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The Gout Dugout.Issue #028. A new test for gout; febuxostat to be sold in some EU countries at last;
April 03, 2010

Welcome to the April 2010 issue of the Gout Dugout newsletter. The ten minutes read that could give you a couple, or more, useful gout ideas.

FEBUXOSTAT IN EUROPE - IS THE LONG WAIT OVER?

Last year, when Febuxostat was approved in the U.S., I recall a reader of this newsletter was able to buy it within 2 or 3 weeks of FDA approval.But in the EU? Febuxostat was actually approved for EU countries in the spring of 2008. In March, almost 2 years later, Febuxostat was finally launched in France, Britain, Germany and Ireland. So if you live in any of these countries and you want it, now is the time to speak to your doctor. For most people it's better than Allopurinol, but it's also much more expensive.

EU countries with socialised health systems - themselves under financial pressure since the credit crunch began in mid 2007 - may have decided what Britain did: we'll pay for it if Allopurinol doesn't work or if a gout patient is intolerant to Allopurinol, or if the gout patient has an extemely high level of uric acid. In the U.S., where it's now got a good market share, some doctors baulk at its cost.

The March launch was in only four EU countries. Febuxostat is now to be distributed in 41 European countries,including non EU ones such as Russia, the Ukraine, Norway and Switzerland, by the Italian pharmaceutical group, Menarini.(With the exception of France where its distributors are Ipsen and Menarini). Expect additional launches in other European countries, hopefully in the near future.

To get contact details thoughout Europe click on this link to go to Menarini's European offices. Click on Europe and then click on the country you are interested in to get contact details

In Asia febuxostat (TMX-67) has made some government regulatory progress. It has been approved in South Korea, where its brand name is FEBURIC - the best and clearest I think of its three, so far, brand names. Its Japanese developers have re-applied for Japanese approval. Distributors have been appointed for Taiwan, Hong Kong and China. They hope to launch it in Hong Kong in 2011 and in China in 2014.

KRYSTEXXA'S (PEGLOTICASE) DEVELOPERS RE-APPLY FOR FDA APPROVAL

There are a lot of high hopes surrounding Krystexxa - it's the new gout drug that, in a recent survey of U.S. rheumatologists, they said it would bring most value to their practice. More value than the other new gout drugs under development. Pegloticase wasn't approved last year despite a committee voting overwhelmingly for its approval. Its developers have been working on the FDA's requirements, and in March they submitted a re-application. The FDA have accepted it. We are told to expect a decision in mid September this year.

It's always a good idea to know as much as you can about gout. Especially if you suffer from tophi, I suggest you read as much as possible about Krystexxa.(Pegloticase).

A NEW TEST FOR GOUT

When I first began to study gout a few years ago, its true diagnosis seemed very straightforward. The signs of gout, and the symptoms, might or might not mean gout but the arthrocentesis test for gout, aka the aspiration test, told the truth. A doctor removed some fluid from the infected area, put it under a microscope with a polarising lens, spotted, or did not spot, the needle shaped MSU crystals and hey presto....it was gout, or it wasn't.

These crystals had first been seen by Antonie Van Leeuwenhoek in 1679 using his powerful and revolutionary microscope, so in the 21st century, 330 years later, you wouldn't think it would be too difficult to do. Or, less reliably, a list of all gout symptoms was examined, and if the patient had most of them, gout was very likely. And some doctors looked at a swollen toe, listened to patients description of pain and announced it's gout without any further ado.

However, gout is misdiagnosed quite often as both patient reports and a number of studies from developed countries have said. So if gout is suspected, make sure you ask for an arthrocentesis (aspiration) test to be done. Plus a test to learn your uric acid level.

New test for gout There's now a new medical imaging technique for spotting gout crystals and tophi which has recently been tested at the Vancouver General Hospital in Vancouver, British Columbia, Canada. A machine called a dual energy computed tomography (CT) scanner, not the usual CT scanner, is capable of colouring uric acid in tissue in red, and of showing tophi deposits - and in more than one place if that's the case.

Your friendly neighbourhood hospital probably hasn't got one of these scanners yet, but there might be one with say a 100 miles (160 kilometres) radius of your home. Or at least one somewhere in the country you live in.

More about this is next month's edition I'll try to find out when this new equipment will be available, and in which countries.

RDEA594 SCORES AGAIN

On the last day of March, Ardea Biosciences, the developers of the new gout drug currently called RDEA594, announced phase 2B trial results. (It couldn't be called RDEA007, I suppose, because after all, that number is licenced to kill, and that wouldn't do its reputation or prospects any good at all). It lowers uric acid by encouraging the kidneys to excrete it.

The trial was one where it was used solo on gout patients who have difficulty excreting normal amounts of uric acid and who all had a serum uric acid level above 8.0 mg/dL.(You'll recall that last month I reported that when used in combination with Febuxostat, patients achieved in some cases an average blood uric acid level of just 1.2 mg/dL,(0.72 mmol/L) which is L.O.W. However they didn't have gout.

Patients in this trial were split into four groups. Two of the groups received increasing amounts of RDEA594 up to 400mg or 600mg daily. And these were the groups in whom a greater percentage of patients achieved the target reduction level of 6.0 mg/dL or below. In the case of the 600 mg daily group it was 45% of patients in the group; and 58% of those ending the trial on 600mg a day, who had starting uric acid levels of less than 10.0 mg/dL, hit the target.

The percentages I've quoted here were the best achieved across all groups. Adverse events in study patients were minor.

RDEA594 achieved quite good results here. Sometime within the next three months Ardea will announce results of its RDEA594 plus Allopurinol study. That should be very interesting. How well can the two together reduce uric acid?

Ardea have said: "We expect to obtain guidance from the US FDA and European Medicines Agency, and initiate the RDEA594 Phase 3 development program, in the second half of 2010".

SPECIAL OFFER ON pH TEST STRIPS

Paying attention to body alkalinity for treating gout is a big, under researched subject, although it has been a known gout treatment since at least the middle of the 19th century. I'll write more about it this year. In the meantime, if you want to learn why it's good for gout, begin at this page, the first in our pH section.

If you take the pH foods route to help lower uric acid levels, you have to know your pH levels. Currently, www.MotherNature.com are selling pH test strips with a 50% discount. Just $7.46 for 90 strips. The offer saves you about $7.50. (If you read this as a back issue though, the offer will probably be finished).

Readers in countries other than the U.S. and Canada should consider this offer too - even when you add in shipping costs, it is very likely this offer is much cheaper than the amount you pay in your own country. And, pH test strips are often not easy to buy in many countries.

If you're interested in this offer, click on the link below.

Phion Laboratories Diagnostic pH Test Strips - 90 count

There are some very good test strip instructions on this page and these pH test strips test both urine and saliva. MotherNature.com also sells pH boosting products such as alkalizing drops and minerals, and antioxidant supplements. All can play a role in lowering uric acid levels and improving body function.

AN ALL NATURAL CURE FOR GOUT

Flamasil could be it. Click on the banner below to read its home page. And read the testimonials page. Flamasil contains many of the ingredients we recommend for gout on www.best-gout-remedies.com.

Alternative Health Research/Flamasilâ„¢

If you are not a subscriber to the Gout Dugout, this free monthly gout newsletter, you can sign up at this page.

Go to www.best-gout-remedies.com home page.

Thanks for reading, and all the best.

John Mepham BA(Hons)Econ.

799,Infantry Street, Palar-Armor Village, Taguig, Metro Manila, Philippines

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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