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

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Presentation transcript:

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

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.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:

LIPID - Study Design Double-blind, randomized, placebo-controlled trial.Double-blind, randomized, placebo-controlled trial. 40 mg pravastatin vs. placebo40 mg pravastatin vs. placebo 9,014 men and women, 31 to 75 years of age, at 87 centers in Australia and New Zealand.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.Patients were eligible if they had had an MI or unstable angina (requiring hospitalization) between 3 and 36 months before study entry. Baseline TC mg/dL, TG < 445 mg/dLBaseline TC mg/dL, TG < 445 mg/dL N Engl J Med 1998;339:

LIPID - Endpoints Primary endpoint: death from CHDPrimary 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.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:

LIPID - Baseline Characteristics CharacteristicPlaceboPravastatin (n=4502)(n=4512) Age < 55 yr, no. (%)1021 (23)1065 (24) < 55 yr, no. (%)1021 (23)1065 (24) yr, no (%)1708 (38)1706 (38) yr, no (%)1708 (38)1706 (38) yr, no (%)1087 (24)1081 (24) yr, no (%)1087 (24)1081 (24) > 70 yr, no (%)686 (15)660 (15) > 70 yr, no (%)686 (15)660 (15) Median, yr6262 Median, yr6262 Sex, no (%) Male3742 (83)3756 (83) Male3742 (83)3756 (83) Female760 (17)756 (17) Female760 (17)756 (17) N Engl J Med 1998;339:

LIPID - Baseline Characteristics CharacteristicPlaceboPravastatin (n=4502)(n=4512) Qualifying event, no (%) Myocardial infarction2875 (64)2879 (64) Myocardial infarction2875 (64)2879 (64) Unstable angina1627 (36)1633 (36) Unstable angina1627 (36)1633 (36) Coronary risk factors, % Current smoker109 Current smoker109 Former smoker6365 Former smoker6365 Hypertension4241 Hypertension4241 Antihypertensive treatment3836 Antihypertensive treatment3836 Diabetes mellitus99 Diabetes mellitus99 Obesity1818 Obesity1818 N Engl J Med 1998;339:

LIPID - Baseline Lipid Levels PlaceboPravastatin (n=4502)(n=4512) Lipid Levels, mg/dL Total cholesterol, median Total cholesterol, median LDL cholesterol, median LDL cholesterol, median HDL cholesterol, median HDL cholesterol, median Triglycerides, median Triglycerides, median Total:HDL ratio Total:HDL ratio N Engl J Med 1998;339:

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:

LIPID - Cardiovascular Events According to Treatment Group EventPlaceboPravastatinRisk p value (n=4502)(n=4512)Reduction Death due to CHD373 (8.3)287 (6.4)24%<0.001 Death due to CVD433 (9.6)331 (7.3)25%<0.001 Death from any cause633 (14.1)498 (11.0)22%<0.001 Death due to CHD or nonfatal MI715 (15.9)557 (12.3)24%<0.001 or nonfatal MI715 (15.9)557 (12.3)24%<0.001 Any MI463 (10.3)336 (7.4)29%<0.001 CABG520 (11.6)415 (9.2)22%<0.001 PTCA253 (5.6)210 (4.7)19%<0.024 CABG or PTCA708 (15.7)585 (13.0) 20%<0.001 Hospitalization for UA1106 (24.6)1005 (22.3)12%0.005 Any stroke204 (4.5)169 (3.7)19%0.048 no. (%) N Engl J Med 1998;339:

LIPID - Reduction in Cardiovascular EventsCHDdeath Death from any cause Death due to CHD or nonfatal MI AnyMI CABG or PTCAHosp For UA AnyStroke P<0.001 P=0.005 P=0.048 N Engl J Med 1998;339:

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

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

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:

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

LIPID - Reduction in CV Events Effect of Sex Female11 (-18-33) Female11 (-18-33) Male26 (17-35) Male26 (17-35) Effect of Age < 55 yrs32 (12-48) < 55 yrs32 (12-48) yrs20 (3-34) yrs20 (3-34) yrs28 (11-41) yrs28 (11-41) > 70 yrs15 (-8-33) > 70 yrs15 (-8-33)Hypertension Yes15 (0-28) Yes15 (0-28) No30 (19-40) No30 (19-40)Diabetes Yes19 (-10-41) Yes19 (-10-41) No25 (15-33) No25 (15-33) Reduction in Risk (95% CI) N Engl J Med 1998;339:

LIPID - Reduction in CV Events, Effect of Baseline Lipids LDL Cholesterol < 135 mg/dL16 (-4-32) < 135 mg/dL16 (-4-32) mg/dL26 (14-37) mg/dL26 (14-37) > 174 mg/dL30 (10-45) > 174 mg/dL30 (10-45) HDL Cholesterol < 39 mg/dL24 (13-34) < 39 mg/dL24 (13-34) > 39 mg/dL25 (8-38) > 39 mg/dL25 (8-38)Triglycerides < 133 mg/dL25 (12-37) < 133 mg/dL25 (12-37) mg/dL24 (9-37) mg/dL24 (9-37) > 230 mg/dL24 (2-41) > 230 mg/dL24 (2-41) Reduction in Risk (95% CI) N Engl J Med 1998;339:

LIPID - Risk Reduction in Prespecified Subgroups With respect to the combined endpoint of death from CHD and nonfatal MI: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:

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) :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:

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.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: