Rahman 1995.
Methods | Single‐centre randomized controlled trial. | |
Participants | 40 participants undergoing open repair of > 5.5 cm. Academic vascular surgery unit, Hull, UK. Statin naive. Mean age (years)/% female: atorvastatin group, ‐ 77.5 years/14%. Placebo: 72.0 years/15%. |
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Interventions | Intervention (N = 20) 80 mg/day atorvastatin. Placebo (N = 20). Therapy given for 4 weeks before surgery. After surgery, statin prescription dealt with by primary care (communication from authors), so duration unclear but likely to have lasted at least 48 hours. | |
Outcomes | Primary outcome: level of MMP‐9 in aortic wall. Secondary outcome: levels of MMP‐2, MMP‐8 and other enzymes in arterial wall. Length of stay reported in Table. |
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Funding sources | No statement about funding sources. | |
Duration of statin use before surgery | Four weeks before surgery. | |
Notes | Additional information obtained from authors 28/9/12. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Computer‐generated sequence, with a subgroup size of 4". |
Allocation concealment (selection bias) | Low risk | Carried out by pharmacy. |
Blinding of participants and personnel (performance bias) Length of stay | Low risk | Paper and personal communication report that study was double‐blind; thus neither participants nor staff members were aware of allocation. Placebo tablets were identical in shape and colour (but were possibly missing numbers and letters). |
Blinding of outcome assessment (detection bias) Length of stay | Low risk | Personal communication from authors. The clinical team (including physiotherapists) assessed fitness for discharge. No formal criteria but that participant was "generally independent and safe". Clinical team unaware of allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included in analyses. No details of loss to follow‐up but all outcomes during hospital stay. |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |
Other bias | Low risk | Baseline characteristics and type of operation similar in both groups. |