PAPAGO‐T 2013.

Methods	4‐Week dietary lead‐in period 12‐Week randomised double‐blind study
Participants	225 men and women aged 20 or older with LDL‐C > 100 mg/dL (2.59 mmol/L) with hypercholesterolaemia with and without type 2 diabetes mellitus HDL‐C < 40 mg/dL (1.03 mmol/L) Exclusion criteria: statin hypersensitivity, hepatic dysfunction, renal dysfunction, pregnancy, possible pregnancy or breastfeeding, poorly controlled diabetes mellitus 113 participants received atorvastatin 112 participants received pitavastatin Atorvastatin 10 mg/d baseline TC: 5.53 mmol/L (214 mg/dL) Atorvastatin 10 mg/d baseline LDL‐C: 3.91 mmol/L (151 mg/dL) Atorvastatin 10 mg/d baseline HDL‐C: 1.25 mmol/L (48 mg/dL) Atorvastatin 10 mg/d baseline TG: 1.73 mmol/L (153 mg/dL)
Interventions	Atorvastatin 10 mg/d Pitavastatin 2 mg/d
Outcomes	Per cent change from baseline at 12 weeks of serum TC, LDL‐C, HDL‐C and TG
Notes	Atorvastatin 10 mg/d treatment arm was analysed
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Atorvastatin 10 mg/d; treatment arm was analysed, and as no placebo group was included for comparison, assessment of random sequence generation is not applicable
Allocation concealment (selection bias)	Unclear risk	Atorvastatin 10 mg/d; treatment arm was analysed, and as no placebo group was included for comparison, assessment of allocation concealment is not applicable
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Atorvastatin 10 mg/d; treatment arm was analysed, and as no placebo group was included for comparison, blinding status is not applicable
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants were included in the efficacy analysis
Selective reporting (reporting bias)	Low risk	All lipid parameters were included in the efficacy analysis
Other bias	Unclear risk	Kowa Ltd funded the trial