Table 1. Open in new tab Overview of the...

Randomised clinical trial	Sample size, n	Age range, years	Major entry criteria^a
Positive trials
WOSCOPS, 1995	6595^b	45–64	LDL 155–230	Men only
AFCAPS/TexCAPS, 1998	6605	45–73	Total 180–264;	Men ≥45 y, postmenopausal women ≥55 y
LDL 130–190;
HDL ≤45
PROSPER, 2002	3239^c	70–82	Total 155–350	≥1 additional risk factor
ASCOT-LLA, 2003	10,305^b	40–79	Total ≤250	Treated SBP >140 mm Hg, DBP >90 mm Hg; ≥3 additional risk factors
MRC/BHF HPS, 2003	2912^c	40–80	Total ≥135	DM type 2
CARDS, 2004	2838	40–75	LDL ≤160	DM type 2, ≥1 additional risk factor
MEGA, 2006	7832	40–70	Total 200–270	Men and postmenopausal women
JUPITER, 2008	17,802	50–97	LDL <130	Men ≥50 y, women ≥60 y; CRP ≥2 mg/l
HOPE-3, 2016	12,705	≥55	–	Men ≥55 y, women ≥65 y, ≥1 additional risk factor
Neutral trials^d
ALLHAT-LLT, 2002	10,355^b	51–81	LDL 120–189	Treated SBP>160 mm Hg, DBP>100 mm Hg; ≥1 additional risk factor
ASPEN, 2006	1905^c	40–75	LDL ≤160	DM type 2

Randomised clinical trial

Sample size, n

Age range, years

Major entry criteria^a

Cholesterol, mg/dl

Other

Positive trials

WOSCOPS, 1995

6595^b

45–64

LDL 155–230

Men only

AFCAPS/TexCAPS, 1998

6605

45–73

Total 180–264;

Men ≥45 y, postmenopausal women ≥55 y

LDL 130–190;

HDL ≤45

PROSPER, 2002

3239^c

70–82

Total 155–350

≥1 additional risk factor

ASCOT-LLA, 2003

10,305^b

40–79

Total ≤250

Treated SBP >140 mm Hg, DBP >90 mm Hg; ≥3 additional risk factors

MRC/BHF HPS, 2003

2912^c

40–80

Total ≥135

DM type 2

CARDS, 2004

2838

40–75

LDL ≤160

DM type 2, ≥1 additional risk factor

MEGA, 2006

7832

40–70

Total 200–270

Men and postmenopausal women

JUPITER, 2008

17,802

50–97

LDL <130

Men ≥50 y, women ≥60 y; CRP ≥2 mg/l

HOPE-3, 2016

12,705

≥55

–

Men ≥55 y, women ≥65 y, ≥1 additional risk factor

Neutral trials^d

ALLHAT-LLT, 2002

10,355^b

51–81

LDL 120–189

Treated SBP>160 mm Hg, DBP>100 mm Hg; ≥1 additional risk factor

ASPEN, 2006

1905^c

40–75

LDL ≤160

DM type 2

Randomised clinical trial	Sample size, n	Age range, years	Major entry criteria^a
Positive trials
WOSCOPS, 1995	6595^b	45–64	LDL 155–230	Men only
AFCAPS/TexCAPS, 1998	6605	45–73	Total 180–264;	Men ≥45 y, postmenopausal women ≥55 y
LDL 130–190;
HDL ≤45
PROSPER, 2002	3239^c	70–82	Total 155–350	≥1 additional risk factor
ASCOT-LLA, 2003	10,305^b	40–79	Total ≤250	Treated SBP >140 mm Hg, DBP >90 mm Hg; ≥3 additional risk factors
MRC/BHF HPS, 2003	2912^c	40–80	Total ≥135	DM type 2
CARDS, 2004	2838	40–75	LDL ≤160	DM type 2, ≥1 additional risk factor
MEGA, 2006	7832	40–70	Total 200–270	Men and postmenopausal women
JUPITER, 2008	17,802	50–97	LDL <130	Men ≥50 y, women ≥60 y; CRP ≥2 mg/l
HOPE-3, 2016	12,705	≥55	–	Men ≥55 y, women ≥65 y, ≥1 additional risk factor
Neutral trials^d
ALLHAT-LLT, 2002	10,355^b	51–81	LDL 120–189	Treated SBP>160 mm Hg, DBP>100 mm Hg; ≥1 additional risk factor
ASPEN, 2006	1905^c	40–75	LDL ≤160	DM type 2

Table 1.

Open in new tab

Overview of the 11 primary prevention randomised clinical trials.

