Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment

Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment

The purpose of this study is compare the effects of simvastatin+ezetimibe with those of simvastatin alone on platelet activity, platelet-leukocyte interactions and inflammatory variables in diabetic patients with or without impaired renal function.

A detailed study protocol is available.

Inclusion Criteria:

• Diabetes mellitus type 1 or type 2
• With or without established microalbuminuria (albumin-to-creatinine ratio (ACR)2,5-25 mg/mmol for men, and 3,5-25 mg/mmol for women, according to ISH and ESC recommended criteria)
• Glomerular filtration rate (GFR) between 15-60 ml/min/1.73m2 (measured the last 6 months) or GFR >75ml/min/1.73m2. The abbreviated Modification of Diet in Renal Disease (MDRD) equation will be used to calculate GFR.
• Age 18-80 years

Exclusion Criteria:

• Definite history of myocardial infarction, coronary revascularisation procedure or stroke. (i.e, a strong clinical indication for statin treatment)
• Functioning renal transplant, or living donor-related transplant planned.
• Patients on dialysis.
• Poor metabolic control, i.e HbA1c > 9%
• Definite history of chronic liver disease, or abnormal liver function (i.e ALT >1,5 x ULN or, if ALT not available, AST > 1,5 x ULN).
• Evidence of active inflammatory muscle disease (e.g dermatomyositis, polymyositis), or CK>3 x ULN;
• Definite previous adverse reaction to a statin or to ezetimibe
• Definite previous adverse reaction to acetylsalicylic acid.
• Definite previous adverse reaction to an ACE-inhibitor.
• Need for concomitant treatment with a strong inhibitor of CYP3A4, such as itrokonazole, ketokonazole, erythromycin, clarithromycin, HIV-protease inhibitors or nefazodone (i.e. agents that may markedly elevate simvastatin levels).