Ikeda 2013.

Study characteristics
Methods	Study design: prospective, randomised, open‐label, blinded end points, two‐arm, parallel treatment group Total duration of study: 1 year Details of any 'run‐in' period: no details given Number of study centres and location: 15 centres in Japan Study setting and date of study: outpatients; August 2007 to September 2009
Participants	Number randomised: 303 participants Number lost to follow‐up/withdrawn: "80 lost to follow‐up, withdrew consent, did not receive study drug, did not complete end point assessment or IMT was not performed or analysable" Number analysed: 223 participants Number of interest: 223 participants Mean age: 66.3 years Age range: 20 to 80 years Gender: 174 men and 129 women Severity of condition: no details given Diagnostic criteria: "LDL‐C at the time of enrolment was no less than 100 and common carotid IMT was 1.1 mm and over." Smoking history: 32 current smokers Inclusion criteria "Diagnosed as having hyperlipidaemia LDL‐C at the time of enrollment is no less than 100 Common carotid IMT is 1.1 mm and over" Exclusion criteria "Received or planned to receive intervention on carotid arteries during the study period Overt liver dysfunction (ALT; 100 IU/L and over) Overt renal dysfunction (serum creatinine; 2.0 mg/dL and over) Receiving cyclosporin Hyperreactive to pitavastatin During pregnancy or lactation"
Interventions	Intervention: pitavastatin, starting at 4 mg daily Comparison: pitavastatin, starting at 2 mg daily Concomitant medications: aspirin, ticlopidine, clopidogrel, beta‐blocker, RA inhibitor, PPAR‐g agonist, sulfonylurea, a‐GI, BG, insulin, calcium blocker, nitrate, diuretic, aldosterone blocker, warfarin, antiarrhythmic agent Excluded medications: no details given
Outcomes	Primary outcome: "absolute changes in carotid intima‐media thickness" Secondary outcomes: "relative change in carotid intima‐media thickness change in LDL‐C, HDL‐C, TG and RLP‐C change in hs‐CRP and IL‐6 new onset or recurrence of ischaemic heart disease, heart failure, stroke, and atherosclerosis obliterans sudden death side effects." Time points reported: 12 months
Notes	Funding for trial: self‐funding Notable conflicts of interest of trial authors: no details given Protocol: UMIN000001229
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Enrolled patients were randomly assigned to intensive or moderate therapy in a 1:1 ratio."
Allocation concealment (selection bias)	Low risk	Quote: "Treatment allocation was computer‐generated by a central randomization facility using a stratified randomization for prognostic factors including gender, presence or absence of diabetes mellitus (DM), age and history of coronary artery disease (CAD)."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The data of carotid ultrasonography were all sent to a core center (Saiseikai Shiga Prefecture Hospital) and analyzed by one sonographer blinded to the randomization and all clinical information."
Incomplete outcome data (attrition bias) All outcomes	Low risk	All prespecified outcomes reported
Selective reporting (reporting bias)	Low risk	All outcome measures reported in the results section
Other bias	Low risk	No other source of bias detected