Gumprecht 2011.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: 6‐8 week washout period, 12 week before‐and‐after study with evening dosing
Participants	Baseline Characteristics 2 mg n: 275 Males (n): 155 Females (n): 120 BMI : 29.4 LDL cholesterol: 143 mg/dL (3.7 mmol/L) Included criteria: Eligible patients were aged 18 – 75 years with type 2 diabetes [haemoglobin A1c (HbA1c) ≤ 7.5%] and combined dyslipidaemia [plasma LDL‐C ≥ 100 and ≤ 220 mg/dL (≥ 2.6 and ≤ 5.7 mmol/L) and triglycerides (TG) ≥ 150 mg/dL ( ≥1.7 mmol/L)], despite dietary therapy, and were receiving an oral antidiabetic treatment (not including glitazones) or insulin. Eligible patients had a body mass index (BMI) of not more than 35 kg/m2, and women of childbearing potential had to use reliable contraception. Excluded criteria: homozygous familial hypercholesterolaemia; other conditions with potential to cause secondary dyslipidaemia, including human immunodeficiency virus infection; HbA1c more than 7.5%; significant cardiovascular disease; history of cerebrovascular disease, neoplastic disease within 10 years, unexplained increased serum creatine kinase (CK) of more than five times the upper limit of the reference range (ULRR); systolic blood pressure above 160 mmHg and diastolic blood pressure above 90 mmHg; history of muscular or neuromuscular disease; and history of resistance to lipid‐lowering therapy or use of supplements that affect lipid metabolism Baseline Group Characteristics: Baseline characteristics were generally well matched across randomised treatment groups in the core study. Most patients were Caucasian (88%) and male (57%), with a mean age of 59 years. All patients were in the NCEP high‐risk category; most were hypertensive (77%) and 49% had previously received a lipid‐modifying therapy.
Interventions	Intervention Characteristics 2 mg
Outcomes	LDL cholesterol Outcome type: Continuous 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: Kowa Research Europe Ltd. supported this trial.
Incomplete outcome data (attrition bias) Total cholesterol	Low risk	[(279 ‐ 274)/279]*100 = 1.8% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol)	Low risk	[(279 ‐ 274)/279]*100 = 1.8% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	[(279 ‐ 274)/279]*100 = 1.8% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) Triglycerides	Low risk	[(279 ‐ 274)/279]*100 = 1.8% 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