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Gout Dugout.Issue #061. Britain provisionally says No to Krystexxa | recording the water you drink
March 30, 2013
Hello and Welcome to the spring (March) 2013 edition of the Gout Dugout newsletter.
This year there will be four issues: this one plus summer (June) autumn (fall/September) and winter (December). I am calling it "spring," and the others likewise after the four seasons, but I am aware that there are readers in countries that don't really have seasons or have them "the other way round" to those in Europe and North America. Where I currently live, we are in the summer.
I am sure you will understand. In the years that I lived in tropical Singapore, where the weather is either hot, hotter, or hot and wet (in the monsoon season), I used to be amused by the fashion merchandising efforts of local department stores. Their front windows were dressed for "spring" fashions, "summer" fashions, "autumn" fashions, even would-you-believe in a place that is almost on the equator, "winter" fashions.
Website changes If you use the website to look things up you'll see there's been a change of design. Pages now have a wider "in your face," look, but it still looks a little like a building site, not a website. However, all the content is there and can be found, and the page-by-page renovation will be finished.
And now to gout.....
At the end of last year Krystexxa's (Pegloticase) approval had almost been confirmed by the European medicine Agency (EMA).
In early January it did confirm it but only for adults with tophi gout. In the U.S. however, in September 2010, it was approved for gout patients who don't respond to other treatment. That means it could be prescribed to more patients in the U.S.
Remember Krystexxa is the drug for heavy duty gout sufferers, when all else fails – it's a course of infusions at designated locations, not a pill you pop. And it is expensive. In the U.S. it will cost the ultimate payer thousands of dollars for a six months' course.
Its developers, Savient Pharmaceuticals, expect to begin marketing it in E.U. countries in mid 2013.
U.S. SAID YES, BUT THE U.K SAYS NO - The U.K.and Krystexxa
Britain's NICE, (National Institute of Clinical Excellence), which advises the U.K National Health Service (NHS) on medicines it might acquire, concluded that Krystexxa (generic name - Pegloticase) had NOT been shown to be a cost effective use of NHS resources as treatment option for tophi gout. They also worry about the long term effects. This is draft guidance.
The final decision will be later, I think in June.
In Britain's public health sector, it is the NHS that has to pay for Krystexxa, not the EMA of the E.U. Krystexxa is very expensive. In the U.S. its sales have not taken the world by storm. For example in Quarter 4 2012, its U.S. sales were just US$4.7 million. I wonder if that's because of the cost.
But no other gout drug can reduce uric acid as much as Krystexxa. It got it down to 2.0 – 3.0 mg/dL in some cases in its trials, considerably below the 6.0 mg/dL level at which good things are expected. Another good trial result was that 40% of one group cleared up more than one tophus in 25 weeks. But it won't always work. And a high per cent of those under Krystexxa medication can expect the most common side effect – infusion reactions.
It seemed to me, reading what NICE said, that it could not justify the cost. A QALY (Quality Adjusted Life Year, a stats concept) figure of GB Pounds 20,000 – 30,000 is their limit and Krystexxa's is GB Pounds 66,000. That's the QALY number, not its British price, which is about GB Pounds 23,000 for 6 months. Many patients would need it for more than six months.
So the answer, for the time being, is NO. IMO if Krystexxa had a more reliable record and fewer side effects, or was significantly cheaper, NICE would have been much more likely to say yes.
But perhaps they'll change their mind. We shall see. If you think you need Krystexxa (and you have tophi gout), and you
live in the U.K. with the right to use the NHS, speak to your doctor. There may be an appeal procedure there somewhere,
especially for very serious tophi cases. Or maybe you could get private medical insurance to cover it.
WATER, WATER EVERYDAY, BUT HOW MUCH DID YOU DRINK?
You know that drinking a lot of water (eight glasses daily minimum) dilutes uric acid. It's the natural remedy all doctors know. But when you first hear of this, it seems a daunting task. And because it's difficult, it is easy to cheat, or fool yourself that you are drinking enough. If this is one of your remedies, can you put your hand on your heart and say "I did my eight glasses to-day."
