Sansanayudh 2010.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: No washout required because participants were not on lipid medications; 8‐week before‐and‐after study with evening dosing
Participants	Baseline Characteristics 1 mg n: 50 Age (years): 59.2 Males (n): 16 Females (n): 34 BMI: 24.55 Total cholesterol: 258.44 mg/dL (6.68 mmol/L) LDL cholesterol: 175.99 mg/dL (4.55 mmol/L) HDL cholesterol: 53.4 mg/dL (1.38 mmol/L) Triglycerides: 145.22 mg/dL (1.64 mmol/L) Included criteria: patients older than 18 years of age with hypercholesterolaemia who had an indication for statin therapy according to the NCEP‐ATPIII guidelines (i.e. CHD or CHD risk equivalents and LDL‐C ≥ 100 mg/dL; ≥ 2 risk factors [10‐y risk 10‐20%] and LDL‐C ≥ 130 mg/dL; ≥ 2 risk factors [10‐y risk 10%] and LDL‐C ≥ 160 mg/dL; 0‐1 risk factor and LDL‐C ≥ 190 mg/dL) Excluded criteria: currently taking drugs known to affect lipid metabolism or interact with pitavastatin or atorvastatin (e.g. estrogen, corticosteroids, azole antifungals, fibrates, ticlopidine, thiazolidinedione, phenobarbital, and valproic acid), had previously been treated with statins, had active liver disease or elevated liver enzyme levels (AST or ALT > 3 times the upper limit of normal[ULN]), had CK levels more than 10 times the ULN, or had severe renal impairment (creatinine clearance 30 mL/min), pregnancy or lactation and triglyceride (TG) level > 400 mg/dL. Baseline Group Characteristics: Baseline characteristics were similar between treatment groups with the exception of mean AST.
Interventions	Intervention Characteristics 1 mg
Outcomes	Total cholesterol Outcome type: Continuous LDL cholesterol Outcome type: Continuous
Notes	Stephen P on 01/02/2018 09:23 Outcomes Given versus calculated percentage changes from baseline for HDL cholesterol and triglycerides had a greater than 10% difference (2.76 vs ‐0.4) and (‐10.4 vs ‐18.4) therefore HDL cholesterol and triglyceride outcomes were not reported.
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	Unclear risk	Judgement Comment: Source of funding was not reported.
Incomplete outcome data (attrition bias) Total cholesterol	Low risk	[(50 ‐ 48)/50]*100 = 4% missing data were replaced by series mean, see Table 3.
Incomplete outcome data (attrition bias) LDL cholesterol)	Low risk	[(50 ‐ 48)/50]*100 = 4% missing data were replaced by series mean, see Table 3.
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	[(50 ‐ 48)/50]*100 = 4% missing data were replaced by series mean, see Table 3.
Incomplete outcome data (attrition bias) Triglycerides	Low risk	[(50 ‐ 48)/50]*100 = 4% missing data were replaced by series mean, see Table 3.
Blinding of outcome assessment (detection bias)WDAEs	High risk	No comparison possible
Selective reporting (reporting bias) for WDAEs	High risk	No WDAE outcome reported