Schrott 1998.

Methods	6‐Week placebo baseline period 6‐Week multi‐centre randomised parallel‐group placebo‐controlled trial
Participants	65 men and women from the USA, mean age 58 (18‐75) years; type IIa and IIb hypercholesterolaemia, LDL 4.1 to 6.5 mmol/L (159‐251 mg/dL), TG ≤ 4.5 mmol/L (399 mg/dL) Exclusion criteria: women likely to become pregnant, hepatic dysfunction, renal dysfunction, uncontrolled HTN, diabetes, metabolic endocrine disease, alcohol consumption > 14‐oz/wk equivalents, taking lipid‐altering drugs Placebo baseline TC: 7.10 mmol/L (275 mg/dL) Placebo baseline LDL‐C: 4.93 mmol/L (191 mg/dL) Placebo baseline HDL‐C: 1.24 mmol/L (48 mg/dL) Placebo baseline TG: 2.09 mmol/L (185 mg/dL) Atorvastatin 10 mg/d baseline TC: 7.17 mmol/L (277 mg/dL) Atorvastatin 10 mg/d baseline LDL‐C: 4.95 mmol/L (191 mg/dL) Atorvastatin 10 mg/d baseline HDL‐C: 1.11 mmol/L (43 mg/dL) Atorvastatin 10 mg/d baseline TG: 2.38 mmol/L (211 mg/dL) Atorvastatin 20 mg/d baseline TC: 7.07 mmol/L (273 mg/dL) Atorvastatin 20 mg/d baseline LDL‐C: 4.85 mmol/L (188 mg/dL) Atorvastatin 20 mg/d baseline HDL‐C: 1.21 mmol/L (47 mg/dL) Atorvastatin 20 mg/d baseline TG: 2.07 mmol/L (183 mg/dL) Atorvastatin 40 mg/d baseline TC: 6.94 mmol/L (268 mg/dL) Atorvastatin 40 mg/d baseline LDL‐C: 4.77 mmol/L (184 mg/dL) Atorvastatin 40 mg/d baseline HDL‐C: 1.42 mmol/L (55 mg/dL) Atorvastatin 40 mg/d baseline TG: 1.60 mmol/L (142 mg/dL) Atorvastatin 60 mg/d baseline TC: 6.94 mmol/L (268 mg/dL) Atorvastatin 60 mg/d baseline LDL‐C: 4.88 mmol/L (189 mg/dL) Atorvastatin 60 mg/d baseline HDL‐C: 1.21 mmol/L (47 mg/dL) Atorvastatin 60 mg/d baseline TG: 1.85 mmol/L (164 mg/dL) Atorvastatin 80 mg/d baseline TC: 7.40 mmol/L (286 mg/dL) Atorvastatin 80 mg/d baseline LDL‐C: 5.08 mmol/L (196 mg/dL) Atorvastatin 80 mg/d baseline HDL‐C: 1.42 mmol/L (55 mg/dL) Atorvastatin 80 mg/d baseline TG: 2.02 mmol/L (179 mg/dL)
Interventions	Placebo Atorvastatin 10 mg/d Atorvastatin 20 mg/d Atorvastatin 40 mg/d Atorvastatin 60 mg/d Atorvastatin 80 mg/d
Outcomes	Per cent change from baseline at 6 weeks of serum TC, LDL‐C, HDL‐C and TG
Notes	WDAEs were not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information about sequence generation was provided to permit judgement of 'yes' or 'no'
Allocation concealment (selection bias)	High risk	Open trial
Blinding (performance bias and detection bias) All outcomes	High risk	Open trial
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data on all participants were reported
Selective reporting (reporting bias)	Low risk	All lipid parameters were measured
Other bias	High risk	Parke‐Davis Pharmaceuticals funded the study; data may support bias for atorvastatin