ADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes

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1 ADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes Effects of a fixed combination of the ACE inhibitor, perindopril, and the diuretic, indapamide on major vascular events

2 Blood pressure and vascular risk in diabetes Best evidence: 2000 UK Prospective Diabetes Study

3 Blood pressure and vascular risk in diabetes Best evidence: 2000 UKPDS SBP UK Prospective Diabetes Study

4 Blood pressure lowering in diabetes: Unresolved issues 2000 Among patients with diabetes, does blood pressure lowering therapy: Produce additional benefits when systolic pressure is lowered below 145 mmhg? Produce similar benefits for hypertensive and non-hypertensive patients? Add to the benefits produced by other cardiovascular preventive therapies including ACE inhibitors?

5 ADVANCE study hypotheses Perindopril-indapamide arm Among patients with diabetes, does blood pressure lowering therapy: Produce additional benefits when systolic pressure is lowered below 145 mmhg? Produce similar benefits for hypertensive and non-hypertensive patients? Add to the benefits produced by other cardiovascular preventive therapies including ACE inhibitors?

6 Inclusion criteria Type 2 diabetes mellitus Age 55 years or older Additional risk of vascular event Age 65 years History of major macrovascular disease History of major microvascular disease First diagnosis of diabetes >10 years prior to entry Other major risk factor Hypertensive or normotensive

7 Randomised study treatments Blood pressure lowering Double-blind perindopril-indapamide versus matching placebo 2.0 / 0.625mg or placebo for first 3 months 4.0 / 1.25mg or placebo thereafter Blood glucose lowering (ongoing) Open-label gliclazide MR-based intensive therapy targeting an HbA1c of 6.5% versus usual guideline-based care

8 Randomised study treatments Blood pressure lowering Double-blind perindopril-indapamide versus matching placebo 2.0 / 0.625mg or placebo for first 3 months 4.0 / 1.25mg or placebo thereafter Blood glucose lowering (ongoing) Open-label gliclazide MR-based intensive therapy targeting an HbA1c of 6.5% versus usual guideline-based care

9 Ancillary drug treatment Blood pressure lowering therapy At discretion of treating physician Only thiazide diuretic contraindicated ACE inhibitor Open-label perindopril (up to 4 mg daily), if indicated All other treatment At discretion of treating physician Except glucose control for those assigned intensive therapy

10 Primary study outcomes Macrovascular Non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (including sudden death) Microvascular New of worsening nephropathy or diabetic eye disease Prespecified analyses: Macrovascular and microvascular jointly Macrovascular and microvascular separately

11 ADVANCE Trial profile with type 2 diabetes registered 1737 withdrew during run-in randomised 5569 assigned perindoprilindapamide combination 4 lost to follow-up 5571 assigned matching placebo 11 lost to follow-up Scheduled end of follow-up: 4.3 years 4908 (88%) assessed at final visit 4081 (73%) adherent to treatment Scheduled end of follow-up: 4.3 years 4863 (87%) assessed at final visit 4143 (74%) adherent to treatment

12 Baseline characteristics Randomised treatment Age (years) Systolic blood pressure (mmhg) Diastolic blood pressure (mmhg) Haemoglobin A1c (%) History of macrovascular disease History of microvascular disease Microalbuminuria Active (n=5569) % 10% 26% Placebo (n=5571) % 10% 26%

13 Baseline characteristics Cardiovascular and diabetes drugs Any blood pressure lowering drug ACE inhibitor* Oral hypoglycaemic drugs Statin Other lipid modifying drug Aspirin Other antiplatelet drugs Randomised treatment Active (n=5569) 75% 43% 91% 28% 9% 44% 4% Placebo (n=5571) 75% 43% 91% 29% 8% 44% 5% *By end of run-in period: 47% were receiving open label perindopril

14 Main results Blood pressure

15 Blood pressure reduction Mean Blood Pressure (mmhg) Placebo Perindopril-Indapamide Δ 5.6 mmhg (95% CI ); p<0.001 Δ 2.2 mmhg (95% CI ); p<0.001 Follow-up (Months) Systolic Diastolic R Average BP during follow-up mmhg mmhg 77.0 mmhg 74.8 mmhg

16 ADVANCE BP reduction in context: UK Prospective Diabetes Study ADV UKPDS SBP UK Prospective Diabetes Study

17 Main results Mortality and morbidity

18 All-cause mortality 10 Placebo Perindopril-Indapamide Cumulative incidence (%) 5 Relative risk reduction 14%: 95% CI 2-25% p= Follow-up (months)

19 Deaths Cumulative incidence (%) Cardiovascular 5% Placebo 5% Perindopril-indapamide Relative risk reduction 18%; p= Follow-up (months) Non-cardiovascular Placebo Perindopril-indapamide Relative risk reduction 8%; p= Follow-up (months)

20 Combined primary outcomes Major macro or microvascular event 20 Placebo Perindopril-Indapamide Cumulative incidence (%) 10 Relative risk reduction 9%: 95% CI: 0 to 17% p= Follow-up (months)

21 Primary outcomes Major macro or microvascular event Number of events Per-Ind Placebo (n=5,569) (n=5,571) Favours Per-Ind Favours Placebo Relative risk reduction (95% CI) Combined macro+micro % (0 to 17) * Macrovascular % (-4 to 19) Microvascular % (-4 to 20) Hazard ratio *2P=0.04

