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. 2014 Jan 27;2014(1):CD005019. doi: 10.1002/14651858.CD005019.pub4

Cofan 2002.

Methods
  • Study design: parallel RCT

  • Time frame: NS

  • Follow‐up: NS

Participants
  • Setting: NS

  • Country: Spain

  • Cyclosporin‐treated KTR with moderate hypercholesterolaemia despite dietary treatment

  • Number: treatment group (30); control group (17)

  • Mean age ± SD: 55 ± 7 years

  • Sex: 63.8% males

  • Exclusion criteria: patients on statins; hepatic disease; diabetes mellitus; previous clinical cardiovascular disease

Interventions Treatment group
  • Pravastatin 20 mg/d

  • Hypolipidaemic diet


Control group
  • Hypolipidaemic diet

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

  • Safety outcomes (hepatic toxicity)

Notes Publication type: Journal publication
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk Not described
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 Pravastatin (3); placebo (1); all due to loss of follow‐up
Intention to treat analysis Unclear risk Not described