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Lessons learnt from the 4D trial.

Christoph Wanner, Vera Krane

    Nephrologie & Therapeutique
    |August 10, 2006
    PubMed
    Summary
    This summary is machine-generated.

    In type 2 diabetes patients on hemodialysis, atorvastatin did not significantly reduce cardiovascular events. Statin therapy is not recommended for this high-risk group at this time.

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    Area of Science:

    • Nephrology
    • Cardiology
    • Clinical Trials

    Background:

    • Renal dysfunction significantly increases cardiovascular disease (CVD) risk.
    • Type 2 diabetes mellitus (T2DM) patients on maintenance hemodialysis represent a particularly high-risk population for CVD.
    • Current CVD management strategies are being investigated in this vulnerable group.

    Purpose of the Study:

    • To evaluate the efficacy of atorvastatin in reducing cardiovascular outcomes in T2DM patients undergoing maintenance hemodialysis.
    • To investigate the role of factors beyond atherogenic lipoprotein phenotype in CVD risk in this patient population.

    Main Methods:

    • The 4D study was a randomized, placebo-controlled trial.
    • 1255 T2DM patients on maintenance hemodialysis received either atorvastatin (20 mg/d) or a placebo.

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  • Cardiovascular outcomes were monitored over a median follow-up of 4 years.

    • Main Results:

    • Atorvastatin showed an 8% relative risk reduction in cardiovascular events, which was not statistically significant (95% CI, 0.77-1.10; P=0.37).
    • The study observed a high incidence of cardiovascular events and a 24% overall cardiovascular mortality.
    • A higher rate of fatal strokes was noted in the atorvastatin group, and the drug's effect on the primary endpoint was non-significant.

    Conclusions:

    • Initiating statin therapy with atorvastatin in T2DM patients on hemodialysis is not recommended currently due to non-significant efficacy and safety concerns.
    • The high CVD risk in this population likely stems from factors other than solely an atherogenic lipoprotein phenotype.
    • Statin therapy may be more beneficial if implemented earlier in the course of vascular damage progression.