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Headline: Krystexxa (pegloticase) wins U.S. FDA approval.
Sub headline: Its developers will now apply for EU approval.
Page title: Krystexxa for gout (Pegloticase) has received US FDA approval.
Description: Krystexxa (Pegloticase) for gout. It’s been approved by the US FDA for ADD NAME AND THE INEVITABLE SAFETY STUDIES THE FDA WILL REQUEST.
Keywords: krystexxa for gout, new gout drugs, gout news, pegloticase for gout, treatment failure gout,
PUT DATE HERE. Krystexxa for gout treatment has been approved by the U.S. FDA. More specifically it has been approved for (CATEGORIES OF GOUT SUFFERERS). This makes it the third new gout drug to be approved by the US FDA in 2009 – the first was Febuxostat, the second was Colchicine, although Colchicine was really a technicality since it's been marketed in its modern form as a tablet since at least the 1930's.
If you don’t think that makes 2009 an exceptional gout news year, note that the last year just one new gout drug was introduced was 1963. The medication was Allopurinol.
The heart of resolving the gout problem is the reduction of uric acid levels. Some drugs block/reduce its production, others improve its excretion. Diets and natural remedies work in these ways too. Krystexxa (trade name), generic name Pegloticase, removes uric acid by turning it into something else, namely Allantoin. Allantoin is better excreted than uric acid. Krystexxa has demonstrated in trials that it can be a very powerful uric acid reducing agent.
When gout is longer lasting in the body it often develops into tophi. These are knobbly shaped lumps of accumukated MSU crystals which disfigure joint and other body areas. They are gout's most vivid image. In trials Krystexxa has cleared up tohpi in some, not all, cases as well as ending gout attacks during a specified time period, in many trial patients.
How do you take Krystexxa for gout? It is not a tablet which makes this decision something of a milestone in the history of gout treatment. All the other major long term treatments are tablets, although pain relievers like indomethacin may be injected in serious cases of pain.
It's given by vein infusion for 2 hours. This will take place at a designated IV infusion center (centre) under guidance of Krystexxa-trained medical staff.In its among among other factors the US FDA has had to carefully consider, infusion reactions (side effects)occured in a sizeable minority of trial patients.
Side effects consisted of chest or back pains, muscle cramps, sweating and flushes. And becuase there were 6 ? deaths from heart attacks ? among trial patients and fewer 3? heart related deaths among trial patients taking a placebo (dummy) medication, Krystexxa will not be precribed for gout sufferers with any history of heart disease.
Krystexxa is really for treatment failure gout patients. If drugs such as allopurinol, febuxostat or probenecid have failed to lower uric acid levels sufficiently, and perhaps if tophi are growing, you are much more likely to be a candidate for a Krystexxa course. And course it is, because the recommendeds treatment period is X months of fortnighly or every 4 weeks treatment.
Who will be prescribed it? Your doctor or rheumatologist whether a heart or other organ problem, will disqualify you from Krystexxa for gout treatment. But it's much harder to know in advance whether you will suffer infusion reactions (side effects) of the sort mentioned above, or perhaps others. Some people in the trials had to discontinue for side effect reasons.
Will the Krystexxa (Pegloticase) treatment end? The course will be for X months. Allopurinol is now cheap and well understood. Many doctors think allopurinol needs to be prescribed for life. Krystexxa will be a LENGTH course. It will be costly. Unlike a tablet there will have to be an end to the course, hopefully with a beneficial outcome.
Will Krystexxa be attempted in tandem with other drugs? No. The idea has not been trialed or tested, and would be considered much too risky.
Coming your way? Keep reading the Gout Dugout Krystexxa's developers, Savient Pharmaceuticals Inc., who have developed it under licence from Duke University and Mountain View Pharmaceuticals, will now seek approvals elsewhere in the world, fortified with the significant knowledge that it is FDA approved. They have said they will next go for EU approval, then elsewhere. Any gout news from the coming development of Krystexxa will be reported in The Gout Dugout.
Read more about the Krystexxa (Pegloticase) trial results and development history here.
Read about the other new gout medication approved by the FDA in 2009 (and the European Medicines Agency in 2008) - Febuxostat. US trade name - Uloric; EU trade name - Adenuric.
Download the documents prepared by Savient Pharmaceuticals for the Arthreitis Advisory Commitee meeting convened by the FDA in June 2009 to discuss Krystexxa approval.
Download the FDA's questions to the Arthreitis Advisory Committee about Krystexxa.
Return from Krystexxa for gout to www.best-gout-remedies.com home page
Promo text FOR OUT dUGOUT, sEND THEM TO SUB PAGE, AND TELL THEM LINK TO BACK ISSUES IS ON THIS PAGE
His early 19th century prose might not be to your taste.
