Statins in Patients With Type 2 Diabetes Mellitus and Previous History of Acute Coronary Syndrome

Helwan University108 enrolled

Overview

The purpose of this study was to compare the efficacy and safety of high dose atorvastatin (40 mg) versus high dose rosuvastatin (20 mg) in Egyptian type II diabetic patients with previous acute coronary syndrome history. This open-labeled prospective, randomized clinical trial compared once daily atorvastatin 40mg (Ator®) versus once daily rosuvastatin 20mg (Crestor®). The primary outcome was the 50% reduction in low-density lipoprotein cholesterol levels at 12 weeks. The secondary outcome was the achievement of low-density lipoprotein cholesterol level \< 55 mg/dl.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

108

Conditions

Hydroxymethylglutaryl-CoA Reductase Inhibitors Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis with type 2 diabetes. * Previous history of acute coronary syndrome. * Abnormal baseline lipid profile. Exclusion Criteria: * Patients taking concurrent lipid lowering agents such as bile acid sequestrants (cholestyramine, colesevelam), niacin, ezetimibe, fenofibrate and/or omega3. * Patients taking concurrent interacting medications such as ciclosporin, gemfibrozil, clarithromycin and/or itraconazole. * Patients with active liver disease, bile duct problems, or ALT \> 3 × upper limit of normal (ULN). * Patients with serum creatinine \> 2 mg/dl. * Patients have incidence or history of hypersensitivity reaction to any of the statin used. * Women who were pregnant, breast-feeding or of child-bearing potential and not using a reliable form of contraception at the time of recruitment

Outcomes

Primary Outcomes

Mean Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)

A measure of participants with response

Time frame: Post intervention at week 12