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ALLHAT- LLT. Lipid Lowering Substudy Trial of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. JAMA 2002;288:2998-3007. ALLHAT- LLT. 10,355 patients with moderate hypercholesterolemia All patients enrolled in the ALLHAT antihypertensive trial
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ALLHAT- LLT Lipid Lowering Substudy Trial of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial JAMA 2002;288:2998-3007
ALLHAT- LLT • 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 CHD • Fasting triglyceride levels <350 mg/dL • NHLBI funded trial Pravastatin 40 mg/day (n=5,170) Usual Care at discretion of primary care physician (n=5,185) • Endpoints: • Primary – All-cause mortality Fatal coronary heart disease and nonfatal MI • Secondary – Fatal coronary heart disease and nonfatal MI, stroke, CHF, cancer • Mean follow-up 4.8 years JAMA 2002;288:2998-3007
ALLHAT- LLT: Clinical Endpoints Fatal Heart Disease or Nonfatal MI RR = 0.91 p = 0.16 All Cause Mortality RR = 0.99 p = 0.88 Stroke RR = 0.91 p = 0.31 Pravastatin Usual Care Pravastatin Usual Care Pravastatin Usual Care JAMA 2002;288:2998-3007
ALLHAT- LLT: Total Cholesterol Usual Care 7.6% Pravastatin 17.2% mg/dL mg/dL Baseline 4 Year Follow-up Baseline 4 Year Follow-up JAMA 2002;288:2998-3007
ALLHAT- LLT: LDL Cholesterol Usual Care 11.0% Pravastatin 27.7% mg/dL mg/dL Baseline 4 Year Follow-up Baseline 4 Year Follow-up JAMA 2002;288:2998-3007
ALLHAT- LLT: Summary Despite 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 arms • A 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