post marketing surveillance of safety and efficacy for cholib in korean patients under the "new drug re-examination".

Conditions: Dyslipidemias

Summary: post marketing surveillance of safety and efficacy for cholib in korean patients under the "new drug re-examination"

the objective of this surveillance is to identify problems and questions on cholib® and on the following matters under the condition that the investigational product is in use. 1. serious adverse event and adverse drug reaction profile * death or a life-threatening condition * hospitalization or prolonged hospitalization * persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically significant events 2. unexpected adverse event/adverse drug reaction profile 3. known adverse drug reaction profile 4. non-serious adverse drug reaction profile 5. other information related to the product safety 6. efficacy evaluation 7. study of extended follow-up surveillance of the safety and efficacy of the subjects who received cholib® for long-term use at least 24 weeks. 8. study of special patient analysis of specific patients such as elderly patients (65 years and above), patients with renal/hepatic disease

Eligibility criteria:
inclusion criteria: - clinical diagnosis of mixed dyslipidaemia who has high triglycerides and low hdl cholesterol level while ldl cholesterol levels are adequately controlled with the corresponding dose of simvastatin monotherapy exclusion criteria: * patients who are hypersensitive (allergic) to peanuts, soybean or any of the ingredients of the medicine * patients who experienced photoallergy or phototoxic reactions during treatment with fibrates or ketoprofen * patients who have active hepatic disorder or have serum transaminase increased continuously without identified reason * patients who have gallbladder disease * patients who have chronic or acute pancreatitis except acute pancreatitis due to severe hypertriglyceridemia * patients who have moderately or severely reduced kidney function(estimated glomerular filtration rate \< 60ml/min/1.73m2) * cholib® administration combined administration with fibrates, statins, danazol, cyclosporine or strong cytochrome p450(cyp)3a4 inhibitor * 145/40mg cholib® combined administration with amiodarone, verapamil, amlodipine or diltiazem * children \<19 years * pregnant or breast-feeding women * patients with biliary cirrhosis * patients who have myopathy and/or previously had rhabdomyolysis or myopathy while taking statins and/or fibrates or had 5 times more creatine phosphokinase than upper limit of normal (uln) while taking statins previously * patients who have rare hereditary problems with lactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption since this drug contains lactose * patients who have rare hereditary problems with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency since this drug contains sucrose * patients who have ldl cholesterol ≥130 mg/dl and triglyceride \< 150mg/dl and hdl cholesterol ≥60mg/dl investigators will refer to the product market authorization (label) for inclusion/exclusion criteria

Keywords: dyslipidemias