Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: Results of AFCAPS/TexCAPS

John R. Downs, Michael Clearfield, Stephen Weis, Edwin Whitney, Deborah R. Shapiro, Polly A. Beere, Alexandra Langendorfer, Evan A. Stein, William Kruyer, Antonio M. Gotto

Research output: Contribution to journalArticle

4744 Citations (Scopus)

Abstract

Context. - Although cholesterol-reducing treatment has been shown to reduce fatal and nonfatal coronary disease in patients with coronary heart disease (CHD), it is unknown whether benefit from the reduction of low- density lipoprotein cholesterol (LDL-C) in patients without CHD extends to individuals with average serum cholesterol levels, women, and older persons. Objective. - To compare lovastatin with placebo for prevention of the first acute major coronary event in men and women without clinically evident atherosclerotic cardiovascular disease with average total cholesterol (TC) and LDL-C levels and below-average high-density lipoprotein cholesterol (HDL- C) levels. Design. - A randomized, double-blind, placebo-controlled trial. Setting. - Outpatient clinics in Texas. Participants. - A total of 5608 men and 997 women with average TC and LDL-C and below-average HDL-C (as characterized by lipid percentiles for an age- and sex-matched cohort without cardiovascular disease from the National Health and Nutrition Examination Survey [NHANES] III). Mean (SD) TC level was 5.71 (0.54) mmol/L (221 [21] mg/dL) (51st percentile), mean (SD) LDL-C level was 3.89 (0.43) mmol/L (150 [17] mg/dL) (60th percentile), mean (SD) HDL-C level was 0.94 (0.14) mmol/L (36 [5] mg/dL) for men and 1.03 (0.14) mmol/L (40 [5] mg/dL) for women (25th and 16th percentiles, respectively), and median (SD) triglyceride levels were 1.78 (0.86) mmol/L (158 [76] mg/dL) (63rd percentile). Intervention. - Lovastatin (20-40 mg daily) or placebo in addition to a low-saturated fat, low-cholesterol diet. Main Outcome Measures. - First acute major coronary event defined as fatal or nonfatal myocardial infarction, unstable angina, or sudden cardiac death. Results. - After an average follow-up of 5.2 years, lovastatin reduced the incidence of first acute major coronary events (183 vs 116 first events; relative risk [RR], 0.63; 95% confidence interval [Cl], 0.50-0.79; P<.001), myocardial infarction (95 vs 57 myocardial infarctions; RR, 0.60; 95% Cl, 0.43-0.83; P = .002), unstable angina (87 vs 60 first unstable angina events; RR, 0.68; 95% Cl, 0.49-0.95; P = .02), coronary revascularization procedures (157 vs 106 procedures; RR, 0.67; 95% Cl, 0.520.85; P= .001), coronary events (215 vs 163 coronary events; RR, 0.75; 95% Cl, 0.61-0.92; P = .006), and cardiovascular events (255 vs 194 cardiovascular events; RR, 0.75; 95% Cl, 0.62-0.91; P = .003). Lovastatin (20-40 mg daily) reduced LDL-C by 25% to 2.96 mmol/L (115 mg/dL) and increased HDL-C by 6% to 1.02 mmol/L (39 mg/dL). There were no clinically relevant differences in safety parameters between treatment groups. Conclusions. - Lovastatin reduces the risk for the first acute major coronary event in men and women with average TC and LDL-C levels and below-average HDL-C levels. These findings support the inclusion of HDL-C in risk-factor assessment, confirm the benefit of LDL-C reduction to a target goal, and suggest the need for reassessment of the National Cholesterol Education Program guidelines regarding pharmacological intervention.

