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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,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
2、 overall mortality have remained uncertain.,N Engl J Med 1998;339:1349-57,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
3、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,LIPID - Endpoints,Primary endpoint: death from CHD Secondary endpoints: death from any cause; death from cardiovascular causes;
4、 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,LIPID - Baseline Characteristics
5、,Characteristic Placebo Pravastatin (n=4502) (n=4512) Age 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,LIPID - Baseline Characteristics,Characteristic Placebo Pravastatin (n=4502) (n=4512) Qualifying even
6、t, 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,LIPID - Baseline Lipid Levels
7、,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,LIPID - Lipid Level Changes With 40 mg Pravastatin Over 5 Y
8、ears of Follow-up,P0.001 for all comparisons vs. placebo,N Engl J Med 1998;339:1349-57,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%
9、 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
10、 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,LIPID - Reduction in Cardiovascular Events,P0.001,P0.001,P0.001,P0.001,P0.001,P=0.005,P=0.048,N Engl J Med 1998;339:1349-57,LIPID - Kaplan Meier Estimate for Primary Endpoint, Death due
11、to CHD,Reduction in Risk, 24% P0.001,N Engl J Med 1998;339:1349-57,LIPID - Kaplan Meier Estimate for All Cause Mortality,Reduction in Risk, 22% P0.001,N Engl J Med 1998;339:1349-57,LIPID - Kaplan Meier Estimate for Death Due to CHD or Nonfatal MI,Reduction in Risk, 24% P0.001,N Engl J Med 1998;339:1
12、349-57,LIPID - Kaplan Meier Estimate for Stroke,Reduction in Risk, 19% P=0.048,N Engl J Med 1998;339:1349-57,LIPID - Reduction in CV Events,Effect of Sex Female 11 (-18-33) Male 26 (17-35) Effect of Age 70 yrs 15 (-8-33) Hypertension Yes 15 (0-28) No 30 (19-40) Diabetes Yes 19 (-10-41) No 25 (15-33)
13、,Reduction in Risk (95% CI),N Engl J Med 1998;339:1349-57,LIPID - Reduction in CV Events, Effect of Baseline Lipids,LDL Cholesterol 174 mg/dL 30 (10-45) HDL Cholesterol 39 mg/dL 25 (8-38) Triglycerides 230 mg/dL 24 (2-41),Reduction in Risk (95% CI),N Engl J Med 1998;339:1349-57,LIPID - Risk Reductio
14、n 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 factor
15、s, (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,LIPID - Summary of Results,Over a period of 6.1 years, in 48 patients for every 1
16、000 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,LIPID - Conclusion,Pravastatin therapy reduced mortality from CHD and overall mortality, as compared with placebo,
