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The Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID)

The Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID). The LIPID Study Group. N Engl J Med 1998;339:1349-57. LIPID - Background.

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The Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID)

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  1. The Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) The LIPID Study Group N Engl J Med 1998;339:1349-57

  2. LIPID - Background • In patients with CHD and a broad range of cholesterol levels, cholesterol-lowering therapy reduces the risk of CV events, but the effects on CV mortality and overall mortality have remained uncertain. N Engl J Med 1998;339:1349-57

  3. LIPID - Study Design • Double-blind, randomized, placebo-controlled trial. • 40 mg pravastatin vs. placebo • 9,014 men and women, 31 to 75 years of age, at 87 centers in Australia and New Zealand. • Patients were eligible if they had had an MI or unstable angina (requiring hospitalization) between 3 and 36 months before study entry. • Baseline TC 155 - 271 mg/dL, TG < 445 mg/dL N Engl J Med 1998;339:1349-57

  4. LIPID - Endpoints • Primary endpoint: death from CHD • Secondary endpoints: death from any cause; death from cardiovascular causes; death from CHD or nonfatal MI; MI; stroke; nonhemorrhagic stroke; coronary revascularization; number of days in the hospital; serum lipid levels; and the relation of changes in lipid levels to the occurrence of cardiovascular endpoints. N Engl J Med 1998;339:1349-57

  5. LIPID - Baseline Characteristics Characteristic Placebo Pravastatin (n=4502) (n=4512) Age < 55 yr, no. (%) 1021 (23) 1065 (24) 55-64 yr, no (%) 1708 (38) 1706 (38) 65-69 yr, no (%) 1087 (24) 1081 (24) > 70 yr, no (%) 686 (15) 660 (15) Median, yr 62 62 Sex, no (%) Male 3742 (83) 3756 (83) Female 760 (17) 756 (17) N Engl J Med 1998;339:1349-57

  6. LIPID - Baseline Characteristics Characteristic Placebo Pravastatin (n=4502) (n=4512) Qualifying event, no (%) Myocardial infarction 2875 (64) 2879 (64) Unstable angina 1627 (36) 1633 (36) Coronary risk factors, % Current smoker 10 9 Former smoker 63 65 Hypertension 42 41 Antihypertensive treatment 38 36 Diabetes mellitus 9 9 Obesity 18 18 N Engl J Med 1998;339:1349-57

  7. LIPID - Baseline Lipid Levels Placebo Pravastatin (n=4502) (n=4512) Lipid Levels, mg/dL Total cholesterol, median 218 218 LDL cholesterol, median 150 150 HDL cholesterol, median 36 36 Triglycerides, median 138 142 Total:HDL ratio 6.07 6.11 N Engl J Med 1998;339:1349-57

  8. LIPID - Lipid Level Changes With 40 mg Pravastatin Over 5 Years of Follow-up P<0.001 for all comparisons vs. placebo N Engl J Med 1998;339:1349-57

  9. LIPID - Cardiovascular Events According to Treatment Group Event Placebo Pravastatin Risk p value (n=4502) (n=4512) Reduction Death due to CHD 373 (8.3) 287 (6.4) 24% <0.001 Death due to CVD 433 (9.6) 331 (7.3) 25% <0.001 Death from any cause 633 (14.1) 498 (11.0) 22% <0.001 Death due to CHD or nonfatal MI 715 (15.9) 557 (12.3) 24% <0.001 Any MI 463 (10.3) 336 (7.4) 29% <0.001 CABG 520 (11.6) 415 (9.2) 22% <0.001 PTCA 253 (5.6) 210 (4.7) 19% <0.024 CABG or PTCA 708 (15.7) 585 (13.0) 20% <0.001 Hospitalization for UA 1106 (24.6) 1005 (22.3) 12% 0.005 Any stroke 204 (4.5) 169 (3.7) 19% 0.048 no. (%) N Engl J Med 1998;339:1349-57

  10. CHD death Death from any cause Death due to CHD or nonfatal MI Any MI CABG or PTCA Hosp For UA Any Stroke LIPID - Reduction in Cardiovascular Events P=0.005 P<0.001 P=0.048 P<0.001 P<0.001 P<0.001 P<0.001 N Engl J Med 1998;339:1349-57

  11. LIPID - Kaplan Meier Estimate for Primary Endpoint, Death due to CHD Reduction in Risk, 24% P<0.001 N Engl J Med 1998;339:1349-57

  12. LIPID - Kaplan Meier Estimate for All Cause Mortality Reduction in Risk, 22% P<0.001 N Engl J Med 1998;339:1349-57

  13. LIPID - Kaplan Meier Estimate for Death Due to CHD or Nonfatal MI Reduction in Risk, 24% P<0.001 N Engl J Med 1998;339:1349-57

  14. LIPID - Kaplan Meier Estimate for Stroke Reduction in Risk, 19% P=0.048 N Engl J Med 1998;339:1349-57

  15. LIPID - Reduction in CV Events Reduction in Risk (95% CI) Effect of Sex Female 11 (-18-33) Male 26 (17-35) Effect of Age < 55 yrs 32 (12-48) 55-64 yrs 20 (3-34) 65-69 yrs 28 (11-41) > 70 yrs 15 (-8-33) Hypertension Yes 15 (0-28) No 30 (19-40) Diabetes Yes 19 (-10-41) No 25 (15-33) N Engl J Med 1998;339:1349-57

  16. LIPID - Reduction in CV Events, Effect of Baseline Lipids Reduction in Risk (95% CI) LDL Cholesterol < 135 mg/dL 16 (-4-32) 135-173 mg/dL 26 (14-37) > 174 mg/dL 30 (10-45) HDL Cholesterol < 39 mg/dL 24 (13-34) > 39 mg/dL 25 (8-38) Triglycerides < 133 mg/dL 25 (12-37) 133-230 mg/dL 24 (9-37) > 230 mg/dL 24 (2-41) N Engl J Med 1998;339:1349-57

  17. LIPID - Risk Reduction in Prespecified Subgroups • With respect to the combined endpoint of death from CHD and nonfatal MI: • There was no evidence of significant heterogeneity (P > 0.08) of the treatment effect in any of the subgroups defined by sex, age, initial lipid levels, and the presence or absence of other risk factors, (i.e., hypertension, smoking and diabetes) • The reduction in risk with pravastatin treatment in each subgroup was consistent with the overall 24% reduction in risk for the entire cohort. N Engl J Med 1998;339:1349-57

  18. LIPID - Summary of Results • Over a period of 6.1 years, in 48 patients for every 1000 randomly assigned to treatment with pravastatin the following events were avoided (with allowance for multiple events in each patient) : • 30 deaths • 28 nonfatal MIs • 9 nonfatal strokes • 23 episodes of CABG • 20 episodes of PTCA • 82 hospital admissions for unstable angina N Engl J Med 1998;339:1349-57

  19. LIPID - Conclusion • Pravastatin therapy reduced mortality from CHD and overall mortality, as compared with placebo, as well as the incidence of all prespecified cardiovascular events in patients with a history of MI or unstable angina who had a broad range of initial cholesterol levels. N Engl J Med 1998;339:1349-57

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