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The Gout Dugout. Issue #013. New gout drugs in 2009, gout pain relief, Britain approves febuxostat.
January 01, 2009
A warm welcome to the January 2009 (1st anniversary) edition of the Gout Dugout newsletter, and to those new readers who have signed up since the November edition.
2009 NEW GOUT DRUGS
2009 promises to be an interesting year on the new gout drugs scene. The US FDA decision about febuxostat may well be imminent now that its Arthritis Advisory Committee has recommended approval by a large majority. Other countries – probably including Canada, Australia and New Zealand – should also make decisions about it this year.
Pegloticase's developing company, Savient Pharmaceuticals, has asked the FDA for a priority review i.e. to get the approval process to move faster and it has set up a committee to try and get this. As a business, Savient needs approval as soon as it can get it. We should learn early this year whether the priority review is granted. They hope to get an approval decision in six months.
Another new gout-drug-under-development to watch is Arcalyst. It has completed its phase 2 trials. Its developing company has said it will start phase 3 trials early this year. This is a medication for relieving gout pain which is taken by injection, not tablet. I gave a simple explanation for how it works in the October 2008 edition.
In the phase 2 trials, used alongside allopurinol, only around 15% of trial patients suffered a gout attack, and none had more than one attack during a 12 week period, whereas almost half of those on a placebo (dummy substance) suffered at least one attack and some more than one. There were no serious side effects. Thus it may turn out to be better than NSAIDS or colchicine and maybe even the corticosteroid, prednisone.
Other new gout drugs under development. Xoma 052, like Arcalyst, is a pain reliever, but it's in earlier trials than Arcalyst. The interesting thing about Xoma 052 is that it inhibits the action of a cytokine. Cytokines are pro- inflammatory hormone proteins, similar in some respects to the bad eicosanoids. In Sears' Omega RX book he explains that fish oils also reduce cytokine levels. Is this a coincidence or are they doing the same thing? I'm not yet sure.
I discussed Sears's (the Zone diet) anti pain treatment in the December 2008 edition, and there's more about this below.
RDEA594, a uric acid lowering drug, will continue its trials but we don't yet know whether it's better than allopurinol or febuxostat.
BRITAIN'S NICE RECOMMENDS FEBUXOSTAT
In December 2008 Britain's NICE (National Institute for Health and Clinical Excellence) recommended febuxostat for NHS (National Health Service) use in England and Wales. British gout patients will have to suffer chronic hyperuricemia and be intolerant of allopurinol to be prescribed it. Or be gout patients for whom allopurinol is contraindicated. If you want to read the official documents about this development visit http://www.nice.org.uk/TA164
The recommended dosage is 80 mg daily, but 120 mg daily may be considered. There are warnings and precautions about its use in people with certain kinds of heart disease, which we already knew about.
Essentially I think that what has happened here is that febuxostat has been placed behind allopurinol because NICE was not convinced that it's better than allopurinol, if allopurinol is used at higher doses than 300 mg. 300 mg was the amount of allopurinol that febuxostat was compared against in its trials and not higher amounts. (A few patients took 100 mg). And febuxostat is 13 times more expensive than allopurinol, at least in Britain. This is a big difference. Hence the recommendation for only the kind of gout patients described in the above paragraph.
So although the European Medicines Agency (EMEA) approved febuxostat (brand name Adenuric in the EU) in April last year, for EU nations, it seems that each EU country still has the final word. If you live in an EU country your best way of finding out if febuxostat is approved is to contact the febuxostat distributor for your country. These are listed on the Public Assessment Report. Use the link on this page https://www.best-gout-remedies.com/febuxostat.html to download it (a PDF document) at the EMEA site. The list of distributors for each EU country with their addresses and telephone numbers begins on page 47 of the document.
GOUT PAIN RELIEF
I wrote about the Sears's (Zone diet) method of pain and inflammation relief in the December edition at some length because this is a big subject with potentially big rewards. No question that you have to know it well and do it properly. In December I added four new pages to www.best-gout-remedies.com which are related to the central argument. These had been mentioned but there's now much more detail. So there are now pages about borage oil, evening primrose oil, oats and flaxseeds. Borage oil, evening primrose oil and oats are all important because they contain gamma linoleic acid (GLA).
GLA is crucial in the conversion of linolenic acid (an omega -6 polyunsaturated fat) into the eicosanoids which have anti-pain, anti-inflammation effects. On the website pages you can read gout pain relief testimonials from this method.
The new page about flaxseeds discusses their pros and cons in the Sears' approach. Their role is because some of their ALA (alpha linolenic acid) is converted into the omega -3 fats EPA and DHA which are vital. Basically I concluded flaxseeds can be of some help in getting EPA and DHA but fish oils and high omega -3 fish are much better. With most high omega -3 fish you have to watch the purines of course. People who can't take fish oils (for example strict vegetarians, or people on blood thinning medications) or eat fish, can get some benefit from flaxseeds. To read these pages click on these links:
A DIETARY DIAGRAM FOR GOUT PAIN RELIEF
I realise that all this is complicated to understand so I have prepared a dietary diagram for gout pain relief, which shows all these substances and their inter-reactions en route to producing more anti-pain, anti-inflammation eicosanoids, some of which are prostaglandins. An artist is currently drawing it and it will be on the website in January. If you want to understand it all you will be able to view it on a single page. Better still, print it out and study it in a comfortable chair or in bed.
BUYING VITAMINS ONLINE
The more or less global recession has increased the number of special offers, and price reductions from online vitamin shops. Realise that the internet is a very competitive place, more than offline. And they don't have a shop's overhead costs, –rent, staff, utilities, advertising, and probably local taxes. Essentially they post you vitamins/dietary supplements from warehouses, large and small. It's almost always cheaper to buy them online, but you have to wait for delivery of course. When I buy online (most of the time) I get delivery in three days or so, so all it requires is a little advance thinking. Sometimes they are out of stock for a while, but so are offline shops. Check it out and you'll probably save money.
Traverse Bay Farm's free shipping offer still applies as I write on their excellent range of cherry and other fruit supplements and the Gout-Haters' cookbooks. Go to and click on the Traverse Bay Farms link on this page.
A look at a test you can do that enables you to know what your eicosanoids levels are now, and after a period on FILLIP - the FIsh oiLs, gLa, Insulin reduction Programme (program). In other words a test that tells you if your eicosanoids have improved and therefore whether you are likely to get relief from gout pain.
Thanks for reading. A Happy New Year to all subscribers!
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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