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Gout Dugout.Issue#049 the gout crystal ball for 2012 | new gout medicine | green tea and gout |
January 27, 2012
A Happy New Year and a warm welcome. Here is the first issue of 2012. The beginning of the 5th year of this gout newsletter's monthly publication.
A GAZE INTO THE 2012 GOUT CRYSTAL BALL
In 2012 we may very well see new approvals for two gout meds, Arcalyst (its possible first approval in the U.S), and Krystexxa could get its second jurisdiction approval, this time in the EU.
Arcalyst (rilonacept ) is perhaps the most interesting of a new breed of new gout medicines currently under development. It works in a somewhat similar way to Ilaris (canakinumab) the med that the FDA decided last year wasn't yet safe enough. But Arcalyst does not seem to have the safety question marks that sank Ilaris in the U.S., perhaps permanently.
Arcalyst, like Krystexxa, is a biologic. It is injected. It can be used instead of NSAIDs and colchicine to lower or eliminate pain and inflammation. Expect the Arcalyst FDA decision by the end of July, with an FDA Arthritis Advisory Committee meeting about it in April or May. The committee's comments will give us our first clues about whether we shall have a new gout medicine. Read more about Arcalyst below. Krystexxa's EU decision will come in the second half of 2012.
What else will be news in 2012? I wouldn't be surprised if more gout causing genes are discovered. And the number of people who suffer gout will continue to rise primarily I think because humanity is eating too many carbohydrates. Expect stories about rising gout incidence world wide, not just in Europe and the U.S.
More gout drug news.... Febuxostat's onward march, not at top speed, will continue. In the immediate future, its developers, Teijin Pharma Ltd., hope to get the following febuxostat approvals - Hong Kong in 2012; China in 2014; and by 2015 - Thailand, Indonesia, Singapore, Malaysia, Vietnam and India. They also plan to market febuxostat in Eastern Europe, Russia, Central and South America, and the Middle East.
Lesinurad (RDEA 594), a drug that improves uric acid excretion, has gone into Phase 3 trials, which will involve around 2,000 gout patients in centres (centers) around the world. URL Pharma's marketing exclusivity (i.e. monopoly) in the U.S. for Colcrys expires on July 30, 2012. Hopefully the Colcrys price will begin to fall after then.
www.best-gout-remedies.com's birthday On 24 May, in 2007 two visitors visited five of the pages on the site by that day's end. So it's best-gout-remedies.com's fifth birthday, and time for a change.
Although there are many more pages, the website's Look and Feel hasn't changed much in 5 years. Thanks to a terrific upcoming update from the site hosts, who are much more the reason why the site has been successful, than I am,
Site Build It
In the Gout Dugout this year, among the questions I'll be looking at closely this year include these leading questions about dealing with gout:
It's an Olympic Year. I'll ask, does heavy exercise raise the risk of gout? And I'll ask:
How much can you lower uric acid with a low purine diet? Just how useful are low purine diets?
How much can you lower uric acid if you lose weight?
And much more on what I think is now probably the leading cause of gout, insulin resistance and associated uric acid levels.
STOCK UP ON GOUT MEDS
Many readers will know this well already, but a reminder keeps it at the front of your mind where it needs to be.
You probably know the feeling, or maybe you don't. Your doctor prescribes XYZ medicine for your gout and if s/he doesn't have a pharmacy on the premises (or next door) as many do in many places, off you trot to a pharmacy only to learn they are out of stock "till next Wednesday."
When the first happened to me I was so annoyed I used to think that it should be illegal for a pharmacy to be out of stock of anything a doctor could prescribe.
The other day my partner went for a common prescription (RX) tablet to a well known pharmacy. She needs this particular med to help deal with a currently nasty bout with arthritis. She was told "out of stock till next week." And the sales assistant
added "And we don't have much demand for that anymore," as if this was a reason for this pharmacy to be out of stock of a still needed med. So be warned and keep your supplies high, if you have any reason to doubt the regularity of pharmacy supply where you live.
I don't say too much about new gout medicine in this gout newsletter because I know readers prefer to read about natural remedies for gout, so I won't stay too long on this one. But when something useful is getting closer to approval with good trial results, it's time to prick up the ears and see what is here for us. As mentioned above, Arcalyst might be approved for the United States by mid-summer.
I have occasionally written about Arcalyst (rilonacept), one of the new gout medicines under development. After two successful Phase 3 trials and a large safety study of 1315 patients, its developers, Regeneron Pharmaceuticals, have applied to the U.S. FDA for its judgement about its efficacy and safety. We shall know by July 30 whether it has been successful.
Arcalyst is a biologic (read: it will be expensive), and an injection. It works to relieve pain and inflammation by inhibiting the Interleukin I protein whose release is associated with gout flares. In some way, IL-1 is a cause of gout inflammation, directly or indirectly. If its release is blocked, gout flares can be controlled or reduced (inhibited in medical parlance). Arcalyst attaches itself to IL-1 to neutralise (neutralize) it.
