TARGET TANGIBLE 1999.

Methods	6‐Week wash‐out period 14‐Week open‐label randomised parallel‐group study Evening dose
Participants	4097 men and women from Germany with CHD aged 35 to 75 years; LDL‐C > 130 mg/dL (3.36 mmol/L), 3748 of 4097 were enrolled in the diet phase A total of 2856 participants met the lipid criteria at the end of the diet phase and were randomly assigned 1897 participants received atorvastatin, 959 received simvastatin Exclusion criteria: statin hypersensitivity, liver disease, muscle disease, active arterial disease, FH, TG > 1000 mg/dL (11.28 mmol/L), heart failure stage III or IV, uncontrolled HTN, cancer, surgery or severe medical disease, nephrotic syndrome, endocrine disorder, LDL apheresis, drug or alcohol abuse, pregnancy threat, participation in another study, lack of consent Atorvastatin baseline TC, HDL‐C and TG were not reported Atorvastatin baseline LDL‐C: 4.86 mmol/L (188 mg/dL)
Interventions	Atorvastatin 10 mg/d for 0 to 5 weeks Atorvastatin conditional titration 20 mg/d for 5 to 10 weeks Atorvastatin conditional titration 40 mg/d for 10 to 14 weeks Simvastatin 10 mg/d for 0 to 5 weeks Simvastatin conditional titration 20 mg/d for 5 to 10 weeks Simvastatin conditional titration 40 mg/d for 10 to 14 weeks
Outcomes	Per cent change from baseline at 4 weeks of serum TC, LDL‐C and TG
Notes	First atorvastatin dose was analysed SD was imputed for LDL‐C only
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Atorvastatin 10 mg/d; intervention 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; intervention 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; intervention 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)	High risk	HDL‐C data were not reported
Other bias	High risk	Parke‐Davis Pharmaceuticals funded the study; data may support bias for atorvastatin