Nakamura 2008.

Study characteristics
Methods	Study design: Randomised controlled trial Study grouping: Parallel group Method: No participant received lipid medications within 6 months of randomisation therefore no washout required 1 month single‐blind randomised placebo‐controlled study only the patients were blinded to the content of the tablets
Participants	Baseline Characteristics 4 mg n: 33 Age (years): 60 Males (n): 25 Females (n): 8 BMI: 25.5 Total cholesterol: 240 mg/dL (6.21 mmol/L) LDL cholesterol: 164 mg/dL (4.24 mmol/L) HDL cholesterol: 43 mg/dL (1.11 mmol/L) Triglycerides: 165 mg/dL (1.86 mmol/L) Placebo n: 32 Age (years): 59 Males (n): 23 Females (n): 9 BMI: 25.9 Total cholesterol: 238 mg/dL (6.15 mmol/L) LDL cholesterol: 156 mg/dL (4.03 mmol/L) HDL cholesterol: 42 mg/dL (1.09 mmol/L) Triglycerides: 163 mg/dL (1.84 mmol/L) Overall n: 65 Age (years): 59.5 Males (n): 48 Females (n): 17 BMI: 25.7 Included criteria: The study enroled 65 consecutive patients with ACS, the presence of carotid plaque [intima‐media thickness (IMT) ≥ 1.1 mm], and hypercholesterolaemia (260 > total cholesterol levels ≥ 220 mg/dL). ACS was diagnosed by the presence of acute ischaemic symptoms lasting ≥ 20 minutes within 48 hours before admission to our hospital, and electrocardiographic (ECG) changes consistent with ACS. The presence of ACS was confirmed by coronary angiography in all patients. Acute myocardial infarction (AMI) was diagnosed when creatine kinase‐MB levels increased by at least 2 times the upper level of normal (3.5 ng/mL). Patients without AMI were considered to have unstable angina pectoris (u‐AP). According to these inclusion criteria, 47 patients were diagnosed as u‐AP, and 18 patients were diagnosed as AMI. Excluded criteria: (1) use of statin or other lipid‐lowering agents during the preceding 6 months, (2) history of hepatic disease, (3) untreated endocrine disorder, (4) history of systemic inflammatory diseases, (5) infectious diseases, (6) history of hypersensitivity to statins, (7) cardiogenic shock or pulmonary oedema at admission, or (8) stroke at admission Baseline Group Characteristics: 65 consecutive patients with ACS were randomised. Profiles of traditional risk factors, calibrated IBS values, and levels of CRP, VEGF, and TNFa were similar between the 2 treatment groups. All ACS patients took aspirin and ticlopidine orally during the follow‐up period, and other medications and invasive therapy for culprit lesions were similar in both treatment groups
Interventions	Intervention Characteristics 4 mg Placebo
Outcomes	Total cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better LDL cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better HDL cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Higher is better Triglycerides Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better WDAE Outcome type: Dichotomous Reporting: Not reported
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Judgement Comment: The ACS patients were randomly assigned using a random number table generated by a computer.
Allocation concealment (selection bias)	High risk	Judgement Comment: Single‐blind allocation concealment was not applied to the investigators.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Judgement Comment: Single‐blind (only participants); however, lipid parameter measurements unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Judgement Comment: Lipid parameters were measured in a remote laboratory.
Selective reporting (reporting bias)	Low risk	Judgement Comment: LDL‐cholesterol outcome was reported and WDAEs were reported; all of the study participants completed the trial with no WDAEs.
Other bias	Low risk	Judgement Comment: This study was supported by Grants‐in‐Aid for (B)(2)‐15390244 and (B)‐19390209, Priority Areas (C) ‘‘Medical Genome Science 15012222’’ from the Ministry of Education, Culture, Sports, Science, and Technology, and by Health and Labor Sciences Research Grants for Comprehensive Research on Aging and Health (H15‐Choju‐012), Tokyo, Japan, government grants
Incomplete outcome data (attrition bias) Total cholesterol	Low risk	All participants were included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol)	Low risk	All participants were included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	All participants were included in the efficacy analysis.
Incomplete outcome data (attrition bias) Triglycerides	Low risk	All participants were included in the efficacy analysis.
Blinding of outcome assessment (detection bias)WDAEs	High risk	Single‐blinded trial
Selective reporting (reporting bias) for WDAEs	Low risk	WDAE outcome reported