Air Force/Texas coronary atherosclerosis prevention study (AFCAPS/TexCAPS): Efficacy and tolerability of long-term treatment with lovastatin in women

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

Research output: Contribution to journalArticle

76 Citations (Scopus)

Abstract

The Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS) is the first coronary heart disease (CHD) primary prevention trial of the cholesterol-reducing agents called “statins” to include women. For 5608 men and 997 postmenopausal women without clinical evidence of cardiovascular disease (CVD) who had average low-density lipoprotein cholesterol (LDL-C) and below average high-density lipoprotein cholesterol (HDL-C), 20-40 mg/day lovastatin reduced first acute major coronary events (AMCEs) 37% (for those receiving placebo and lovastatin, respectively, 183 and 116 first AMCEs defined as fatal or nonfatal myocardial infarction [MI], unstable angina, or sudden cardiac death; relative risk [RR] 0.63; 95% confidence interval [95% CI] 0.50, 0.79; p < 0.001). Statistically significant reductions in prespecified secondary end points (coronary revascularizations, unstable angina, MI, cardiovascular end point events, and coronary end point events) were also associated with lovastatin treatment in the overall cohort. This paper provides results in women, a prespecified subgroup. Among women, 20-40 mg/day lovastatin reduced LDL-C 25% and increased HDL-C 9% (p < 0.001). A prespecified analysis revealed consistency with the overall results regardless of gender (i.e., there were no statistical differences between men and women in risk reduction for first AMCEs with lovastatin). However, the number of women who had an AMCE was small, and there was insufficient power to detect a treatment group difference among women (7 of 499 vs. 13 of 498 first AMCEs in those receiving lovastatin and placebo, respectively; RR 0.54; 95% CI 0.22, 1.35; p = 0.183). Numerical reductions in all prespecified secondary end points were observed for women treated with lovastatin, but again, the numbers of events were small and the differences were not statistically significant. Chronic long-term treatment with lovastatin was well tolerated, with no treatment group differences in the frequency of cancer, muscle symptoms, and clinically important liver enzyme elevations. In AFCAPS/TexCAPS, a consistent pattern of numerical reductions in all prespecified primary and secondary cardiovascular end points was observed in women treated with lovastatin for primary prevention of CHD. However, because of the small number of events, there was insufficient power to detect significant treatment group differences. Lovastatin treatment was associated with statistically significant decreases in LDL-C and increases in HDL-C, and chronic long-term treatment with 20-40 mg/day lovastatin was well tolerated in women.

Original languageEnglish
Pages (from-to)971-981
Number of pages11
JournalJournal of Women’s Health and Gender-Based Medicine
Volume10
Issue number10
DOIs
StatePublished - 1 Dec 2001

Fingerprint

Lovastatin
Coronary Artery Disease
Air
Therapeutics
LDL Cholesterol
HDL Cholesterol
Unstable Angina
Primary Prevention
Coronary Disease
Muscle Neoplasms
Myocardial Infarction
Placebos
Confidence Intervals
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Sudden Cardiac Death
Reducing Agents
Risk Reduction Behavior
Cardiovascular Diseases
Cholesterol

