NASDAC 2005.

Methods	8‐Week wash‐out period 8‐Week multi‐centre randomised double‐blind parallel‐group before‐and‐after study
Participants	919 men and women with dyslipidaemia from USA, aged 18 to 80 years; LDL‐C > 100 mg/dL (2.6 mmol/L), TG < 600 mg/dL (6.8 mmol/L) Exclusion criteria: statin hypersensitivity, gastrointestinal disease, hepatic dysfunction, uncontrolled HTN, alcohol or drug abuse, pregnancy threat, renal dysfunction, uncontrolled hypothyroidism, severe disease within 3 months of screening Atorvastatin 10 mg/d baseline TC: 6.56 mmol/L (254 mg/dL) Atorvastatin 10 mg/d baseline LDL‐C: 4.44 mmol/L (172 mg/dL) Atorvastatin 10 mg/d baseline HDL‐C: 1.23 mmol/L (48 mg/dL) Atorvastatin 10 mg/d baseline TG: 1.96 mmol/L (174 mg/dL) Atorvastatin 20 mg/d baseline TC: 6.56 mmol/L (254 mg/dL) Atorvastatin 20 mg/d baseline LDL‐C: 4.33 mmol/L (167 mg/dL) Atorvastatin 20 mg/d baseline HDL‐C: 1.16 mmol/L (45 mg/dL) Atorvastatin 20 mg/d baseline TG: 2.32 mmol/L (205 mg/dL) Atorvastatin 40 mg/d baseline TC: 6.56 mmol/L (254 mg/dL) Atorvastatin 40 mg/d baseline LDL‐C: 4.44 mmol/L (172 mg/dL) Atorvastatin 40 mg/d baseline HDL‐C: 1.21 mmol/L (47 mg/dL) Atorvastatin 40 mg/d baseline TG: 1.97 mmol/L (174 mg/dL) Atorvastatin 80 mg/d baseline TC: 6.79 mmol/L (263 mg/dL) Atorvastatin 80 mg/d baseline LDL‐C: 4.57 mmol/L (177 mg/dL) Atorvastatin 80 mg/d baseline HDL‐C: 1.18 mmol/L (46 mg/dL) Atorvastatin 80 mg/d baseline TG: 2.28 mmol/L (202 mg/dL)
Interventions	Atorvastatin 10 mg/d Atorvastatin 20 mg/d Atorvastatin 40 mg/d Atorvastatin 80 mg/d
Outcomes	Per cent change from baseline at 8 weeks of serum TC, LDL‐C, HDL‐C and TG
Notes	SDs were imputed
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Atorvastatin 10 mg/d; atorvastatin 20 mg/d, atorvastatin 40 mg/d and atorvastatin 80 mg/d; interventions were analysed, and as no placebo group was included for comparison, assessment of random sequence generation is not applicable
Allocation concealment (selection bias)	Unclear risk	Atorvastatin 10 mg/d, atorvastatin 20 mg/d, atorvastatin 40 mg/d and atorvastatin 80 mg/d; interventions were analysed, and as no placebo group was included for comparison, assessment of allocation concealment is not applicable
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Atorvastatin 10 mg/d, atorvastatin 20 mg/d, atorvastatin 40 mg/d and atorvastatin 80 mg/d interventions were analysed, and as no placebo group was included for comparison, blinding status is not applicable
Incomplete outcome data (attrition bias) All outcomes	Low risk	Atorvastatin 20 mg/d: 3/228 were not included in the efficacy analysis because participants did not have at least 1 post‐baseline observation Atorvastatin 40 mg/d: 2/231 were not included in the efficacy analysis because participants did not have at least 1 post‐baseline observation Atorvastatin 80 mg/day: 2/231 were not included in the efficacy analysis because participants did not have at least 1 post‐baseline observation 1% of participants were excluded from the efficacy analysis
Selective reporting (reporting bias)	Low risk	All lipid parameters were measured
Other bias	High risk	Pfizer Inc funded the study; data may support bias for atorvastatin