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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

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

optimus background
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.

optimus background cont
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.

optimus study design
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.

optimus demographics
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.

optimus demographics cont
OPTIMUS: Demographics (Cont.)

Angiolillo, et al. Circulation. 2007 Jan; 115: 708-716.

optimus trial primary endpoint
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.

optimus trial results
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.

optimus trial results1
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.

optimus limitations
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.

optimus summary
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.