PREVAIL‐US 2016.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: 6‐week washout/dietary stabilisation; 12‐week before‐and‐after study
Participants	Baseline Characteristics 4 mg n: 164 Age (years): 58.8 Males (n): 81 Females (n): 83 BMI: 30.2 HDL cholesterol: 50 mg/dL (1.29 mmol/L) Included criteria: Participants were aged 18 to 80 years with either primary hyperlipidaemia or mixed dyslipidaemia. After a 6‐week washout/dietary stabilisation, subjects had LDL‐C levels of 130 to 220 mg/dL and TG levels ≤ 400 mg/dL. Excluded criteria: Familial hypercholesterolaemia, secondary causes of dyslipidaemia such as nephrotic syndrome, previous intolerance or allergy to statins, uncontrolled diabetes mellitus (defined as a glycosylated haemoglobin level > 8%), poorly controlled hypertension (blood pressure ≥ 160/100 mm Hg), or the presence of any unstable medical conditions Baseline Group Characteristics: The majority of participants in both groups were white (89.0% and 86.0%, respectively). Approximately 70% of participants in both groups were diagnosed with primary hyperlipidaemia and the other 30% with mixed dyslipidaemia.
Interventions	Intervention Characteristics 4 mg
Outcomes	HDL cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Higher 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)	High risk	Judgement Comment: LDL‐cholesterol outcome was not reported.
Other bias	High risk	Judgement Comment: Dr. Sponseller is an employee of Kowa Pharmaceuticals America, Inc. Kowa Pharmaceuticals sell pitavastatin
Incomplete outcome data (attrition bias) Total cholesterol	High risk	No outcome reported
Incomplete outcome data (attrition bias) LDL cholesterol)	High risk	No outcome reported
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	[(164 ‐ 157)/164]*100 = 4.3% participants were not included in the efficacy analysis
Incomplete outcome data (attrition bias) Triglycerides	High risk	No outcome reported
Blinding of outcome assessment (detection bias)WDAEs	High risk	No comparison possible
Selective reporting (reporting bias) for WDAEs	High risk	No WDAE outcome reported