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) |
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Interventions | Atorvastatin 10 mg/d Atorvastatin 20 mg/d Atorvastatin 40 mg/d Atorvastatin 80 mg/d |
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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 |