Rewards of Research

The most rewarding aspect of research is being part of the process of new drug approval. Recently, a drug that we have worked with for the past seven years was approved.The name you will see is Effient (known chemically as prasugrel) and when we worked on it first, it was only a number. We were involved in the first safety and dose ranging study and then in the pivotal trial.

This drug will compete with the drug Plavix - a drug familiar to all patients that have stents and to most patients who have coronary disease. This story also provides another lesson in how we as physicians learn about drugs.

When Plavix was first brought to market it immediately replaced the drug Ticlid which caused side effects in almost 30% of the patients who received it. Ticlid also has some very nasty side effects, so we as physicians were happy to see it go. Luckily very few patients are allergic to the compound because we use it after coronary stenting without giving patients the opportunity to determine if they can tolerate it. It was believed that one size fit all; that 75mg. of drug was adequate for all.

Plavix is a prodrug, which means that after swallowing the pill it is split into a drug and a waste particle. It is this drug that is the effective part of Plavix. The drug is split in the liver with an enzyme system that, lo and behold, is very variable. It turns out that roughly 25% of patients who take Plavix are non responders. Another 25% are medium responders. Approximately 50% respond appropriately. In addition, recently it was reported that the combination of Nexium with Plavix, which is commonly used to decrease stomach bleeding, further disrupts the prodrug conversion.

Plavix and the addition of aspirin is integral to the treatment of patients who have stents. Stent closure is associated with a 30% mortality, so we do everything possible to prevent it.

Next…Why this new drug may be an advance.

Tags: Effient, Plavix, prasugrel, prodrug

This entry was posted on Monday, August 10th, 2009 at 6:22 am and is filed under Aortic Aneurysms /Stents / Grafts, Coronary Artery Disease. 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.