Goto 1996b.
| Methods | 4‐week placebo run‐in washout period 12‐week before‐and‐after study |
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| Participants | 294 men and women with type IIa, type IIb and type IV hypercholesterolaemia aged 20‐70 years old with moderate hypertension, mild diabetes mellitus, obese, cholelithiasis, TC ≥ 220 mg/dL (5.69 mmol/L) and TG ≤ 400 mg/dL (4.52 mmol/L) Exclusion criteria: hypothyroidism, Cushings syndrome, obstructive gallbladder disease, SLE, nephrosis, poorly controlled diabetes, severe hypertension, alcohol abuse, drug induced hyperlipidaemia, diet therapy for obesity, secondary hyperlipidaemia, severe heart, brain, kidney, liver diseases, MI within 3 months, cerebrovascular disorder, statin hypersensitivity, pregnancy potential and lactation Cerivastatin 0.05 mg/d baseline TC: 7.30 mmol/L (282 mg/dL) Cerivastatin 0.05 mg/d baseline LDL‐C: 5.22 mmol/L (202 mg/dL) Cerivastatin 0.05 mg/d baseline HDL‐C: 1.31 mmol/L (51 mg/dL) Cerivastatin 0.05 mg/d baseline TG: 1.86 mmol/L (165 mg/dL) Cerivastatin 0.10 mg/d baseline TC: 7.21 mmol/L (279 mg/dL) Cerivastatin 0.10 mg/d baseline LDL‐C: 5.20 mmol/L (201 mg/dL) Cerivastatin 0.10 mg/d baseline HDL‐C: 1.23 mmol/L (48 mg/dL) Cerivastatin 0.10 mg/d baseline TG: 1.94 mmol/L (172 mg/dL) Cerivastatin 0.15 mg/d baseline TC: 7.13 mmol/L (276 mg/dL) Cerivastatin 0.15 mg/d baseline LDL‐C: 5.04 mmol/L (195 mg/dL) Cerivastatin 0.15 mg/d baseline HDL‐C: 1.39 mmol/L (54 mg/dL) Cerivastatin 0.15 mg/d baseline TG: 1.60 mmol/L (142 mg/dL) Cerivastatin 0.20 mg/d baseline TC: 7.25 mmol/L (280 mg/dL) Cerivastatin 0.20 mg/d baseline LDL‐C: 5.11 mmol/L (198 mg/dL) Cerivastatin 0.20 mg/d baseline HDL‐C: 1.40 mmol/L (54 mg/dL) Cerivastatin 0.20 mg/d baseline TG: 1.84 mmol/L (163 mg/dL) |
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| Interventions | Cerivastatin 0.05 mg/d evening dosing Cerivastatin 0.1 mg/d evening dosing Cerivastatin 0.15 mg/d evening dosing Cerivastatin 0.2 mg/d evening dosing |
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| Outcomes | Percentage change from baseline at 4‐12 weeks of blood TC, LDL‐C, HDL‐C and TG | |
| Source of funding | Unknown | |
| Notes | ||
| 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 | [(71‐65)/71]*100 = 8.5% participants were not included in the efficacy analysis for the cerivastatin 0.05 mg/d group for total cholesterol [(79‐73)/79]*100 = 7.6% participants were not included in the efficacy analysis for the cerivastatin 0.1 mg/d group for total cholesterol [(70‐67)/70]*100 = 4.3% participants were not included in the efficacy analysis for the cerivastatin 0.15 mg/d group for total cholesterol [(74‐70)/74]*100 = 5.4% participants were not included in the efficacy analysis for the cerivastatin 0.2 mg/d group for total cholesterol |
| Incomplete outcome data (attrition bias) LDL cholesterol | High risk | [(71‐61)/71]*100 = 14.1% participants were not included in the efficacy analysis for the cerivastatin 0.05 mg/d group [(79‐66)/79]*100 = 16.5% participants were not included in the efficacy analysis for the cerivastatin 0.1 mg/d group [(70‐63)/70]*100 = 10.0% participants were not included in the efficacy analysis for the cerivastatin 0.15 mg/d group [(74‐64)/74]*100 = 13.5% participants were not included in the efficacy analysis for the cerivastatin 0.2 mg/d group [(294‐254)/294]*100 = 13.6% participants were not included in the efficacy analysis for all doses |
| Incomplete outcome data (attrition bias) HDL cholesterol | Low risk | [(71‐65)/71]*100 = 8.5% participants were not included in the efficacy analysis for the cerivastatin 0.05 mg/d group [(79‐73)/79]*100 = 7.6% participants were not included in the efficacy analysis for the cerivastatin 0.1 mg/d group [(70‐67)/70]*100 = 4.3% participants were not included in the efficacy analysis for the cerivastatin 0.15 mg/d group [(74‐70)/74]*100 = 5.4% participants were not included in the efficacy analysis for the cerivastatin 0.2 mg/d group |
| Incomplete outcome data (attrition bias) Triglycerides | Low risk | [(71‐63)/71]*100 = 11.3% participants were not included in the efficacy analysis for the cerivastatin 0.05 mg/d group [(79‐70)/79]*100 = 8.9% participants were not included in the efficacy analysis for the cerivastatin 0.1 mg/d group [(70‐65)/70]*100 = 7.1% participants were not included in the efficacy analysis for the cerivastatin 0.15 mg/d group [(74‐69)/74]*100 = 6.8% participants were not included in the efficacy analysis for the cerivastatin 0.2 mg/d group |
| Selective reporting (reporting bias) | Low risk | LDL‐C outcome was reported |
| Other bias | Unclear risk | Source of funding not reported |