Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease "Polypill"


Phase 2 Results

Eligibility Criteria

Inclusion criteria
All men over 50 to 80 and all women 55 to 80 who are resident in Kalaleh, Golestan, for at least one year.
Exclusion criteria
- Existing cardiovascular disease (stroke, transient ischaemic attack, myocardial infarction or angina)
- Already taking antihypertensive drugs, aspirin or statins
- Already have clinical indications for treatment with antihypertensive drugs, aspirin or statins.
- Blood pressure >160/100 mm Hg
- Total Cholesterol > 240 mg/dL (or LDL >190 mg/dL)
- Probable diabetes: HbA1c >6.0
Contraindication to a component of the Polypill
Contraindications to aspirin
- Previous history of allergy to aspirin
- History of peptic ulcer bleeding in whole life or endoscopic evidence of peptic ulcer within the past 3 months
Contraindications to statins
- Liver failure Contraindications to further blood pressure lowering
- Systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤70 mm Hg
- Symptomatic postural hypotension
- Difference between mean seated BP and standing BP greater than 20 mm Hg
Contraindications to thiazide
- Uric acid >8 for men and uric acid >6 for women / gout (~10%)
- Creatinine >1.2 mg/dl
Other predominant medical problem that may limit compliance with study treatment including:
- History of alcohol abuse: more than 60cc for women and more than 80cc for men
- History of drug abuse: IV drug abuser or eating or smoking more than 4 times a week
- Limiting psychiatric illness (eg: mania, schizophrenia, severe depression, psychosis or dementia)
- Limiting physical disability sufficient to prevent subject from walking
- Other life-threatening condition such as cancer