See also:

WOSCOPS study, 1995	TRC2589
	download pdf: pravastatin | cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment	pravastatine 40 mg daily
Control treatment	placebo
Concomittant treatment	diet
Treatments description	total cholesterol change 20.0%  LDL change -26%  HDL change +5%

Patients

Patients	men aged 45-64 yr with no history of myocardial infarction and with raised plasma cholesterol levels (LDL cholesterol of at least 155 mg/dL, total cholesterol of at least 252 mg/dL)
Inclusion criteria	fasting LDL cholesterol level of at least 155 mg per deciliter during the second and third visits, with at least one value of 174 mg per deciliter or above (4.5 mmol per liter) and one value of 232 mg per deciliter or below (6.0 mmol per liter); no serious ECG abnormalities according to Minnesota code 1 (pathologic Q waves), 4-1, 5-1, or 7-1-1 or arrhythmia such as atrial fibrillation; and no history of myocardial infarction or other serious illness, although men with stable angina who had not been hospitalized within the previous 12 months were eligible
Baseline characteristics	Age (mean), yrs 55 yr  Women (%) 0  prior MI or CHD (%) 5%  Total cholesterol (mmol/l) 7.1 mmol/L  LDL (mmol/l) 4.99 mmol/L  HDL (mmol/l) 1.14 mmol/L  Triglycerides (mg/dl) 163  Diabetes(%) 1%  BMI (kg/m2) 26  Stroke history NA  LV hypertrophy NA  History of hypertension (%) 15%

Method and design

Randomized effectives	3302 / 3293 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	4.9 years
Number of centre	multicenter
Geographic area	Scotland
Hypothesis	Superiority
Primary endpoint	coronary events (CHD death, MI)

Results

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

Coronary event

174 / 3302
248 / 3293
0,70 [0,58;0,84]

All cause death

106 / 3302
136 / 3293
0,78 [0,61;1,00]

Cardiovascular death

50 / 3302
73 / 3293
0,68 [0,48;0,98]

cardiovascular events

145 / 3302
248 / 3293
0,58 [0,48;0,71]

Fatal stroke

6 / 3302
4 / 3293
classic 1,50 [0,42;5,30]

new-onset diabetes

75 / 2999
93 / 2975
0,80 [0,59;1,08]

Coronary death

38 / 3302
52 / 3293
0,73 [0,48;1,10]

stroke (fatal and non fatal)

46 / 3302
51 / 3293
0,90 [0,61;1,34]

Non fatal MI

143 / 3302
204 / 3293
0,70 [0,57;0,86]

Rhabdomyolysis

0 / 3302
0 / 3293
classic 1,00 [0,00;254,88]

Death from cancer

44 / 3302
49 / 3293
0,90 [0,60;1,34]

Coronary death and non fatal MI

174 / 3302
248 / 3293
0,70 [0,58;0,84]

cardiac death

38 / 3302
52 / 3293
0,73 [0,48;1,10]

non cardiovascular death

68 / 3302
83 / 3293
0,82 [0,60;1,12] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
Coronary event	174 / 3302 (5,3%)	248 / 3293 (7,5%)	0,70	[0,58;0,84]
All cause death	106 / 3302 (3,2%)	136 / 3293 (4,1%)	0,78	[0,61;1,00]
Cardiovascular death	50 / 3302 (1,5%)	73 / 3293 (2,2%)	0,68	[0,48;0,98]
cardiovascular events	145 / 3302 (4,4%)	248 / 3293 (7,5%)	0,58	[0,48;0,71]
Fatal stroke	6 / 3302 (0,2%)	4 / 3293 (0,1%)	1,50	[0,42;5,30]
new-onset diabetes	75 / 2999 (2,5%)	93 / 2975 (3,1%)	0,80	[0,59;1,08]	sub group	12095
Coronary death	38 / 3302 (1,2%)	52 / 3293 (1,6%)	0,73	[0,48;1,10]
stroke (fatal and non fatal)	46 / 3302 (1,4%)	51 / 3293 (1,5%)	0,90	[0,61;1,34]
Non fatal MI	143 / 3302 (4,3%)	204 / 3293 (6,2%)	0,70	[0,57;0,86]
Rhabdomyolysis	0 / 3302 (0,0%)	0 / 3293 (0,0%)	1,00	[0,02;50,25]		18904
Death from cancer	44 / 3302 (1,3%)	49 / 3293 (1,5%)	0,90	[0,60;1,34]
Coronary death and non fatal MI	174 / 3302 (5,3%)	248 / 3293 (7,5%)	0,70	[0,58;0,84]
cardiac death	38 / 3302 (1,2%)	52 / 3293 (1,6%)	0,73	[0,48;1,10]
non cardiovascular death	68 / 3302 (2,1%)	83 / 3293 (2,5%)	0,82	[0,60;1,12]
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 4.9 years)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
Coronary event	5,27%	7,53%	-2,26%
All cause death	3,21%	4,13%	-0,92%
Cardiovascular death	1,51%	2,22%	-0,70%
cardiovascular events	4,39%	7,53%	-3,14%
Fatal stroke	1,82‰	1,21‰	0,06%
new-onset diabetes	2,50%	3,13%	-0,63%
Coronary death	1,15%	1,58%	-0,43%
stroke (fatal and non fatal)	1,39%	1,55%	-0,16%
Non fatal MI	4,33%	6,19%	-1,86%
Death from cancer	1,33%	1,49%	-0,16%
Coronary death and non fatal MI	5,27%	7,53%	-2,26%
cardiac death	1,15%	1,58%	-0,43%
non cardiovascular death	2,06%	2,52%	-0,46%

Meta-analysis of all similar trials:

cholesterol lowering intervention in cardiovascular prevention for primary prevention

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

cholesterol lowering intervention in cardiovascular prevention for all chronical situations

Reference(s)

TrialResults-center ID	TRC2589
Trials register #	NA

• Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, McKillop JH, Packard CJ,. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group.. N Engl J Med 1995; 333:1301-7
  Pubmed | Hubmed | Fulltext
• . A coronary primary prevention study of Scottish men aged 45-64 years: trial design. The West of Scotland Coronary Prevention Study Group.. J Clin Epidemiol 1992;45:849-60
  Pubmed | Hubmed | Fulltext

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