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

Saltissi HD 2002.

Methods
  • Study design: stratified, placebo‐controlled RCT

  • Time frame: NR

  • Follow‐up period: 24 weeks

Participants
  • Country: Australia

  • Setting: single centre

  • Inclusion criteria: HD or CAPD for 9 months, non‐HDL > 135 mg/dL, LDL > 116 mg/dL, TG < 600 mg/dL

  • Number (treatment/control): 22/12

  • Age (mean ± SD) years: treatment group (59.5 ± 13.9); control group (62.8 ± 9.6)

  • Sex (M/F): treatment group (6/16); control group (5/7)

  • Exclusion criteria: impaired hepatic function; elevated creatine phosphokinase; myocardial insufficiency; uncontrolled DM; active infection; malignancy; treatment with other lipid‐lowering agents

Interventions Treatment group
  • Simvastatin

    • Dose: 5 mg and dose was increased to 20 mg as needed to achieve non‐HDL < 135 mg/dL

  • Treatment duration: 24 weeks


Control group
  • Placebo

Outcomes Lipid parameters (TC, LDL, HDL, TG, Lp (a), Apo A1)
Notes This is the same study as Saltissi PD 2002
Industry funding received
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk NR
Allocation concealment (selection bias) Unclear risk NR
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk NR
Incomplete outcome data (attrition bias) 
 All outcomes High risk 42/57 patients (74%) completed study
Selective reporting (reporting bias) Low risk Published reports included all expected outcomes
ITT analysis High risk Not conducted