PHS II: Vitamins E and C in the prevention of cardiovascular disease in men: the Physician's Healthy Study II randomized controlled study.

OUTCOME

• Composite endpoint of major cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular disease death).

NUMBER OF PARTICIPANTS

• 14641 male physicians aged > 50 years (5.1% with prevalent cardiovascular disease at randomization).

COMPARISONS

• Vitamin E + vitamin C vs vitamin E + placebo vs placebo + vitamin C vs double placebo.

STUDY DESIGN

• Randomized, double-blind, placebo-controlled, factorial trial.

ACCORD-EYE: Action to Control Cardiovascular Risk in Diabetes - Eye Sub Study

OUTCOME

• Combinted outcome of progression of diabetic retinopathy of at least 3 stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale, photocoagulation (laser therapy for diabetic eye disease), or vitrectomy (a type of surgery for diabetic eye disease).

EXPECTED TOTAL ENROLLMENT

• 4065 patients from ACCORD study.

COMPARISONS

• Hypoglycaemic agents (either intensive or standard control of blood sugary) and, dependent on participants, either antihypertensive agents (either intensive or standard control) or lipid-modifying agents (simvastatin and either fenofibrate, either placebo).

STUDY DESIGN

• Observational substudy of ACCORD study.

Intensive glycaemic control arm was closed in early 2008.