Weiss 1998.
Methods | 8‐week dietary‐stabilisation drug washout period 12‐week before and after trial |
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Participants | 1776 men and women 18‐75 years old with moderate hypercholesterolaemia LDL‐C ≥150 mg/dL (3.88 mmol/L) exclusion criteria: triglycerides ≥ 350 mg/dL (3.95 mmol/L) SGOT > 1.2 X ULN type 1 diabetes mellitus, participants were 40% above ideal weight Fluvastatin 20 mg/day baseline TC : 6.81 mmol/L (263 mg/dL) Fluvastatin 20 mg/day baseline LDL‐C : 4.59 mmol/L (177 mg/dL) Fluvastatin 20 mg/day baseline HDL‐C : 1.29 mmol/L (50 mg/dL) Fluvastatin 20 mg/day baseline triglycerides: 2.06 mmol/L (182 mg/dL) |
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Interventions | Fluvastatin 20 mg/day for 0‐6 weeks Fluvastatin could be titrated to 40 mg/day for 6‐12 weeks |
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Outcomes | per cent change from baseline at 6 weeks of plasma TC, LDL‐C, HDL‐C, and triglycerides | |
Source of Funding | unknown | |
Notes | the titrated time period of 6‐12 weeks was not included in the analysis | |
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 | 8.3% participants were not 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 |