Deans' stroke musings: FDA panel to weigh revoking key use of Abbott drug Trilipix

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Tuesday, May 17, 2011

FDA panel to weigh revoking key use of Abbott drug Trilipix

http://www.fayobserver.com/articles/2011/05/17/1094794?sac=Bus
WASHINGTON - A panel of advisers to the Food and Drug Administration will consider this week whether to revoke a key indication from Abbott's blockbuster cholesterol drug Trilipix.
Trilipix is a fibrate, a drug that lowers blood fats called triglycerides while boosting "good" cholesterol. The drug is approved for combination use with statins like Lipitor and Zocor, which lower "bad" cholesterol and are the most widely-used class of cholesterol drugs.
But a 5,000-patient government study released in March showed that diabetic patients taking Trilipix plus a statin had just as many heart attacks as patients taking a statin alone. The study was designed to show that the combination reduced heart attack, stroke and other deadly events in patients with Type 2 diabetes.
On Thursday, the FDA will ask an outside panel to consider several options for Trilipix, according to documents posted online Tuesday. Those options include revoking the drug's approval for use with statins, updating its label with information about the study, or simply leaving it on the market as is. The panel's recommendation is not binding.
The group will also discuss data from the study that showed a higher rate of heart attacks among women who took Trilipix in combination with a statin.
In its scientific review posted online, the FDA said drugs like Trilipix have shown "potential" to reduce heart attacks for over 40 years.
"However, data from large clinical outcomes trials have produced mixed results," the agency concludes.
Drugmaker Abbott Laboratories said it supports adding information to the label from the government study. But company executives say two-thirds of the patients enrolled in the study would not be eligible for Trilipix based on physician prescribing guidelines.
"The patients who benefit from this drug are very easy to identify: they have high triglycerides and low HDL (high-density lipoprotein) cholesterol and that is reflected in the current labeling," said Dr. James Stolzenbach, an Abbott vice president who oversees cholesterol medications.
North Chicago-based Abbott Laboratories reported combined sales of $1.6 billion last year for Trilipix and TriCor, an older drug that contains the same active ingredient. The drugs' primary use is as a combination with statins, though they are also approved as stand-alone drugs for certain patients with bad cholesterol.
Wells Fargo analyst Larry Biegelsen said the most likely outcome of Thursday's meeting will be the addition of new study data to the Trilipix label. That step would have "modest" impact on the company's overall sales since Tricor is scheduled to lose patent protection next year, limiting future sales of the company's cholesterol franchise.