Huhle 1999.
Methods | 4‐week dietary placebo run‐in period 8‐week randomised, double‐blind, placebo‐controlled trial |
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Participants | 22 men and women age 30‐70 years serum LDL‐C > 160 mg/dL (4.14 mmol/L) serum TG < 300 mg/dL (3.39 mmol/L) exclusion criteria: type 1 diabetes mellitus, pregnancy severe liver and/or pancreatic disease renal failure, MI within 2 months of trial, heart failure, uncontrolled hypertension and medications that affect lipids within 3 weeks of trial |
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Interventions | Placebo 0‐8 weeks Fluvastatin 40 mg twice daily for 0‐8 weeks |
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Outcomes | per cent change from baseline at 8 weeks of serum TC, LDL‐C, HDL‐C, and triglycerides | |
Source of Funding | unknown | |
Notes | WDAEs were not reported 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) | Unclear risk | Random sequence generation method not reported |
Allocation concealment (selection bias) | Unclear risk | Aallocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind treatment placebo and fluvastatin capsule appearances were not reported as appearing identical Lipid parameter measurements unlikely influenced by lack of proper 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 | WDAEs were not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 9% 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 |