Teramoto 2001.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: 4 to 6‐week washout period; 8‐week before‐and‐after study with evening dosing; HDL cholesterol data weres not included in the efficacy analysis because the calculated percentage change versus given percentage change was greater than 10%.
Participants	Baseline Characteristics Pitavastatin 2 mg/day n: 313 Age (years): 57.4 Males (n): 106 Females (n): 207 Total cholesterol: 290 mg/dL (7.50 mmol/L) LDL cholesterol: 201.7 mg/dL (5.22 mmol/L) HDL cholesterol: 55.9 mg/dL (1.45 mmol/L) Triglycerides: 175 mg/dL (1.98 mmol/L) Included criteria: Serum total cholesterol value of 220 mg/dL (5.69 mmol/L) or more. Ages: 20‐75 years old. Excluded criteria: Patients with poor control of diabetes and patients with severe hypertension, patients with severe hepatopathy, renal impairment, myocardial infarction and cerebrovascular disorder attack (within 3 months after the attack) and patients with heart failure, women who are breastfeeding, pregnant women or women who desire pregnancy, patients with a history of drug hypersensitivity or a history of serious side effects, other patients who were judged inappropriate as subjects of this trial by the investigators, no consent of trial participation Baseline Group Characteristics: NR
Interventions	Intervention Characteristics Pitavastatin 2 mg/day Evening administration:
Outcomes	Total cholesterol Outcome type: Continuous LDL cholesterol Outcome type: Continuous Triglycerides Outcome type: Continuous
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	[(313 ‐ 295)/313]*100 = 5.8% were not included in the efficacy analysis for total cholesterol at 4 weeks; [(313 ‐ 277)/313]*100 = 11.5% were not included in the efficacy analysis for total cholesterol at 8 weeks.
Incomplete outcome data (attrition bias) LDL cholesterol)	Unclear risk	[(313 ‐ 289)/313]*100 = 7.7% were not included in the efficacy analysis for LDL cholesterol at 4 weeks; [(313 ‐ 268)/313]*100 = 14.4% were not included in the efficacy analysis for LDL cholesterol at 8 weeks.
Incomplete outcome data (attrition bias) HDL cholesterol	High risk	No data included in the efficacy analysis because the data differed by more than 10% between given and calculated values
Incomplete outcome data (attrition bias) Triglycerides	High risk	[(313 ‐ 138)/313]*100 = 55.9% were not included in the efficacy analysis for triglycerides at 4 weeks; [(313 ‐ 133)/313]*100 = 57.5% were not included in the efficacy analysis for triglycerides at 8 weeks.
Blinding of outcome assessment (detection bias)WDAEs	High risk	No comparison possible
Selective reporting (reporting bias) for WDAEs	High risk	No WDAE outcome reported