A factorial randomized trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes

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1 A factorial randomized trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes

2 Hypotheses: Among individuals with type 2 diabetes, the risks of major microvascular and macrovascular events will be reduced by: I. glucose control with a sulfonylurea (gliclazide-mr) based regimen targeting a hemoglobin A 1c of 6.5% of less II. Routine BP lowering with a fixed combination of an ACE inhibitor (perindopril) and a diuretic (indapamide)

3 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 Any level of blood pressure Any level of glucose control but no definite indication for long-term insulin

4 Participant allocation Registration N = 12,877 Randomization N = 11,140 6 week run-in period with active fixed combination BP lowering glucose control glucose control glucose control glucose control and and and and Routine BP lowering Placebo Routine BP lowering Placebo (N = 2,783) (N = 2,788) (N = 2,786) (N = 2,783)

5 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 Pre-specified joint and separate analyses of macrovascular and microvascular outcomes

6 Study population

7 Baseline characteristics I Characteristic glucose control and per/ind (N=2,783) glucose control and placebo (N=2,788) glucose control and per/ind (N=2,786) glucose control and placebo (N=2,783) Age (SD) 66 (6) 66 (6) 66 (6) 66 (6) Female, n (%) 1198 (43) 1181 (42) 1168 (42) 1188 (43) Duration of diabetes, years (SD) 8.0 (6.4) 7.8 (6.3) 8.0 (6.4) 8.0 (6.3) History of macrovascular disease, n (%) 896 (32.2) 898 (32.2) 902 (32.4) 894 (32.1) History of microvascular disease, n (%) 282 (10.1) 289 (10.4) 288 (10.3) 296 (10.6) Systolic BP, mmhg (SD) (22.1) (21.3) (21.6) (21.2)

8 Baseline characteristics II Characteristic glucose control and per/ind (N=2,783) glucose control and placebo (N=2,788) glucose control and per/ind (N=2,786) glucose control and placebo (N=2,783) Hemoglobin A 1c, % (SD) 7.5 (1.6) 7.5 (1.6) 7.6 (1.6) 7.5 (1.5) FBG, mmol/l (SD) 8.6 (2.8) 8.5 (2.7) 8.5 (2.8) 8.4 (2.8) FBG, mg/dl (SD) 155 (50) 153 (49) 153 (50) 151 (50) BP lowering drugs, n (%) 2089 (75.1) 2094 (75.1) 2077 (74.6) 2105 (75.6) Glucose lowering, n (%) 2543 (91.4) 2541 (91.1) 2539 (91.1) 2506 (90.1)

9 Timeline June 2001 January 2002 January 2003 January 2004 January 2005 January 2006 January 2007 January 2008 March 2003 Recruitment period Nov May 2007 Decision to extend study follow-up Blood pressure lowering comparison Blood glucose lowering comparison

10 Main results of the glucose control comparison

11 Randomized glucose lowering strategies control arm Gliclazide MR (sulfonylurea) in all participants Unrestricted additional therapy to achieve target HbA 1c 6.5% control arm Sulfonylurea other than Gliclazide MR Unrestricted additional therapy according to standard local guidelines All other treatment At discretion of treating physician

12 glucose control strategy More frequent visits Emphasis on lifestyle management Drug titration at physician s discretion based on HbA 1c and FBG levels: Maximize gliclazide MR dose Add other oral agents Add long-acting insulin Use multiple insulin injection therapy

13 ADVANCE Trial profile with type 2 diabetes registered 1737 withdrew during run-in randomized 5571 assigned intensive glucose control 5569 assigned standard glucose control 7 vital status unknown Scheduled end of follow-up: 5.0 years 4828 (87%) assessed at final visit 10 vital status unknown Scheduled end of follow-up: 5.0 years 4741 (85%) assessed at final visit

14 Glucose control drugs At randomization Sulfonylurea Metformin Thiazolidinediones Acarbose Glinides Insulin Randomized treatment (n=5571) 71% 61% 4% 9% 2% 1% (n=5569) 71% 60% 4% 8% 2% 1%

