Saunders 2000.
Methods | 6‐8‐week run‐in period 8‐week before‐and‐after study |
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Participants | 221 men and women aged 18‐75 years with type IIa or IIb hypercholesterolaemia TG < 400 mg/dL (4.52 mmol/L) LDL‐C > 160 mg/dL (4.14 mmol/L) for patients with 0‐1 risk factor, > 130 mg/dL (3.36 mmol/L) for those with > 2 risk factors, or > 100 mg/dL (2.59 mmol/L) for those with documented CHD or PVD Exclusion criteria: MI (within the previous year), unstable angina, angina at rest, stroke or recent TIAs, recent coronary revascularisation, uncontrolled hypertension or hypothyroidism, diabetes, chronic liver disease, renal dysfunction, or drug or alcohol abuse, CK levels > 3 x ULN Cerivastatin 0.3 mg/d baseline TC: 6.84 mmol/L (264 mg/dL) Cerivastatin 0.3 mg/d baseline LDL‐C: 4.63 mmol/L (179 mg/dL) Cerivastatin 0.3 mg/d baseline HDL‐C: 1.32 mmol/L (51 mg/dL) Cerivastatin 0.3 mg/d baseline TG: 1.96 mmol/L (174 mg/dL) |
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Interventions | Cerivastatin 0.3 mg/d evening dosing Pravastatin 20 mg/d evening dosing |
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Outcomes | Percentage change from baseline at 8 weeks of blood TC, LDL‐C, HDL‐C and TG | |
Source of funding | Unknown | |
Notes | Pravastatin 20 mg/d group was not included in the efficacy analysis SDs were imputed by the method of Furukawa 2006 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Controlled before‐and‐after design |
Allocation concealment (selection bias) | High risk | Controlled before‐and‐after design |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Lipid parameter measurements unlikely influenced by lack of blinding |
Blinding of outcome assessment (detection bias) LDL‐C | Low risk | Lipid parameters were measured in a remote laboratory |
Blinding of outcome assessment (detection bias) WDAE | High risk | No comparison possible |
Incomplete outcome data (attrition bias) Total cholesterol | Low risk | [(221‐202)/221]*100 = 8.6% participants were not included in the efficacy analysis |
Incomplete outcome data (attrition bias) LDL cholesterol | Low risk | [(221‐202)/221]*100 = 8.6% participants were not included in the efficacy analysis |
Incomplete outcome data (attrition bias) HDL cholesterol | Low risk | [(221‐202)/221]*100 = 8.6% participants were not included in the efficacy analysis |
Incomplete outcome data (attrition bias) Triglycerides | Low risk | [(221‐202)/221]*100 = 8.6% participants were not included in the efficacy analysis |
Selective reporting (reporting bias) | Unclear risk | LDL‐C outcome was reported |
Other bias | Unclear risk | Source of funding not reported |