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OPTIMUS

OPTIMUS. Randomized Comparison of a High Clopidogrel Maintenance Dose in Patients with Diabetes Mellitus and Coronary Artery Disease: Results of the Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS) Study.

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OPTIMUS

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  1. OPTIMUS Randomized Comparison of a High Clopidogrel Maintenance Dose in Patients with Diabetes Mellitus and Coronary Artery Disease: Results of the Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS) Study Dominick J. Angiolillo, MD, PhD; Steven B. Shoemaker, MD; Bhaloo Desai, PhD; Hang Yuan, PhD; Ronald K. Charlton, PhD; Esther Bernardo, BSc; Martin M. Zenni, MD; Luis A. Guzman, MD; Theodore A. Bass, MD; Marco A. Costa, MD, PhD Published online in Circulation January 29, 2007

  2. OPTIMUS: Background • After treatment with clopidogrel, patients with type 2 diabetes mellitus have reduced platelet inhibition compared with patients who are not diabetic. • Recent studies have shown that type 2 diabetes mellitus patients have reduced response to P2Y12 receptor antagonists, including clopidogrel, compared with nondiabetic subjects. Angiolillo, et al. Circulation. 2007 Jan; 115: 708-716.

  3. OPTIMUS: Background (cont.) • The aim of this pilot study was to evaluate the impact of a high maintenance dose of clopidogrel on platelet function profiles in type 2 diabetes mellitus patients with coronary artery disease (CAD) on long-term dual antiplatelet therapy who demonstrate suboptimal platelet inhibition. Angiolillo, et al. Circulation. 2007 Jan; 115: 708-716.

  4. OPTIMUS: Study Design 40 patients > 18 years with type 2 diabetes mellitus and coronary artery disease All patients also received aspirin (81 mg daily). Prospective. Randomized. Parallel-Group. R Group A 75 mg of Clopidogrel 30 days,n=20 Group B 150 mg of Clopidogrel 30 days, n=20 Platelet Function Testing Platelet Function Testing 75 mg of Clopidogrel 30 days n=20 75 mg of Clopidogrel 30 days n=20 Platelet Function Testing At 60 days • Primary Endpoint: Maximal ADP-induced platelet aggregation Angiolillo, et al. Circulation. 2007 Jan; 115: 708-716.

  5. OPTIMUS: Demographics *IDDM = Insulin-dependent diabetes mellitus; †NIDDM = Non-insulin-dependent diabetes mellitus; ±HbA1-C = hemoglobin A1C Angiolillo, et al. Circulation. 2007 Jan; 115: 708-716.

  6. OPTIMUS: Demographics (Cont.) Angiolillo, et al. Circulation. 2007 Jan; 115: 708-716.

  7. OPTIMUS Trial: Primary Endpoint Study Time Point 2: Maximal ADP-Induced (20 µmol/L) Platelet Aggregation p = 0.002 • Platelet aggregation was significantly reduced in the 150mg group compared with the 75mg group (63.1% vs. 52.3%, p=0.002) (%) n = 20 n = 20 Angiolillo, et al. Circulation. 2007 Jan; 115: 708-716.

  8. OPTIMUS Trial: Results Late Adenosine Diphosphate Induced (20 µmol/L) Platelet Aggregation • At one month, patients assigned to the 150mg clopidogrel maintenance dose had an approximate 15% reduction in late (5 minutes) platelet aggregation after stimulus with 20 µmol/L ADP p <0.0001 (%) n = 20 n = 20 Angiolillo, et al. Circulation. 2007 Jan; 115: 708-716.

  9. OPTIMUS Trial: Results Study Time Point 3: Maximal ADP-Induced Platelet Aggregation (20µmol/L) p=0.55 p=0.97 • Patients assigned to 150mg dose returned to values comparable to those at baseline after a switch back to standard dosing (75mg) (%) n = 20 n = 20 n = 20 n = 20 Angiolillo, et al. Circulation. 2007 Jan; 115: 708-716.

  10. OPTIMUS: Limitations • The study did not account for performance of multiple significance tests or for potential correlation among various measures of platelet function. • This study was also not powered to evaluate the risk of bleeding with the use of high-dose clopidogrel in association with aspirin. • The study was not designed to measure clinical outcomes and therefore the results are exploratory and should not be applied to clinical practice. Angiolillo, et al. Circulation. 2007 Jan; 115: 708-716.

  11. OPTIMUS: Summary • This study demonstrates that the current recommended maintenance dose of clopidogrel is associated with a high incidence of suboptimal response for patients with type 2 diabetes mellitus and coronary artery disease. • Though some patients continued to show high platelet aggregation levels despite increased doses of clopidogrel, the study showed the overall biological effectiveness of a 150mg maintenance dose regimen compared with standard doses of 75mg in high risk patients Angiolillo, et al. Circulation. 2007 Jan; 115: 708-716.

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