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Lipid Lowering Substudy Trial of the Lipid Lowering Substudy Trial of the

Lipid Lowering Substudy Trial of the - PowerPoint Presentation

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Lipid Lowering Substudy Trial of the - PPT Presentation

Antihypertensive and LipidLowering Treatment to Prevent Heart Attack Trial JAMA 200228829983007 ALLHAT LLT 10355 patients with moderate hypercholesterolemia All patients enrolled in the ALLHAT antihypertensive trial ID: 564100

usual care allhat pravastatin care usual pravastatin allhat llt year 288 statin heart jama 2002 follow 2998 3007 moderate cholesterol baseline mortality

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Slide1

Lipid Lowering Substudy Trial of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial

JAMA 2002;288:2998-3007

ALLHAT- LLTSlide2

10,355 patients with moderate hypercholesterolemia

All patients enrolled in the ALLHAT antihypertensive trial

Fasting LDL-C level of 120-189 mg/dL with no known CHD

or

100-129 mg/dL with known CHDFasting triglyceride levels <350 mg/dL NHLBI funded trial

Endpoints:Primary – All-cause mortality Fatal coronary heart disease and nonfatal MISecondary – Fatal coronary heart disease and nonfatal MI, stroke, CHF, cancerMean follow-up 4.8 years

ALLHAT- LLT

JAMA 2002;288:2998-3007

Pravastatin 40 mg/day(n=5,170)

Usual Care

at discretion of primary care physician

(n=5,185)Slide3

All Cause Mortality

RR = 0.99

p = 0.88

ALLHAT- LLT: Clinical Endpoints

Pravastatin

Usual Care

Fatal Heart Disease

or Nonfatal MI

RR = 0.91p = 0.16

Stroke

RR = 0.91

p = 0.31

JAMA 2002;288:2998-3007

Pravastatin

Usual Care

Pravastatin

Usual CareSlide4

Pravastatin

17.2%

ALLHAT- LLT: Total Cholesterol

Baseline

4 Year Follow-upUsual Care 7.6%

mg/dL

Baseline

4 Year Follow-up

JAMA 2002;288:2998-3007

mg/dLSlide5

Pravastatin

 2

7.7%

ALLHAT- LLT: LDL Cholesterol

Baseline

4 Year Follow-upUsual Care 11.0%

mg/dL

Baseline

4 Year Follow-up

JAMA 2002;288:2998-3007

mg/dLSlide6

ALLHAT- LLT: SummaryDespite moderate reduction in cholesterol with pravastatin, there was no difference in mortality, CHD or stroke compared with usual care for moderate hypercholesterolemia

High crossover rate from usual care to statin treatment (8% at year 2 and 17% at year 4) may explain the only moderate difference in cholesterol reduction and the lack of clinical benefit between the two armsA greater benefit was observed in blacks than in nonblacks with pravastatin for fatal heart disease or nonfatal MI endpoint (RR 0.73 vs 1.02, p=0.03)

Lack of clinical benefit with statin therapy contrasts with other large statin trials (4S, CARE, LIPID, and PROSPER)Meta-analysis of 9 large statin trials including ALLHAT-LLT shows CHD events  27% and mortality 

14% with statin therapy