June 16, 2011

The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial

.   .   

The SHARP study was a large randomized controlled trial which assessed the efficacy and safety of the combination of simvastatin plus ezetimibe in patient with moderate-to-severe kidney disease. Consistent with Nephrology Now’s report on the trial results as presented at the 2010 ASN meeting, the intervention arm had a 17% relative risk reduction in major atherosclerotic events, 11·3% in the simvastatin plus ezetimibe group vs 13·4% in the placebo group.

Related Articles:

Chronic Kidney Disease, Internal Medicine for Nephrologists, Vascular Disease/Calcification
  • Ojpjpo

    The big deal is that MERCK used public money (NHMRC etc) to fund a EZETROL + statin arm without a statin only arm

  • curious monkey

    The absolute benefit in the Rx group:  prevent 93 events – not just serious events or death, but any atherosclerotic event – in 4650 patients = absolute benefit of 2 %.

    This works out to a number needed to treat over 5 years to prevent 1 event of 50. The cost of combined generic simvasatin + brand name ezetimibe therapy in my jurisdiction (Canada) is about $ 1250/year.  The cost of treating 50 people for 5 years for drug and pharmacist fees alone is $ 60,000/year – for 5 years = $ 300,000 to prevent 1 event….

  • Wittykidney

    MERCK Is well known to design such trials – eg RENAAL etc. What’s the big deal about this? There was no difference in mortality between 2 arms. The combined MACE showed statistically significant benefit? Its likely a chance findings – and the comapny is pushing it as an Ezetrol effect. Whereas other EZETROL trials [ENHANCE, SEAS] were negative so far and its the only weakly positive Trial.

  • Jhhl

    Dear Ojpjpo,
    good question. We have been part of the trial and had this question too.
    The “pharma” had possibly no interest to check the power of Simvastatin alone, a well known and cheap available drug.

  • Jhhl

    Dear Ojpjpo,
    good question. We have been part of the trial and had this question too.
    The “pharma” had possibly no interest to check the power of Simvastatin alone, a well known and cheap available drug.

  • Ojpjpo

    How does a publicly funded NHMRC trial not include a simvastatin only arm?  What price do we pay for big pharma trials?