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

Helwan University

Status

Completed

Conditions

Diabetes Mellitus

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Treatments

Drug: Rosuvastatin 20 Mg Oral Tablet

Drug: Atorvastatin 40 Mg Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT05306990

pharmacy practice department

Details and patient eligibility

About

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.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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