Type 2 Diabetic Patients Maintained on Statin Therapy

Lead Sponsor: Damanhour University

Collaborator: Tanta University

Patients with diabetes mellitus (DM) are at increased risk of atherosclerotic cardiovascular disease (ACVD). The achievement of the LDL-C target with statins for the reduction of ACVD risk is recommended. However, the risk is still present. Therefore, we investigated the impact of high sensitivity C-reactive protein (hsCRP), sortilin, adiponectin and leptin biomarkers that linking inflammatory hypothesis of diabetes mellitus and atherosclerosis in diabetic patients treated with rosuvastatin and atrovastatin. Methods: Based on exclusion criteria, ninety-five type 2 diabetic patients were eligible and randomly assigned to receive either 20 mg per day atorvastatin (ATROVA group, n= 40) or 20 mg per day rosuvastatin (ROSUVA group, n= 35) for three months and twenty patients (Non-statin group, n=20) not treated with statin and served as control.

a prospective, open-label trial, conducted between January 2018 and August 2018. Participants were enrolled if they had moderate cardiovascular risk (Framingham risk score of 10-20%), in other words 2 or more major risk factors for coronary artery disease (CAD), and LDL-cholesterol level ≥100 mg/dl. All patients gave informed consent before entering the study. Of seventy-five patients were randomly assigned to receive either 20 mg per day atorvastatin (Atrostat®, Delta Pharmaceutical Industries, Cairo, Egypt) tablets (ATROVA group, n= 40) or 20 mg per day Rosuvastatin (Rosuvastatin Calcium®, Chemipharm Co. Cairo, Egypt) tablets (ROSUVA group, n= 35) as recommended in NCEP ATP III (21). Twenty patients (Non-statin group, n=20), not treated with statin, were used for comparison. Patients included in the study were maintained on oral hypoglycemic agents (OHA) according to their treatment regimen. Clinical and biochemical assessment was done at baseline and after 12 weeks. Serum High-sensitivity CRP (hsCRP), sortilin, Adiponectin and Leptin level was determined using ELISA Kit. Blood pressure (BP) and anthropometrical parameters, such as body-mass index (BMI) were calculated using the equation (BMI = weight (kg)/height (m2). Blood pressure was measured twice, after keeping participants in a sitting position for 15 min. The mean value of two consecutive measurements with 5 min intervals was used for study purposes. HbA1c% was determined by ion exchange method. Serum triglycerides (TGs), total cholesterol (TCH), and high-density lipoprotein cholesterol (HDL-C) were determined colorimetrically. Low-density lipoprotein-cholesterol (LDL-C) was calculated according to Friedewald formula. Serum Atherogenic Index (AI) is calculated through the following: Atherogenic Index = TCH/HDL-C as TCH/HDL-C ratio is an excellent CVD risk predictor and a good biomarker for deciding on the intensity and the need for therapeutic intervention.

• Diabetes Mellitus, Type 2

Intervention Type: Drug

Intervention Name: Atorvastatin (Atrostat®, Delta Pharmaceutical Industries, Cairo, Egypt) tablets.

Description: either 20 mg per day atorvastatin (ATROVA group, n= 40) or 20 mg per day rosuvastatin (ROSUVA group, n= 35) for three months and twenty patients (Non-statin group, n=20) not treated with statin and served as control.

Arm Group Label: ATROVA group

Other Name: Rosuvastatin (Rosuvastatin Calcium®, Chemipharm Co. Cairo, Egypt) tablets.

Intervention Type: Drug

Intervention Name: Rosuvastatin (Rosuvastatin Calcium®, Chemipharm Co.

Description: 20 mg per day rosuvastatin (ROSUVA group, n= 35) for three months

Arm Group Label: ROSUVA group

Criteria:

Inclusion Criteria:

- type II diabetic patients with hypercholesterolemia

Exclusion Criteria:

- liver impairment,

- renal insufficiency,

- coronary artery disease,

- metabolic disorders,

- type I diabetes,

- autoimmune diseases, cancer, infection,

- use of anti-inflammatory drugs,

- recent major surgery,

- weight-loss or modified anti-hypertensive medications 12 weeks or less prior to enrolment,

- ongoing or previous use of lipid-lowering medications (including other statins, fibric acid derivatives, nicotinic acid, cholestyramine, ezetimibe or omega-3 fatty acids) and contraindications to the use of statins.

Gender: All

Minimum Age: 30 Years

Maximum Age: 60 Years

Healthy Volunteers: No

Egypt

December 2018

Type: Principal Investigator

Investigator Affiliation: Damanhour University

Investigator Full Name: Rehab Werida

Investigator Title: Clinical Pharmacy Lecturer

• Adiponectin
• Sortilin
• Leptin
• Atherosclerosis
• Diabetes type II
• Rosuvastatin
• Atorvastatin

• Diabetes Mellitus, Type 2

Label: ATROVA group

Type: Experimental

Description: atorvastatin (20 mg per day)

Label: ROSUVA group

Type: Experimental

Description: Rosuvastatin (20 mg per day)

Label: Non-statin group

Type: No Intervention

Description: Placebo

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: seventy-five patients were randomly assigned to receive either 20 mg per day atorvastatin (Atrostat®, Delta Pharmaceutical Industries, Cairo, Egypt) tablets (ATROVA group, n= 40) or 20 mg per day Rosuvastatin (Rosuvastatin Calcium®, Chemipharm Co. Cairo, Egypt) tablets (ROSUVA group, n= 35) as recommended in NCEP ATP III (21). Twenty patients (Non-statin group, n=20), not treated with statin, were used for comparison. Patients included in the study were maintained on oral hypoglycemic agents (OHA) according to their treatment regimen.

Primary Purpose: Prevention

Masking: None (Open Label)

Masking Description: prospective, open-label trial