Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome

Exclusion Criteria

• •Heart failure IV class (NYHA)
• •Acute decompensated heart failure
• •Life expectancy no more than 1 year
• •Chronic kidney disease (CKD) with Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
• •Severe chronic liver diseases with Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \> 3 Upper Limit of Normal (ULN)
• •Known gallbladder disease, including cholecystolithiasis
• •Creatinphosphokinase (CPK) \> 5 ULN at baseline
• •Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia
• •Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen,
• •Known allergy to peanut or arachis oil or soya lecithin or related products
• •Hypersensitivity to simvastatin or fenofibrate or to any of the excipients of the investigational drugs
• •Concomitant administration of potent cytochrome P450 isoenzyme 3A4 inhibitors (e.g. itraconazole, ketoconazole, fluconazole, posaconazole, Human Immunodeficiency Virus (HIV) protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone)
• •Pregnancy and lactation