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New Indication in CAD

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Background : Coronary Artery Disease
Home : Healthcare professionals : PERSUADE Data Sheet
PERSUADE Data Sheet


Objective

To determine the long-term effects (four years) of perindopril on the diabetic patients enrolled in EUROPA (12% of the study population) in terms of the primary and secondary endpoints.


Rationale

Cardiovascular disease accounts for 75% of all deaths among people with diabetes of European origin. In the USA, coronary heart disease is present in between 8% and 20% of people with diabetes over 45 years of age. Their risk of heart disease is 2-4 times higher than in people who do not have diabetes. It is the main cause of disability and death of people with type 2 diabetes in industrialised countries.

Angiotensin-converting enzyme inhibitors (ACEIs) such as perindopril are known to be effective in treating hypertensive patients with diabetes, particularly in terms of reducing the incidence of diabetic nephropathy and proteinuria in patients with microalbuminuria.

But to date the effects of an ACEI on diabetic patients with coronary artery disease, who are not necessarily hypertensive, have not been fully established.


Scientific Committee

Prof K Fox (Chairman, UK), Prof P J Grant (UK), Prof P Hildebrandt (Denmark), Prof C Kluft (Netherlands), Prof C E Mogensen (Denmark), Prof L Ryden (Sweden)


Study endpoints

Primary endpoint

Combined risk of cardiovascular death, MI (heart attack) and cardiac arrest (a sudden cessation of heartbeat resulting in the loss of circulation) with successful resuscitation (recovery).

Secondary endpoints

Risk of:
Cardiovascular mortality
Myocardial infarction (fatal and non-fatal)
Heart failure
Total mortality
Revascularisation procedures (PTCA or CABG)
Stroke
Unstable angina pectoris


Study design

As eligible patients were enrolled into the main EUROPA study, those with diabetes were identified. Of the 12,218 patients enrolled, 1,502 (12% of the patient population) were identified as diabetics.

After a 4-week run-in period, patients were randomly assigned to receive treatment with either perindopril 8 mg once daily or placebo for four years on top of other preventive therapies (aspirin, beta-blockers, statins). 721 of the identified diabetic patients were allocated to the perindopril group, and 781 to the placebo group.

Patients were seen at two and four weeks during the run-in period, then examined at three, six and 12 months and thereafter at six-monthly intervals. The last examinations were carried out in April 2003, at which time the average duration of treatment was four years.


Study patients

12,218 patients aged 26 to 89 years (mean age 60 years) without heart failure were recruited and randomised if they had documented coronary artery disease, which was defined as either:

Previous MI (heart attack) at least three months before selection (65%)

Surgery or revascularisation (55%).

Patient characteristics

The diabetic patients were similar to the rest of the EUROPA study population in terms of baseline characteristics; in addition previous myocardial infarction: 66%, previous revascularisation: 55% were similar.

Use of existing medications (platelet inhibitors: 93%, beta blockers: 64%, lipid lowering agents: 53%, calcium channel blockers: 38%, nitrates: 52% and diuretics: 14%) were also at similar levels to those of the EUROPA population. There were more patients with hypertension (40% vs. 27%) and peripheral vascular disease (13% vs. 7%) in PERSUADE compared to EUROPA .

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