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

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

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemias

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 193

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of, 14577
    • Daesung Medical Center
  • Busan, Korea, Republic of, 47354
    • Isam Clinic
  • Busan, Korea, Republic of, 47889
    • DongRae BongSeng Hospital
  • Daegu, Korea, Republic of, 42612
    • Hyundai Medical Clinic
  • Daegu, Korea, Republic of, 42812
    • SANGIN Clinic of Internal Medicine
  • Daejeon, Korea, Republic of, 35365
    • Konyang University Hospital
  • Gyeonggi-do, Korea, Republic of, 12048
    • Namyangju Hanyang General Hospital
  • Gyeongsang, Korea, Republic of, 53042
    • Kim Young Ho Internal Medicine Clinic
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06973
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are prescribed Cholib as per doctor's medical judgement in normal medical parctice setting

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse event after Cholib administration in general medical practice	Any adverse events occurred after Cholib® dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.	24 weeks
Incidence of serious adverse event after Cholib administration in general medical practice	Any serious adverse events occurred after Cholib® dosing will be recorded. Description of serious adverse event(s) including type of serious adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the serious adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be serious adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be serious adverse events.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate four categories based on Serum-Triglyceride, HDL cholesterol, LDL cholesterol, creatine kinase (CK), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine level after Cholib® dosing and test date	All subjects who received Cholib® for at least 12 weeks and follow-up at 24 weeks will be evaluated for efficacy using the four-criteria as follows: Improved, unchanged, exacerbated, not assessable	24 weeks

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): November 10, 2020
• Study Completion (Actual): November 10, 2020

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Dyslipidemias
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: FESI5001