See also:

MEGA study, 2006	TRC4974
[NCT00211705]	download pdf: pravastatin | cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment	pravastatin 10 mg daily (20 mg per day if the total cholesterolconcentration did not decrease to 5·69 mmol/L or less)
Control treatment	control
Concomittant treatment	diet
Treatments description	total cholesterol change -11% (at 1 year)  LDL change -17% (at 1 year)  HDL change +4% (at 1 year)

Patients

Patients	patients with hypercholesterolaemia (total cholesterol 5·69–6·98 mmol/L) and no history of coronary heart disease or stroke
Inclusion criteria	men and postmenopausal women; aged 40–70 years; bodyweight of 40 kg or more; hypercholesterolaemia with a total cholesterol concentration between 5·69–6·98 mmol/L
Exclusion criteria	familial hypercholesterolaemia; history of coronary heart disease or stroke;
Baseline characteristics	Age (mean), yrs 58.3 y  Women (%) 68.5%  Total cholesterol (mmol/l) 6.27  LDL (mmol/l) 4.05  HDL (mmol/l) 1.49  Triglycerides (mg/dl) 1.44  Diabetes(%) 21%  BMI (kg/m2) 23.8   History of hypertension (%) 42%

Method and design

Randomized effectives	3866 / 3966 (studied vs. control)
Design	Parallel groups
Blinding	open, blind assessment
Follow-up duration	5.3 y
Geographic area	Japan
Hypothesis	Superiority
Primary endpoint	CHD events

Remarks / Comments

,

Results

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

Coronary event

66 / 3866
101 / 3966
0,67 [0,49;0,91]

All cause death

55 / 3866
79 / 3966
0,71 [0,51;1,00]

Cardiovascular death

11 / 3866
18 / 3966
0,63 [0,30;1,33]

cardiovascular events

125 / 3866
172 / 3966
0,75 [0,59;0,93]

Haemmorhagic stroke

14 / 3866
16 / 3966
0,90 [0,44;1,84]

new-onset diabetes

172 / 3013
164 / 3073
1,07 [0,87;1,32]

Coronary death

17 / 3866
33 / 3966
0,53 [0,29;0,95]

stroke (fatal and non fatal)

50 / 3866
62 / 3966
0,83 [0,57;1,20]

MACE

98 / 3866
144 / 3966
0,70 [0,54;0,90]

Non fatal MI

16 / 3866
30 / 3966
0,55 [0,30;1,00]

non cardiovascular death

44 / 3866
61 / 3966
0,74 [0,50;1,09] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
Coronary event	66 / 3866 (1,7%)	101 / 3966 (2,5%)	0,67	[0,49;0,91]
All cause death	55 / 3866 (1,4%)	79 / 3966 (2,0%)	0,71	[0,51;1,00]
Cardiovascular death	11 / 3866 (0,3%)	18 / 3966 (0,5%)	0,63	[0,30;1,33]
cardiovascular events	125 / 3866 (3,2%)	172 / 3966 (4,3%)	0,75	[0,59;0,93]
Haemmorhagic stroke	14 / 3866 (0,4%)	16 / 3966 (0,4%)	0,90	[0,44;1,84]
new-onset diabetes	172 / 3013 (5,7%)	164 / 3073 (5,3%)	1,07	[0,87;1,32]	sub group	12095
Coronary death	17 / 3866 (0,4%)	33 / 3966 (0,8%)	0,53	[0,29;0,95]	fatal and non fatal MI
stroke (fatal and non fatal)	50 / 3866 (1,3%)	62 / 3966 (1,6%)	0,83	[0,57;1,20]
MACE	98 / 3866 (2,5%)	144 / 3966 (3,6%)	0,70	[0,54;0,90]
Non fatal MI	16 / 3866 (0,4%)	30 / 3966 (0,8%)	0,55	[0,30;1,00]		4115
non cardiovascular death	44 / 3866 (1,1%)	61 / 3966 (1,5%)	0,74	[0,50;1,09]
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 4115: Nakamura H, Arakawa K, Itakura H, Kitabatake A, Goto Y, Toyota T, Nakaya N, Nishimoto S, Muranaka M, Yamamoto A, Mizuno K, Ohashi YPrimary prevention of cardiovascular disease with pravastatin in Japan (MEGA Study): a prospective randomised controlled trial.Lancet 2006 Sep 30;368:1155-63 0: 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 5.3 y)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
Coronary event	1,71%	2,55%	-0,84%
All cause death	1,42%	1,99%	-0,57%
Cardiovascular death	2,85‰	4,54‰	-0,17%
cardiovascular events	3,23%	4,34%	-1,10%
Haemmorhagic stroke	3,62‰	4,03‰	-0,04%
new-onset diabetes	5,71%	5,34%	0,37%
Coronary death	4,40‰	8,32‰	-0,39%
stroke (fatal and non fatal)	1,29%	1,56%	-0,27%
MACE	2,53%	3,63%	-1,10%
Non fatal MI	4,14‰	7,56‰	-0,34%
non cardiovascular death	1,14%	1,54%	-0,40%

Meta-analysis of all similar trials:

cholesterol lowering intervention in cardiovascular prevention for all chronical situations

cholesterol lowering intervention in cardiovascular prevention for primary prevention

Reference(s)

TrialResults-center ID	TRC4974
Trials register #	NCT00211705

• Nakamura H, Arakawa K, Itakura H, Kitabatake A, Goto Y, Toyota T, Nakaya N, Nishimoto S, Muranaka M, Yamamoto A, Mizuno K, Ohashi Y. Primary prevention of cardiovascular disease with pravastatin in Japan (MEGA Study): a prospective randomised controlled trial.. Lancet 2006 Sep 30;368:1155-63
  Pubmed | Hubmed | Fulltext
• Nakamura H. [Primary prevention trial by lowering hyperlipidemia on the cardiovascular disease (MEGA Study)]. Nippon Ronen Igakkai Zasshi 2009;46:18-21
  Pubmed | Hubmed | Fulltext

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