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. 2020 Jan 25;2020(1):CD012501. doi: 10.1002/14651858.CD012501.pub2

Arakawa 1996.

Methods 4‐week placebo washout period
12‐week before‐and‐after study
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)
Interventions Cerivastatin 0.15 mg/d evening dosing
Cerivastatin 0.3 mg/d evening dosing
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