STARSHIP 2006.
Methods | 6‐Week wash‐out period 6‐Week multi‐centre open‐label randomised trial | |
Participants | 696 Hispanic men and women from the USA with hypercholesterolaemia aged > 17 years; LDL‐C 130 to 300 mg/dL (3.36‐7.76 mmol/L), TG < 400 mg/dL (4.51 mmol/L) 339 participants received atorvastatin, 357 received rosuvastatin Exclusion criteria: homozygous familial type I, III or V hypercholesterolaemia; active arterial disease, uncontrolled HTN, poorly controlled diabetes mellitus, active liver disease of hepatic dysfunction, unexplained CK increase > 3 × ULN Atorvastatin 10 mg/d baseline TC: 6.41 mmol/L (247 mg/dL) Atorvastatin 10 mg/d baseline LDL‐C: 4.24 mmol/L (164mg/dL) Atorvastatin 10 mg/d baseline HDL‐C: 1.24 mmol/L (48 mg/dL) Atorvastatin 10 mg/d baseline TG: 2.02 mmol/L (179 mg/dL) Atorvastatin 20 mg/d baseline TC: 6.44 mmol/L (249 mg/dL) Atorvastatin 20 mg/d baseline LDL‐C: 4.27 mmol/L (165 mg/dL) Atorvastatin 20 mg/d baseline HDL‐C: 1.21 mmol/L (47 mg/dL) Atorvastatin 20 mg/d baseline TG: 2.10 mmol/L (186 mg/dL) |
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Interventions | Atorvastatin 10 mg/d Atorvastatin 20 mg/d Rosuvastatin 10 mg/d Rosuvastatin 20 mg/d |
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Outcomes | Per cent change from baseline at 6 weeks of serum TC, LDL‐C, HDL‐C and TG | |
Notes | Atorvastatin groups were analysed SDs were imputed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Atorvastatin 10 mg/d and atorvastatin 20 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 and atorvastatin 20 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 and atorvastatin 20 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 10 mg/d: 7/168 were not included in the efficacy analysis because of withdrawal of consent, adverse events, loss to follow‐up Atorvastatin 20 mg/d: 10/171 were not included in the efficacy analysis because of withdrawal of consent, adverse events, loss to follow‐up 5% of participants were excluded from the efficacy analysis |
Selective reporting (reporting bias) | Low risk | All lipid parameters were measured |
Other bias | High risk | AstraZeneca funded the study; data may support bias against atorvastatin. |