15 Glucose control drugs At end of follow-up Sulfonylurea Metformin Thiazolidinediones Acarbose Glinides Insulin Randomized treatment (n=4828) 91% 74% 17% 19% 1% 40% (n=4741) 59% 67% 11% 13% 3% 24%

16 Main results Hemoglobin A 1c

17 Hemoglobin A 1c Mean HbA 1c (%) Δ 0.67% (95% CI ); p<0.001 Mean HbA 1c at final visit 7.3 % 6.5% Follow-up (Months)

18 HbA 1c at end of follow-up >7.5% 7.1% to 7.5% 6.6% to 7.0% 6.0% to 6.5% <6.0% control control

19 Main results Primary outcomes

20 Combined primary outcomes Major macro or microvascular event Cumulative incidence (%) Relative risk reduction 10%: 95% CI: 2 to 18% p= Follow-up (months)

21 Primary outcomes Major macro or microvascular event Number of patients with event (n=5,571) (n=5,569) Relative risk reduction (95% CI) Combined macro+micro % (2 to 18) Macrovascular % (-6 to 16) Microvascular % (3 to 23) Hazard ratio P=0.013 P=0.015

22 Major macrovascular events Cumulative incidence (%) Relative risk reduction 6%: 95% CI: -6 to 16% p= Follow-up (months)

23 Major macrovascular events Number of patients with event (n=5,571) (n=5,569) Relative risk reduction (95% CI) Macrovascular % (-6 to 16) Non-fatal stroke % (-24 to 15) Non-fatal MI % (-23 to 22) Cardiovascular death % (-4 to 26) Hazard ratio

24 Major microvascular events Cumulative incidence (%) Relative risk reduction 14%: 95% CI: 3 to 23% p= Follow-up (months)

25 Major microvascular events Number of patients with event (n=5,571) (n=5,569) Relative risk reduction (95% CI) Microvascular % (3 to 23) New or worsening retinopathy % (-10 to 18) New or worsening nephropathy % (7 to 34) Hazard ratio P=0.01 P=0.006

26 Main results Secondary outcomes

27 All-cause mortality Cumulative incidence (%) Relative risk reduction 7%: 95% CI -6 to 17% p= Follow-up (months)

28 Death Number of patients with event (n=5,571) (n=5,569) Relative risk reduction (95%CI) All deaths % (-6 to 17) Cardiovascular death % (-4 to 26) Non-cardiovascular death % (-20 to 16) Hazard ratio

29 Coronary and cerebrovascular events Number of patients with event (n=5,571) (n=5,569) Relative risk reduction (95% CI) Total coronary events % (-10 to 13) Major coronary events % (-7 to 21) Total cerebrovascular events % (-26 to 7) Major cerebrovascular events % (-16 to 19) Hazard ratio Non-fatal MI or death from coronary heart disease Non-fatal stroke or death from cerebrovascular disease

30 Renal events Number of patients with event (n=5,571) (n=5,569) Relative risk reduction (95% CI) Total renal events % (5 to 17) New microalbuminuria % (2 to 15) New or worsening nephropathy % (7 to 34) *** Hazard ratio P<0.001 P=0.02 ***P=0.006

31 Nephropathy Number of patients with event (n=5,571) (n=5,569) Relative risk reduction (95% CI) New or worsening nephropathy % (7 to 34) Macroalbuminuria % (15 to 43) Doubling of serum creatinine* % (-63 to 18) End-stage renal disease % (-8 to 62) Hazard ratio *to at least 200 μmol/l (2.3 mg/dl) P=0.006 P<0.001

32 Eye events Number of patients with event (n=5,571) (n=5,569) Relative risk reduction (95% CI) Total eye events % (-5 to 5) New or worsening retinopathy % (-10 to 18) Visual deterioration % (-5 to 5) Hazard ratio

33 Heart failure, PVD and neuropathy Number (%) of patients with event (n=5,571) (n=5,569) Relative risk reduction (95% CI) All heart failure % (-14 to 21) All peripheral vascular disease % (-9 to 19) New or worsening neuropathy % (-10 to 2) Hazard ratio

