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ALLHAT-LLT Trial: Statin Therapy in Moderate Hypercholesterolemia

The ALLHAT-LLT trial evaluated statin therapy in 10,355 patients with moderate hypercholesterolemia, showing no significant difference in mortality or cardiovascular events compared to usual care. Statin use led to cholesterol reduction but did not result in clinical benefits.

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ALLHAT-LLT Trial: Statin Therapy in Moderate Hypercholesterolemia

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  1. ALLHAT- LLT Lipid Lowering Substudy Trial of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial JAMA 2002;288:2998-3007

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

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