None listed
Conditions
Interventions
None listed
Sponsors
Celltrion Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: common criteria 1) Over 19 years old (Adult) 2) From 1st January 2015 to 10th May 2016, patient who start to take carnitine complex combination therapy over 12 weeks 3) 40 IU/L = ALT = 400 IU/L (at index date) 4) The patients have medical recode for consecutive over 90 day before index date 5) From 60 days before index date, No change of dosage of medication for metabolic disease during taking carnitine complex sub group 1. Type 2 DM : all common criteria is met. 1) Patients who are diagnosed with type 2 DM and take OPH over 90 days before index date 2) Before 60 days from index date, No change of dosage of OPH during taking carnitine complex 2. HTN : all common criteria is met. 1) Patients who are diagnosed with HTN and take antihypertensive over 90 days before index date 2) Before 60 days from index date, No change of dosage of antihypertensive during taking carnitine complex 3. Hyperlipidemia : all common criteria is met. 1) Patients who are diagnosed with Hyperlipidemia and take medication for Hyperlipidemia over 90 days before index date 2) Before 60 days from index date, No change of dosage of medication for Hyperlipidemia during taking carnitine complex
Exclusion criteria
Exclusion criteria: 1) Under 19 years old 2) Chronic alcoholic disease 3) Acute hepatitis A 4) Chronic hepatitis B 5) Viral liver disease, alcoholic liver disesase, biliary obstruction, cirrhosis, drug induced liver disease 6) Type 1 DM or gestational diabetes or patient who is administered insulin. 7) Patients who take antiobestic drug before 30 days from index date
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of ALT, AST | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of body weight, BMI;Safety for Carnitine complex combination therapy;the change of indicator of metabolic diseases (type 2 DM, HTN, Hyperlipidemia) | — |
Countries
Korea, Republic of
Contacts
Public ContactDaewon Jun
Hanyang University
Outcome results
None listed