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

Okopien 2005.

Methods no washout period required because no patient was receiving hypolipidaemic treatment within 3 months of the trial
3‐month before and after trial
Participants 131 men and women with type IIa and IIb dyslipidaemia 33 type IIa participants received fluvastatin
type IIa plasma TC > 200 mg/dL ( 5.17 mmol/L), LDL‐C >135 mg/dL (3.49 mmol/L) TG < 200 mg/dL (2.26 mmol/L)
type IIb plasma TC > 200 mg/dL ( 5.17 mmol/L), LDL‐C >135 mg/dL (3.49 mmol/L) TG > 200 mg/dL (2.26 mmol/L)
ineffective dietary treatment for at least 3 months
common carotid intima‐media thickness ≥0.7 mm
exclusion criteria: age > 65 years or < 35 years, other types of primary dyslipidaemias, secondary dyslipidaemia,
acute or chronic inflammation, symptomatic congestive heart failure, unstable coronary artery disease, MI or stroke within 6 month of trial, moderate or severe arterial hypertension, hepatic or renal dysfunction, malabsorption syndromes, received other drugs that may affect trial, HRT or oral contraception and poor patient compliance
Fluvastatin 40 mg/day baseline TC : 7.15 mmol/L (276 mg/dL)
 Fluvastatin 40 mg/day baseline LDL‐C : 4.71 mmol/L (182 mg/dL)
 Fluvastatin 40 mg/day baseline HDL‐C : 1.27 mmol/L (49 mg/dL)
Fluvastatin 40 mg/day baseline triglycerides: 1.614 mmol/L (143 mg/dL)
Interventions Type IIa Fluvastatin 40 mg/day
Type IIa Simvastatin 20 mg/day
Type IIb Ciprofibrate 100 mg/day
Type IIb Fenofibrate 200 mg/day
Outcomes per cent change from baseline at 1‐3 months of plasma TC, LDL‐C, HDL‐C, and triglycerides
Source of Funding statuary grant NN‐4‐061/98 of the Medical University of Silesia
Notes Type IIa Simvastatin 20 mg/day
Type IIb Ciprofibrate 100 mg/day
Type IIb Fenofibrate 200 mg/day
groups were not included in the efficacy analysis
SDs were imputed by the method of Furukawa 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 No comparison possible
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 Low risk statuary grant NN‐4‐061/98 of the Medical University of Silesia