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 |