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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet; Karolinska University Hospital
• Collaborator: Danderyd Hospital
• Treatments: Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Simvastatin

Criteria

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).