ESRD: sevelamer fails to demonstrate superior CV safety

  • Spoendlin J & al.
  • JAMA Intern Med
  • 6 may. 2019

  • de Yael Waknine
  • Clinical Essentials
El acceso al contenido completo es sólo para profesionales sanitarios registrados. El acceso al contenido completo es sólo para profesionales sanitarios registrados.

Takeaway

  • Sevelamer (Renagel, Renvela), a calcium-free phosphate binder, failed to show superior cardiovascular (CV) safety vs calcium acetate in patients with end-stage renal disease (ESRD).

Why this matters

  • 2017 clinical practice guidelines advised restricting calcium-based phosphate binders due to potential CV risk, shifting prescribing patterns to the more expensive sevelamer.
  • Null CV findings suggest that prior data from small trials may not translate into routine clinical practice.

Study design

  • Observational cohort study of patients aged ≥65 years with ESRD within 180 days of starting hemodialysis using data from the US Renal Data System (USRDS) linked with Medicare claims.
  • Propensity-score weighted analysis of those initiating sevelamer (n=2639; mean age, 75.6 years; 44.9% men) and calcium acetate (n=2065; mean age, 75.5 years; 45.0% men).
  • Funding: None disclosed.

Key results

  • CV event incidence rate (fatal and nonfatal myocardial infarction, stroke) per 1000 person-years: sevelamer, 458; calcium acetate, 464.
    • After propensity score fine-stratification weighting: HR=0.96 with 95% CI crossing the unity barrier (0.84-1.10).
  • Results were supported in subanalysis by age/sex:
    • Age 
    • Age ≥75 years (HR=0.83; 95% CI, 0.69-1.01).
    • Men (HR=1.02; 95% CI, 0.83-1.26).
    • Women (HR=0.92; 95% CI, 0.76-1.11).
  • Crude mortality rate per 1000 person-years: sevelamer, 208.4; calcium acetate, 216.8.

Limitations

  • Excluded predialysis use.
  • Newer binders not captured.