See also:

AFCAPS/TexCAPS study, 1998	TRC2586
	download pdf: lovastatin | cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment	lovastatin 20-40 mg/d
Control treatment	placebo
Concomittant treatment	diet
Treatments description	total cholesterol change -20%  LDL change -28%  HDL change +5.3%

Patients

Patients	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
Inclusion criteria	Men aged 45 to 73 years and postmenopausai women aged 55 to 73 years; no prior history, signs, or symptoms of definite myocardial infarction,angina,claudication, cerebrovascular accident, or transient ischemic attack; TC between 180-264 mg/dL, LDL between 130-190 mg/dL, HDL <=45 mg/dL for mena and <=47 mg/dL for women and TG <=400 mg/dL or LDL between 125-129 mg/dl and ratio of TG/HDL >6
Exclusion criteria	uncontrolled hypertension, secondary hyperlipidemia, or type 1 or type 2 diabetes mellitus that was either managed with insulin or associated with a glycohemoglobin level of at least 10%
Baseline characteristics	Age (mean), yrs H: 57; F: 62  Women (%) 15  prior MI or CHD (%) 0%  Total cholesterol (mmol/l) 5.71 mmol/L  LDL (mmol/l) 3.89 mmol/L  HDL (mmol/l) 0.94 mmol/L  Triglycerides (mg/dl) 158

Method and design

Randomized effectives	3304 / 3301 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	5.2 years
Premature discontinuation	Premature discontinuation for efficacy
Number of centre	2
Geographic area	USA
Hypothesis	Superiority
Primary endpoint	major coronary event
Remarks

Remarks / Comments

Results

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

Coronary event

163 / 3304
215 / 3301
0,76 [0,62;0,92]

All cause death

80 / 3304
77 / 3301
1,04 [0,76;1,41]

Cardiovascular death

17 / 3304
25 / 3301
0,68 [0,37;1,26]

new-onset diabetes

72 / 3094
74 / 3117
0,98 [0,71;1,35]

Coronary death

11 / 3304
15 / 3301
0,73 [0,34;1,59]

stroke (fatal and non fatal)

14 / 3304
17 / 3301
0,82 [0,41;1,67]

Rhabdomyolysis

1 / 3304
2 / 3301
classic 0,50 [0,05;5,51]

Coronary death and non fatal MI

163 / 3304
215 / 3301
0,76 [0,62;0,92]

non cardiovascular death

63 / 3304
52 / 3301
1,21 [0,84;1,74] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
Coronary event	163 / 3304 (4,9%)	215 / 3301 (6,5%)	0,76	[0,62;0,92]
All cause death	80 / 3304 (2,4%)	77 / 3301 (2,3%)	1,04	[0,76;1,41]
Cardiovascular death	17 / 3304 (0,5%)	25 / 3301 (0,8%)	0,68	[0,37;1,26]
new-onset diabetes	72 / 3094 (2,3%)	74 / 3117 (2,4%)	0,98	[0,71;1,35]	sub group	12095
Coronary death	11 / 3304 (0,3%)	15 / 3301 (0,5%)	0,73	[0,34;1,59]
stroke (fatal and non fatal)	14 / 3304 (0,4%)	17 / 3301 (0,5%)	0,82	[0,41;1,67]
Rhabdomyolysis	1 / 3304 (0,0%)	2 / 3301 (0,1%)	0,50	[0,05;5,51]		18904
Coronary death and non fatal MI	163 / 3304 (4,9%)	215 / 3301 (6,5%)	0,76	[0,62;0,92]
non cardiovascular death	63 / 3304 (1,9%)	52 / 3301 (1,6%)	1,21	[0,84;1,74]
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 0: 18904: Law M, Rudnicka ARStatin safety: a systematic review.Am J Cardiol 2006;97:52C-60C 12095: Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, TognonStatins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials.Lancet 2010 Feb 27;375:735-742

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 5.2 years)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
Coronary event	4,93%	6,51%	-1,58%
All cause death	2,42%	2,33%	0,09%
Cardiovascular death	5,15‰	7,57‰	-0,24%
new-onset diabetes	2,33%	2,37%	-0,05%
Coronary death	3,33‰	4,54‰	-0,12%
stroke (fatal and non fatal)	4,24‰	5,15‰	-0,09%
Rhabdomyolysis	0,30‰	0,61‰	-0,03%
Coronary death and non fatal MI	4,93%	6,51%	-1,58%
non cardiovascular death	1,91%	1,58%	0,33%

Meta-analysis of all similar trials:

cholesterol lowering intervention in cardiovascular prevention for patients with LDL elevation and without CHD

cholesterol lowering intervention in cardiovascular prevention for all chronical situations

cholesterol lowering intervention in cardiovascular prevention for primary prevention

Reference(s)

TrialResults-center ID	TRC2586
Trials register #	NA

• Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA, Langendorfer A, Stein EA, Kruyer W, Gotto AM Jr,. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study.. JAMA 1998; 279:1615-22
  Pubmed | Hubmed | Fulltext
• Cui Y, Watson DJ, Girman CJ, Shapiro DR, Gotto AM, Hiserote P, Clearfield MB. Effects of increasing high-density lipoprotein cholesterol and decreasing low-density lipoprotein cholesterol on the incidence of first acute coronary events (from the Air Force/Texas Coronary Atherosclerosis Prevention Study).. Am J Cardiol 2009;104:829-34
  Pubmed | Hubmed | Fulltext

(c) 2004-2016 TrialResults-center - All Rights Reserved