But if you suffer gout you already know what an elusive animal you are dealing with. Arcalyst will reduce the flares for some, (a majority you'll be pleased to read) but not for others. In a Phase II trial recently reported in the Journal Arthritis & Rheumatism it was injected into gout patients in the U.S. for 17 weeks (an initial double dose, then weekly for 16 weeks). Others in the study got a placebo.
Results Those taking rilonacept had significantly fewer flares than those who didn't. Note I said significantly fewer, not zero. At the same time patients took that old stand-by Allopurinol at 300 mg a day to lower uric acid. After 12 weeks just 15 % on rilonacept and allopurinol had suffered a flare, a good success rate. Somewhat similar results were found in its Phase 3 studies. The average number of gout flares reduced 72-80%.And importantly in view of what happened to Ilaris, the side effects were moderate (not serious) infections in some patients.
It looks like the place of this drug in the world of gout might be to replace colchicine, and to be used instead of NSAIDs when they can't be used. Some give up on uric acid lowering meds when they cause gout attacks. This med can cut them.
But are there any clouds on the fairly sunny horizon here? Colchicine and NSAIDs are cheap but if approved, one gout expert has said Arcalyst will be costly. Wall Street loves biologic drugs like rilonacept because it know biologics are costly and thus I imagine more profitable. The Wall Street catchphrase is "biologic pricing." However we shall not know its price until and if it's approved.
Sooooo..it might cost you, or your payer, a lot of money to find out it isn't going to work, but more likely from the study I've quoted above, and other rilonacept studies, you'll have something which cuts flares drastically whilst allopurinol or febuxostat or something else, reduce your uric acid, and you get gout under control, but not eliminated.
In major trials 20-28% (rounded numbers) suffered infections, but only 0.5% suffered serious infections in Arcalyst's safety study. Deaths in the safety study (0.3%)were lower among those on Arcalyst than those on placebo (dummy)(0.9%). Its continuing UPSURGE safety and efficacy study began in November last year.
GREEN TEA AND GOUT
Way back in the last few months of 1972, the Hong Kong based magazine I worked for in the early to mid 1970's, The Far Eastern Economic Review, wanted me to visit Japan and I went there three times in the course of three months. There were problems with our Japanese sales rep, and our advertisers and their ad agencies needed to know the magazine was still doing well, which it was.
In those days some large Japanese companies, and the biggest Japanese ad agency, Dentsu, flew the national flag of their foreign visitors on the day of their visit on their company flagpoles (maybe they still do) and effused elaborate courtesies, including a big bow, wide smiles and green tea for their guests. (In those days, thank heaven I didn't suffer from backache. What a squeeky old bow I would have given). So honour (honor) demanded at least an equal response.
Wherever I went I was offered green tea, as ubiquitous in Japan as tea (black) is in Britain and the Indian sub Continent. You can see I had to drink it. But green tea isn't everyone's cup of tea, and it isn't mine. However, I couldn't fake it. After all, after I'd left, someone would notice how much remained in the cup and I wasn't having that. The magazine would lose a couple of points. The things I did for that magazine….
In those days green tea was hardly known in the West. These days, there isn't a supermarket that does not stock it and everyone thinks it's healthy. I have even seen green tea extract as a flavour (flavor) for gin, which is surely taking things too far.
How good is green tea for gout?
It's not often enough that we get a study about a natural remedy. We shall learn something more about whether if you have gout green tea will help, in a couple of months. There is a current study into whether various amounts of green tea extract will lower uric acid in healthy humans, which has been organised (organized) by Chiang Mai University in Thailand.
Green tea has been found to inhibit xanthine oxidase, in a test tube. That is the way allopurinol and febuxostat work. But can it do this in humans?
The study's principal investigator tells me its results will be published in a couple of months and I'll feature them in a future edition of this newsletter.
Will green tea lower uric acid in healthy humans? We shall learn more in a few months.
The UASure is a DIY home uric acid test kit. It measures the level of uric acid in the blood. Click on the link below to visit a company who can ship it world-wide, including the United States and Canada, from Britain.
I say this because it cannot be bought in many countries.
If you are not a subscriber to the Gout Dugout, this free monthly gout newsletter, you can sign up at this page - click on the link below.
Go to the www.best-gout-remedies.com home page by clicking on the link below.
NEXT MONTH'S EDITION - ISSUE NUMBER 50.
Among other items we'll look at a recent, very encouraging study, that confirmed uric acid crystals will break down below a serum uric acid level of 6.0 mg/dL, and remain dissolved as long as the level is under 7.0 mg/dL.
Thanks for reading, and all the best of health.
799, Infantry Street,
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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