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

Sarano 2003.

Methods 8‐week dietary washout period
16‐week before and after trial
Participants 56 men and women with coronary artery disease with type 2 diabetes mellitus controlled with oral medication LDL‐C = 4.1 mmol/L (159 mg/dL)
Triglycerides > 2.3 mmol/L (204 mg/dL)
30 men and women with coronary artery disease and mixed hyperlipidaemia without diabetes mellitus
all participants ranged in age from 40‐70 years
40 participants received fluvastatin
Included patients were on a standard lipid‐lowering diet and those with type 2 diabetes a diet with reduced carbohydrate content
Inclusion criteria: unstable angina, MI, coronary bypass surgery, balloon angioplasty within 6 months of study, type 1 diabetes mellitus, uncontrolled diabetes, renal dysfunction, hepatic dysfunction
no exclusion criteria
cholelithiasis and triglycerides > 4.5 mmol/L (399 mg/dL)
Fluvastatin 40 mg/day baseline TC : 7.88 mmol/L (305 mg/dL)
 Fluvastatin 40 mg/day baseline LDL‐C : 5.45 mmol/L (211 mg/dL)
 Fluvastatin 40 mg/day baseline HDL‐C : 1.01 mmol/L (39 mg/dL)
Fluvastatin 40 mg/day baseline triglycerides: 3.14 mmol/L (278 mg/dL)
Interventions Fluvastatin 40 mg/day
Fenofibrate 200 mg/day
Outcomes per cent change from baseline at 4 weeks of serum TC, LDL‐C, HDL‐C, and triglycerides
Source of Funding unknown
Notes Fenofibrate 200 mg/day group was 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 Unclear risk Source of funding was not reported