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)

Curt D. Furberg, Jackson T. Wright, Barry R. Davis, Jeffrey A. Cutler, Michael Alderman, Henry Black, William Cushman, Richard Grimm, L. Julian Haywood, Frans Leenen, Suzanne Oparil, Jeffrey Probstfield, Paul Whelton, Chuke Nwachuku, David Gordon, Michael Proschan, Paula Einhorn, Charles E. Ford, Linda B. Piller, J. Kay Dunn & 37 others David Goff, Sara Pressel, Judy Bettencourt, Barbara DeLeon, Lara M. Simpson, Joe Blanton, Therese Geraci, Sandra M. Walsh, Christine Nelson, Mahboob Rahman, Anne Juratovac, Robert Pospisil, Lillian Carroll, Sheila Sullivan, Jeanne Russo, Gail Barone, Rudy Christian, Sharon Feldman, Tracy Lucente, David Calhoun, Kim Jenkins, Peggy McDowell, Janice Johnson, Connie Kingry, Juan Alzate, Karen L. Margolis, Leslie Ann Holland-Klemme, Brenda Jaeger, Jeffrey Williamson, Gail Louis, Pamela Ragusa, Angela Williard, R. L.Sue Ferguson, Joanna Tanner, John Eckfeldt, Richard Crow, John Pelosi

Research output: Contribution to journalArticle

1112 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2998-3007
Number of pages10
JournalJournal of the American Medical Association
Volume288
Issue number23
DOIs
StatePublished - Dec 18 2002

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Pravastatin
Antihypertensive Agents
Coronary Disease
Myocardial Infarction
Lipids
Mortality
LDL Cholesterol
Therapeutics
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Cholesterol
Triglycerides
Confidence Intervals
Hispanic Americans
Type 2 Diabetes Mellitus
HDL Cholesterol
Cardiovascular Diseases
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

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). / Furberg, Curt D.; Wright, Jackson T.; Davis, Barry R.; Cutler, Jeffrey A.; Alderman, Michael; Black, Henry; Cushman, William; Grimm, Richard; Haywood, L. Julian; Leenen, Frans; Oparil, Suzanne; Probstfield, Jeffrey; Whelton, Paul; Nwachuku, Chuke; Gordon, David; Proschan, Michael; Einhorn, Paula; Ford, Charles E.; Piller, Linda B.; Dunn, J. Kay; Goff, David; Pressel, Sara; Bettencourt, Judy; DeLeon, Barbara; Simpson, Lara M.; Blanton, Joe; Geraci, Therese; Walsh, Sandra M.; Nelson, Christine; Rahman, Mahboob; Juratovac, Anne; Pospisil, Robert; Carroll, Lillian; Sullivan, Sheila; Russo, Jeanne; Barone, Gail; Christian, Rudy; Feldman, Sharon; Lucente, Tracy; Calhoun, David; Jenkins, Kim; McDowell, Peggy; Johnson, Janice; Kingry, Connie; Alzate, Juan; Margolis, Karen L.; Holland-Klemme, Leslie Ann; Jaeger, Brenda; Williamson, Jeffrey; Louis, Gail; Ragusa, Pamela; Williard, Angela; Ferguson, R. L.Sue; Tanner, Joanna; Eckfeldt, John; Crow, Richard; Pelosi, John.

In: Journal of the American Medical Association, Vol. 288, No. 23, 18.12.2002, p. 2998-3007.

