Rationale, design, methods and baseline demography of participants of the Anglo-Scandinavian Cardiac Outcomes Trial. ASCOT investigators.
OBJECTIVE
To test the primary hypothesis that a newer antihypertensive treatment regimen (calcium channel blocker +/- an angiotensin converting enzyme inhibitor) is more effective than an older regimen (beta-blocker +/- a diuretic) in the primary prevention of coronary heart disease (CHD). To test a second primary hypothesis that a statin compared with placebo will further protect against CHD endpoints in hypertensive subjects with a total cholesterol < or = 6.5 mmol/l.


METHODS
Prospective, randomized, open, blinded endpoint trial with a double-blinded 2 x 2 factorial component.


METHODS
Patients were recruited mainly from general practices.


METHODS
Men and women aged 40-79 were eligible if their blood pressure was > or = 160 mmHg systolic or > or = 100 mmHg diastolic (untreated) or > or = 140 mmHg systolic or > or = 90 mmHg diastolic (treated) at randomization.


METHODS
Patients received either amlodipine (5/ 10 mg) +/- perindopril (4/8 mg) or atenolol (50/ 100 mg) +/- bendroflumethiazide (1.25/2.5 mg) +K+ with further therapy as required to reach a blood pressure of < or = 140 mmHg systolic and 90 mmHg diastolic. Patients with a total cholesterol of < or = 6.5 mmol/l were further randomized to receive either atorvastatin 10 mg or placebo daily.


METHODS
Non-fatal myocardial infarction (MI) and fatal coronary heart disease (CHD).


RESULTS
19 342 men and women were initially randomized, of these 10297 were also randomized into the lipid-lowering limb. All patients had three or more additional cardiovascular risk factors.


CONCLUSIONS
The study has 80% power (at the 5% level) to detect a relative difference of 20% in CHD endpoints between the calcium channel blocker-based regimen and the beta-blocker-based regimen. The lipid-lowering limb of the study has 90% power at the 1% level to detect a relative difference of 30% in CHD endpoints between groups.
Sever
P S
PS
Imperial College School of Medicine, London, UK. p.sever@ic.ac.uk
Dahlöf
B
B
Poulter
N R
NR
Wedel
H
H
Beevers
G
G
Caulfield
M
M
Collins
R
R
Kjeldsen
S E
SE
McInnes
G T
GT
Mehlsen
J
J
Nieminen
M
M
O'Brien
E
E
Ostergren
J
J
D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage; D000924:Anticholesteremic Agents / Q000008:administration & dosage; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000008:administration & dosage; D002784:Cholesterol / Q000097:blood; D002985:Clinical Protocols; D003327:Coronary Disease / Q000517:prevention & control*; D004232:Diuretics / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012537:Scandinavian and Nordic Countries; D006113:United Kingdom
D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D000924:Anticholesteremic Agents; D002121:Calcium Channel Blockers; D004232:Diuretics; D002784:Cholesterol