The Ins and Outs of Clinical Research Studies

The American Heart Association meeting took place in Orlando this year and provided additional insight into the treatment of heart disease. One study in particular was eagerly awaited. This was the Arbiter6-Halts study. Study results are embargoed before presentation or publication. What this means is that no results can be discussed or presented in any format until its release time. This is in spite of many people knowing the results. The only time this is not done is if something is of great importance to public health. Then it is rushed to print on line. The web has made this vastly easier but all the more difficult in that information often “escapes” early.

In Arbiter’s case, the study compared niacin — a drug that I have blogged about several times in the past.  It is a very useful drug but one that is very difficult to take secondary to side effects. As I have also blogged, we are presently involved in an early phase study working on a compound that acts like niacin without the side effects.

Niacin was being compared to Zetia, or as it is known generically, ezetimibe. I have not spoken much about this drug because of my own bias about it. It is, however, widely used and has undergone several evaluations; most have been negative as far as its use.

When this study was stopped early this past summer, Wall Street immediately began to dump the stock of the company that manufactures it. This was compounded by the chairman of the company having to have a conference call and providing negative earnings guidance for the company. This was all before the data was presented and individuals had an opportunity to review it. Just another example of how intertwined everything we do is.

Also involved in this issue is the difference between the old and new FDA approval process. In the past, as in Zetia’s case, drugs were approved because they lowered cholesterol. Now the drug must lower cholesterol and provide a clinical benefit. This is a high hurdle but a distinction that is critical. Why take a drug unless you get a benefit for it? When Zetia was approved it did not have outcome data. This is why these studies are so important.

Next…what is Zetia?

Tags: Arbiter6-Halts study, Ezetimibe, Niacin, Zetia

This entry was posted on Tuesday, December 1st, 2009 at 7:04 am and is filed under Cholesterol. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.