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. 2018 Mar 6;2018(3):CD012282. doi: 10.1002/14651858.CD012282.pub2

Milani 1995.

Methods 4‐week single‐blind placebo run‐in period
4‐week before and after trial
Participants 20 men and women with type IIa primary hypercholesterolaemia age 53 years
LDL‐C ≥ 160 mg/dL (4.14 mmol/L) Triglycerides ≤ 250 mg/dL (2.82 mmol/L)
exclusion criteria: secondary forms of dyslipidaemia, obesity, abnormal liver or renal function, patients with neoplasms, acute MI, coronary bypass surgery
Fluvastatin 40 mg/day baseline TC : 7.6 mmol/L (294 mg/dL)
 Fluvastatin 40 mg/day baseline LDL‐C : 5.5 mmol/L (213 mg/dL)
 Fluvastatin 40 mg/day baseline HDL‐C : 1.1 mmol/L (42.5 mg/dL)
Fluvastatin 40 mg/day baseline triglycerides: 2.1 mmol/L (186 mg/dL)
Interventions 40 mg/day fluvastatin for 4 weeks
40 mg/day pravastatin for 4 weeks
Outcomes per cent change from baseline at 4 weeks of plasma TC, LDL‐C, HDL‐C and triglycerides
Source of Funding unknown
Notes 40 mg/day pravastatin for 4 weeks group was not analysed
SDs were imputed by the method of Furikawa 2006
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Controlled before and after design
Allocation concealment (selection bias) High risk Controlled before and after design
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Lipid parameter measurements unlikely influenced by lack of blinding
Blinding of outcome assessment (detection bias) 
 LDL‐cholesterol Low risk Lipid parameters were measured in a remote laboratory
Blinding of outcome assessment (detection bias) 
 WDAEs High risk Not a blinded trial
WDAEs were not reported compared to placebo
Incomplete outcome data (attrition bias) 
 All outcomes 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 was not reported