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)
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...
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creator | Furberg, Curt D Wright, Jackson T Davis, Barry R Cutler, Jeffrey A |
description | 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-control |
doi_str_mv | 10.1001/jama.288.23.2998 |
format | Article |
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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.</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.288.23.2998</identifier><identifier>PMID: 12479764</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>Chicago, IL: American Medical Association</publisher><subject>Aged ; Anticholesteremic Agents - therapeutic use ; Antihypertensive agents ; Biological and medical sciences ; Cardiovascular Diseases - epidemiology ; Cardiovascular Diseases - prevention & control ; Cardiovascular system ; Cause of Death ; Cholesterol ; Clinical outcomes ; Female ; General and cellular metabolism. Vitamins ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use ; Hypercholesterolemia - complications ; Hypercholesterolemia - drug therapy ; Hypertension - complications ; Hypertension - drug therapy ; Lipids - blood ; Male ; Medical sciences ; Middle Aged ; Patients ; Pharmacology. Drug treatments ; Pravastatin - therapeutic use ; Proportional Hazards Models ; Risk Factors</subject><ispartof>JAMA : the journal of the American Medical Association, 2002-12, Vol.288 (23), p.2998-3007</ispartof><rights>2003 INIST-CNRS</rights><rights>Copyright American Medical Association Dec 18, 2002</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a437t-b40bff5cc5cbb67e8b4592dd70b490b0af1d5f9cc1fbb29cd960b9f2b2acc99d3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.288.23.2998$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.288.23.2998$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,314,776,780,3327,27901,27902,76232,76235</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=14428823$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12479764$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Furberg, Curt D</creatorcontrib><creatorcontrib>Wright, Jackson T</creatorcontrib><creatorcontrib>Davis, Barry R</creatorcontrib><creatorcontrib>Cutler, Jeffrey A</creatorcontrib><creatorcontrib>ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial</creatorcontrib><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)</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>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.</description><subject>Aged</subject><subject>Anticholesteremic Agents - therapeutic use</subject><subject>Antihypertensive agents</subject><subject>Biological and medical sciences</subject><subject>Cardiovascular Diseases - epidemiology</subject><subject>Cardiovascular Diseases - prevention & control</subject><subject>Cardiovascular system</subject><subject>Cause of Death</subject><subject>Cholesterol</subject><subject>Clinical outcomes</subject><subject>Female</subject><subject>General and cellular metabolism. Vitamins</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</subject><subject>Hypercholesterolemia - complications</subject><subject>Hypercholesterolemia - drug therapy</subject><subject>Hypertension - complications</subject><subject>Hypertension - drug therapy</subject><subject>Lipids - blood</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Patients</subject><subject>Pharmacology. Drug treatments</subject><subject>Pravastatin - therapeutic use</subject><subject>Proportional Hazards Models</subject><subject>Risk Factors</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdklGL1DAQgIso3nr6ri8SBEXBrknabhrfyqKu0OMO6T0vk3TqZm3TvSTdY-9H-pvMsSsn5mVC5puPMDNJ8pLROaOUfdrCAHNelnOezbmU5aNkxoqsTLNClo-TGaWyTEVe5mfJM--3NB6WiafJGeO5kGKRz5LfF7AdHbmcgh4H9MRYcjG26CBgfyCrww6d3ow9-oAuhsHoj8fXgNabPZIrCAZt8OQH2HYczB22JIzkysEefIhJS_aeXPsJerIEh59Js0FS2WA2_2piManNzrRpPd6iM_YnaRxCGKL76MP9_XWF4AKpQgD9KxImWt9Xdb2qmrSumw_Pkycd9B5fnOJ5cv31S7NcpfXlt-_Lqk4hz0RIVU5V1xVaF1qphcBS5YXkbSuoyiVVFDrWFp3UmnVKcalbuaBKdlxx0FrKNjtP3h29OzfeTLE768F4jX0PFsfJrwUXouCCRvDNf-B2nJyNf1tzxrI4B5pF6PUJmtSA7XrnzADusP47pgi8PQHgNfSdA6uNf-DyPC4Bvxe9OnJxLx6yslhwkf0B5ieuxg</recordid><startdate>20021218</startdate><enddate>20021218</enddate><creator>Furberg, Curt D</creator><creator>Wright, Jackson T</creator><creator>Davis, Barry R</creator><creator>Cutler, Jeffrey A</creator><general>American Medical Association</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>20021218</creationdate><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)</title><author>Furberg, Curt D ; Wright, Jackson T ; Davis, Barry R ; Cutler, Jeffrey A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a437t-b40bff5cc5cbb67e8b4592dd70b490b0af1d5f9cc1fbb29cd960b9f2b2acc99d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Aged</topic><topic>Anticholesteremic Agents - therapeutic use</topic><topic>Antihypertensive agents</topic><topic>Biological and medical sciences</topic><topic>Cardiovascular Diseases - epidemiology</topic><topic>Cardiovascular Diseases - prevention & control</topic><topic>Cardiovascular system</topic><topic>Cause of Death</topic><topic>Cholesterol</topic><topic>Clinical outcomes</topic><topic>Female</topic><topic>General and cellular metabolism. Vitamins</topic><topic>Humans</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</topic><topic>Hypercholesterolemia - complications</topic><topic>Hypercholesterolemia - drug therapy</topic><topic>Hypertension - complications</topic><topic>Hypertension - drug therapy</topic><topic>Lipids - blood</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Patients</topic><topic>Pharmacology. Drug treatments</topic><topic>Pravastatin - therapeutic use</topic><topic>Proportional Hazards Models</topic><topic>Risk Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Furberg, Curt D</creatorcontrib><creatorcontrib>Wright, Jackson T</creatorcontrib><creatorcontrib>Davis, Barry R</creatorcontrib><creatorcontrib>Cutler, Jeffrey A</creatorcontrib><creatorcontrib>ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Furberg, Curt D</au><au>Wright, Jackson T</au><au>Davis, Barry R</au><au>Cutler, Jeffrey A</au><aucorp>ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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)</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2002-12-18</date><risdate>2002</risdate><volume>288</volume><issue>23</issue><spage>2998</spage><epage>3007</epage><pages>2998-3007</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><coden>JAMAAP</coden><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 = 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.</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><pmid>12479764</pmid><doi>10.1001/jama.288.23.2998</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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issn | 0098-7484 1538-3598 |
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source | MEDLINE; American Medical Association Journals |
subjects | Aged Anticholesteremic Agents - therapeutic use Antihypertensive agents Biological and medical sciences Cardiovascular Diseases - epidemiology Cardiovascular Diseases - prevention & control Cardiovascular system Cause of Death Cholesterol Clinical outcomes Female General and cellular metabolism. Vitamins Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Hypercholesterolemia - complications Hypercholesterolemia - drug therapy Hypertension - complications Hypertension - drug therapy Lipids - blood Male Medical sciences Middle Aged Patients Pharmacology. Drug treatments Pravastatin - therapeutic use Proportional Hazards Models Risk Factors |
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) |
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