LIPS 2003.

Methods	no patient received lipid‐lowering medications for at least 6 weeks 3‐4 year randomised double‐blind placebo‐controlled trial
Participants	1677 men and women age 18‐80 years with unstable angina, stable angina, silent ischaemia who had undergone successful first PCI procedure of 1 or more lesions in the native coronary arteries during the same hospitalisation patients having a re stenosed target lesion within 6 months of first angioplasty were to be included 844 were randomised to fluvastatin and 833 to placebo TC ≥ 3.5 mmol/L (135 mg/dL) and < 7.0mmol/L (270 mg/dL) and a fasting TG < 4.5 mmol/L (400 mg/dL) after at least 6 week without lipid‐lowering therapy For patients status post MI within 24 hours to 4 weeks, TC > 3.5 to , 5.5 mmol/L, or for those patients with type 1 or type 2 diabetes mellitus, TC must have been ≥3.5 to ≤6.0 mmol/L exclusion criteria:BP > 180/100 despite medical therapy, undiagnosed hypertension, left ventricular ejection fraction < 30%, medical history of PCI or CABG procedure more than 6 months previous, or with severe non‐CHD such as valvular disease, idiopathic cardiomyopathy or congenital heart disease severe renal dysfunction, obesity BMI > 35, cancer or other disease with life expectancy of less than 4 years, with death, MI, or CABG between TCT procedure and hospital discharge, GI or liver impairment or major surgery within 3 months of randomisation treatment with probucol within 12 months prior to randomisation or with lipid‐lowering agents other than study medication, erythromycin, ketoconazole or anticonvulsant therapies currently participating in a study of any device or drug requiring clinical or angiographic follow‐up except in stent or a diagnostic registry with no angiographic follow‐up, or who had previously participated in this study Placebo baseline TC : 5.2 mmol/L (201 mg/dL) Placebo baseline LDL‐C : 3.4 mmol/L (131 mg/dL) Placebo baseline HDL‐C : 1.0 mmol/L (39 mg/dL) Placebo baseline triglycerides: 1.7 mmol/L (151 mg/dL) Fluvastatin 40 mg/day baseline TC : 5.2 mmol/L (201 mg/dL) Fluvastatin 40 mg/day baseline LDL‐C : 3.4 mmol/L (131 mg/dL) Fluvastatin 40 mg/day baseline HDL‐C : 1.0 mmol/L (39 mg/dL) Fluvastatin 40 mg/day baseline triglycerides: 1.8 mmol/L (159 mg/dL)
Interventions	Placebo Fluvastatin 40 mg twice daily
Outcomes	per cent change from baseline at 6 weeks of serum TC, LDL‐C, HDL‐C and triglycerides
Source of Funding	Novartis
Notes	SDs were imputed by the method of Furukawa 2006
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Sequence generation was done by central allocation
Allocation concealment (selection bias)	Low risk	Dispensing of sequentially numbered sets of study medication distributed to each site, and eligible patients received the next sequential medication pack at that site randomisation may have been done by central allocation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind study Lipid parameter measurements unlikely influenced by lack of proper blinding
Blinding of outcome assessment (detection bias) LDL‐cholesterol	Low risk	Investigators were blinded to the lipid results from week 0 through the duration of the study LDL‐C was determined at a central laboratory (Analytico Medinet, Breda, the Netherlands)
Blinding of outcome assessment (detection bias) WDAEs	High risk	WDAEs reported were for the 3.9 year time period not the 6 week time period
Incomplete outcome data (attrition bias) All outcomes	High risk	17.2`% of 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 trial