Type 2 Diabetic Patients Maintained on Statin Therapy
Condition: Dyslipidemia Associated With Type II Diabetes Mellitus
MeSH terms: Dyslipidemias; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

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.
    

Intervention name(s): Atorvastatin 40 Mg Oral Tablet; Rosuvastatin 10 Mg Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg per day atorvastatin (ATROVA group, n= 80) for 6 months; 10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months
Other intervention name(s): Atorvastatin 40mg tablet per day; Resovastatin 10 mg daily
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 160 patients were randomly assigned to receive either 40 mg per day atorvastatin tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin 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.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Adiponectin; Sortilin; Leptin; Dyslipidemia; Diabetes type II; Rosuvastatin; Atorvastatin