See also:

VA-HIT study, 1999	TRC2585
[NCT00283335]	download pdf: gemfibrozil | cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment	gemfibrozil 1.2g daily
Control treatment	placebo
Concomittant treatment	diet
Treatments description	total cholesterol change -4%  LDL change 0%  HDL change +6%

Patients

Patients	men with coronary heart disease, an HDL cholesterol level of 40 mg per deciliter (1.0 mmol per liter) or less, and an LDL cholesterol level of 140 mg per deciliter (3.6 mmol per liter) or less
Inclusion criteria	documented history of coronary heart disease (defined as a history of myocardial infarction, angina corroborated by objective evidence of ischemia, coronary revascularization, or angiographic evidence of stenosis greater than 50 percent of the luminal diameter in one or more major epicardial coronary arteries), age of less than 74 years, absence of serious coexisting conditions, HDL cholesterol level of 40 mg per deciliter (1.0 mmol per liter) or less, an LDL cholesterol level of 140 mg per deciliter (3.6 mmol per liter) or less, and a triglyceride level of 300 mg per deciliter (3.4 mmol per liter) or less
Baseline characteristics	Age (mean), yrs 64  Women (%) 0  prior MI or CHD (%) 100  Total cholesterol (mmol/l) 4.5 mmol/L  LDL (mmol/l) 2.9 mmol/L  HDL (mmol/l) 0.8 mmol/L  Triglycerides (mg/dl) 160.5  Diabetes(%) 25%  BMI (kg/m2) 29

Method and design

Randomized effectives	1264 / 1267 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	5.1 years
Number of centre	20
Geographic area	USA
Hypothesis	Superiority
Primary endpoint	nonfatal myocardial infarction or death from coronary causes

Results

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

Coronary event

219 / 1264
275 / 1267
0,80 [0,68;0,94]

All cause death

198 / 1264
220 / 1267
0,90 [0,76;1,08]

cardiovascular events

258 / 1264
330 / 1267
0,78 [0,68;0,90]

Coronary death

93 / 1264
118 / 1267
0,79 [0,61;1,02]

stroke (fatal and non fatal)

58 / 1264
76 / 1267
0,76 [0,55;1,07]

Non fatal MI

146 / 1264
184 / 1267
0,80 [0,65;0,97]

Death from cancer

45 / 1264
51 / 1267
0,88 [0,60;1,31]

Cancer

125 / 1264
138 / 1267
0,91 [0,72;1,14]

cardiac death

93 / 1264
118 / 1267
0,79 [0,61;1,02]

non cardiovascular death

102 / 1264
93 / 1267
1,10 [0,84;1,44] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
Coronary event	219 / 1264 (17,3%)	275 / 1267 (21,7%)	0,80	[0,68;0,94]		0
All cause death	198 / 1264 (15,7%)	220 / 1267 (17,4%)	0,90	[0,76;1,08]
cardiovascular events	258 / 1264 (20,4%)	330 / 1267 (26,0%)	0,78	[0,68;0,90]		12545
Coronary death	93 / 1264 (7,4%)	118 / 1267 (9,3%)	0,79	[0,61;1,02]
stroke (fatal and non fatal)	58 / 1264 (4,6%)	76 / 1267 (6,0%)	0,76	[0,55;1,07]
Non fatal MI	146 / 1264 (11,6%)	184 / 1267 (14,5%)	0,80	[0,65;0,97]
Death from cancer	45 / 1264 (3,6%)	51 / 1267 (4,0%)	0,88	[0,60;1,31]
Cancer	125 / 1264 (9,9%)	138 / 1267 (10,9%)	0,91	[0,72;1,14]
cardiac death	93 / 1264 (7,4%)	118 / 1267 (9,3%)	0,79	[0,61;1,02]
non cardiovascular death	102 / 1264 (8,1%)	93 / 1267 (7,3%)	1,10	[0,84;1,44]
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 0: 12545: Jun M, Foote C, Lv J, Neal B, Patel A, Nicholls SJ, Grobbee DE, Cass A, Chalmers J, Perkovic VEffects of fibrates on cardiovascular outcomes: a systematic review and meta-analysis.Lancet 2010 May 10;:

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 5.1 years)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
Coronary event	17,33%	21,70%	-4,38%
All cause death	15,66%	17,36%	-1,70%
cardiovascular events	20,41%	26,05%	-5,63%
Coronary death	7,36%	9,31%	-1,96%
stroke (fatal and non fatal)	4,59%	6,00%	-1,41%
Non fatal MI	11,55%	14,52%	-2,97%
Death from cancer	3,56%	4,03%	-0,47%
Cancer	9,89%	10,89%	-1,00%
cardiac death	7,36%	9,31%	-1,96%
non cardiovascular death	8,07%	7,34%	0,73%

Meta-analysis of all similar trials:

cholesterol lowering intervention in cardiovascular prevention for all chronical situations

cholesterol lowering intervention in cardiovascular prevention for patients with prior MI or with CHD

cholesterol lowering intervention in post myocardial infarction for all type of patients

HDL increasing drugs in cardiovascular prevention for all type of patients

Reference(s)

TrialResults-center ID	TRC2585
Trials register #	NCT00283335

• Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam MB, Faas FH, Linares E, Schaefer EJ, Schectman G, Wilt TJ, Wittes J,. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group.. N Engl J Med 1999; 341:410-8
  Pubmed | Hubmed | Fulltext
• Adabag AS, Mithani S, Al Aloul B, Collins D, Bertog S, Bloomfield HE. Efficacy of gemfibrozil in the primary prevention of atrial fibrillation in a large randomized controlled trial.. Am Heart J 2009 May;157:913-8
  Pubmed | Hubmed | Fulltext

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