PROactive: Study design
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VBWG PROactive: Study design Dormandy JA et al. Lancet. 2005;366:1279-89 Charbonnel B et al. Diabetes Care. 2004;27:1647-53 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: Composite of all-cause mortality, MI, ACS, coronary or peripheral revascularization, amputation, stroke Secondary outcomes: Individual components of primary outcome, CV mortality Follow-up: 4 years
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PROactive: Study design. 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 - PowerPoint PPT Presentation
Transcript of PROactive: Study design
VBWG
PROactive: Study design
Dormandy JA et al. Lancet. 2005;366:1279-89.Charbonnel B et al. Diabetes Care. 2004;27:1647-53.
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: Composite of all-cause mortality, MI, ACS, coronary or peripheral revascularization, amputation, stroke
Secondary outcomes: Individual components of primary outcome, CV mortality
Follow-up: 4 years
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PROactive: Baseline characteristics
Charbonnel B et al. Diabetes Care. 2004;27:1647-53.
Patient description Mean ± SD
Age (yrs) 61.8 ± 7.7Male (%) 66.1Caucasian (%) 98.5Type 2 diabetes (yrs since onset) 9.5 ± 7.0Weight (lbs) 194 ± 34BMI (kg/m2) 30.9 ± 4.8Waist circumference (in) 41.46 ± 4.7Systolic BP (mm Hg) 143.4 ± 17.8Triglycerides (mg/dL) 198.4 ± 158.8HDL-C (mg/dL) 44.9 ± 12LDL-C (mg/dL) 114.5 ± 37A1C (%) 8.08 ± 1.41
VBWG
PROactive: CV medications at study entry
Charbonnel B et al. Diabetes Care. 2004;27:1647-53.
-Blockers 2859 (55%)
ACEI 3286 (63%)
ARB 356 (7%)
CCB 1855 (35%)
Nitrates 2058 (39%)
Thiazide 830 (16%)
Antiplatelets 4394 (84%) Aspirin 3829 (73%)
Statins 2135 (41%)
Fibrates 448 (9%)
Current therapy n (%)
VBWG
PROactive: Reduction in primary outcome
Dormandy JA et al. Lancet. 2005;366:1279-89.
Number at risk
Pioglitazone 2488 2373 2302 2218 2146 348Placebo 2530 2413 2317 2215 2122 345
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10
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25
06
20
0 12 18 24 30 36
Pioglitazone(514 events)
Placebo(572 events)
Time from randomization (months)
Proportionof events
(%)
All-cause mortality, nonfatal MI (including silent MI), ACS, revascularization, leg amputation, stroke
*Unadjusted
10% RRRHR* 0.90 (0.80–1.02)
P = 0.095
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PROactive: Reduction in secondary outcome
Dormandy JA et al. Lancet. 2005;366:1279-89.
Number at risk
Pioglitazone 2536 2487 2435 2381 2336 396
Placebo 2566 2504 2442 2371 2315 390
5
10
15
25
06
20
0 12 18 24 30 36
Pioglitazone(301 events)
Placebo(358 events)
Time from randomization (months)
Proportionof events
(%)
16% RRRHR* 0.84 (0.72–0.98)
P = 0.027
Combined nonfatal MI, all-cause mortality, stroke
*Unadjusted
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PROactive: Reduced need for insulin
Dormandy JA et al. Lancet. 2005;366:1279-89.
Number at risk
Pioglitazone 1700 1654 1603 1554 1499 244
Placebo 1646 1544 1472 1401 1325 202
5
10
15
25
06
20
0 12 18 24 30 36
Pioglitazone(183 events)
Placebo(362 events)
Time from randomization (months)
Proportionof events
(%)
53% RRRHR* 0.47 (0.39–0.56)
P < 0.0001
*Unadjusted
