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PROactive: Study design

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

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PROactive: Study design

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  1. 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 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 Dormandy JA et al. Lancet. 2005;366:1279-89. Charbonnel B et al. Diabetes Care. 2004;27:1647-53.

  2. PROactive: Baseline characteristics Patient description Mean ± SD Age (yrs) 61.8 ± 7.7 Male (%) 66.1 Caucasian (%) 98.5 Type 2 diabetes (yrs since onset) 9.5 ± 7.0 Weight (lbs) 194 ± 34 BMI (kg/m2) 30.9 ± 4.8 Waist circumference (in) 41.46 ± 4.7 Systolic BP (mm Hg) 143.4 ± 17.8 Triglycerides (mg/dL) 198.4 ± 158.8 HDL-C (mg/dL) 44.9 ± 12 LDL-C (mg/dL) 114.5 ± 37 A1C (%) 8.08 ± 1.41 Charbonnel B et al. Diabetes Care. 2004;27:1647-53.

  3. 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 4394 (84%) Aspirin 3829 (73%) Statins 2135 (41%) Fibrates 448 (9%) Charbonnel B et al. Diabetes Care. 2004;27:1647-53.

  4. 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 Placebo(572 events) 20 Pioglitazone(514 events) 15 Proportionof events(%) 10 5 0 0 6 12 18 24 30 36 Time from randomization (months) Number at risk Pioglitazone 2488 2373 2302 2218 2146 348 Placebo 2530 2413 2317 2215 2122 345 *Unadjusted Dormandy JA et al. Lancet. 2005;366:1279-89.

  5. PROactive: Reduction in secondary outcome Combined nonfatal MI, all-cause mortality, stroke 25 20 Placebo(358 events) 16% RRR HR* 0.84 (0.72–0.98)P = 0.027 15 Proportionof events(%) 10 Pioglitazone(301 events) 5 0 0 6 12 18 24 30 36 Time from randomization (months) Number at risk Pioglitazone 2536 2487 2435 2381 2336 396 Placebo 2566 2504 2442 2371 2315 390 *Unadjusted Dormandy JA et al. Lancet. 2005;366:1279-89.

  6. PROactive: Reduced need for insulin 25 Placebo(362 events) 20 53% RRR HR* 0.47 (0.39–0.56)P < 0.0001 15 Proportionof 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.

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