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 |
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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) |
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Interventions | Fluvastatin 20 mg/day Simvastatin 10 mg /day |
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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 |
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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 |