Balletshofer 2005.

Methods	4‐week run‐in period 12‐week RCT
Participants	58 men and women with type 2 diabetes aged 35‐75 years old LDL‐C 100 mg/dL (2.57 mmol/L)‐190 mg/dL (4.91 mmol/L) Exclusion criteria: patients under therapy with heparin, known thrombophilia, neoplasia, unstable angina, known intolerance or hypersensitivity to statins, major organ system failure, transplantation, organic brain syndrome, clinically manifest hypothyroidism, pregnancy or lactation period, women of childbearing potential not using adequate methods of contraception, myopathy (CK > 3 times ULN), impaired hepatic function (SGOT or SGPT > 2 times ULN), SCr > 2 mg/dL, intake of drugs influencing endothelial function if a dose change (inc. start or withdrawal) occurred within the last 12 weeks prior to the screening visit, intake of statins within the last 8 weeks prior to the screening visit, drug or alcohol abuse, reversal of a normal sleep/wake cycle (e.g. patients on nightshift) Placebo baseline TC: 6.0 mmol/L (232.1 mg/dL) Placebo baseline LDL‐C: 3.9 mmol/L (150.8 mg/dL) Placebo baseline HDL‐C: 1.1 mmol/L (42.5 mg/dL) Placebo baseline TG: 2.3 mmol/L (203.7 mg/dL) Cerivastatin 0.2 mg/d baseline TC: 5.9 mmol/L (228.2 mg/dL) Cerivastatin 0.2 mg/d baseline LDL‐C: 3.8 mmol/L (146.9 mg/dL) Cerivastatin 0.2 mg/d baseline HDL‐C: 1.3 mmol/L (50.3 mg/dL) Cerivastatin 0.2 mg/d baseline TG: 2.0 mmol/L (177.1 mg/dL) Cerivastatin 0.8 mg/d baseline TC: 5.4 mmol/L (208.8 mg/dL) Cerivastatin 0.8 mg/d baseline LDL‐C: 3.5 mmol/L (135.3 mg/dL) Cerivastatin 0.8 mg/d baseline HDL‐C: 1.2 mmol/L (46.4 mg/dL) Cerivastatin 0.8 mg/d baseline TG: 1.8 mmol/L (159.4 mg/dL)
Interventions	Placebo Cerivastatin 0.2 mg/d Cerivastatin 0.8 mg/d
Outcomes	Percentage change from baseline at 12 weeks of plasma TC, LDL‐C, HDL‐C, TG and WDAEs
Source of funding	Unknown
Notes	SDs were imputed by the method of Furukawa 2006
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of random sequence generation was not reported
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment was not reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Lipid parameter measurements unlikely influenced by lack of sufficient blinding
Blinding of outcome assessment (detection bias) LDL‐C	Low risk	LDL‐C was measured in a remote laboratory
Blinding of outcome assessment (detection bias) WDAE	Unclear risk	Blinding method was not described
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
Selective reporting (reporting bias)	Low risk	LDL‐C outcome was reported
Other bias	Unclear risk	Source of funding not reported