Budinski 2009.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Parallel group Methods: 6 to 8‐week dietary lead‐in period; 12‐week before‐and‐after trial
Participants	Baseline Characteristics 2 mg n: 316 Age (years): 58.4 Male: 142 Female: 174 Familial hypercholesterolaemia: 1 Total cholesterol: 263.5 mg/dL (6.81mmol/L) LDL cholesterol: 183.5 mg/dL (4.75 mmol/L) HDL cholesterol: 48.5 mg/dL (1.25 mmol/L) Triglycerides: 157.7 mg/dL (1.78 mmol/L) 2 mg then uptitrated to 4 mg at week 4 n: 300 Age (years): 57.9 Male: 136 Female: 164 Familial hypercholesterolaemia: 2 Total cholesterol: 263.3 mg/dL (6.81 mmol/L) LDL cholesterol: 181.8 mg/dL (4.70 mmol/L) HDL cholesterol: 49.9 mg/dL (1.29 mmol/L) Triglycerides: 157.4 mg/dL (1.78 mmol/L) 2 mg combined data n: 616 Age (years): Male: 278 Female: 338 Familial hypercholesterolaemia: 3 Overall n: 616 Included criteria: men and non‐pregnant, nonlactating women, aged 18 to 75 years, diagnosed with primary hypercholesterolaemia or combined dyslipidaemia. mean fasting LDL‐C levels of 160 mg/dL or more (4.1 mmol/L) and less than or equal to 220 mg/dL (5.7mmol/L), and TG levels of less than or equal to 400 mg/dL (4.5 mmol/L) at the end of the lead‐in period Excluded criteria: previous contraindications or intolerance to statin therapy, homozygous familial hypercholesterolaemia, familial hypoalpha‐lipoproteinaemia, conditions that might have caused secondary dyslipidaemia, uncontrolled diabetes mellitus, pregnancy, conditions affecting absorption, distribution, metabolism or excretion of drugs, symptomatic heart failure (New York Heart Association classification III or IV), significant cardiovascular disease, impaired pancreatic function, liver enzyme levels greater than 1.5‐times the upper limit of normal, impaired renal function, impaired urinary tract function, uncontrolled hypothyroidism, symptomatic cerebrovascular disease, left ventricular ejection fraction less than 0.25, uncontrolled hypertension, muscular or neuromuscular disease, neoplastic disease, treatment with other lipid‐lowering drugs and treatment that would interact with the pharmacokinetics of statins. Women of childbearing potential were only allowed to participate if they were using a reliable contraceptive method. Baseline Group Characteristics: The treatment groups were well matched in terms of age, vital statistics (height, weight and BMI) and disease diagnosis and duration. Approximately 79% of patients in each treatment group had primary hypercholesterolaemia (78.4 to 79.1%) and most of the remainder had combined dyslipidaemia. The groups were also well matched in diagnosis of hypertension and in baseline lipid values. Study subjects included slightly more women than men, and this balance was reflected across the treatment groups
Interventions	Intervention Characteristics 2 mg 2 mg then uptitrated to 4 mg at week 4 2 mg combined data
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: Lower is better Triglycerides Outcome type: Continuous 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	High risk	Judgement Comment: Kowa Research Europe Ltd. sponsored the trial.
Incomplete outcome data (attrition bias) Total cholesterol	Low risk	[(316 ‐ 315)/316]*100 = 0.3% were not included in the efficacy analysis for the pitavastatin 2 mg/day; [(300 ‐ 298)/300]*100 = 0.7% were not included in the efficacy analysis for the pitavastatin 2 mg/day then titrated to 4 mg/day at week 4.
Incomplete outcome data (attrition bias) LDL cholesterol)	Low risk	[(316 ‐ 315)/316]*100 = 0.3% were not included in the efficacy analysis for the pitavastatin 2 mg/day; [(300 ‐ 298)/300]*100 = 0.7% were not included in the efficacy analysis for the pitavastatin 2 mg/day then titrated to 4 mg/day at week 4.
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	[(316 ‐ 315)/316]*100 = 0.3% were not included in the efficacy analysis for the pitavastatin 2 mg/day; [(300 ‐ 298)/300]*100 = 0.7% were not included in the efficacy analysis for the pitavastatin 2 mg/day then titrated to 4 mg/day at week 4.
Incomplete outcome data (attrition bias) Triglycerides	Low risk	[(316 ‐ 315)/316]*100 = 0.3% were not included in the efficacy analysis for the pitavastatin 2 mg/day; [(300 ‐ 298)/300]*100 = 0.7% were not included in the efficacy analysis for the pitavastatin 2 mg/day then titrated to 4 mg/day at week 4.
Blinding of outcome assessment (detection bias)WDAEs	High risk	No comparison possible
Selective reporting (reporting bias) for WDAEs	High risk	No WDAE outcome reported