Cite this

Clearfield, Michael ; Downs, John R. ; Weis, Stephen ; Whitney, Edwin J. ; Kruyer, William ; Shapiro, Deborah R. ; Stein, Evan A. ; Langendorfer, Alexandra ; Beere, Polly A. ; Gotto, Antonio M. / Air Force/Texas coronary atherosclerosis prevention study (AFCAPS/TexCAPS) : Efficacy and tolerability of long-term treatment with lovastatin in women. In: Journal of Women’s Health and Gender-Based Medicine. 2001 ; Vol. 10, No. 10. pp. 971-981.
@article{439db93aa99344ef9421a3a5cb4603bb,
title = "Air Force/Texas coronary atherosclerosis prevention study (AFCAPS/TexCAPS): Efficacy and tolerability of long-term treatment with lovastatin in women",
abstract = "The Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS) is the first coronary heart disease (CHD) primary prevention trial of the cholesterol-reducing agents called “statins” to include women. For 5608 men and 997 postmenopausal women without clinical evidence of cardiovascular disease (CVD) who had average low-density lipoprotein cholesterol (LDL-C) and below average high-density lipoprotein cholesterol (HDL-C), 20-40 mg/day lovastatin reduced first acute major coronary events (AMCEs) 37{\%} (for those receiving placebo and lovastatin, respectively, 183 and 116 first AMCEs defined as fatal or nonfatal myocardial infarction [MI], unstable angina, or sudden cardiac death; relative risk [RR] 0.63; 95{\%} confidence interval [95{\%} CI] 0.50, 0.79; p < 0.001). Statistically significant reductions in prespecified secondary end points (coronary revascularizations, unstable angina, MI, cardiovascular end point events, and coronary end point events) were also associated with lovastatin treatment in the overall cohort. This paper provides results in women, a prespecified subgroup. Among women, 20-40 mg/day lovastatin reduced LDL-C 25{\%} and increased HDL-C 9{\%} (p < 0.001). A prespecified analysis revealed consistency with the overall results regardless of gender (i.e., there were no statistical differences between men and women in risk reduction for first AMCEs with lovastatin). However, the number of women who had an AMCE was small, and there was insufficient power to detect a treatment group difference among women (7 of 499 vs. 13 of 498 first AMCEs in those receiving lovastatin and placebo, respectively; RR 0.54; 95{\%} CI 0.22, 1.35; p = 0.183). Numerical reductions in all prespecified secondary end points were observed for women treated with lovastatin, but again, the numbers of events were small and the differences were not statistically significant. Chronic long-term treatment with lovastatin was well tolerated, with no treatment group differences in the frequency of cancer, muscle symptoms, and clinically important liver enzyme elevations. In AFCAPS/TexCAPS, a consistent pattern of numerical reductions in all prespecified primary and secondary cardiovascular end points was observed in women treated with lovastatin for primary prevention of CHD. However, because of the small number of events, there was insufficient power to detect significant treatment group differences. Lovastatin treatment was associated with statistically significant decreases in LDL-C and increases in HDL-C, and chronic long-term treatment with 20-40 mg/day lovastatin was well tolerated in women.",
author = "Michael Clearfield and Downs, {John R.} and Stephen Weis and Whitney, {Edwin J.} and William Kruyer and Shapiro, {Deborah R.} and Stein, {Evan A.} and Alexandra Langendorfer and Beere, {Polly A.} and Gotto, {Antonio M.}",
year = "2001",
month = "12",
day = "1",
doi = "10.1089/152460901317193549",
language = "English",
volume = "10",
pages = "971--981",
journal = "Journal of Women’s Health and Gender-Based Medicine",
issn = "1524-6094",
publisher = "Mary Ann Liebert Inc.",
number = "10",

}

Air Force/Texas coronary atherosclerosis prevention study (AFCAPS/TexCAPS) : Efficacy and tolerability of long-term treatment with lovastatin in women. / Clearfield, Michael; Downs, John R.; Weis, Stephen; Whitney, Edwin J.; Kruyer, William; Shapiro, Deborah R.; Stein, Evan A.; Langendorfer, Alexandra; Beere, Polly A.; Gotto, Antonio M.

In: Journal of Women’s Health and Gender-Based Medicine, Vol. 10, No. 10, 01.12.2001, p. 971-981.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Air Force/Texas coronary atherosclerosis prevention study (AFCAPS/TexCAPS)

T2 - Efficacy and tolerability of long-term treatment with lovastatin in women

AU - Clearfield, Michael

AU - Downs, John R.

AU - Weis, Stephen

AU - Whitney, Edwin J.

AU - Kruyer, William

AU - Shapiro, Deborah R.

AU - Stein, Evan A.

AU - Langendorfer, Alexandra

AU - Beere, Polly A.

AU - Gotto, Antonio M.

