Ding 1997.
Methods | participants could not be taking any lipid‐lowering drugs and had to adhere to a low‐cholesterol diet for at least 6 weeks 12‐week randomised double‐blind placebo‐controlled trial |
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Participants | 46 type 2 diabetic patients stable diabetes control Placebo baseline TC : 6.2 mmol/L (240 mg/dL) Placebo baseline LDL‐C : 4.3 mmol/L (166 mg/dL) Placebo baseline HDL‐C : 1.2 mmol/L (46 mg/dL) Placebo baseline triglycerides: 1.6 mmol/L (142 mg/dL) Fluvastatin 20 mg/day baseline TC : 6.3 mmol/L (244 mg/dL) Fluvastatin 20 mg/day baseline LDL‐C : 4.5 mmol/L (174 mg/dL) Fluvastatin 20 mg/day baseline HDL‐C : 1.1 mmol/L (42.5 mg/dL) Fluvastatin 20 mg/day baseline triglycerides: 1.5 mmol/L (132 mg/dL) |
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Interventions | Placebo 0‐6 weeks Placebo 6‐12 weeks Fluvastatin 20 mg/day 0‐6 weeks Fluvastatin 40 mg/day 6‐12 weeks |
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Outcomes | per cent change from baseline at 6 weeks of serum TC, LDL‐C, HDL‐C, triglycerides and WDAEs | |
Source of Funding | unknown | |
Notes | Placebo 6‐12 weeks Fluvastatin 40 mg/day 6‐12 weeks groups were not analysed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random sequence generation was not reported |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment was not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind 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 | Low risk | no patient discontinued medication because of adverse effects |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 13% 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 |