User:Ewingdo/sandbox/AFCAPS-TexCAPs

Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS)
Study typerandomized clinical trial
Published1998
ArticleDowns, John R.; et al. (27 May 1998). "Primary Prevention of Acute Coronary Events With Lovastatin in Men and Women With Average Cholesterol Levels: Results of AFCAPS/TexCAPS". JAMA. 279 (20): 1615. doi:10.1001/jama.279.20.1615.

The Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS) was a landmark clinical trial designed to evaluate the effectiveness of lovastatin, a cholesterol-lowering medication, in the primary prevention of acute major coronary events in individuals with average cholesterol levels and no prior history of coronary heart disease. This study provided important evidence supporting the use of statins in a broader population for cardiovascular disease prevention.[1]

Background

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Coronary heart disease (CHD) is a leading cause of morbidity and mortality worldwide. Statins, which lower low-density lipoprotein (LDL) cholesterol levels, have been shown to reduce the risk of recurrent cardiovascular events in patients with established CHD. However, their role in primary prevention, particularly among individuals with average cholesterol levels, was less clear. The AFCAPS/TexCAPS trial aimed to determine whether lovastatin could reduce the risk of first-time major coronary events in such a population.[1]

Study design

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The AFCAPS/TexCAPS was a randomized, double-blind, placebo-controlled trial that enrolled 6,605 men aged 45 to 73 years and postmenopausal women aged 55 to 73 years with average total cholesterol and low-density cholesterol (LDL) levels but low high-density lipoprotein (HDL) cholesterol levels. Participants were randomly assigned to receive either lovastatin (20-40 mg daily) or a placebo. The study was conducted at two sites in Texas, Lackland Air Force Base in San Antonio and the University of Nort Texas Health Science Center in Fort Worth. The primary endpoint was the occurrence of the first acute major coronary event, which included fatal or nonfatal myocardial infarction, unstable angina, and sudden cardiac death. Secondary endpoints included the need for revascularization and other cardiovascular events.[1][2]

Key findings

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The AFCAPS/TexCAPS trial results, published in 1998, demonstrated several significant outcomes. There was a reduction of the primary endpoint with lovastatin reducing the risk of first acute major coronary events by 37% compared to placebo (3.5% in the lovastatin group vs. 5.5% in the placebo group). Additionally, lovastatin therapy reduced total cholesterol and LDL cholesterol levels and increased HDL cholesterol levels. Finally, lovastatin was well-tolerated, with a safety profile similar to the placebo's. There were no significant differences in the incidence of serious adverse events between the two groups.[1]

Clinical implications

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The AFCAPS/TexCAPS trial had significant implications for the prevention of coronary heart disease. The trial provided strong evidence that statin therapy with lovastatin can reduce the risk of first-time major coronary events in individuals with average cholesterol levels, supporting the use of statins for primary prevention in a broader population. Additionally, the results influenced clinical guidelines by expanding the indications for statin therapy to include individuals with average cholesterol levels but other risk factors for coronary heart disease.[1][3]

Long-term impact

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The AFCAPS/TexCAPS trial demonstrated the benefits of statins in primary prevention, even among individuals without elevated cholesterol levels. Its findings contributed to the widespread adoption of statins for cardiovascular risk reduction and informed subsequent research and guideline development.[1][4][5]

References

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  1. ^ a b c d e f Downs, John R.; Clearfield, Michael; Weis, Stephen; et al. (27 May 1998). "Primary Prevention of Acute Coronary Events With Lovastatin in Men and Women With Average Cholesterol Levels: Results of AFCAPS/TexCAPS". JAMA. 279 (20): 1615. doi:10.1001/jama.279.20.1615.
  2. ^ Downs, John R; Beere, Polly A; Whitney, Edwin; et al. (August 1997). "Design & Rationale of the Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS)". The American Journal of Cardiology. 80 (3): 287–293. doi:10.1016/s0002-9149(97)00347-0.
  3. ^ Clearfield, Michael; Downs, John R.; Lee, Michael; et al. (December 2005). "Implications from the Air Force/Texas Coronary Atherosclerosis Prevention Study for the Adult Treatment Panel III Guidelines". The American Journal of Cardiology. 96 (12): 1674–1680. doi:10.1016/j.amjcard.2005.07.079.
  4. ^ Clearfield, Michael; Whitney, Edwin J.; Weis, Stephen; et al. (April 2000). "Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS): Baseline Characteristics and Comparison with USA Population". European Journal of Cardiovascular Risk. 7 (2): 125–133. doi:10.1177/204748730000700207.
  5. ^ Downs, John R; Clearfield, Michael; Tyroler, H.Alfred; et al. (May 2001). "Air force/texas coronary atherosclerosis prevention study (afcaps/texcaps): Additional perspectives on tolerability of long-term treatment with lovastatin". The American Journal of Cardiology. 87 (9): 1074–1079. doi:10.1016/s0002-9149(01)01464-3.