Han 2012.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: No washout required because no participant received lipid medications, 4 weeks before‐and‐after trial
Participants	Baseline Characteristics 2 mg n: 97 Males (n): 66 Females (n): 31 Total cholesterol: 5.73 mmol/L (222 mg/dL) LDL cholesterol: 3.76 mmol/L (145 mg/dL) HDL cholesterol: 1.18 mmol/L (45.6 mg/dL) Triglycerides: 2.30 mmol/L (204 mg/dL) Age (years): 55.5 Included criteria: Adult subjects, aged 25 to 75 years, with elevated ALT concentrations (≥ 1.25 times and ≤ 2.5 times the upper limit of the normal range [ULN]; 40 IU/L) were recruited from the lipid clinics of 10 major hospitals in Korea. All subjects were non‐alcoholics and serologically negative for viral hepatitis markers. None had been treated with statins for more than 3 months before screening, and all had basal fasting LDL‐C concentration levels ≥ 3.36 mmol/L (≥ 130 mg/dL).After 2 weeks of an intervention‐free screening period, subjects were re‐evaluated, including by measurements of serum ALT levels. Subjects who did not meet any of the exclusion criteria were grouped into those with persistently elevated (> 1.25 times and ≤ 2.5 times ULN; 50–100 IU/L) and reduced (50 IU/L) concentrations. Excluded criteria: Overt and irreversible liver cirrhosis, serologically positive for viral markers or active viral hepatitis, cholestatic features (serum bilirubin > 2 X ULN), fasting triglyceride levels ≥ 4.52 mmol/L (400mg/dL), acute or unstable conditions, including a recent history (3 months) of myocardial infarction, advanced heart failure (New York Heart Association class III‐IV), renal dysfunction (serum creatinine ≥ 2.0 mg/dL), uncontrolled hypertension (DBP ≥ 100 mmHg), and thyroid dysfunction (TSH ≥ 1.5 X ULN). Medications prohibited from 1 month before the screening period until the completion of study included drugs that could potentially improve liver function test results (betaine, thiazolidinediones), those that could induce significant hepatic damage (synthetic estrogens, androgen, oral contraceptives, amiodarone, tamoxifen, erythromycin, tetracycline, sulfa antibiotics, methotrexate, perhexiline maleate, valproic acid, cocaine, zidovudine, didanosine, fialuridine, isoniazid, rifampicin, other anti‐tuberculosis medications, trazodone, nefazodone, venlafaxine, chlorpromazine, quinidine, gemfibrozil, herb medication), those that could affect lipid profiles (other HMG‐CoA reductase inhibitors, fibrates, niacin, ezetimibe, steroids, anti‐obesity drugs), and those known to have serious drug interactions with statins (ketoconazole, itraconazole, erythromycin, clarithromycin, cyclosporin, norethindrone, ethyl estradiol). Baseline Group Characteristics: Of these subjects, 129 were male and 60 were female, their mean age was 55.1 years, and 28% had been diagnosed with diabetes, 68% with hypertension, and 72% with metabolic syndrome. All demographic features; habits such as exercise, smoking, and drinking; and medication profiles were similar between the two groups.
Interventions	Intervention Characteristics 2 mg
Outcomes	Total cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better LDL cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better HDL cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Higher is better Triglycerides Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Judgement Comment: Controlled before‐and‐after design
Allocation concealment (selection bias)	High risk	Judgement Comment: Controlled before‐and‐after design
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Judgement Comment: Lipid parameter measurements unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Judgement Comment: Lipid parameters were measured in a remote laboratory.
Selective reporting (reporting bias)	Low risk	Judgement Comment: LDL‐cholesterol outcome was reported.
Other bias	High risk	Judgement Comment: The study was supported by JW Pharmaceutical Co, Korea.
Incomplete outcome data (attrition bias) Total cholesterol	High risk	[(103 ‐ 88)/103)]*100 = 14.6% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol)	High risk	[(103 ‐ 88)/103)]*100 = 14.6% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol	High risk	[(103 ‐ 88)/103)]*100 = 14.6% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) Triglycerides	High risk	[(103 ‐ 88)/103)]*100 = 14.6% were not included in the efficacy analysis.
Blinding of outcome assessment (detection bias)WDAEs	High risk	No comparison possible
Selective reporting (reporting bias) for WDAEs	High risk	No WDAE outcome reported