22 Effects by age, sex, BP and HbA1c Combined primary endpoint Number of events Per-Ind Placebo (n=5,569) (n=5,571) Favours Per-Ind Favours Placebo Relative risk reduction (95% CI) Age (years) < % (-10 to 19) >= % (0 to 21) Sex Male % (-1 to 20) Female % (-7 to 21) SBP (mmhg) < % (-5 to 23) % (-2 to 19) History of hypertension No % (-17 to 29) Yes % (0 to 18) HbA1c (%) % (-4 to 20) > % (-1 to 22) All participants % (0 to 17) Hazard ratio 2.0 Phomogeneity all >0.1

23 Effects by ancillary treatment Combined primary endpoint Number of events Per-Ind Placebo (n=5,569)(n=5,571) Favours Per-Ind Favours Placebo Relative risk reduction (95% CI) Treatment with any BP lowering drug No % (-15 to 24) Yes % (0 to 19) Treatment with ACE inhibitor No % (-3 to 21) Yes % (-4 to 20) Treatment with statins No % (0 to 19) Yes % (-10 to 23) Treatment with anti-platelet drug No % (-2 to 22) Yes % (-5 to 18) All participants % (0 to 17) Hazard ratio 2.0 Phomogeneity all >0.1

24 Coronary events Number of events Per-Ind Placebo (n=5,569) (n=5,571) Favours Per-Ind Favours Placebo Relative risk reduction (95% CI) All coronary heart disease % (2 to 24) * Major coronary heart disease % (-6 to 24) Other coronary heart disease % (-1 to 27) Hazard ratio Non-fatal MI or death from coronary heart disease Unstable angina requiring hospitalisation, coronary revascularisation or silent MI *2P=0.02

25 Cerebrovascular events Number of events Per-Ind Placebo (n=5,569) (n=5,571) Favours Per-Ind Favours Placebo Relative risk reduction (95% CI) All cerebrovascular disease % (-10 to 20) * Major cerebrovascular disease % (-18 to 19) Other cerebrovascular disease % (-6 to 41) Hazard ratio Non-fatal stroke or death from cerebrovascular disease Transient ischaemic attack or subarachnoid haemorrhage 2.0 *2P=0.40

26 Renal events Number of events Per-Ind Placebo (n=5,569)(n=5,571) Favours Per-Ind Favours Placebo Relative risk reduction (95% CI) Total renal events % (15 to 27)* New or worsening nephropathy % (-1 to 32) New microalbuminuria % (14 to 27) Hazard ratio 2.0 *2P=<0.01

27 Eye events Number of events Per-Ind Placebo (n=5,569) (n=5,571) Favours Per-Ind Favours Placebo Relative risk reduction (95% CI) Total eye events % (-1 to 10)* New or worsening eye disease % (-18 to 15) Visual deterioration % (-1 to 10) Hazard ratio 2.0 *2P=0.09

28 Absolute benefits of routine treatment with perindopril and indapamide After 5 years, treatment would prevent: One major vascular event One death One coronary event One renal event* Among every 66 patients 79 patients 75 patients 20 patients *mostly new onset microalbuminuria

29 Risk factors levels At end of follow-up Parameter Systolic BP (mmhg) Diastolic BP (mmhg) Haemoglobin A1c (%) Total cholesterol (mmol/l) * HDL cholesterol (mmol/l) * LDL cholesterol (mmol/l) * Triglycerides (mmol/l) * Randomised treatment Active (n=5569) Placebo (n=5571) * Measurements taken at month 48

30 Ancillary drug therapy At end of follow-up Any BP lowering drug ACE inhibitor Oral hypoglycaemic drugs Insulin Statin Other lipid modifying drug Aspirin Other antiplatelet drugs Randomised treatment Active (n=5569) 74% 50% 90% 33% 44% 8% 56% 6% Placebo (n=5571) 83% 60% 91% 30% 45% 7% 55% 6%

31 Summary Routine treatment of type 2 diabetic patients with perindopril-indapamide resulted in: > 14% reduction in total mortality > 18% reduction in cardiovascular death > 9% reduction in major vascular events > 14% reduction in total coronary events > 21% reduction in total renal events Benefits appeared to be similar in all major subgroups. Treatment was very well tolerated, with few side effects and adherence similar to that with placebo.

32 Blood pressure lowering in diabetes: Unresolved issues 2000 Among patients with diabetes, does blood pressure lowering therapy: Produce additional benefits when systolic pressure is lowered below 145 mmhg? YES Produce similar benefits for hypertensive and non-hypertensive patients? YES Add to the benefits produced by other cardiovascular preventive therapies including ACE inhibitors? YES

33 Global projections for diabetes (millions) % % % % % % % World 2007 = 246 million 2025 = 380 million Increase +55% Diabetes Atlas, 3rd edition, IDF 2006

34 Potential global benefits of treatment If the benefits observed in ADVANCE were applied to just half the world s diabetic population Approximately 1.5 million deaths could be avoided over this period Diabetes Atlas, 3rd edition, IDF 2006

35

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