Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe

Heidelberg University

Status: Completed

Conditions: Inflammation; Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Simvastatin 80 mg; Drug: Sim10/Eze10

Study type: Interventional

Funder types: Other

Identifiers

NCT01424891

SimEze

Details and patient eligibility

About

Lowering LDL cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the effects of newer cholesterol lowering agents such as ezetemibe with respect to their anti-inflammatory potential are less intensively studied. Therefore the investigators analyzed whether equipotent LDL-lowering therapy with simvastatin alone and in combination with ezetimibe have comparable effects on NF-ĸB-activation in peripheral blood mononuclear cells (PBMCs) of patients with type 2 diabetes.

Enrollment: 31 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 35 to 80 years old
• type 2 diabetes
• HbA1c value between 6.0 % and 9.0 %
• elevated LDL-c values > 100 mg/dl with no lipid lowering treatment within the last six month

Exclusion criteria

• refused informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Treatment with placebo over 8 weeks

Treatment:

Drug: Placebo

Simvastatin 80 mg

Active Comparator group

Description:

treatment with 80 mg of simvastatin over 8 weeks

Treatment:

Drug: Simvastatin 80 mg

Sim10/Eze10

Active Comparator group

Description:

treatment with 10 mg of simvastatin in combination with 10 mg ezetimibe over 8 weeks

Treatment:

Drug: Sim10/Eze10