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

Tvorogova 1998.

Methods no washout period required because no patient was receiving hypolipidaemic treatment within 3 months of trial entry
1‐month dietary stabilisation period
3‐month before and after trial
Participants 61 patients with primary hyperlipoproteinaemia, CAD with stable angina class II and III
Total cholesterol > 6.5 mmol/L (250 mg/dL)
LDL‐C > 4.3 mmol/L (165 mg/dL)
36 patients mean age of 45.9 years received simvastatin
25 patients mean age of 47.2 years received fluvastatin
exclusion criteria: diabetes, nephrotic syndrome, chronic renal failure, liver disease, hypothyroidism, congestive heart failure, obesity grade II and III, worsening of diseases of the gastrointestinal tract
Fluvastatin 20 mg/day baseline TC : 10.52 mmol/L (407 mg/dL)
 Fluvastatin 20 mg/day baseline LDL‐C : 7.92 mmol/L (306 mg/dL)
 Fluvastatin 20 mg/day baseline HDL‐C : 1.27 mmol/L (49 mg/dL)
Fluvastatin 20 mg/day baseline triglycerides: 2.5 mmol/L (221 mg/dL)
Interventions Fluvastatin 20 mg/day
Simvastatin 10 mg /day
Outcomes per cent change from baseline at 3 months of blood TC, LDL‐C, HDL‐C, and triglycerides
Source of Funding unknown
Notes Simvastatin 10 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