Shimabukuro 2011.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: 4‐week dietary lead‐in period; 3‐month before‐and‐after study
Participants	Baseline Characteristics 2 mg n: 16 Age (years): 65.6 Males (n): 5 Females (n): 11 BMI: 25 Total cholesterol: 6.50 mmol/L (251 mg/dL) LDL cholesterol: 4.32 mmol/L (167 mg/dL) HDL cholesterol: 1.34 mmol/L (52 mg/dL) Triglycerides: 1.77 mmol/L (157 mg/dL) Included criteria: men or women aged 30‐79 with type 2 diabetes with hypercholesterolaemia [total cholesterol ≥ 5.70 mmol/L (220 mg/dL)] and/or hypertriglyceridaemia [triglycerides 1.70–3.96 mmol/L (150–350 mg/dL)] Excluded criteria: a past history of hypersensitivity to statins; hepatic dysfunction [serum levels of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 100 IU], suspected disorder of hepatic metabolism or biliary obstruction (acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer and jaundice); renal dysfunction [serum creatinine ≥ 133 umol/L(1.5 mg/dL)], pregnant, possibly pregnant or breastfeeding women; patients with poorly controlled diabetes mellitus [HbA1c > 9.4% (National Glycohemoglobin Standardization Program), 79 mmol/L (International Federation of Clinical Chemistry and Laboratory Medicine)], recent history of cerebrovascular disease, coronary heart disease or congestive heart failure; familial hypercholesterolaemia; secondary hyperlipidaemia other than that associated with diabetes mellitus Baseline Group Characteristics: There were no differences in characteristics between two groups
Interventions	Intervention Characteristics 2 mg
Outcomes	Total cholesterol Outcome type: Continuous Reporting: Fully reported Unit of measure: Percentage change from baseline Direction: Lower is better LDL cholesterol Outcome type: Continuous Reporting: Fully reported Unit of measure: Percentage change from baseline Direction: Lower is better HDL cholesterol Outcome type: Continuous Reporting: Fully reported Unit of measure: Percentage change from baseline Direction: Higher is better Triglycerides Outcome type: Continuous Reporting: Fully 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	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	Low risk	All participants were 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