34 Cognitive function and dementia Number of patients with event (n=5,571) (n=5,569) Relative risk reduction (95% CI) Dementia % (-86 to 13) Cognitive decline % (-7 to 11) Hazard ratio

35 Effects in patient subgroups

36 Effects by age, sex, SBP & glucose control Combined primary endpoint Age (years) < % (1 to 25) % (-3 to 17) Sex Male % (0 to 19) Female % (-3 to 22) SBP (mmhg) < % (-4 to 21) % (1 to 20) HbA 1c (%) < % (-3 to 22) % (0 to 20) Fasting blood glucose (mmol/l) Number of patients with event (n=5,571) (n=5,569) Relative risk reduction (95% CI) < 7.9 (142 mg/dl) % (0 to 23) 7.9 (142 mg/dl) % (-2 to 18) All participants % (2 to 18) Hazard ratio Phomogeneity all >0.1

37 Effects by disease history & ancillary treatment Combined primary endpoint History of macrovascular disease Number of patients with event (n=5,571) (n=5,569) Relative risk reduction (95% CI) No % (4 to 23) Yes % (-10 to 16) History of microvascular disease No % (2 to 19) Yes % (-16 to 21) Treatment with any BP lowering drugs No % (-7 to 27) Yes % (1 to 18) Treatment with ACE inhibitors No % (3 to 24) Yes % (-7 to 16) Treatment with statins No % (1 to 19) Yes % (-6 to 24) Treatment with anti-platelet drugs No % (-2 to 20) Yes % (0 to 21) All participants % (2 to 18) Phomogeneity all >0.1 Hazard ratio

38 Effects by age, sex, SBP and glucose control Cardiovascular death Number of patients with event (n=5,571) (n=5,569) Relative risk reduction (95% CI) Age (years) < % (-39 to 31) % (-3 to 30) Sex Male % (-8 to 28) Female % (-18 to 35) SBP (mmhg) < % (3 to 45) % (-19 to 22) HbA 1c (%) < % (-8 to 38) % (-12 to 27) Fasting blood glucose (mmol/l) < 7.9 (142 mg/dl) % (-3 to 38) 7.9 (142 mg/dl) % (-18 to 25) All participants % (-4 to 26) Hazard ratio Phomogeneity all >0.1

39 Effects by age, sex, SBP and glucose control All cause mortality Number (%) of patients with event (n=5,571) (n=5,569) Relative risk reduction (95% CI) Age (years) < % (-20 to 28) % (-8 to 18) Sex Male % (-13 to 16) Female % (-6 to 32) SBP (mmhg) < % (-1 to 33) % (-17 to 14) HbA 1c (%) < % (-17 to 20) % (-7 to 22) Fasting blood glucose (mmol/l) < 7.9 (142 mg/dl) % (-2 to 28) 7.9 (142 mg/dl) % (-19 to 15) All participants % (-6 to 17) Hazard ratio Phomogeneity all >0.1

40 Hypoglycemia

41 Rates of hypoglycemia Minor and severe Events per 100 patient years %* Minor hypoglycemia control control +87%* Severe hypoglycemia *p<0.001

42 Comparative rates of severe hypoglycemia 2.0% 1.6% 1.2% 0.8% 0.4% Proportion of patients with at least one event each year 0.0% control control UKPDS ADVANCE

43 Body weight

44 Difference in body weight Difference 0.75kg (0.56, 0.94) 1.65lbs (1.23, 2.07), p< Weight (kg) Follow-up (months)

45 Conclusions on safety glucose lowering was safe No excess mortality No weight gain No excess of serious sequelae from hypoglycemia Death or disability Cognitive function

46 Summary effects on main efficacy outcomes glucose control resulted in: 10% reduction in combined primary outcome 14% reduction in microvascular events 21% reduction in nephropathy No significant effects on macrovascular events No significant effects on all-cause or cardiovascular mortality Consistent treatment effects in patient subgroups

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