Fibrates: Cholesterol-Modifying Drug Bites The Dust

| December 13, 2012

The medical research community seems to have an unending capacity to churn out research which appears to support the ‘cholesterol hypothesis’ and the use of cholesterol-lowering drugs. This time fibrates enjoys a bit of the limelight.

A favourite tactic here is to express any benefits as a relative reduction in risk. This way of expressing things is of little benefit though. More meaningful are measures such as the absolute reduction in risk and number needed to treat (e.g. how many people need to be treated for a specified period of time to prevent one heart attack).

I wrote about this last week with regards to cholesterol-modifying drugs known as fibrates. The research reveals that, as is usually the way, the benefits of treatment are quite tiny in reality.

Worse still, some cholesterol-modifying drugs turn out to be downright dangerous. One such example is torcetrapib, which Pfizer spent about $800 million developing. Torcetrapib is what is known as a CETP (cholesterylester transfer protein) inhibitor, and slows the conversion of supposedly healthy HDL-cholesterol into supposedly unhealthy LDL-cholesterol. If you believe the conventional wisdom on cholesterol (I don’t), then this should translate into benefits for health with regards to cardiovascular disease (e.g. heart disease and stroke). However, once tested, it turned out that torcetrapib actually killed people. Pfizer promptly and quite rightly ceased development of the drug.

Torcetrapib is not the only CETP-inhibitor that a drug company has sought to exploit commercially, though. Roche has sunk not inconsiderable funds into a drug known as dalcetrapib. That was until the middle of this year when Roche decided to drop this drug. And a recently-published study shows us why [1].

In this study, published in the New England Journal of Medicine, almost 16,000 patients who had suffered from ‘acute coronary syndrome’ (e.g. angina or heart attack) were treated with dalcetrapib or placebo for an average of about two and a half years.

These are just the sort of patients one would expect to benefit most from an intervention because, as a group, they would generally be at high risk of future problems. Also, the number of subjects here is huge, and therefore more than big enough to detect any real benefit the drug may have.

Fibarets: Stacking the odds in favour of the benefits

The researchers assessed the effects of dalcetrapib using a ‘composite endpoint’ – which essentially means lumping several outcomes together. The composite outcome included death from heart disease, non-fatal heart attack, ischaemic stroke (strokes due to blockage of blood vessels rather than bleeding), unstable angina (angina that can come on at rest), and cardiac arrest with resuscitation. This approach of combining several outcomes together makes it more likely that a ‘statistically significant’ benefit for a drug will be found (compared to when only one single outcome is chosen).

In short, this study was designed in a way which would, generally speaking, stack the odds in favour of finding benefits for dalcetrapib. But the study showed that this drug had no benefits at all.

Biochemical analysis revealed that dalcetrapib did, as expected, have a considerable HDL-boosting effect. So, here again we have an example of how the conventional wisdom around cholesterol (‘HDL-cholesterol is healthy’) turns out not to be supported by the evidence.

Another interesting thing about the study was that dalcetrapib was found to increase markers of inflammation – a process which is believed to play a key part in the development of heart disease and stroke.

I’m not surprised that the researchers (funded by Roche, perhaps predictably) decided in the end that the study should be terminated early. Early termination of studies is known to generally inflate the benefits of drugs and downplay their risks. Who knows what may have happened if they’d continued.

Of course you’re unlikely to hear about the dalcetrapib study because it wasn’t announced with the blaze of publicity usually afforded to more ‘positive’ studies. But this is often the way with medical research and cholesterol-related research in particular: spin positive results to make the drugs appear better and less toxic than they are in reality, while sweeping negative results and inconvenient truths under the carpet.

Here’s to a healthy heart

Dr John Briffa
Editor
for The Cholesterol Truth



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Bear in mind we are not addressing anyone’s personal situation and you should rely on this for informational purposes only. Please consult with your own physician before acting on any recommendations contained herein.


References:

1. Schwartz GG, et al. Effects of Dalcetrapib in Patients with a Recent Acute Coronary Syndrome. N Engl J Med 29 November 2012 (epub)

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