baseline characteristics. patient flow completed 6 107 completed 6 108 perindopril 6 110 placebo 6...
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Baseline characteristicsBaseline characteristics
Patient flowPatient flow
CompletedCompleted6 1076 107
CompletedCompleted6 1086 108
PerindoprilPerindopril6 1106 110
PlaceboPlacebo6 1086 108
RandomisedRandomised12 21812 218
Not randomisedNot randomised1 4371 437
RegisteredRegistered13 65513 655
424 centres :424 centres : 12 218 patients 12 218 patients
102102
176176141141
130130
5757
12511251
21762176
115115
9494
300300
399399
285285
511511890890
1717
2222
20682068
17721772
277277
134134
209209
6565
197197
830830
Not randomisedNot randomised
Overall: 1 437 of 13 655 ptsOverall: 1 437 of 13 655 pts 10.510.5
IntoleranceIntolerance
HypotensionHypotension
Creatinine/Potassium riseCreatinine/Potassium rise
Poor compliancePoor compliance
Major clinical eventMajor clinical event
Non medical reasonsNon medical reasons
UnspecifiedUnspecified
2.42.4
2.12.1
1.11.1
0.60.6
0.50.5
0.50.5
3.33.3
%%
PerindoprilPerindopril(mean (mean SD) SD)
Placebo Placebo (mean (mean SD) SD)
Age Age (yrs)(yrs) 60 60 9 9 60 60 9 9
Male Male (%)(%) 86 86 8585
Weight Weight (kg)(kg) 81 81 12 12 80 80 12 12
HR HR (bpm)(bpm) 68 68 10 10 68 68 10 10
SBP SBP (mmHg)(mmHg) 137 137 16 16 137 137 15 15
DBP DBP (mmHg)(mmHg) 82 82 8 8 82 82 8 8
Baseline characteristicsBaseline characteristics
PerindoprilPerindopril(%)(%)
PlaceboPlacebo (%)(%)
Myocardial infarctionMyocardial infarction 64.964.9 64.764.7
RevascularisationRevascularisation 54.754.7 55.255.2
Stroke / TIAStroke / TIA 3.43.4 3.33.3
Heart failureHeart failure 1.31.3 1.21.2
Peripheral vascular Peripheral vascular diseasedisease 7.17.1 7.47.4
Medical historyMedical history
PerindoprilPerindopril(%)(%)
PlaceboPlacebo
(%)(%)
HypertensionHypertension 27.027.0 27.227.2
Diabetes mellitusDiabetes mellitus 11.811.8 12.812.8
HypercholesterolaemiaHypercholesterolaemia 63.363.3 63.363.3
Current smokerCurrent smoker 15.415.4 15.115.1
Risk factorsRisk factors
Perindopril Perindopril (%)(%)
PlaceboPlacebo(%)(%)
Platelet inhibitorsPlatelet inhibitors 91.991.9 92.792.7
-blockers-blockers 62.062.0 61.361.3
Lipid lowering drugsLipid lowering drugs 57.857.8 57.357.3
NitratesNitrates 42.842.8 43.043.0
Ca-blockersCa-blockers 31.731.7 31.031.0
DiureticsDiuretics 9.19.1 9.49.4
Oral anticoagulantsOral anticoagulants 4.44.4 4.24.2
Baseline medicationBaseline medication
ResultsResults
Primary endpointPrimary endpoint
% CV death, MI or cardiac arrest% CV death, MI or cardiac arrest
Placebo annual event rate: 2.4%Placebo annual event rate: 2.4%
Perindopril Perindopril
PlaceboPlacebo
p = 0.0003p = 0.0003RRR: 20%RRR: 20%
YearsYears00
22
44
66
88
1010
1212
1414
00 11 22 33 44 55
Primary Primary and first secondary endpointand first secondary endpoint
0.50.5 1.01.0 2.02.0
2020
1414
2222
4646
1414
RRR RRR (%)(%)PerindoprilPerindoprilbetterbetter
PlaceboPlacebobetterbetter
CV mortality, MI, CACV mortality, MI, CA
CV mortalityCV mortality
Non fatal MINon fatal MI
Cardiac arrestCardiac arrest
Total mortality, MI, UAP,CATotal mortality, MI, UAP,CA
Sub-groups analysisSub-groups analysis
RRR RRR (%)(%)