Original languageEnglish
Pages (from-to)1615-1622
Number of pages8
JournalJournal of the American Medical Association
Volume279
Issue number20
DOIs
StatePublished - 27 May 1998

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Lovastatin
Primary Prevention
LDL Cholesterol
Cholesterol
Unstable Angina
Coronary Disease
Myocardial Infarction
Placebos
Cardiovascular Diseases
Fat-Restricted Diet
Nutrition Surveys
Sudden Cardiac Death
Ambulatory Care Facilities
HDL Cholesterol
Triglycerides
Outcome Assessment (Health Care)
Pharmacology
Guidelines
Confidence Intervals
Lipids

Cite this

Downs, John R. ; Clearfield, Michael ; Weis, Stephen ; Whitney, Edwin ; Shapiro, Deborah R. ; Beere, Polly A. ; Langendorfer, Alexandra ; Stein, Evan A. ; Kruyer, William ; Gotto, Antonio M. / Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels : Results of AFCAPS/TexCAPS. In: Journal of the American Medical Association. 1998 ; Vol. 279, No. 20. pp. 1615-1622.
@article{ef9eb22b7745459ca46ab47ef0c54127,
title = "Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: Results of AFCAPS/TexCAPS",
abstract = "Context. - Although cholesterol-reducing treatment has been shown to reduce fatal and nonfatal coronary disease in patients with coronary heart disease (CHD), it is unknown whether benefit from the reduction of low- density lipoprotein cholesterol (LDL-C) in patients without CHD extends to individuals with average serum cholesterol levels, women, and older persons. Objective. - To compare lovastatin with placebo for prevention of the first acute major coronary event in men and women without clinically evident atherosclerotic cardiovascular disease with average total cholesterol (TC) and LDL-C levels and below-average high-density lipoprotein cholesterol (HDL- C) levels. Design. - A randomized, double-blind, placebo-controlled trial. Setting. - Outpatient clinics in Texas. Participants. - A total of 5608 men and 997 women with average TC and LDL-C and below-average HDL-C (as characterized by lipid percentiles for an age- and sex-matched cohort without cardiovascular disease from the National Health and Nutrition Examination Survey [NHANES] III). Mean (SD) TC level was 5.71 (0.54) mmol/L (221 [21] mg/dL) (51st percentile), mean (SD) LDL-C level was 3.89 (0.43) mmol/L (150 [17] mg/dL) (60th percentile), mean (SD) HDL-C level was 0.94 (0.14) mmol/L (36 [5] mg/dL) for men and 1.03 (0.14) mmol/L (40 [5] mg/dL) for women (25th and 16th percentiles, respectively), and median (SD) triglyceride levels were 1.78 (0.86) mmol/L (158 [76] mg/dL) (63rd percentile). Intervention. - Lovastatin (20-40 mg daily) or placebo in addition to a low-saturated fat, low-cholesterol diet. Main Outcome Measures. - First acute major coronary event defined as fatal or nonfatal myocardial infarction, unstable angina, or sudden cardiac death. Results. - After an average follow-up of 5.2 years, lovastatin reduced the incidence of first acute major coronary events (183 vs 116 first events; relative risk [RR], 0.63; 95{\%} confidence interval [Cl], 0.50-0.79; P<.001), myocardial infarction (95 vs 57 myocardial infarctions; RR, 0.60; 95{\%} Cl, 0.43-0.83; P = .002), unstable angina (87 vs 60 first unstable angina events; RR, 0.68; 95{\%} Cl, 0.49-0.95; P = .02), coronary revascularization procedures (157 vs 106 procedures; RR, 0.67; 95{\%} Cl, 0.520.85; P= .001), coronary events (215 vs 163 coronary events; RR, 0.75; 95{\%} Cl, 0.61-0.92; P = .006), and cardiovascular events (255 vs 194 cardiovascular events; RR, 0.75; 95{\%} Cl, 0.62-0.91; P = .003). Lovastatin (20-40 mg daily) reduced LDL-C by 25{\%} to 2.96 mmol/L (115 mg/dL) and increased HDL-C by 6{\%} to 1.02 mmol/L (39 mg/dL). There were no clinically relevant differences in safety parameters between treatment groups. Conclusions. - Lovastatin reduces the risk for the first acute major coronary event in men and women with average TC and LDL-C levels and below-average HDL-C levels. These findings support the inclusion of HDL-C in risk-factor assessment, confirm the benefit of LDL-C reduction to a target goal, and suggest the need for reassessment of the National Cholesterol Education Program guidelines regarding pharmacological intervention.",
author = "Downs, {John R.} and Michael Clearfield and Stephen Weis and Edwin Whitney and Shapiro, {Deborah R.} and Beere, {Polly A.} and Alexandra Langendorfer and Stein, {Evan A.} and William Kruyer and Gotto, {Antonio M.}",
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doi = "10.1001/jama.279.20.1615",
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Downs, JR, Clearfield, M, Weis, S, Whitney, E, Shapiro, DR, Beere, PA, Langendorfer, A, Stein, EA, Kruyer, W & Gotto, AM 1998, 'Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: Results of AFCAPS/TexCAPS', Journal of the American Medical Association, vol. 279, no. 20, pp. 1615-1622. https://doi.org/10.1001/jama.279.20.1615

Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels : Results of AFCAPS/TexCAPS. / Downs, John R.; Clearfield, Michael; Weis, Stephen; Whitney, Edwin; Shapiro, Deborah R.; Beere, Polly A.; Langendorfer, Alexandra; Stein, Evan A.; Kruyer, William; Gotto, Antonio M.

In: Journal of the American Medical Association, Vol. 279, No. 20, 27.05.1998, p. 1615-1622.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels

T2 - Results of AFCAPS/TexCAPS

AU - Downs, John R.

AU - Clearfield, Michael

AU - Weis, Stephen

AU - Whitney, Edwin

AU - Shapiro, Deborah R.

AU - Beere, Polly A.

AU - Langendorfer, Alexandra

AU - Stein, Evan A.

AU - Kruyer, William

AU - Gotto, Antonio M.

PY - 1998/5/27

Y1 - 1998/5/27

N2 - Context. - Although cholesterol-reducing treatment has been shown to reduce fatal and nonfatal coronary disease in patients with coronary heart disease (CHD), it is unknown whether benefit from the reduction of low- density lipoprotein cholesterol (LDL-C) in patients without CHD extends to individuals with average serum cholesterol levels, women, and older persons. Objective. - To compare lovastatin with placebo for prevention of the first acute major coronary event in men and women without clinically evident atherosclerotic cardiovascular disease with average total cholesterol (TC) and LDL-C levels and below-average high-density lipoprotein cholesterol (HDL- C) levels. Design. - A randomized, double-blind, placebo-controlled trial. Setting. - Outpatient clinics in Texas. Participants. - A total of 5608 men and 997 women with average TC and LDL-C and below-average HDL-C (as characterized by lipid percentiles for an age- and sex-matched cohort without cardiovascular disease from the National Health and Nutrition Examination Survey [NHANES] III). Mean (SD) TC level was 5.71 (0.54) mmol/L (221 [21] mg/dL) (51st percentile), mean (SD) LDL-C level was 3.89 (0.43) mmol/L (150 [17] mg/dL) (60th percentile), mean (SD) HDL-C level was 0.94 (0.14) mmol/L (36 [5] mg/dL) for men and 1.03 (0.14) mmol/L (40 [5] mg/dL) for women (25th and 16th percentiles, respectively), and median (SD) triglyceride levels were 1.78 (0.86) mmol/L (158 [76] mg/dL) (63rd percentile). Intervention. - Lovastatin (20-40 mg daily) or placebo in addition to a low-saturated fat, low-cholesterol diet. Main Outcome Measures. - First acute major coronary event defined as fatal or nonfatal myocardial infarction, unstable angina, or sudden cardiac death. Results. - After an average follow-up of 5.2 years, lovastatin reduced the incidence of first acute major coronary events (183 vs 116 first events; relative risk [RR], 0.63; 95% confidence interval [Cl], 0.50-0.79; P<.001), myocardial infarction (95 vs 57 myocardial infarctions; RR, 0.60; 95% Cl, 0.43-0.83; P = .002), unstable angina (87 vs 60 first unstable angina events; RR, 0.68; 95% Cl, 0.49-0.95; P = .02), coronary revascularization procedures (157 vs 106 procedures; RR, 0.67; 95% Cl, 0.520.85; P= .001), coronary events (215 vs 163 coronary events; RR, 0.75; 95% Cl, 0.61-0.92; P = .006), and cardiovascular events (255 vs 194 cardiovascular events; RR, 0.75; 95% Cl, 0.62-0.91; P = .003). Lovastatin (20-40 mg daily) reduced LDL-C by 25% to 2.96 mmol/L (115 mg/dL) and increased HDL-C by 6% to 1.02 mmol/L (39 mg/dL). There were no clinically relevant differences in safety parameters between treatment groups. Conclusions. - Lovastatin reduces the risk for the first acute major coronary event in men and women with average TC and LDL-C levels and below-average HDL-C levels. These findings support the inclusion of HDL-C in risk-factor assessment, confirm the benefit of LDL-C reduction to a target goal, and suggest the need for reassessment of the National Cholesterol Education Program guidelines regarding pharmacological intervention.

