Vytorin continues to get hit hard. Information they released today to calm critics seemed to only intensify the scrutiny, with the FDA announcing they plan to review the safety and efficacy of ezetimibe (Zetia) which is also in Vytorin.
I have previously blogged about not taking an alarmest view on Vytorin (Vytorin and Zetia: What to do now? ) since it may be appropriate for some patients (though not likely most). However, I received a "Dear Doctor" letter today regarding the ENHANCE study that I thought non-recipients might be interested in.
"Dear Doctor" letters are often required by the FDA when there is a label change to a drug or signifcant concern. This is usually, but not always bad news. I have received many of these letters over the years, which have always beed delivered by my US postal carrier, but today's letter was delivered by UPS. It appears today's letter was not prompted by the FDA, but a proactive approach by Merck/Schering to ensure I don't stop writing prescriptions for Vytorin. Unfortunately, the letter is not yet posted on their web site. However, below are direct "several key points to consider" that appear in bold, with my interpretation (in italics) of what they are really trying to tell me below (capital letters Merk's editing not mine):
Lowering LDL-C remains the primary target of lipid-modifying therapy.
Just because our study showed that lowering the LDL didn't make a difference, doesn't mean you shouldn't follow guidelines that recommend lowering the LDL! Of course, the latest update to these guidelines were written in 2004. It is likely that they will change based on this study. The Medical Letter (non-comerically biased source of drug information for clinicians) just came out with its guidelines yesterday and recommended limited use of Vytorin and Zetia.
ENHANCE was an imaging study; it was not designed to examine differences in clinical outcomes, such as reductions in heart attacks or strokes.
Just because our drugs didn't prevent artery clogging doesn't' mean that they won't prevent heart attacks and strokes! Of course if there study did show that it prevented artery clogging, I guarantee Merk reps would be in my office the next day telling me that this data suggested Vytorin would likely prevent heart attacks and strokes. You can't have it both ways. Also, Lipitor has show to both reduce plaque build up and prevent heart attacks and strokes.
A Clinical Outcomes Study Comparing VYTORIN and Simvastatin is Under Way.
Don't draw any conclusions until the real study comes out. Of course, it will take a few years until these results are public. That's millions of prescriptions they hope we doctors write until their study (which will likely show similar disappointing results) is done.
What should you tell your patients who are taking VYTORIN (ezetimibe/simvistatin)?
When counselling your patients on VYTORIN or ZETIA, we would encourage you to respond based on your independent clinical judgement about the importance of lowering LDL-C by eating right, staying active, and following recommended prescribed medications.
We hope you will blow off this study and tell your patients everything's OK.
Merck/Schering -Plough hopes to present addtional results of the ENHANCE trial at the American College of Cardiology in March.
Pay attention to this one folks! They have just told you there next step in how they will try to persuade doctors, patients and legistlators that these results should not be taken seriously. Basically, their premise is that the results don't make sense, since other studies have shown that simvistatin does indeed decrease artery clogging. They have already used this as their rationale for delaying the results. What they will likely do at the big cardiology meeting is show (with lots of graphs, tables and images) how bad their data was, how inaccurate the ultrasound readings were, and how none of the results can be trusted. They were hoping to have all of this evidence ready when the results were announced, but the media and public forced their hand in presenting the data early.