Meaney 2009.

Study characteristics
Methods	Study design: randomised, comparative, open‐label trial Total duration of study: 12 months Details of any 'run‐in' period: no details given Number of study centres and location: 2 centres in Mexico Study setting and date of study: outpatients; no details given
Participants	Number randomised: 90 participants Number lost to follow‐up/withdrawn: 26 participants were removed from the study Number analysed: 90 participants Number of interest: 90 participants Mean age: "59 +/‐ 7 in group A, 57 +/‐ 8 in group B and 58 +/‐ 9 in group C." Age range: 40 to 72 years Gender: 44 men and 53 women Severity of condition: high‐risk coronary patients Diagnostic criteria: "10‐year absolute risk for coronary death or myocardial infarction > 20 according to the ATP III recommendations." Smoking history: no details given Inclusion criteria: "any gender, aged 40 to 72 years, with a 10‐year absolute risk for coronary death or MI > 20 according to the ATP III recommendations. None of the participants had received ezetimibe previously, but the vast majority of them had received statins, generally at low or very low doses." Exclusion criteria: "people with severe systemic diseases, including liver diseases, chronic renal failure, heart failure, malignancies, autoimmune diseases, AIDS, or a history of alcohol or other drug abuse, pregnant or fertile women without a totally reliable contraception method or breastfeeding mothers."
Interventions	Intervention and comparison: Group A: pravastatin 40 mg once daily Group B: simvastatin 40 mg once daily Group C: combination of 20 mg of simvastatin and 10 mg of ezetimibe Concomitant medications: "if the therapeutic goals were not attained (< 100 mg/dL of low‐density lipoprotein cholesterol for type C and < 70 mg for type D), participants in group A received pravastatin 40 mg and ezetimibe 10 mg, group B received simvastatin 80 mg, and group C received simvastatin 40 mg and ezetimibe 10 mg." Excluded medications: no details given
Outcomes	Primary outcome: "change of IMT over the course of 1 year." Secondary outcomes: "changes in LDL and in high sensitive C‐reactive protein (CRPhs)" Time points reported: "the participants were evaluated every 2 months clinically and for the detection of secondary effects. Lipids were analysed at 2 months and 6 months after randomisation for titration purposes, as well as at the end of the trial 1 year later. Vascular ultrasounds and C‐reactive proteins (CRP) were conducted and measured, respectively, at the beginning and at the end of the trial."
Notes	Funding for trial: "we acknowledge our gratitude to the following institutions that gave us unrestricted research grants: Merck Sharp & Dohme, Mexico; the Mexican Association for the Prevention of Atherosclerosis and its Complications (AMPAC); and the National Association of Cardiologists serving the State Employees (ANCISSSTE)" Notable conflicts of interest of trial authors: "the design of the study, the conduct of the trial, and the analysis of the data were done only by the investigators"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Low risk	Quote: "Ninety patients were randomly allocated to 1 of 3 groups of 30 patients each."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Each group was assigned a different open‐label treatment."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Carotid IMT was measured by a trained ultrasonographer who was blinded to all clinical and treatment information."
Incomplete outcome data (attrition bias) All outcomes	Low risk	All prespecified outcomes reported
Selective reporting (reporting bias)	Low risk	All outcome measures have been reported in the results section
Other bias	Low risk	No other source of bias detected