Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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IMPROVE-IT heart drug trial balderdash

The drumbeat of heart news coming out of the American Heart Association is loud and clear.  But some who read and listen closely are seeing and hearing arrhythmias – disturbances in the signal.


The New York Times reported:

For the first time since statins have been regularly used, a large study has found that another type of cholesterol-lowering drug can protect people from heart attacks and strokes.


The finding can help millions at high risk of heart attacks who cannot tolerate statins or do not respond to them sufficiently. And it helps clarify the role of LDL cholesterol, the dangerous form. Some had argued that statins reduced heart attack risk not just by lowering LDL levels but also by reducing inflammation. The new study indicates that the crucial factor is LDL, and the lower the levels, the better.


The hype today is due to a presentation at the American Heart Association Annual meeting in Chicago.  Researchers provided results of the IMPROVE-IT trial.  The study enrolled 18,000 subjects who had suffered heart attacks or chest pain and randomized them to either Vytorin or the statin, called simvastatin, alone. Over the six year duration of the study, 34.7% of the subjects who were being treated with simvastatin alone had a heart attack, stroke, acute hospitalization or revascularization procedure.  This compares to 32.7% of those treated with the combination of simvastatin and ezetimibe (aka Vytorin)  Yes, indeed, that is a 2% absolute difference.  At first glance, not very impressive although it was a statistically significant difference and the greatest impact was in heart attack and stroke.  But it is still only a 2% difference.  LDL-cholesterol levels were lower in the people treated with the combination as compared to those who only received the statin (54mg/dl vs. 69mg/dl).  Many would argue that the study confirmed that lowering of LDL-cholesterol is important.  And, the lower the better.


Going down the standard criteria used by HNR, most reporting to date would not score very well.  One article, by Mathew Herper of  Forbes  did the best, in my estimation, in putting the study results into context and perspective.


If you are one of the millions of American adults taking your daily ration of a statin, you should read the Forbes article before you run off to your primary care physician asking for the “game changer”.


Pharma Guy's insight:


To some cardiologists who have been critics of the drug, the size of the effect – a 6.4% relative decrease – remains an issue.  “I will be the first to say it is a positive result, that it is a meaningful, it shows that lowering LDL with a non-statin, in this case ezetimibe, does in fact reduce morbidity and mortality a little bit,” says Steven Nissen of the Cleveland Clinic. “But it’s a very specific population, it is a very small population, and it took a very long time. It should not be overstated.”


Allen Taylor, chief of the cardiology division at Medstar Georgetown University Hospital, was even stronger: “Risk reduction of 6% is nothing to dance around about,” he says. “It’s very clinically marginal. It’s positive only because it’s so big and so long they brought it down to such a low chance of failing that even a marginal clinical result like this could be statistically in the bounds of value.”

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Can a SmartWatch Result in More OTC Switches?

Can a SmartWatch Result in More OTC Switches? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

At some point, one simply has to assume that the smartwatch, along with the smartphone, will be able to help drugs that are sitting behind the prescription pad to make their way to the OTC counter.  For many drugs, such as statins, the inability to monitor one’s own liver functions and cholesterol levels has meant that attempt to switch statins from RX to OTC have failed.  (I attended most, if not all of the AdComms.)  But as our technology advances and becomes more accessible, and our watches and phones stop telling us the time and making our calls in favor of providing us with ever expanding amounts of information about ourselves, at some point it is likely that the watch and the phone will help us do things that we can only do with our doctors now – and hence opening up a bit the vault of drugs that can be switched from RX to OTC.  Just “watch”.

Pharma Guy's insight:


The argument against OTC statins such as Lipitor is that these drugs can be highly toxic to the liver if not used properly and require periodic blood tests to monitor such problems.


I understand the reasoning stated above -- that "SmartWatches" may someday be able to monitor  liver functions well enough so that patients can medicate themselves.


However, will consumers pay attention to what their watches are saying? Will they understand what their watches are saying? Will their watches be accurate and not generate "false" data? 


The last is most worrisome because it could lead to expensive medical testing that is not required.

Adding to the debate is a benefit/risk analysis of statins based on a little-known but useful statistic, the number needed to treat. You can read more about that here: "The Statin Lottery: Number Needed to Treat Statistic". According to Dr. Jerome R. Hoffman, professor of clinical medicine at the University of California at Los Angeles, people could do as well dieting and exercising to lower cholesterol while avoiding the cost and potential side effects of taking a statin every day. BTW, people pay out of pocket for OTC drugs that were covered by insurance when the drugs were Rx. Those costs could exceed copays.

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