Arakawa 1996.
Methods | 4‐week placebo washout period 12‐week before‐and‐after study |
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Participants | 73 men and women with type IIa and IIb hyperlipidaemia aged 20‐64 years old, hypertension, mild diabetes, obesity, cholelithiasis TC ≥ 260 mg/dL (6.72 mmol/L) TG < 400 mg/dL (4.52 mmol/L) Exclusion criteria: secondary hyperlipidaemia, hypothyroidism, Cushings syndrome, obstructive gallbladder disease, SLE, nephrotic syndrome, poorly controlled diabetes, severe hypertension, alcohol abuse, drug‐induced hyperlipidaemia, dietary treatment for obesity, heart, brain, kidney, liver diseases, MI within 3 months, cerebrovascular disorder, statin hypersensitivity, pregnancy potential and lactation, those participants considered inappropriate by the investigator Cerivastatin 0.05 mg/d baseline TC: 7.30 mmol/L (282 mg/dL) Cerivastatin 0.15 mg/d baseline TC: 7.79 mmol/L (301 mg/dL) Cerivastatin 0.15 mg/d baseline LDL‐C: 5.66 mmol/L (219 mg/dL) Cerivastatin 0.3 mg/d baseline TC: 7.98 mmol/L (309 mg/dL) Cerivastatin 0.3 mg/d baseline LDL‐C: 5.76 mmol/L (223 mg/dL) |
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Interventions | Cerivastatin 0.15 mg/d evening dosing Cerivastatin 0.3 mg/d evening dosing |
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Outcomes | Percentage change from baseline at 4‐12 weeks of blood TC and LDL‐C | |
Source of funding | Unknown | |
Notes | HDL‐C and TG data were excluded because the given data and the calculated values differed by > 10% | |
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 | Low risk | All participants were included in the efficacy analysis for the cerivastatin 0.15 mg/d group for TC [(40‐39)/40]*100 = 2.5% participants were not included in the efficacy analysis for the cerivastatin 0.3 mg/d group |
Incomplete outcome data (attrition bias) LDL cholesterol | Low risk | [(33‐28)/33]*100 = 15.2% participants were not included in the efficacy analysis for the cerivastatin 0.15 mg/d group [(40‐39)/40]*100 = 2.5% participants were not included in the efficacy analysis for the cerivastatin 0.3 mg/d group [(73‐67)/73]*100 = 8.2% participants were not included in the efficacy analysis for combined doses |
Incomplete outcome data (attrition bias) HDL cholesterol | High risk | Not included in the efficacy analysis because the given values and the calculated values differed by > 10% |
Incomplete outcome data (attrition bias) Triglycerides | High risk | Not included in the efficacy analysis because the given values 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 |