Tuesday, November 23, 2010

Advances in Cardiovascular Treatment - "Silver Bullet" Cure?

Merck pharmaceutical has just released initial clinical trial study results for a new drug that is being touted as having the potential to stop progressive cardiovascular plaque in it's tracks. Associated with a new class of drugs-Anacetrapib is making some waves in the clinical science community. Unlike statin drug therapies, which increase HDL (good cholesterol) levels-assisting in slowing the progression of coronary plaque development, this new drug significantly reduces LDL (plaque causing cholesterol)-essentially removing the risk of plaque development.

The initial trial studied 1,623 heart patients (with known coronary heart disease) for a period of 18 months. The results noted a significant impact on lowering LDL (by 40%) as well as increasing HDL levels (by 138%!).

This all sounds very exciting, and lends to initial thoughts that this may be the "Silver Bullet" in cardiovascular disease that will bump this off the list as the number one (or even top 5) killers in the U.S. However, a number of cautionary notes should be made:

1) This is an extremely small study group over a short period of time. It will take at least another (5) years of study and thousands of trial participants (Merck indicates a pending study of 30,000 global participants) to support initial theory and determine overall efficacy.

2) During this small trial, 8 participants taking the drug required further cardiovascular intervention (bypass and/or angioplasty)

3) LDL levels dropped to extremely low and dangerous levels in 18% of the participants-so they were removed from the study prior to completion.

4) There were a reported 11 deaths for which it is unclear if it was related to abnormally low LDL levels.

5) This is in the same class of drugs which was previously studied- and withdrawn- by Pfizer due to high incidents of heart attacks and deaths.

Lastly, as this underwriter has seen with statin therapies (the wonder drugs of the Millennium) in elderly patients, due to the number of side effects experienced there is always a large percentage of the population that cannot tolerate these drugs. Just think of the most recent pharmaceutical ad you watched on t.v. which always wraps up with the list of potential side effects and it becomes very clear that anything too good to be true, often times comes at a price!

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