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PERISCOPE Comparison of Pioglitazone vs. Glimepiride on Progression of Coronary Atherosclerosis in Patients with Type 2

PERISCOPE Comparison of Pioglitazone vs. Glimepiride on Progression of Coronary Atherosclerosis in Patients with Type 2 Diabetes. Steven E. Nissen MD.

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PERISCOPE Comparison of Pioglitazone vs. Glimepiride on Progression of Coronary Atherosclerosis in Patients with Type 2

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  1. PERISCOPEComparison of Pioglitazone vs. Glimepiride on Progression of Coronary Atherosclerosisin Patients with Type 2 Diabetes Steven E. Nissen MD Stephen J. Nicholls MBBS PhD, Kathy Wolski MPH, Richard Nesto MD,Stuart Kupfer MD, Alfonso Perez MD, Horacio Jure MD, Robert De Larochellière MD, Cezar S. Staniloae MD, Kreton Mavromatis MD, Jacqueline Saw MD, Bo Hu PhD, A. Michael Lincoff MD,and E. Murat Tuzcu MD for the PERISCOPE Investigators*

  2. Background and Objectives • Cardiovascular disease is the leading causeof death in patients with diabetes. • Few studies have compared outcomes for diabetes medications beyond their glucose lowering efficacy. • We sought to compare coronary disease progression measured by intravascular ultrasound for two alternative treatment strategies: • Glimepiride (an insulin secretagogue) • Pioglitazone (an insulin sensitizer)

  3. Methods • Patients selected with type 2 diabetes undergoing angiography for clinical indications. • Baseline intravascular ultrasound (IVUS) performed to determine atheroma volume. • 543 patients randomized to glimepiride 1-4mgor pioglitazone 15-45mg titrated to maximally tolerated dose by 16 weeks. • After 18 months, IVUS of the originally examined coronary artery performed in 360 participants.

  4. Baseline Patient Characteristics (n=543) *P = 0.002 †P = 0.01

  5. Baseline Medications (n=543)

  6. Baseline Laboratory Values & Blood Pressure* *N=360 (patients with both baseline and final IVUS) †P = 0.05

  7. Glycohemoglobin Levels during the Trial HbA1c (%) Weeks after Randomization

  8. Mean Changes in Blood Pressure (n = 360) Systolic Diastolic P = 0.03 P = 0.003

  9. Percentage Changes: Biochemical Parameters HDL-cholesterol LDL-cholesterol 16.0% 6.9% 6.6% P <0.001 P = 0.69 4.1% hs C-reactive Protein Triglycerides 0.6% -18.0% P <0.001 P <0.001 -15.3% -44.9%

  10. Primary Efficacy Parameter Change in Percent Atheroma Volume (%) P < 0.001 P = 0.002 P = 0.44 Glimepiride Pioglitazone

  11. Intravascular Ultrasound: Secondary Endpoints Atheroma Thickness (mm) Atheroma Volume (mm3) Most Diseased 10mm (mm3) 0.011 -1.5 P =0.006 P =0.06 P = 0.93 -2.0 -2.1 -0.011 -5.5 Glimepiride Pioglitazone

  12. Change in PAV in Pre-specified Subgroups ≥ 60 years < 60 years Age Male Female Gender ≥ median < median BMI SystolicBP < 130 mmHg ≥ 130 mmHg P = 0.07 Statinuse Yes (306)no (54) Diabetesduration < median ≥ median ≥ median < median HbA1c 2 1 0 1 Favors Glimepiride Favors Pioglitazone

  13. Change in PAV in Exploratory Subgroups ≤ median > median HDL-C ≤ median > median LDL-C ≥ median < median Trigs MetabolicSyndrome Yes (295)no (65) ≥ median < median CRP ≤ median > median PAV 2 1 0 1 Favors Glimepiride Favors Pioglitazone

  14. Adjudicated Major Cardiovascular Events

  15. Other Adverse Effects

  16. PERISCOPE: Comparison to Other Trials REVERSAL pravastatin CAMELOT placebo PERISCOPE glimepiride ACTIVATE placebo REVERSAL atorvastatin ILLUSTRATE atorvastatin PERISCOPE pioglitazone ASTEROID rosuvastatin

  17. Conclusions • Pioglitazone, on a background of optimal medical therapy, prevented progression of coronary atherosclerosis, P = 0.002 compared with glimepiride. • Compared with glimepiride, pioglitazone produced similar, although more durable, glucose-lowering. • Pioglitazone favorably affected BP, raised HDL-C (16.0% vs. 4.1%), lowered triglycerides (-15.3% vs. +0.6%) and reduced hsCRP (-44.9% vs. -18.0%). • Hypoglycemia and angina were more common with glimepiride treatment; edema, fractures and weight gain more frequent with pioglitazone treatment.

  18. Some Final Thoughts There exist few comparative effectiveness trials examining endpoints other than glycemic controlfor anti-diabetic medications. Given the recent controversy about the effects of diabetes treatments on cardiovascular disease, we urgently must close this knowledge gap. We hope the PERISCOPE trial will encourage further studies examining alternative diabetes management strategies, particularly clinical outcomes trials.

  19. Backup Slides

  20. Changes in Laboratory Values and BP

  21. Other Biomarkers: Insulin Levels and BNP Change in Fasting Insulin Levels Final Brain Natiuretic Peptide 8.5% 32.4 P<0.001 22.6 P<0.001 -28.3% Placebo Pioglitazone

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