Do you want some help counting the glasses? You might need to be a techie and someone who carries around a mobile, to do this – I'll explain.
I had an interesting message on the website a few weeks ago about an application for an iPod called "Waterlogged." (pun intended I am sure). My correspondent was delighted with it. He switches on his mobile and the app loads a glass photo image (he took the picture himself of his own glass), whose water level rises as he drinks more. Of course the detailed work of recording every glass you drink must be done. Each downed glass must be recorded.
The trick with gout cures is to do things diligently, methodically and regularly. If this helps you stick to your routine it might appeal. But if like me, you prefer cheaper solutions to things if possible, there's always the old notebook and pencil.
Set a daily goal. You could start by aiming at say five a day and work your way up to 8/10 a day. And use Waterlogged to look back at previous daily targets. Did you hit them? Are you really getting any better/worse/same?
So who might like this?
* People who use their mobiles a lot.
* People who LIKE using it, as does my correspondent. And find it fun. If you think it would help you to drink 8/10 glasses a day, then use it.
* Not expensive. Lifetime subscription: US
$2.99; annual subscription US$1.99; three months $0.99. You need an iPhone, iPod touch, or IPad. Needs iOS 4.2 or later. It's optimised for iphone 5.
Gouty folk who have read widely about gout – and they should – probably know the aspirin and gout riddle. Low dose aspirin stimulates gout attacks, high dose aspirin encourages uric acid excretion and so falling serum (blood) uric acid.
The low dose theory was tested in a study published in January in the Annals of the Rheumatic Diseases Journal. Did it support the theory? Yes it did. About 300 gout sufferers were examined for a year during hazard (risk of attack) and control (gout quiet) periods. The researchers concluded that a dose of 325 mg daily, or below, led to the odds of a subsequent gout attack rising by 81%. If they took less than 100 mg daily (i.e. still lower) during those two days, the risk rose to 91%. The results were the same for men and women, they did not vary by age (19 or 75, same result), and applied irrespective of weight or the degree of kidney disease present in the participant.
So if you're taking low dose aspirin – beware, or discuss a high dose which itself carries other risks, with your doctor. Precisely how much is low dose aspirin, as opposed to medium or high is very often not said. So I should say that in this study less than 325 mg a day was low. In many places that is one 325 mg tablet daily. In others, low dose aspirin is less than 100 mg daily or half a 325 mg tablet.
The study didn't examine the other big question about low dose aspirin and gout – will it worsen the attack. It's widely
thought it does.
Ilaris, which has the extraordinary generic name of canakinumab, is a new gout drug (an injection) which could be used against gout's pain and inflammation instead of NSAIDS and colchicine. It halts, or reduces pain, by inhibiting the cytokine IL-1B. In the past three months the European Medicines Agency (EMA) has given its preliminary approval. This has to be ratified by the European Commission.
On the other hand, the US FDA turned down Ilaris because it did not like its risk/reward ratio.
Click on the Flamasil ad to go to the Flamasil website
IT'S NEW ON THE WEBSITE
In last year's September issue, I wrote a piece about those interesting cherries studies where cherry juice concentrate, working somewhat like Ilaris and Rilonacept, had some success against pain and inflammation.
If you want to read about these studies again, or read more than I said before, there are now two pages about them on the website. They showed cherry juice concentrate does offer something which is good for gout – reduced flares – in most of those who took it twice daily for a few months in one of the studies.
Cherry juice concentrate inhibits IL-1B too said the study, but I think probably not nearly as strongly as Ilaris. The pages are also laid out in some of the new format the whole website will eventually use.
Visit these pages:
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 to the United States and Canada, from Britain.
If you are not a subscriber to the Gout Dugout, this free 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.
TIP Use the website's search box, located towards the bottom of the Home Page, to find site references to any word you enter into it. It is a good way to find out where and what the site has to say about any gout topic. There are currently around 200 pages, including all the back issues of this newsletter. It works. Use it!
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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