Eriksson 2011.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Methods: 6‐8 week washout period, 4 week before‐and‐after trial with evening dosing
Participants	Baseline Characteristics 2 mg n: 233 Males (n): 158 Females (n): 75 Age (years): 60.1 Heterozygous Familial Hypercholesterolemia: 4 Included criteria: Patients of either gender were eligible for inclusion in the study if they were aged 18‐75 years and had primary hypercholesterolaemia or combined dyslipidaemia that was uncontrolled (LDL‐C ≥ 3.4 mmol/L [130 mg/dL] and ≤ 5.7mmol/L [220 mg/dL]; triglycerides ≤ 4.6 mmol/L [400 mg/dL]) despite dietary measures. In addition, patients were required to have at least two of the following cardiovascular risk factors: cigarette smoking; blood pressure of 140/90 mmHg or above or receiving antihypertensive therapy; a high‐density lipoprotein cholesterol (HDL‐C) concentration of 1 mmol/L (40 mg/dL) or below; a family history of CHD in a male or female first‐degree relative below 55 or below 65 years of age, respectively; age above 45 years in men or above 55 years in women. An HDL‐C concentration above 1.55 mmol/L (60 mg/dL) was considered to offset one risk factor. Patients who were receiving lipid‐modifying therapies were eligible for inclusion if such treatment was withdrawn at least 8 weeks before randomisation. Excluded criteria: The principal exclusion criteria were homozygous familial hypercholesterolaemia, unstable medical conditions, or conditions associated with secondary dyslipidaemia, conditions that might affect drug pharmacokinetics, significant cardiovascular disease, or symptomatic heart failure (left ventricular ejection fraction 0.25) or cerebrovascular disease, uncontrolled or poorly controlled hypertension, uncontrolled diabetes (> 8% glycated haemoglobin), impaired liver or kidney function, or other serious medical conditions. Women of childbearing potential were required to have a negative pregnancy test at the start of the dietary run‐in period and before starting treatment, and to use adequate contraception throughout the study. Baseline Group Characteristics: The two groups were well matched in terms of their baseline characteristics. The mean age of the patients was approximately 60 years, about two‐thirds were male, and all except one were white. The majority of patients (>80%) had primary hypercholesterolaemia, and approximately three‐quarters were at moderate or high cardiovascular risk according to the NCEP criteria.
Interventions	Intervention Characteristics 2 mg
Outcomes	LDL‐cholesterol Outcome type: Continuous Reporting: Fully reported Unit of measure: Percentage change from baseline Direction: Lower is better Data value: Change from baseline
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	High risk	Judgement Comment: The study was supported by Kowa Research Europe Ltd.
Incomplete outcome data (attrition bias) Total cholesterol	Low risk	[(236 ‐ 233)/236]*100 =1.3% participants were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol)	Low risk	[(236 ‐ 233)/236]*100 =1.3% participants were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	[(236 ‐ 233)/236]*100 =1.3% participants were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) Triglycerides	Low risk	[(236 ‐ 233)/236]*100 =1.3% participants 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