Randomised clinical trial	Sample size, n	Age range, years	Major entry criteria^a
Randomised clinical trial	Sample size, n	Age range, years	Cholesterol, mg/dl	Other
Positive trials
WOSCOPS, 1995	6595^b	45–64	LDL 155–230	Men only
AFCAPS/TexCAPS, 1998	6605	45–73	Total 180–264;	Men ≥45 y, postmenopausal women ≥55 y
			LDL 130–190;
			HDL ≤45
PROSPER, 2002	3239^c	70–82	Total 155–350	≥1 additional risk factor
ASCOT-LLA, 2003	10,305^b	40–79	Total ≤250	Treated SBP >140 mm Hg, DBP >90 mm Hg; ≥3 additional risk factors
MRC/BHF HPS, 2003	2912^c	40–80	Total ≥135	DM type 2
CARDS, 2004	2838	40–75	LDL ≤160	DM type 2, ≥1 additional risk factor
MEGA, 2006	7832	40–70	Total 200–270	Men and postmenopausal women
JUPITER, 2008	17,802	50–97	LDL <130	Men ≥50 y, women ≥60 y; CRP ≥2 mg/l
HOPE-3, 2016	12,705	≥55	–	Men ≥55 y, women ≥65 y, ≥1 additional risk factor
Neutral trials^d
ALLHAT-LLT, 2002	10,355^b	51–81	LDL 120–189	Treated SBP>160 mm Hg, DBP>100 mm Hg; ≥1 additional risk factor
ASPEN, 2006	1905^c	40–75	LDL ≤160	DM type 2

Randomised clinical trial	Sample size, n	Age range, years	Major entry criteria^a
Randomised clinical trial	Sample size, n	Age range, years	Cholesterol, mg/dl	Other
Positive trials
WOSCOPS, 1995	6595^b	45–64	LDL 155–230	Men only
AFCAPS/TexCAPS, 1998	6605	45–73	Total 180–264;	Men ≥45 y, postmenopausal women ≥55 y
			LDL 130–190;
			HDL ≤45
PROSPER, 2002	3239^c	70–82	Total 155–350	≥1 additional risk factor
ASCOT-LLA, 2003	10,305^b	40–79	Total ≤250	Treated SBP >140 mm Hg, DBP >90 mm Hg; ≥3 additional risk factors
MRC/BHF HPS, 2003	2912^c	40–80	Total ≥135	DM type 2
CARDS, 2004	2838	40–75	LDL ≤160	DM type 2, ≥1 additional risk factor
MEGA, 2006	7832	40–70	Total 200–270	Men and postmenopausal women
JUPITER, 2008	17,802	50–97	LDL <130	Men ≥50 y, women ≥60 y; CRP ≥2 mg/l
HOPE-3, 2016	12,705	≥55	–	Men ≥55 y, women ≥65 y, ≥1 additional risk factor
Neutral trials^d
ALLHAT-LLT, 2002	10,355^b	51–81	LDL 120–189	Treated SBP>160 mm Hg, DBP>100 mm Hg; ≥1 additional risk factor
ASPEN, 2006	1905^c	40–75	LDL ≤160	DM type 2

ALLHAT-LLT: Lipid-Lowering Trial component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial; ASCOT-LLA: Prevention of Coronary and Stroke Events with Atorvastatin in Hypertensive Patients in the Anglo-Scandinavian Cardiac Outcomes Trial: The Lipid Lowering Arm; ASPEN: Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus; CARDS: Collaborative Atorvastatin Diabetes Study; CI: confidence interval; CRP: C-reactive protein; CVD: cardiovascular disease; DBP: diastolic blood pressure; DM: diabetes mellitus; ESC: European Society of Cardiology; HDL: high-density lipoprotein; HOPE-3: Heart Outcomes Prevention Evaluation 3; JUPITER: Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin; LDL: low-density lipoprotein; MEGA: Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese Study Group; MRC/BHF HPS: Heart Protection Study of Cholesterol Lowering with Simvastatin; PROSPER: Prospective Study of Pravastatin in the Elderly at Risk; SBP: systolic blood pressure; WOSCOPS: West of Scotland Coronary Prevention Study.

Major criteria presented are simplified for presentation purposes. Details regarding all inclusion and exclusion criteria have been described previously ¹¹ and are summarised in Table 1 in the Supplementary Material.

Up to 15% of the participants had a history of cardiovascular disease at baseline; no data presented on subgroup of participants free from cardiovascular disease.

Data from persons free from cardiovascular disease at baseline.

ALLHAT-LLT and ASPEN trials are denoted as neutral, as no statistically significant effect of statin use on clinical cardiovascular end points was reported.

This Feature Is Available To Subscribers Only