TY - JOUR
T1 - Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care
T2 - The antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT-LLT)
AU - Furberg, Curt D.
AU - Wright, Jackson T.
AU - Davis, Barry R.
AU - Cutler, Jeffrey A.
AU - Alderman, Michael
AU - Black, Henry
AU - Cushman, William
AU - Grimm, Richard
AU - Haywood, L. Julian
AU - Leenen, Frans
AU - Oparil, Suzanne
AU - Probstfield, Jeffrey
AU - Whelton, Paul
AU - Nwachuku, Chuke
AU - Gordon, David
AU - Proschan, Michael
AU - Einhorn, Paula
AU - Ford, Charles E.
AU - Piller, Linda B.
AU - Dunn, J. Kay
AU - Goff, David
AU - Pressel, Sara
AU - Bettencourt, Judy
AU - DeLeon, Barbara
AU - Simpson, Lara M.
AU - Blanton, Joe
AU - Geraci, Therese
AU - Walsh, Sandra M.
AU - Nelson, Christine
AU - Rahman, Mahboob
AU - Juratovac, Anne
AU - Pospisil, Robert
AU - Carroll, Lillian
AU - Sullivan, Sheila
AU - Russo, Jeanne
AU - Barone, Gail
AU - Christian, Rudy
AU - Feldman, Sharon
AU - Lucente, Tracy
AU - Calhoun, David
AU - Jenkins, Kim
AU - McDowell, Peggy
AU - Johnson, Janice
AU - Kingry, Connie
AU - Alzate, Juan
AU - Margolis, Karen L.
AU - Holland-Klemme, Leslie Ann
AU - Jaeger, Brenda
AU - Williamson, Jeffrey
AU - Louis, Gail
AU - Ragusa, Pamela
AU - Williard, Angela
AU - Ferguson, R. L Sue
AU - Tanner, Joanna
AU - Eckfeldt, John
AU - Crow, Richard
AU - Pelosi, John
PY - 2002/12/18
Y1 - 2002/12/18
N2 - 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=10355), 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.
AB - 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=10355), 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.
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U2 - 10.1001/jama.288.23.2998
DO - 10.1001/jama.288.23.2998
M3 - Article
C2 - 12479764
AN - SCOPUS:0037132607
SN - 0098-7484
VL - 288
SP - 2998
EP - 3007
JO - JAMA
JF - JAMA
IS - 23
ER -