Kakuda 2013.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: Participants were not on any medication; no washout required; 4‐week before‐and‐after trial
Participants	Baseline Characteristics 2 mg n: 10 Males (n): 10 Females (n): 0 Total cholesterol: 197.9 mg/dL (5.12 mmol/L) LDL cholesterol: 121.5 mg/dL (3.14 mmol/L) HDL cholesterol: 56.6 mg/dL (1.46 mmol/L) Included criteria: Japanese men, who agreed to undergo pitavastatin treatment and mixed meal test, were involved in this study (n = 10;age: 33.9 ± 10.1 years; body height 172.0 ± 4.3 cm; body weight 80.2 ± 25.3 kg; body mass index (BMI) 27.0 ± 8.3kg/m2; waist circumference 88.5 ± 18.9 cm) Excluded criteria: not reported. Baseline Group Characteristics: Japanese men, (n = 10; age 33.9 ± 10.1 years; body height 172.0 ± 4.3 cm; body weight 80.2 ± 25.3 kg; body mass index (BMI) 27.0 ± 8.3 kg/m2 ; waist circumference 88.5 ± 18.9 cm). None of them had received medication.
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
Notes	Stephen P on 02/02/2018 08:13 Outcomes Triglyceride outcome was not included in the efficacy analysis because the values were expressed as medians.
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	All participants were included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol)	Low risk	All participants were included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	All participants were included in the efficacy analysis.
Incomplete outcome data (attrition bias) Triglycerides	High risk	Triglyceride data 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