Kim 1999.

Methods	4‐week placebo run‐in period 6‐week RCT Allocations via block randomisation in groups of 6
Participants	32 men and women with primary hypercholesterolaemia aged 18‐75 years. Average LDL‐C measured during diet‐stabilisation and placebo run‐in stage had to be > 160 mg/dL (4.14 mmol/L) with definite personal history of coronary heart disease and each measurement had to be not > ± 12% from the average (> 130 mg/dL (3.36 mmol/L) for participants with > 2 risk factors for CAD or CVD) fasting plasma TG below 350 mg/dL (3.95 mmol/L) for all participants, consent received from all participants During period A, included participants had to have diet satisfied by dietician (i.e. meeting dietician recommendations). Compliance rate to placebo during period A was between 80%‐120%; 26 did not finish placebo run‐in period A; 47 participants were randomised Exclusion criteria: women of childbearing age but not on IUD or OCP; pregnant or breastfeeding; participants with history of MI, unstable angina, stroke, TIA, and uncontrolled hypertension within 3 months of starting trial; CABG or PCI within 6 months of starting trial. Regardless of whether they're on treatment or not, if fasting glucose is > 140 mg/dL or having other endocrine disease, or someone with systolic BP > 180 mmHg or diastolic BP > 110 mmHg; clinically known to have cataract or malignant tumour or psychiatric condition or chronic seizures or “homogenous hypercholesterolaemia” (homogenous family history?). BMI > 30, SCr > 2 mg/dL, AST/ALT/amylase > 1.5 ULN or CK > 3, chronic or acute infection, if require regular care visits or compliance expected to be affected, if alcohol or drug abuse in medical history (> 14 drinks/week for alcohol use), if occupational shift work requiring working overnight, bodybuilders or weightlifters, people on other cholesterol medications are excluded; if they stop the statin 4 weeks before or fibrates 8 weeks before or probucol 6 months before, then they can be included in the trial; people with sensitivities to statins, anyone involved with any other trial within 30 d of starting this trial Placebo baseline TC: 6.42 mmol/L (248 mg/dL) Placebo baseline LDL‐C: 4.36 mmol/L (169 mg/dL) Placebo baseline HDL‐C: 1.26 mmol/L (49 mg/dL) Placebo baseline TG: 1.77 mmol/L (157 mg/dL) Cerivastatin 0.1 mg/d baseline TC: 6.97 mmol/L (270 mg/dL) Cerivastatin 0.1 mg/d baseline LDL‐C: 4.86 mmol/L (188 mg/dL) Cerivastatin 0.1 mg/d baseline HDL‐C: 1.19 mmol/L (46 mg/dL) Cerivastatin 0.1 mg/d baseline TG: 2.01 mmol/L (178 mg/dL) Cerivastatin 0.3 mg/d baseline TC: 6.77 mmol/L (262 mg/dL) Cerivastatin 0.3 mg/d baseline LDL‐C: 4.59 mmol/L (177 mg/dL) Cerivastatin 0.3 mg/d baseline HDL‐C: 1.31 mmol/L (51 mg/dL) Cerivastatin 0.3 mg/d baseline TG: 1.90 mmol/L (168 mg/dL)
Interventions	Placebo evening dosing Cerivastatin 0.1 mg/d evening dosing Cerivastatin 0.3 mg/d evening dosing
Outcomes	Percentage change from baseline at 4‐6 weeks of blood TC, LDL‐C, HDL‐C, and TG
Source of funding	Unknown
Notes
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	Allocation concealment was not reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Lipid parameter measurements unlikely influenced by lack of sufficient 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	WDAEs were not reported
Incomplete outcome data (attrition bias) Total cholesterol	Low risk	All participants were included in the efficacy analysis
Incomplete outcome data (attrition bias) LDL cholesterol	Low risk	All participants were included in the efficacy analysis
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	All participants were included in the efficacy analysis
Incomplete outcome data (attrition bias) Triglycerides	Low risk	All participants were 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