AB - Context. - Although cholesterol-reducing treatment has been shown to reduce fatal and nonfatal coronary disease in patients with coronary heart disease (CHD), it is unknown whether benefit from the reduction of low- density lipoprotein cholesterol (LDL-C) in patients without CHD extends to individuals with average serum cholesterol levels, women, and older persons. Objective. - To compare lovastatin with placebo for prevention of the first acute major coronary event in men and women without clinically evident atherosclerotic cardiovascular disease with average total cholesterol (TC) and LDL-C levels and below-average high-density lipoprotein cholesterol (HDL- C) levels. Design. - A randomized, double-blind, placebo-controlled trial. Setting. - Outpatient clinics in Texas. Participants. - A total of 5608 men and 997 women with average TC and LDL-C and below-average HDL-C (as characterized by lipid percentiles for an age- and sex-matched cohort without cardiovascular disease from the National Health and Nutrition Examination Survey [NHANES] III). Mean (SD) TC level was 5.71 (0.54) mmol/L (221 [21] mg/dL) (51st percentile), mean (SD) LDL-C level was 3.89 (0.43) mmol/L (150 [17] mg/dL) (60th percentile), mean (SD) HDL-C level was 0.94 (0.14) mmol/L (36 [5] mg/dL) for men and 1.03 (0.14) mmol/L (40 [5] mg/dL) for women (25th and 16th percentiles, respectively), and median (SD) triglyceride levels were 1.78 (0.86) mmol/L (158 [76] mg/dL) (63rd percentile). Intervention. - Lovastatin (20-40 mg daily) or placebo in addition to a low-saturated fat, low-cholesterol diet. Main Outcome Measures. - First acute major coronary event defined as fatal or nonfatal myocardial infarction, unstable angina, or sudden cardiac death. Results. - After an average follow-up of 5.2 years, lovastatin reduced the incidence of first acute major coronary events (183 vs 116 first events; relative risk [RR], 0.63; 95% confidence interval [Cl], 0.50-0.79; P<.001), myocardial infarction (95 vs 57 myocardial infarctions; RR, 0.60; 95% Cl, 0.43-0.83; P = .002), unstable angina (87 vs 60 first unstable angina events; RR, 0.68; 95% Cl, 0.49-0.95; P = .02), coronary revascularization procedures (157 vs 106 procedures; RR, 0.67; 95% Cl, 0.520.85; P= .001), coronary events (215 vs 163 coronary events; RR, 0.75; 95% Cl, 0.61-0.92; P = .006), and cardiovascular events (255 vs 194 cardiovascular events; RR, 0.75; 95% Cl, 0.62-0.91; P = .003). Lovastatin (20-40 mg daily) reduced LDL-C by 25% to 2.96 mmol/L (115 mg/dL) and increased HDL-C by 6% to 1.02 mmol/L (39 mg/dL). There were no clinically relevant differences in safety parameters between treatment groups. Conclusions. - Lovastatin reduces the risk for the first acute major coronary event in men and women with average TC and LDL-C levels and below-average HDL-C levels. These findings support the inclusion of HDL-C in risk-factor assessment, confirm the benefit of LDL-C reduction to a target goal, and suggest the need for reassessment of the National Cholesterol Education Program guidelines regarding pharmacological intervention.

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DO - 10.1001/jama.279.20.1615

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EP - 1622

JO - Journal of the American Medical Association

JF - Journal of the American Medical Association

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