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The Gout Dugout. Issue #015.Febuxostat approved by the FDA; the Dietary Diagram for gout pain relief
March 02, 2009
A warm welcome to the March 2009 edition of the Gout Dugout newsletter, and to those new readers who have signed up since the February edition.
THE US FDA APPROVES FEBUXOSTAT
Friday February 13 2009 was a lucky day for Takeda Pharmaceuticals North America - the announcement day that Febuxostat has been approved in the U.S. After marathon years of trials, extension trials, and an extra extension trial caused by concern about its effect on the heart, Takeda have finally got the decision they hoped for, and so have gout sufferers in the U.S. Febuxostat is the most widely trialed gout drug in history. Its brand name in the U.S. is Uloric.
I didn’t send out a flash issue of The Gout Dugout, because it will take a while for Takeda to sell and distribute Febuxostat to medical outlets.
You can read about how Febuxostat has performed against
Allopurinol on these pages:
Whether this is the case when Allopurinol is taken above 300 mg daily is not known from trial based knowledge since it wasn’t compared to Allopurinol above 300 mg daily. Allopurinol can be prescribed at up to 750 – 800 mg daily, in some countries, in people who can tolerate it at this level.
Britain’s National Institute for Health and Clinical Excellence, (NICE) when deliberating about Febuxostat for Britain’s National Health Service, said Allopurinol is much cheaper, (actually it said 13 times cheaper after very comprehensive costs/benefits analysis) so we next have to see what Febuxostat costs in the U.S.
Is Takeda mindful of the global recession? I hope so. As soon as some reliable information about U.S. pricing is available, I’ll feature it in this newsletter.
Takeda have set up a website for Uloric. At this site you can read about the decision and download prescription information. That will tell you whether your doctor can prescribe it for you. If you live in the U.S., and it’s only for U.S. residents, you can subscribe to the Uloric news updates from this site.
Febuxostat has now been approved in both the U.S., and in EU countries, after rigorous and expert examination of its trials. After such endorsement it’s hard to see other countries not approving it, although it was mainly trialed with male Caucasians in the U.S. and Canada.
My information so far is that it has not yet been approved in Canada and Australia, among leading English speaking countries.
I’m glad to say that the dietary diagram for gout inflammation and pain relief is now on the website. You can view it at this page. If you read better off screen, by all means print it for your own use but its copyrighted, so it’s for your own use only.
I must admit it looks fairly complicated, but the really key points are.
1. EPA inhibits the activity of the D5D enzyme.2. GLA is the precursor of "good" eicosanoids. 3. The D5D enzyme is also inhibited by lower levels of insulin.
And in the glossary under the diagram on the website page, I have listed the five major dietary steps you can take to improve your eicosanoid balance. As I said in last month’s issue the main thing is to get an approximate idea of how it all fits together, do the AA: EPA test (or the TG: HDL one, much more widely available in most countries), and the insulin test. Then use pharmaceutical grade fish oils plus GLA (FILLIP) as long as your doctor agrees.
But you will probably have more faith in what you’re doing if you understand it better, and the book to read is the Omega RX Zone by Barry Sears PhD.
Both the AA: EPA test, and the TG: HDL test are about judging your eicosanoid levels, both before and during the FILLIP treatment. There is another way, although not as scientific. Here’s a useful link that’s not yet on the website. You can download the eicosanoid status report free at Barry Sears's other site.
By all means, email me if you have any questions or comments. firstname.lastname@example.org
PEGLOTICASE PUT BACK, BUT NOT ON THE BACK BURNER
Pegloticase offers enormous promise among treatment failure gout patients (i.e. when all else has failed). In last month’s newsletter I reported that its review by the US FDA was likely to be before the end of April this year. Not now. The FDA has recently said it will not complete its review until the end of July, but its priority review status remains in place.
We’ll look at some of the finer points of the FILLIP treatment and there’s the start of a series about coping with gout.
P.S. You may distribute this newsletter freely and free-of-charge, providing any links in it remain unchanged and it remains intact. Partial copying is not allowed.
NB. The contents of this newsletter contain medical information, not medical advice. Please always discuss gout remedies with a doctor or other health care professional before implementing any treatment.
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