0.50.5 1.01.0 2.02.0
Perindopril betterPerindopril better Placebo betterPlacebo better
Previous MIPrevious MI
No previous MINo previous MI
22.422.4
12.112.1
Age Age 56 yrs 56 yrs
Age 57 - 65Age 57 - 65
Age > 65 yrsAge > 65 yrs
27.327.3
14.314.3
18.218.2
MaleMale
FemaleFemale
19.319.3
22.022.0
Sub-groups analysisSub-groups analysis
0.50.5 1.01.0 2.02.0
HypertensionHypertension
RRR RRR (%)(%)PerindoprilPerindoprilbetterbetter
PlaceboPlacebobetterbetter
No hypertensionNo hypertension
Diabetes mellitusDiabetes mellitus
No diabetes mellitusNo diabetes mellitus
Stroke/TIAStroke/TIA
No stroke/TIANo stroke/TIA
18.618.6
19.919.9
18.918.9
19.019.0
15.815.8
19.919.9
92% patients on platelet inhibitors92% patients on platelet inhibitors
Sub-groups analysisSub-groups analysis
RRR RRR (%)(%)
Lipid lowering drugLipid lowering drug
PerindoprilPerindoprilbetterbetter
PlaceboPlacebobetterbetter
0.50.5 1.01.0 2.02.0
No lipid lowering drugNo lipid lowering drug
-blockers-blockers
No No -blockers-blockers
Calcium blockersCalcium blockers
No calcium blockersNo calcium blockers
16.316.3
22.322.3
26.426.4
7.07.0
15.815.8
22.222.2
Secondary endpointsSecondary endpoints
Fatal & non fatal MI, unstable anginaFatal & non fatal MI, unstable angina
0.50.5 1.01.0 2.02.0
Perindopril betterPerindopril better Placebo betterPlacebo better
Total mortality, MI, UAP,CATotal mortality, MI, UAP,CA
CV mortality & MICV mortality & MI
CV mortality, MI & strokeCV mortality, MI & stroke
CV mortality, MI, revascularisationCV mortality, MI, revascularisation
CV mortality, MI, unstable anginaCV mortality, MI, unstable angina
Non fatal and fatal MINon fatal and fatal MI
Total mortalityTotal mortality
CV mortalityCV mortality
Unstable anginaUnstable angina
Cardiac arrest Cardiac arrest
StrokeStroke
RevascularisationRevascularisation
Heart failureHeart failure
RRR RRR (%)(%)
14.014.0
19.319.3
17.417.4
11.311.3
15.515.5
16.516.5
23.923.9
11.011.0
13.913.9
7.17.1
45.645.6
4.34.3
4.24.2
39.239.2
Fatal and non fatal MIFatal and non fatal MI
PerindoprilPerindopril
PlaceboPlacebo
00
22
44
66
88
1010
00 11 22 33 44 55 YearsYears
(%)(%)
p < 0.001p < 0.001RRR: 24%RRR: 24%
Hospitalisation for heart failureHospitalisation for heart failure
Perindopril Perindopril
PlaceboPlacebo
5500 11 22 33 44 YearsYears
p = 0.002p = 0.002RRR: 39%RRR: 39%
0.00.0
0.50.5
1.01.0
1.51.5
2.02.0(%)(%)
-1-1 -1/2-1/2 00 33 66 1212 1818 2424 3030 3636 4242 4848 5454 6060
MonthsMonths
7070
8080
9090
100100
110110
120120
130130
140140
mmHgmmHg
Blood pressureBlood pressure
SBP: 5 mmHgSBP: 5 mmHgDBP: 2 mmHgDBP: 2 mmHg
Perindopril Perindopril 8mg8mg PlaceboPlacebo
Adherence to treatmentAdherence to treatment
0 6 12 18 24 30 36
MonthsMonths
0
20
40
60
80
100
120(%)
PlaceboPlacebo
Perindopril Perindopril 8mg8mg
Withdrawal from treatmentWithdrawal from treatment
PerindoprilPerindopril
%%
PlaceboPlacebo
%%
CoughCough 2.72.7 0.50.5
HypotensionHypotension 1.01.0 0.30.3
Kidney failureKidney failure 0.30.3 0.30.3
IntoleranceIntolerance 2.42.4 1.31.3
Study end-pointStudy end-point 6.26.2 7.57.5
HypertensionHypertension 0.40.4 0.80.8
Refuse to continueRefuse to continue 4.34.3 4.24.2
Other reasonOther reason 5.75.7 5.85.8