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CHICAGO

CHICAGO. C arotid intima-media t HIC kness in A therosclerosis using pio G litaz O ne trial. CHICAGO: Background and rationale. Even in the presence of optimal cardiovascular (CV) risk factor control (  LDL-C and  BP), individuals with T2DM remain at high risk for CV events

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CHICAGO

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  1. CHICAGO Carotid intima-media tHICkness in Atherosclerosis using pioGlitazOne trial

  2. CHICAGO: Background and rationale • Even in the presence of optimal cardiovascular (CV) risk factor control (LDL-C and BP), individuals with T2DM remain at high risk for CV events • Thiazolidinediones have shown favorable effects on systemic inflammation, coagulation, lipids, and endothelial function • Carotid intima-media thickness (CIMT) is a highly validated surrogate endpoint to detect future CV disease risk CHICAGO compared the long-term effects of pioglitazone vs glimepiride on CIMT progression in ethnically and racially diverse, urban patients with T2DM T2DM = type 2 diabetes mellitus Mazzone T et al. JAMA. 2006.

  3. CHICAGO: Study design N = 462 with T2DM Pioglitazone 15–45 mg*(n = 232) Glimepiride 1–4 mg*(n = 230) Double-blindComparator-controlled Primary endpoint:Change in mean posterior-wall CIMT in right and left common carotid arteries Follow-up: 18 months Primary CIMT analysis†: n = 175Intention-to-treat (ITT) analysis: n = 230 Primary CIMT analysis†: n = 186ITT analysis: n = 228 *Initial dose based on sulfonylurea use and titrated to achieve fasting plasma glucose (FPG) ≤140 mg/dL†Baseline + 1 qualifying CIMT image Mazzone T et al. JAMA. 2006.

  4. CHICAGO: Baseline demographics Mazzone T et al. JAMA. 2006.

  5. CHICAGO: Medical history Mazzone T et al. JAMA. 2006.

  6. CHICAGO: Baseline CV medications Mazzone T et al. JAMA. 2006.

  7. CHICAGO: Baseline risk factors NR = not reported Mazzone T et al. JAMA. 2006.

  8. CHICAGO: Treatment effect on posterior wall CIMT 0.016 0.012 Change from baseline (least-square means, mm) 0.008 P = 0.02 0.004 0 -0.004 -0.008 -0.012 Baseline Week 24 Week 48 Week 72 Glimepiride Pioglitazone Mazzone T et al. JAMA. 2006.

  9. CHICAGO: Treatment effect on posterior wall CIMT in prespecified subgroups Favorspioglitazone Favorsglimepiride -0.04 -0.03 -0.02 -0.01 0 0.01 0.02 Treatment-group difference in posterior wall CIMT(mean change, mm) Mazzone T et al. JAMA. 2006. *Within 7 days of 1st study drug dose

  10. CHICAGO: Treatment effect on glucose control 0.2 ‡ † * 0 A1C change from baseline (least square means, %) -0.2 -0.4 -0.6 Baseline 16 24 32 40 48 60 72 Week Glimepiride Pioglitazone *P = 0.04; †P = 0.01; ‡P = 0.002 (treatment-group difference) Mazzone T et al. JAMA. 2006.

  11. CHICAGO: Treatment effect on HDL-C 8 * * 6 * HDL-C change from baseline (least square means, mg/dL) 4 6.45 mg/dL(95% CI 4.97–7.93) 2 0 -2 Baseline† 24 48 72 Week Glimepiride (n = 206) Pioglitazone (n = 201) *P < 0.001 (treatment-group difference) †HDL-C mg/dL (SE): Glimepiride 47.6 (0.91), Pioglitazone 47.1 (0.90) Mazzone T et al. JAMA. 2006. Courtesy of SM Haffner, MD.

  12. CHICAGO: Adverse events Mazzone T et al. JAMA. 2006.

  13. CHICAGO: Summary • In an ethnically and racially diverse patient population with T2DM, treatment with pioglitazone demonstrated clinical benefits: • Progression of carotid atherosclerosis was retarded vs sulfonylurea (P = 0.02) • Benefits observed across all prespecified subgroups: age, gender, SBP, diabetes duration, BMI, A1C, statin use • Edema and weight gain were higher in TZD group • CIMT may be preferred for assessing treatment-related changes in carotid atherosclerosis Mazzone T et al. JAMA. 2006. Bernard S et al. Diabetes Care. 2005;28:1158-62.

  14. CHICAGO: Implications • Compared with previous trial cohorts, patients in CHICAGO were well-treated at baseline and had near-optimal risk factor control: • Mean LDL-C 113.8 mg/dL (pioglitazone) and 111.3 mg/dL (glimepiride) • 130.1/78.3 mm Hg (pioglitazone) and 128.7/77.1 mm Hg (glimepiride) • Slowed atherosclerosis progression is consistent with clinical endpoint data reported in PROactive* • Additional data will contribute to the overall understanding and clinical significance of CHICAGO results *PROspective pioglitAzone Clinical Trial In macroVascular Events Mazzone T et al. JAMA. 2006.Dormandy JA et al. Lancet. 2005;366:1279-89.

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