Saito 2002b.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: more than 4 weeks run‐in period; 12‐week before‐and‐after study with evening dosing
Participants	Baseline Characteristics 2 mg n: 125 Age (years): 57.5 Males (n): 40 Females (n): 85 BMI: 23.9 Total cholesterol: 279.7 mg/dL (7.23 mmol/L) LDL cholesterol: 194.2 mg/dL (5.02 mmol/L) HDL cholesterol: 56.8 mg/dL (1.47 mmol/L) Triglycerides: 158 mg/dL (1.78 mmol/L) Fredrickson IIa: 73 Fredrickson IIb: 52 Included criteria: Women and men between the ages of 20 and 75 years with primary hyperlipidaemia, with a TC value ≥ 220 mg/dL and TG values ≤ 400 mg/dL Excluded criteria: Pregnant women and those who were breastfeeding, subjects who had taken pitavastatin, had participated in other studies 4 months prior to the study, suffered from uncontrolled diabetes mellitus or severe hypertension or had a cerebrovascular disorder or myocardial infarction diagnosed 3 months prior to the study, heart failure, hepatic or renal dysfunction or drug allergy. Baseline Group Characteristics: Based on baseline characteristics, all demographic and prognostic factors and lipid parameters were well balanced between the two treatment groups.
Interventions	Intervention Characteristics 2 mg
Outcomes	Total cholesterol Outcome type: Continuous Reporting: Partially reported Unit of measure: Percentage change from baseline Direction: Lower is better LDL cholesterol Outcome type: Continuous Reporting: Partially reported 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 Reporting: Partially reported 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	Unclear risk	Judgement Comment: Source of funding was not reported.
Incomplete outcome data (attrition bias) Total cholesterol	Low risk	[(125 ‐ 120)]*100 = 4% participants were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol)	Low risk	[(125 ‐ 120)]*100 = 4% participants were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	[(125 ‐ 120)]*100 = 4% participants were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) Triglycerides	High risk	[(125 ‐ 75)]*100 = 40% 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