL and/or HDL-C <40 mg/dL

1° prevention

957

0.47 (0.23–0.98)

0.043

Saito, 2008 [45]

Patients not achieving LDL-C and non-HDL-C goalsc

1° prevention

6592

0.62 (0.43–0.88)

0.007

Sasaki, 2012 [48]

JELIS

2° prevention

3664

0.81 (0.657–0.998)

0.048

Yokoyama, 2007 [36]

Prior myocardial infarction

2° prevention

1050

0.73 (0.54–0.98)

0.033

Matsuzaki, 2009 [49]

Prior coronary intervention

2° prevention

895

0.65 (0.48–0.89)

0.007

Matsuzaki, 2009 [49]

  1. CI confidence interval, HDL-C high-density lipoprotein cholesterol, HR hazard ratio, JELIS Japan EPA Lipid Intervention Study, LDL-C low-density lipoprotein cholesterol, non-HDL-C non-high-density lipoprotein cholesterol, TG triglyceride
  2. aThe primary endpoint, major coronary events, consisted of sudden cardiac death, myocardial infarction, unstable angina pectoris, angioplasty, stenting, or coronary artery bypass grafting [36]
  3. bDefined as fasting plasma glucose ≥110 mg/dL at study registration or after 6 months, physician-diagnosed diabetes mellitus, or use of antidiabetic drugs within first year of study [46]
  4. cLDL-C goal as recommended in 2007 Japanese Atherosclerosis Society guidelines and a non-HDL-C goal of 30 mg/dL higher than the LDL-C goal as recommended in Adult Treatment Panel III guidelines [48]