Transplant Trial Watch

Effect of Statins on the Progression of Coronary Calcification in Kidney Transplant Recipients.

Yazbek DC, Carvalho AB, et al.

PLoS ONE [Electronic Resource] 2016; 11(4): e0151797.


Aims
To evaluate the effect of statins on coronary calcification (CAC) progression in kidney transplant recipients.

Interventions
Participants were randomly assigned to 10mg/day of statin, or control.

Participants
120 kidney transplant recipients aged 18-60 years who underwent kidney transplantation within 60 days of commencing the study.

Outcomes
The primary outcome measured was CAC progression. Other measured outcomes included blood count, serum creatinine, glucose, lipid profile, ionized calcium, serum phosphorus, total alkaline phosphatase, intact parathyroid hormone, pH, bicarbonate, C-reactive protein, proteinuria and phosphaturia.

Follow-up
12 months

CET Conclusions
This randomised controlled trial from Brazil investigated the role of statins in preventing the progression of coronary calcification (CAC) in renal transplant recipients. CAC is associated with increased cardiovascular morbidity, and previous studies in renal failure patients have demonstrated a reduction in CAC with statin therapy making this a potentially useful intervention in renal transplant recipients who have an increased risk of cardiovascular mortality. In the present study, no difference was found between CAC progression with or without statin therapy at 1 year. It should be noted that despite randomisation, there were significant differences in baseline risk between the two groups including baseline lipid profiles. The study was powered to demonstrate a 50% difference in coronary calcification between groups – a relatively large effect size which may have led to a study that was underpowered to demonstrate a smaller (but possibly clinically important) effect. Finally, follow-up is only 1 year, and benefit on the progression of calcification in stable patients may be longer-term.

Jadad score
3

Data analysis
Modified intention-to-treat analysis

Allocation concealment
Yes

Trial registration
Brazilian Clinical Trials Registry - RBR-32RFMB

Funding source
Non-industry funded