| Study characteristics |
| Methods |
Randomised trial 4 x 4 factorial. |
| Participants |
253 men and women aged 45‐70 (mean age 58) with hypertension, hypercholesterolaemia and asymptomatic carotid atherosclerosis based in Italy. None with any clinical evidence of CVD. |
| Interventions |
25 mg hydrochlorothiazide + 40 mg pravastatin followed up for 2.6 years. |
| Outcomes |
Primary outcomes: carotid atherosclerosis. Secondary outcomes: non‐fatal MI, CVD death, stroke, cholesterol and cancer. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation was computer‐generated in blocks of 4 |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double blind |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
ITT used, 20% drop‐outs reported |
| Selective reporting (reporting bias) |
Low risk |
|
| Other bias |
Unclear risk |
Funded by pharmaceutical industry |