PY - 2001/12/1

Y1 - 2001/12/1

N2 - The Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS) is the first coronary heart disease (CHD) primary prevention trial of the cholesterol-reducing agents called “statins” to include women. For 5608 men and 997 postmenopausal women without clinical evidence of cardiovascular disease (CVD) who had average low-density lipoprotein cholesterol (LDL-C) and below average high-density lipoprotein cholesterol (HDL-C), 20-40 mg/day lovastatin reduced first acute major coronary events (AMCEs) 37% (for those receiving placebo and lovastatin, respectively, 183 and 116 first AMCEs defined as fatal or nonfatal myocardial infarction [MI], unstable angina, or sudden cardiac death; relative risk [RR] 0.63; 95% confidence interval [95% CI] 0.50, 0.79; p < 0.001). Statistically significant reductions in prespecified secondary end points (coronary revascularizations, unstable angina, MI, cardiovascular end point events, and coronary end point events) were also associated with lovastatin treatment in the overall cohort. This paper provides results in women, a prespecified subgroup. Among women, 20-40 mg/day lovastatin reduced LDL-C 25% and increased HDL-C 9% (p < 0.001). A prespecified analysis revealed consistency with the overall results regardless of gender (i.e., there were no statistical differences between men and women in risk reduction for first AMCEs with lovastatin). However, the number of women who had an AMCE was small, and there was insufficient power to detect a treatment group difference among women (7 of 499 vs. 13 of 498 first AMCEs in those receiving lovastatin and placebo, respectively; RR 0.54; 95% CI 0.22, 1.35; p = 0.183). Numerical reductions in all prespecified secondary end points were observed for women treated with lovastatin, but again, the numbers of events were small and the differences were not statistically significant. Chronic long-term treatment with lovastatin was well tolerated, with no treatment group differences in the frequency of cancer, muscle symptoms, and clinically important liver enzyme elevations. In AFCAPS/TexCAPS, a consistent pattern of numerical reductions in all prespecified primary and secondary cardiovascular end points was observed in women treated with lovastatin for primary prevention of CHD. However, because of the small number of events, there was insufficient power to detect significant treatment group differences. Lovastatin treatment was associated with statistically significant decreases in LDL-C and increases in HDL-C, and chronic long-term treatment with 20-40 mg/day lovastatin was well tolerated in women.

AB - The Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS) is the first coronary heart disease (CHD) primary prevention trial of the cholesterol-reducing agents called “statins” to include women. For 5608 men and 997 postmenopausal women without clinical evidence of cardiovascular disease (CVD) who had average low-density lipoprotein cholesterol (LDL-C) and below average high-density lipoprotein cholesterol (HDL-C), 20-40 mg/day lovastatin reduced first acute major coronary events (AMCEs) 37% (for those receiving placebo and lovastatin, respectively, 183 and 116 first AMCEs defined as fatal or nonfatal myocardial infarction [MI], unstable angina, or sudden cardiac death; relative risk [RR] 0.63; 95% confidence interval [95% CI] 0.50, 0.79; p < 0.001). Statistically significant reductions in prespecified secondary end points (coronary revascularizations, unstable angina, MI, cardiovascular end point events, and coronary end point events) were also associated with lovastatin treatment in the overall cohort. This paper provides results in women, a prespecified subgroup. Among women, 20-40 mg/day lovastatin reduced LDL-C 25% and increased HDL-C 9% (p < 0.001). A prespecified analysis revealed consistency with the overall results regardless of gender (i.e., there were no statistical differences between men and women in risk reduction for first AMCEs with lovastatin). However, the number of women who had an AMCE was small, and there was insufficient power to detect a treatment group difference among women (7 of 499 vs. 13 of 498 first AMCEs in those receiving lovastatin and placebo, respectively; RR 0.54; 95% CI 0.22, 1.35; p = 0.183). Numerical reductions in all prespecified secondary end points were observed for women treated with lovastatin, but again, the numbers of events were small and the differences were not statistically significant. Chronic long-term treatment with lovastatin was well tolerated, with no treatment group differences in the frequency of cancer, muscle symptoms, and clinically important liver enzyme elevations. In AFCAPS/TexCAPS, a consistent pattern of numerical reductions in all prespecified primary and secondary cardiovascular end points was observed in women treated with lovastatin for primary prevention of CHD. However, because of the small number of events, there was insufficient power to detect significant treatment group differences. Lovastatin treatment was associated with statistically significant decreases in LDL-C and increases in HDL-C, and chronic long-term treatment with 20-40 mg/day lovastatin was well tolerated in women.

UR - http://www.scopus.com/inward/record.url?scp=0035689576&partnerID=8YFLogxK

U2 - 10.1089/152460901317193549

DO - 10.1089/152460901317193549

M3 - Article

C2 - 11788107

AN - SCOPUS:0035689576

VL - 10

SP - 971

EP - 981

JO - Journal of Women’s Health and Gender-Based Medicine

JF - Journal of Women’s Health and Gender-Based Medicine

SN - 1524-6094

IS - 10

ER -