The purpose of this study is to determine whether treating pre-diabetic \& pre-hypertensive individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., ACEI) plus anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower Cardiovascular Disease (CVD) events.
The risks of CVD are not confined to a subset of established "hypertensive" or "diabetic" population, but also increase among those with suboptimal blood pressure and glycemic level, namely "pre-hypertensive" or "pre-diabetic" population. Evidence on the effectiveness of drug interventions to lower CVD events in pre-clinical stage population has been scant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
8,900
Poly-pill - composed of Metformin (500 mg), Enalapril (10 mg) and Simvastatin (10 mg) in single tablet given once daily after dinner for 4 years
Identical Placebo Tablet
Ubon ratchathani Public Health Office
Muang District, Changwat Ubon Ratchathani, Thailand
Cardiovascular Events
Fatal or Non-fatal Myocardial Infarction, Angina Pectoris, Congestive Heart Failure, Coronary Revascularization, Fatal or Non-fatal Stroke, Amputation of Lower Extremities (non-traumatic cause)
Time frame: 4-year
Micro-vascular Complications
Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy
Time frame: 4-year
Cumulative Incidence of Diabetes
Time frame: 4-year
Cumulative Incidence of Hypertension
Time frame: 4-year
Incidence of Individual Cardiovascular Disease
Coronary Artery Disease - Myocardial Infarction, Angina Pectoris, Congestive Heart Failure, Coronary Revascularization Stroke- Cerebral Hemorrhage, Cerebral Infarction, Subarachnoid Hemorrhage Peripheral Artery Disease- Leg amputation, endovascular or surgical intervention in leg arteries
Time frame: 4-year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.