Transcript Document

PROactive: Study design
VBWG
Objective:
Assess the effects of pioglitazone on reducing
macrovascular events in type 2 diabetes
Design:
Randomized, double-blind, placebo-controlled
Population:
N = 5238 with type 2 diabetes and history of
macrovascular disease
Treatment:
Pioglitazone (up to 45 mg) or placebo
Primary
outcome:
Secondary
outcomes:
Follow-up:
Composite of all-cause mortality, MI, ACS,
coronary or peripheral revascularization,
amputation, stroke
Individual components of primary outcome,
CV mortality
4 years
Dormandy JA et al. Lancet. 2005;366:1279-89.
Charbonnel B et al. Diabetes Care. 2004;27:1647-53.
VBWG
PROactive: Baseline characteristics
Patient description
Mean ± SD
Age (yrs)
Male (%)
Caucasian (%)
Type 2 diabetes (yrs since onset)
Weight (lbs)
BMI (kg/m2)
Waist circumference (in)
Systolic BP (mm Hg)
Triglycerides (mg/dL)
HDL-C (mg/dL)
LDL-C (mg/dL)
A1C (%)
61.8 ± 7.7
66.1
98.5
9.5 ± 7.0
194 ± 34
30.9 ± 4.8
41.46 ± 4.7
143.4 ± 17.8
198.4 ± 158.8
44.9 ± 12
114.5 ± 37
8.08 ± 1.41
Charbonnel B et al. Diabetes Care. 2004;27:1647-53.
VBWG
PROactive: CV medications at study entry
Current therapy
n
(%)
-Blockers
2859
(55%)
ACEI
3286
(63%)
ARB
356
(7%)
CCB
1855
(35%)
Nitrates
2058
(39%)
Thiazide
830
(16%)
Antiplatelets
Aspirin
4394
3829
(84%)
(73%)
Statins
2135
(41%)
Fibrates
448
(9%)
Charbonnel B et al. Diabetes Care. 2004;27:1647-53.
VBWG
PROactive: Reduction in primary outcome
All-cause mortality, nonfatal MI (including silent MI), ACS, revascularization,
leg amputation, stroke
25
10% RRR
HR* 0.90 (0.80–1.02)
P = 0.095
20
Placebo
(572 events)
Pioglitazone
(514 events)
15
Proportion
of events 10
(%)
5
0
0
6
Number at risk
Pioglitazone
Placebo
*Unadjusted
2488
2530
12
18
24
30
Time from randomization (months)
2373
2413
2302
2317
2218
2215
2146
2122
36
348
345
Dormandy JA et al. Lancet. 2005;366:1279-89.
VBWG
PROactive: Reduction in secondary outcome
Combined nonfatal MI, all-cause mortality, stroke
25
20
Placebo
(358 events)
16% RRR
15
HR* 0.84 (0.72–0.98)
P = 0.027
Proportion
of events 10
(%)
Pioglitazone
(301 events)
5
0
0
6
Number at risk
12
18
24
30
Time from randomization (months)
36
Pioglitazone
2536
2487
2435
2381
2336
396
Placebo
2566
2504
2442
2371
2315
390
*Unadjusted
Dormandy JA et al. Lancet. 2005;366:1279-89.
VBWG
PROactive: Reduced need for insulin
25
Placebo
(362 events)
20
53% RRR
HR* 0.47 (0.39–0.56)
P < 0.0001
15
Proportion
of events 10
(%)
Pioglitazone
(183 events)
5
0
0
6
12
18
24
30
36
Time from randomization (months)
Number at risk
Pioglitazone
1700
1654
1603
1554
1499
244
Placebo
1646
1544
1472
1401
1325
202
*Unadjusted
Dormandy JA et al. Lancet. 2005;366:1279-89.