Dergunov 2003.
Methods | 8‐week dietary run‐in period 16‐week before and after trial |
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Participants | 67 men with controlled hypertension LDL‐C > 4.1 mmol/L (159 mg/dL) TG 0.49‐3.26 mmol/L (43‐289 mg/dL) exclusion criteria: none reported Fluvastatin 20 mg/day baseline TC : 6.93 mmol/L (268 mg/dL) Fluvastatin 20 mg/day baseline LDL‐C : 5.07 mmol/L (196 mg/dL) Fluvastatin 20 mg/day baseline HDL‐C : 1.06 mmol/L (41 mg/dL) Fluvastatin 20 mg/day baseline triglycerides: 1.765 mmol/L (156 mg/dL) |
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Interventions | Fluvastatin 20 mg/day for 0‐4 weeks Fluvastatin 20‐40 mg/day for 4‐8 and 8‐12 weeks Off fluvastatin for 12‐16 weeks |
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Outcomes | per cent change from baseline at 4 weeks of serum TC, LDL‐C, HDL‐C, and triglycerides | |
Source of Funding | partially by Russian Foundation for Basic Research grant 01‐04‐48140 | |
Notes | ||
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 | Partially funded by Russian Foundation for Basic Research grant 01‐04‐48140 |