Major outcomes in moderately hypercholesterolemic， hypertensive patients randomized to pravastatin vs usual care: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT).
 
ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.

CONTEXT: Studies have demonstrated that statins administered to individuals with risk factors for coronary heart disease (CHD) reduce CHD events. However， many of these studies were too small to assess all-cause mortality or outcomes in important subgroups.

OBJECTIVE: To determine whether pravastatin compared with usual care reduces all-cause mortality in older， moderately hypercholesterolemic， hypertensive participants with at least 1 additional CHD risk factor.

DESIGN AND SETTING: Multicenter (513 primarily community-based North American clinical centers)， randomized， nonblinded trial conducted from 1994 through March 2002 in a subset of participants from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). PARTICIPANTS: Ambulatory persons (n = 10 355)， aged 55 years or older， with low-density lipoprotein cholesterol (LDL-C) of 120 to 189 mg/dL (100 to 129 mg/dL if known CHD) and triglycerides lower than 350 mg/dL， were randomized to pravastatin (n = 5170) or to usual care (n = 5185). Baseline mean total cholesterol was 224 mg/dL; LDL-C， 146 mg/dL; high-density lipoprotein cholesterol， 48 mg/dL; and triglycerides， 152 mg/dL. Mean age was 66 years， 49% were women， 38% black and 23% Hispanic， 14% had a history of CHD， and 35% had type 2 diabetes.

INTERVENTION: Pravastatin， 40 mg/d， vs usual care. MAIN OUTCOME MEASURES: The primary outcome was all-cause mortality， with follow-up for up to 8 years. Secondary outcomes included nonfatal myocardial infarction or fatal CHD (CHD events) combined， cause-specific mortality， and cancer. RESULTS: Mean follow-up was 4.8 years. During the trial， 32% of usual care participants with and 29% without CHD started taking lipid-lowering drugs. At year 4， total cholesterol levels were reduced by 17% with pravastatin vs 8% with usual care; among the random sample who had LDL-C levels assessed， levels were reduced by 28% with pravastatin vs 11% with usual care. All-cause mortality was similar for the 2 groups (relative risk [RR]， 0.99; 95% confidence interval [CI]， 0.89-1.11; P =.88)， with 6-year mortality rates of 14.9% for pravastatin vs 15.3% with usual care. CHD event rates were not significantly different between the groups (RR， 0.91; 95% CI， 0.79-1.04; P =.16)， with 6-year CHD event rates of 9.3% for pravastatin and 10.4% for usual care.

CONCLUSIONS: Pravastatin did not reduce either all-cause mortality or CHD significantly when compared with usual care in older participants with well-controlled hypertension and moderately elevated LDL-C. The results may be due to the modest differential in total cholesterol (9.6%) and LDL-C (16.7%) between pravastatin and usual care compared with prior statin trials supporting cardiovascular disease prevention.

JAMA. 2002 Dec 18;288(23):2998-3007