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

• Status: Completed
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helwan University
• Treatments: Atorvastatin; Rosuvastatin Calcium

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