Research output: Contribution to journalArticle

Furberg, CD, Wright, JT, Davis, BR, Cutler, JA, Alderman, M, Black, H, Cushman, W, Grimm, R, Haywood, LJ, Leenen, F, Oparil, S, Probstfield, J, Whelton, P, Nwachuku, C, Gordon, D, Proschan, M, Einhorn, P, Ford, CE, Piller, LB, Dunn, JK, Goff, D, Pressel, S, Bettencourt, J, DeLeon, B, Simpson, LM, Blanton, J, Geraci, T, Walsh, SM, Nelson, C, Rahman, M, Juratovac, A, Pospisil, R, Carroll, L, Sullivan, S, Russo, J, Barone, G, Christian, R, Feldman, S, Lucente, T, Calhoun, D, Jenkins, K, McDowell, P, Johnson, J, Kingry, C, Alzate, J, Margolis, KL, Holland-Klemme, LA, Jaeger, B, Williamson, J, Louis, G, Ragusa, P, Williard, A, Ferguson, RLS, Tanner, J, Eckfeldt, J, Crow, R & Pelosi, J 2002, '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)', Journal of the American Medical Association, vol. 288, no. 23, pp. 2998-3007. https://doi.org/10.1001/jama.288.23.2998
Furberg, Curt D. ; Wright, Jackson T. ; Davis, Barry R. ; Cutler, Jeffrey A. ; Alderman, Michael ; Black, Henry ; Cushman, William ; Grimm, Richard ; Haywood, L. Julian ; Leenen, Frans ; Oparil, Suzanne ; Probstfield, Jeffrey ; Whelton, Paul ; Nwachuku, Chuke ; Gordon, David ; Proschan, Michael ; Einhorn, Paula ; Ford, Charles E. ; Piller, Linda B. ; Dunn, J. Kay ; Goff, David ; Pressel, Sara ; Bettencourt, Judy ; DeLeon, Barbara ; Simpson, Lara M. ; Blanton, Joe ; Geraci, Therese ; Walsh, Sandra M. ; Nelson, Christine ; Rahman, Mahboob ; Juratovac, Anne ; Pospisil, Robert ; Carroll, Lillian ; Sullivan, Sheila ; Russo, Jeanne ; Barone, Gail ; Christian, Rudy ; Feldman, Sharon ; Lucente, Tracy ; Calhoun, David ; Jenkins, Kim ; McDowell, Peggy ; Johnson, Janice ; Kingry, Connie ; Alzate, Juan ; Margolis, Karen L. ; Holland-Klemme, Leslie Ann ; Jaeger, Brenda ; Williamson, Jeffrey ; Louis, Gail ; Ragusa, Pamela ; Williard, Angela ; Ferguson, R. L.Sue ; Tanner, Joanna ; Eckfeldt, John ; Crow, Richard ; Pelosi, John. / 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). In: Journal of the American Medical Association. 2002 ; Vol. 288, No. 23. pp. 2998-3007.
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title = "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)",
abstract = "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.",
author = "Furberg, {Curt D.} and Wright, {Jackson T.} and Davis, {Barry R.} and Cutler, {Jeffrey A.} and Michael Alderman and Henry Black and William Cushman and Richard Grimm and Haywood, {L. Julian} and Frans Leenen and Suzanne Oparil and Jeffrey Probstfield and Paul Whelton and Chuke Nwachuku and David Gordon and Michael Proschan and Paula Einhorn and Ford, {Charles E.} and Piller, {Linda B.} and Dunn, {J. Kay} and David Goff and Sara Pressel and Judy Bettencourt and Barbara DeLeon and Simpson, {Lara M.} and Joe Blanton and Therese Geraci and Walsh, {Sandra M.} and Christine Nelson and Mahboob Rahman and Anne Juratovac and Robert Pospisil and Lillian Carroll and Sheila Sullivan and Jeanne Russo and Gail Barone and Rudy Christian and Sharon Feldman and Tracy Lucente and David Calhoun and Kim Jenkins and Peggy McDowell and Janice Johnson and Connie Kingry and Juan Alzate and Margolis, {Karen L.} and Holland-Klemme, {Leslie Ann} and Brenda Jaeger and Jeffrey Williamson and Gail Louis and Pamela Ragusa and Angela Williard and Ferguson, {R. L.Sue} and Joanna Tanner and John Eckfeldt and Richard Crow and John Pelosi",
year = "2002",
month = "12",
day = "18",
doi = "10.1001/jama.288.23.2998",
language = "English (US)",
volume = "288",
pages = "2998--3007",
journal = "JAMA - Journal of the American Medical Association",
issn = "0002-9955",
publisher = "American Medical Association",
number = "23",

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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

VL - 288

SP - 2998

EP - 3007

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0002-9955

IS - 23

ER -