Skip to main content
. 2013 Sep 11;2013(9):CD004289. doi: 10.1002/14651858.CD004289.pub5

Stegmayr 2005.

Methods
  • Study design: open RCT

  • Time frame: from February 1998

  • Follow‐up period: 5 years

Participants
  • Country: Sweden

  • Setting: multicentre

  • Inclusion criteria: GFR < 30 mL/min/1.73 m²

  • Number (treatment/control): 70/73

  • Age (mean ± SD) years: treatment group (67.8 ± 12.4); control group (69.4 ± 10.2)

  • Sex (M/F): treatment group (48/22); control group (51/22)

  • Exclusion criteria: aged < 18 years; fertile women not taking oral contraceptives; pregnant or lactating women; active liver disease; history of adverse reactions to statins; patients with functioning kidney transplant not on dialysis; patients on waiting list for transplantation; those on protein‐restricted diet < 40 g protein/day; poor compliance to medication and follow‐up; history of progressive malignancy and life expectancy < 6 months

Interventions Treatment group
  • Atorvastatin

    • Dose: 10 mg/d

  • Treatment duration: 35 ± 20.1 months (range 1 to 67 months)


Control group
  • Placebo

  • Treatment duration: 31 ± 21.4 months (range 0.5 to 69 months)

Outcomes
  • All‐cause mortality

  • AMI

  • need for PTCA

  • CABG

  • Lipid profile

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk NR
Allocation concealment (selection bias) Low risk Randomisation by means of a telephone call to the study data centre where sealed envelopes were drawn
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Not blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients analysed
Selective reporting (reporting bias) Low risk Published reports included all expected outcomes
ITT analysis Low risk Conducted