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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Efficacy and Safety of Atorvastatin 40mg Versus Rosuvastatin 20mg in Type II Diabetic Patients With Previous Acute Coronary Syndrome : Randomized Clinical Trial

Conditions
-----------------
Hydroxymethylglutaryl-CoA Reductase Inhibitors, Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Atorvastatin 40 Mg Oral Tablet
* Drug: Rosuvastatin 20 Mg Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin<br>Atorvastatin tablets Dosage and frequency: 40mg orally once daily | Drug: Atorvastatin 40 Mg Oral Tablet<br>* patients followed up for 3 months<br>* Other names: Ator;|
| Active Comparator: Rosuvastatin<br>Rosuvastatin tablets Dosage and frequency: 20mg orally once daily | Drug: Rosuvastatin 20 Mg Oral Tablet<br>* patients followed up for 3 months<br>* Other names: crestor;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) | A measure of participants with response | Post intervention at week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute coronary syndrome, High intensity statin therapy, Atorvastatin, Rosuvastatin, Diabetes mellitus