AlvarezSala 2008.
| Methods | 10‐week dietary washout period 12‐week before and after trial |
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| Participants | 82 men and women 18‐75 years old with primary hypercholesterolaemia LDL‐C ≥130 mg/dL (≥ 3.4 mmol/L) triglycerides ≤ 400 mg/dL (≤ 4.5 mmol/L) exclusion criteria: congestive heart failure III‐IV; uncontrolled arrhythmia; MI; unstable angina or severe or unstable peripheral artery disease in the preceding 3 months; uncontrolled diabetes; uncontrolled endocrine or metabolic diseases, renal or hepatic dysfunction; myopathic disorders, coagulation disorders; and /or any condition that would make protocol compliance unlikely pregnancy or lactation and confounding drugs 44 participants received fluvastatin 80 mg/day 38 participants received fluvastatin 80 mg/day + ezetimibe 10 mg/day Fluvastatin 80 mg/day baseline TC : 7.7 mmol/L (298 mg/dL) Fluvastatin 80 mg/day baseline LDL‐C : 5.6 mmol/L (217 mg/dL) Fluvastatin 80 mg/day baseline HDL‐C : 1.5 mmol/L (58 mg/dL) Fluvastatin 80 mg/day baseline triglycerides: 1.6 mmol/L (142 mg/dL) |
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| Interventions | Fluvastatin XL 80 mg/day Fluvastatin XL 80 mg/day + ezetimibe 10 mg/day |
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| Outcomes | per cent change from baseline at 12 weeks of serum TC, LDL‐C, HDL‐C, and triglycerides | |
| Source of Funding | Novartis | |
| Notes | Fluvastatin XL 80 mg/day + ezetimibe 10 mg/day group was not included in the efficacy analysis | |
| 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‐cholesterol | Low risk | Lipid parameters were measured in a remote laboratory |
| Blinding of outcome assessment (detection bias) WDAEs | High risk | No comparison possible |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 11.4% participants were not included in the efficacy analysis |
| Selective reporting (reporting bias) | Low risk | LDL‐C outcome was reported |
| Other bias | High risk | Novartis funded the study |