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. 2013 Sep 11;2013(9):CD004289. doi: 10.1002/14651858.CD004289.pub5

Vernaglione 2003.

Methods
  • Study design: prospective RCT

  • Time frame: NR

  • Follow‐up period: 6 months

Participants
  • Country: Italy

  • Setting: single centre

  • Inclusion criteria: serum CRP levels ≥ 3 mg/L (42.2% of the entire population) undergoing HD treatment for at least 6 months, had patent autologous vascular access, and treated with the same dialyser in the last 3 months

  • Number (treatment/control): 16/17

  • Age (mean ± SD) years: treatment group (65.2 ± 11.8); control group (65.5 ± 10.2)

  • Sex (M/F): treatment group (4/12); control group (8/9)

  • Exclusion criteria: patients with liver diseases, neoplasms, recent surgical interventions or trauma, sepsis, chronic inflammatory diseases, and those who had received prolonged treatments with NSAIDs and/or steroids and/or vitamins E or C

Interventions Treatment group
  • Atorvastatin

    • Dose: 10 mg/d

  • Treatment duration: 6 months


Control group
  • Placebo

Outcomes
  • Lipid parameters (TC, LDL, HDL, TG)

  • Serum CRP

  • Serum albumin

  • Serum urea, SCr

  • Adverse events: Serum ALT, AST, glutamyltransferase, CK, lactate dehydrogenase

Notes  
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 Unclear risk NR
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk NR
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk NR
Selective reporting (reporting bias) High risk Published reports did not include all expected outcomes
ITT analysis Unclear risk NR