CAP 2008.
Methods | 6‐Week wash‐out period 26‐Week multi‐centre prospective randomised double‐blind double‐dummy design |
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Participants | 340 men and women aged < 80 years with documented CAD; low‐grade inflammation, LDL‐C 1.29 to 3.87 mmol/L (50‐150 mg/dL), TG ≤ 4.56 mmol/L (400 mg/dL) 170 received 10 mg/d, 169 received 80 mg/d Exclusion criteria: presence of secondary hyperlipidaemia or type 1 diabetes mellitus or type 2 with insulin therapy, inadequately controlled diabetes mellitus, alcohol or drug abuse, inadequate compliance, progressive or life‐threatening disease with life expectancy < 1 year, statin intolerance, active hepatic disease or hepatic dysfunction, use of a potent cytochrome P45 3A4 inhibitor, women who were pregnant or breastfeeding Atorvastatin 10 mg/d baseline TC: 5.41 mmol/L (209 mg/dL) Atorvastatin 10 mg/d baseline LDL‐C: 3.26 mmol/L (126 mg/dL) Atorvastatin 10 mg/d baseline HDL‐C: 1.24 mmol/L (48 mg/dL) Atorvastatin 10 mg/d baseline TG: 2.05 mmol/L (182 mg/dL) Atorvastatin 80 mg/d baseline TC: 5.34 mmol/L (206 mg/dL) Atorvastatin 80 mg/d baseline LDL‐C: 3.26 mmol/L (126 mg/dL) Atorvastatin 80 mg/d baseline HDL‐C: 1.24 mmol/L (48 mg/dL) Atorvastatin 80 mg/d baseline TG: 1.85 mmol/L (164 mg/dL) |
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Interventions | Atorvastatin 10 mg/d Atorvastatin 80 mg/d |
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Outcomes | Per cent change from baseline at 5 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; intervention was 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; intervention was 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; intervention was 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 10 mg/d: All 170 were included in the analysis Atorvastatin 80 mg/d: 1/170 was not included in the ITT analysis because of lack of post‐baseline data 0.3% of participants were excluded from the efficacy analysis |
Selective reporting (reporting bias) | Low risk | All lipid parameters were measured |
Other bias | High risk | Pfizer funded the study; data may support bias for atorvastatin |