What really happened to heart patients taking a cholesterol drug?
Restoring mortality data in the FOURIER cardiovascular outcomes trial of evolocumab in patients with cardiovascular disease: a reanalysis based on regulatory data
Not medical advice. For informational purposes only. Always consult a healthcare professional. Terms
Surprising Findings
More heart-related deaths occurred in the evolocumab group after independent review, reversing the perceived safety advantage.
PCSK9 inhibitors like evolocumab were hailed as breakthroughs for preventing heart attacks, with trials claiming cardiovascular benefit. Finding a potential increase in cardiac deaths — especially heart failure — contradicts the expected protective effect and raises red flags about long-term safety.
Practical Takeaways
If you or a loved one is taking evolocumab for heart disease, discuss this reanalysis with your doctor — especially if there’s a history of heart failure.
Not medical advice. For informational purposes only. Always consult a healthcare professional. Terms
Surprising Findings
More heart-related deaths occurred in the evolocumab group after independent review, reversing the perceived safety advantage.
PCSK9 inhibitors like evolocumab were hailed as breakthroughs for preventing heart attacks, with trials claiming cardiovascular benefit. Finding a potential increase in cardiac deaths — especially heart failure — contradicts the expected protective effect and raises red flags about long-term safety.
Practical Takeaways
If you or a loved one is taking evolocumab for heart disease, discuss this reanalysis with your doctor — especially if there’s a history of heart failure.
Publication
Journal
BMJ Open
Year
2022
Authors
J. Erviti, J. Wright, K. Bassett, M. Ben-Eltriki, C. Jauca, L. C. Saiz, L. Leache, Marta Gutiérrez-Valencia, T. Perry
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Claims (4)
Taking a drug called evolocumab can lower the chance of having a first major heart problem by 25% in people at high risk who’ve never had a heart attack or stroke before.
People with heart disease who took a drug called evolocumab had more heart-related deaths than those who took a dummy pill, according to a reanalysis of a major study — but the difference wasn’t quite strong enough to rule out chance.
People taking a cholesterol drug called evolocumab had almost twice as many heart failure deaths as those on a dummy pill in one big study, but this wasn’t mentioned in the main report—so scientists are wondering if the drug might actually harm the heart in some ways.
A second look at heart death data from a major drug trial found more heart-related deaths in the treatment group than were first reported, while the placebo group had fewer — suggesting the original study may have missed some key facts.