Goto 1996a.
Methods | 4‐week washout period 12‐week before‐and‐after study |
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Participants | 163 men and women with type IIa and IIb hyperlipidaemia aged 20‐70 years old were randomised to receive cerivastatin 162 men and women with type IIa and IIb hyperlipidaemia aged 20‐70 years old were randomised to receive pravastatin TC ≥ 220 mg/dL (5.69 mmol/L), moderate hypertension, mild diabetes, obese, cholelithiasis Exclusion criteria: secondary hyperlipidaemia, hypothyroidism, Cushings syndrome, obstructive gallbladder disease, SLE, uncontrolled diabetes, severe hypertension, alcoholism, various hormonal agents, drugs that interfere with lipid metabolism, severe brain disease, liver and kidney dysfunction, diet therapy for obesity, pancreatic disease, cerebrovascular disease, MI within 3 months of trial, drug hypersensitivity, potential for pregnancy and lactation Cerivastatin 0.15 mg/d baseline TC: 7.12 mmol/L (275 mg/dL) Cerivastatin 0.15 mg/d baseline LDL‐C: 4.98 mmol/L (193 mg/dL) |
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Interventions | Cerivastatin 0.15 mg/d evening dosing Pravastatin 10 mg/d |
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Outcomes | Percentage change from baseline at 8 weeks of blood TC and LDL‐C | |
Source of funding | Unknown | |
Notes | Pravastatin 10 mg/d was not analysed HDL‐C and TG data were excluded because the given data and the calculated values differed by > 10% |
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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‐C | Low risk | Lipid parameters were measured in a remote laboratory |
Blinding of outcome assessment (detection bias) WDAE | High risk | No comparison possible |
Incomplete outcome data (attrition bias) Total cholesterol | High risk | [(163‐137)/163]*100 = 16.0% participants were not included in the efficacy analysis |
Incomplete outcome data (attrition bias) LDL cholesterol | High risk | [(163‐130)/163]*100 = 20.2% participants were not included in the efficacy analysis |
Incomplete outcome data (attrition bias) HDL cholesterol | High risk | Excluded because the given data and the calculated values differed by > 10% |
Incomplete outcome data (attrition bias) Triglycerides | High risk | Excluded because the given data and the calculated values differed by > 10% |
Selective reporting (reporting bias) | Low risk | LDL‐C outcome was reported |
Other bias | Unclear risk | Source of funding not reported |