FDA Gives Crestor New Indication

On this blog on June 15th 2009, I wrote about the JUPITER Study and its meaning to patients who are at risk for cardiovascular events.  Crestor or rosuvastatin is the most potent statin in the family of statin drugs.  Its potency is derived from the drug’s half life.  The longer the drug is in your system, the lower your LDL goes.

All companies strive to have drugs approved and then to enlarge the group of patients that the drug can possibly benefit.  Even though I can give any drug I want to for any reason to any patient, the FDA does not allow the process of “detailing” for other than “approved” indications.  Detailing is the process where a representative of the company will come into my office and give me very specific information regarding the drug.  This material is highly vetted by the government and the company and serves as a major source of drug information for busy doctors, who have difficulty in keeping up with the latest in fields that might not be their expertise.

So when a drug gets a new indication, it’s a big deal.  The FDA was stricter in their new indication than the inclusion criteria for the study, but none the less, this indication lowers the bar to whom this drug should be offered. I personally believe that as the readers of my blogs know; I am a big fan of widespread use of the statin drugs to possibly prevent cardiovascular events.

Specifically the FDA has approved the use of Crestor in men greater than or equal to 50 years old and women greater than or equal to 60 years old, who have fasting LDL levels <130 mg/dl, hs-CRP > 2.0 mg/dl, triglycerides <500 mg/dl and one additional cardiac risk factor.  The study required no additional risk factors but in an analysis of the study, all the benefit was in those patients who had additional risk factors.  Further analysis showed that the greatest benefit was in those patients with a 10-yr Framingham risk of 5% to 20% and who would not have been treated under the guidelines.

It is estimated that close to 17 million more patients are now eligible for treatment and the reduction of cardiovascular events in this many patients can decrease the overall healthcare costs substantially.

I congratulate the authors of the JUPITER study on a job well done and I predict that we will have a further lowering of the bar as time goes on.  There is even a movement to not test for cholesterol levels at all but just give the drug in moderate levels to everyone who has hypertension.  This concept is know as the “polypill” and gets more interest in Europe than the United States.  I predict, however, that I will be writing more blogs in the future about how more and more people will possibly derive benefit from these wonderful drugs.

Tags: Crestor, Jupiter Study, LDL, polypill, statin drugs
Posted in Cholesterol | 2 Comments »

And Away Goes Trouble Down the Drain…

In the middle ages, Alchemists dreamed of transmuting coal into gold.  In much the same ways Cardiologists have dreamed of a substance that would remove plaque that had already formed akin to Drano removing scale and rust from pipes.  The best we have so far is statins like Lipitor and Crestor, which has been shown to diminish plaque burden by Intravascular Ultrasound or as it is known IVUS.  The mechanism by which statins work is believed to be more reorganization of plaque than the removal of material.

In June 2003 a study was published in JAMA 2003, which electrified the field of cardiology.  Here was the promise fulfilled, a substance that would remove plaque.  That substance is ApoA-1 Milano now called ETC-216 as it was purchased by Esperion and renamed.

Over the time period November2001 and March 2003, 123 participated in the study.  All had ACS- acute coronary syndrome and I have blogged about this syndrome frequently.  They were randomized into three groups’ placebo, low-dose and high-dose, and underwent once a week infusions of Apo for five weeks.  IVUS was done before and after, and then analyzed to see the differences in plaque volume and composition.

The mean percent decrease was 1.06% in the treatment group and an increase of .14% in the control group.  The absolute reduction in atheroma volume was 4.2% and this carried a p value of <.001.  The lower the p value the more significant thus this is a very significant result.

In the short span of five weeks, atherosclerotic coronary lesions were shown to reverse.  Further, the dose of ApoA-1 did not matter.  Both the low-dose and high-dose had the same effect and it is believed that the mechanism of action is the stimulation of reverse cholesterol transport.

That’s were it ended.  Since 2003 no further work was done because Esperion was purchased by Pfizer and Pfizer was probably doing that to “bury” it because it was working on its blockbuster oral drug torcetrapib.  That failed and Pfizer said adios to cardiac research.

The Medicines Company has a track record of delivering new drugs to market that have not been adequately studied.  Let’s hope that the work will now be started and finished to show whether this compound is the beginning of a new treatment strategy for atherosclerosis.  I will keep you informed.

Tags: Acute Coronary Syndrome, ApoA-1 Milano, Atherosclerosis, atherosclerotic coronary lesions, Crestor, ETC-216, Intravascular Ultrasound (IVUS), lipitor, plaque
Posted in Acute Coronary Syndrome, Cholesterol | No Comments »