Post Marketing Surveillance of Safety and Efficacy for Cholib in Korean Patients Under the "New Drug Re-examination".

Abbott

Status: Completed

Conditions: Dyslipidemias

Study type: Observational

Funder types: Industry

Identifiers

NCT02489331

FESI5001

Details and patient eligibility

About

Post marketing surveillance of safety and efficacy for Cholib in Korean patients under the "New Drug Re-examination"

Full description

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

Enrollment: 193 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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