Monday, October 31, 2011

Merck Knows More about Zetia than They’re Telling Us


I’d like to try to change the way you think about preventative medications.
The goal of prescribing blood pressure-lowering medications is not to lower blood pressure.  The goal of prescribing cholesterol-lowering medications is not to lower cholesterol.  The goal of prescribing medications for osteoporosis (low bone density) is not to raise bone density.  Let me explain.  The goal of medications that lower blood pressure and cholesterol is to prevent heart attacks and strokes.  The goal of medicines that treat osteoporosis is to prevent fractures.
The distinction may seem silly but is actually critical.  Strokes, heart attacks and fractures are what doctors and researches call clinical outcomes.  Clinical outcomes are things that directly affect patients, things that patients can Cialis Super Active notice for themselves.  Blood pressure, cholesterol and bone density, on the other hand, are intermediate (or non-clinical) outcomes, things that doctors can measure but that patients can’t feel directly.
The important lesson is that medicines that improve intermediate outcomes don’t always improve clinical outcomes.  There are medications that lower blood pressure without decreasing stroke or heart attack risk.  There are medications that lower cholesterol without decreasing stokes or heart attacks (like estrogen).  So the important question to ask is not “will this medicine improve my bone density?”  The important question is “will this medicine decrease my risk of fracture?”
Statins, a family of cholesterol-lowering medications which include Lipitor, Zocor, Crestor, and others, have been a boon for patients because of their proven benefit in preventing strokes and heart attacks.  Zetia, a cholesterol-lowering medicine that works differently than statins, has been proven to lower cholesterol but has never been studied to see if it improves clinical endpoints.
Last week’s NY Times had a disturbing article about Merck’s handling of data from a study about Zetia.  After completing a trial testing the effectiveness of Zetia, Merck has decided that they will only release data about some of the outcomes that were measured.  That’s definitely a reason for the rest of us to worry and for patients on Zetia to talk to their doctor.
Many of my colleagues and patients are very hostile to the pharmaceutical industry.  I’m not.  Without the pharmaceutical industry, after all, we’d never have statins.  I assume that, like all industries, they will try to sell us more than we need and will try to put the best spin on their products.  So the burden is on us, the consumers, to be educated and discriminating shoppers.
(Thanks to my colleague, Dr. Yaron Elad, for bringing the article to my attention.)
Tangential Miscellany:
A bright and happy Chanukah to all my Jewish readers!

Zetia Side Effects


Name:Zetia
Generic:Ezetimibe
Manufacturer:Merck/Schering-Plough
Date approved:October 25, 2002
Status:Prescription only
Approved uses:Treatment for patients who cannot control their cholesterol levels by diet alone
Off-Label uses:None at present
Side effects:
  • Rhabdomyolysis - severe muscle damage including pain, tenderness and weakness
  • Liver Damage
  • Possible Allergic Reaction
Related topics:Unsafe Drugs, Vytorin, Zocor, Simvastatin, Cholesterol
Common Misspellings:zedia, exetimibe, ezitimibe,



Zetia (Ezetimibe)

Zetia (generic name ezetimibe) is a cholesterol medication used to lower levels of total cholesterol and LDL (bad) cholesterol in the blood. It is used for Tadalista patients who cannot control their cholesterol levels by diet alone. It can be used by itself or with certain other medicines to treat high cholesterol. By lowering cholesterol levels better than older medications called statins can do alone, Zetia is meant to help better prevent the development of arterial plaque, which can lead to heart disease and heart attacks.

However, an extensive study completed in mid 2006, and released in January 2008 has shown that taking Zetia had no benefit on the buildup of arterial plaque when compared with patients taking only statins such as Zocor. This finding is significant, as Zetia is more expensive than the generic version of Zocor (simvastatin). The manufacturer has disputed the study's findings, but within weeks of the study's release a class action lawsuit has already been filed against Merck and Schering-Plough. The Zetia lawsuit alleges that the companies have known since 2006 that their drug was no more effective than the cheaper generic Zocor, despite leading consumers to believe the opposite.

New Study Shows Zetia Not As Effective As Claimed

Zetia , a popular cholesterol drug manufactured by Merck, is under fire thanks to a recent study that suggests the drug is not as effective as advertised. Although the active ingredient ezetimibe has been shown to reduce cholesterol slightly, it is not as effective as Niacin, a cheap vitamin B drug. Zetia is a break through cholesterol medication that blocks cholesterol absorbtion in the intestines whereas its competitors, Lipitor, Zocor and other statin-type drugs, block cholesterol production in the liver.

Zetia Does Not Reduce Heart Attack Risk

Finally, the results of the trial were released in January of 2008. In a study to specifically measure the reduction of the growth of fatty plaques in arteries, both Zetia and Vytorin were shown to increase the fatty plaque growth in the patients' arteries, almost doubling the rate of growth when compared to another leading high-cholesterol medication. This one result leads many to believe that several cardiac complications and events could have been enabled by taking medication specifically prescribed to as a support for people at high risk for such problems.