Type 2 Diabetic Patients Maintained on Statin Therapy

Efficacy of Atorvastatin Versus Rosuvastatin on LV Function and Inflammatory Biomarkers in Type 2 Diabetic Patients With Dyslipidemia

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, 150 type 2 diabetic patients were eligible and randomly assigned to receive either 40 mg per day atorvastatin (ATROVA group, n= 80) or 10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia Associated With Type II Diabetes Mellitus
• Intervention / Treatment: Drug: Atorvastatin 40 Mg Oral Tablet; Drug: Rosuvastatin 10 Mg Oral Tablet

Detailed Description

a prospective, double blind trial, conducted between January 2018 and January 2020. 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 150 patients were randomly assigned to receive either 40 mg per day atorvastatin tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin (Rosuvastatin Calcium®, Chemipharm Co. Cairo, Egypt) tablets (ROSUVA group, n= 80) as recommended in NCEP ATP III (21). 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 6 months. 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. 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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atrovastatin; atorvastatin (40 mg per day) for 6 months	Drug: Atorvastatin 40 Mg Oral Tablet; 40 mg per day atorvastatin (ATROVA group, n= 80) for 6 months; Other Names: Atorvastatin 40mg tablet per day
Experimental: Rosuvastatin; Rosuvastatin (10 mg per day) for 6 months	Drug: Rosuvastatin 10 Mg Oral Tablet; 10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months; Other Names: Resovastatin 10 mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hs-CRP (pg/mL)	biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis.	6 months
sortilin (ng/mL)	Serum Level	6 months
adiponectin (ng/mL)	Serum Level	6 months
leptin (ng/mL)	Serum Level	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucose level	fasting blood glucose (FBG) (mg/mL)	6 months
glycated hemoglobin	glycated hemoglobin (Hb A1c%)	6 months
total cholesterol	TCH: total cholesterol (mg/dL)	6 months
low density lipoprotein-cholesterol	LDL-C: low density lipoprotein-cholesterol (mg/dL), HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).	6 months
high density lipoprotein-cholesterol	HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).	6 months
Triglycerides	Triglycerides (mg/dL).	6 months

Collaborators and Investigators

• Sponsor: Damanhour University
• Collaborators: Tanta University
• Investigators: Study Director: Rehab Werida, Lecturer, Damanhour University

Publications and helpful links

General Publications

• Krysiak R, Zmuda W, Okopien B. The effect of simvastatin-ezetimibe combination therapy on adipose tissue hormones and systemic inflammation in patients with isolated hypercholesterolemia. Cardiovasc Ther. 2014 Apr;32(2):40-6. doi: 10.1111/1755-5922.12057.

Helpful Links

• The effect of simvastatin-ezetimibe combination therapy on adipose tissue hormones and systemic inflammation in patients with isolated hypercholesterolemia.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Dyslipidemia; Atorvastatin; Rosuvastatin; Leptin; Adiponectin; Sortilin; Diabetes type II
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Lipid Metabolism Disorders; Diabetes Mellitus, Type 2; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium
• Other Study ID Numbers: Statin Therapy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No