Parkinson got much right about gout but he didn't have today's understanding. A great deal was learnt after his lifetime, including the role of purines and uric acid. Nevertheless, Parkinson had at least one remedy for gout which he reported worked to cure a patient. (It may have cured more than one). And if you've read the pages on www.best-gout-remedies.com about the components of his remedy (below), you'll understand why it can work in some cases. And yes, it does include that old friend of gout sufferers, baking soda (bicarbonate of soda). His cure was (my comments in brackets):
1. Avoid alcohol (thus reducing purines).
2. Eat a good quantity of fruit and vegetables (which will reduce purines and supply antioxidants, including the natural Vitamin C which encourages uric acid excretion).
3. 15 grains (that's a 19th century measurement, it's NOT grams) of sodium bicarbonate (baking soda) a day. (thus encouraging uric acid dilution and excretion and MSU crystals reduction).
He didn't say avoid offal, (liver, hearts, kidneys etc.), which we now know is purine rich food. But just the above three choices ought to at least reduce uric acid somewhat, and stave off a gout attack, depending on what else you do.
Remember, always discuss taking baking soda (bicarbonate of soda, sodium bicarbonate) with a doctor first. Many of its possible side effects are on the baking soda page at BGR.com
I am indebted to "Gout, The Patrician Malady" by Roy Porter and G.S. Rousseau for this information about James Parkinson's gout cure. You can purchase this book at online bookshops or you may find it in your local library. The book is a history of gout through the ages, a history of how physicians, academics, writers and sufferers struggled to understand it. There's some wacky remedies in it, as you might expect from earlier centuries' ideas. It's rich in detail, so rich in fact that you'll probably need three readings to take it all in.
THE PURINE THEORY IS ALIVE AND WELL
The link below is to an interesting recent story I read - a huge reminder about the power of alcohol to trigger a gout attack. In this case the story teller, an American gout sufferer, had been drinking pretty heavily for five days in America before
another five days drinking in Britain, where this fellow had gone on an enjoyable pub crawl and brewing techniques practice trip. The whole ten days turned out to be a gout trigger.
Read this interesting story here, but if you just want to read the gout attack part, go straight to the last paragraph.
GOUT AND PARKINSON'S DISEASE
In the 18th and 19th centuries the consolation of getting gout was the belief that other ailments or diseases were now less likely to strike. And I have read of more than one gout sufferer of those days write that his back pain (or whatever was troubling him - gout was almost invariably a man's disease in those days, or it was the men who wrote most about it) - disappeared when the gout attack arrived.
In October a similar sort of story hit some of the world's English language media. Researchers in the U.S. have discovered that high levels of uric acid retard the onset of Parkinson's disease.(PD). Parkinson's disease is the feared neurological disorder where the body no longer responds to the commands of the brain. One common symptom is shaking of the hands, but there are many others. The reserachers aren't saying you won't get PD, just that high uric acid (UA) levels slow progression to it. And perhaps if you get it, a high UA level will slow its progression, no mean achievement if you have to live with it for decades, as some do.
In the Barry Sears' books I frequently mention, and (LINK IN TEXT) which are most discussed on this page on the website, because the fish oil and insulin reduction treatment I call FILLIP for gout and its pain ... he has some interesting things to say about using fish oils for Parkinson's and other disorders like Alzheimers and dementia. (LINK IN TEXT)If you're interested in this you can read more about it here.
TRAVERSE BAY FARMS SPECIAL OFFER ON CHERRY JUICE CONCENTRATE
I often mention Traverse Bay Farms in this newsletter because I believe they make very good cherry and other fruit products. You know that people report that cherries help them deal with gout. There's also the studies. Cherries have been shown to reduce uric acid levels although not as much as drug medications do.
A reader emailed me this month and said he got relief from gout by drinking cherry extract plus 8 ounces of water to which he added one teaspoon of baking soda (bicarbonate of soda). Three glasses in three hours was often enough for relief. But sometimes, depending on severity, he took Tylenol (paracetamol) or Indomethacin. This kept the atatcks to a minor level and limited to one day. Make sure you check with your doctor before you take baking soda (bicarbonate of soda). There could be side effects that affect you.
In November Traverse Bay Farms have a special offer on their cherry juice concentrate - basically it's free shipping when you order six bottles. Last month I wrote about the options you have for intaking cherries in the winter and spring with the exception of copy about cherry jam/preserves/conserves. (Which I'll do next month). The juice concentrate is probably the best and the cheapest option and here we have a special where you don't pay to go and get it which you might if you make extra journeys to get cherry products. (Fuel, vehicle depreciation, fares whatever). And if you are house bound because of a gout attack this means you don't have to ask someone to go get it for you.
MUST SAY SOMETHING ABOUT THE JUICE CONCENTRATE
"Their website quotes a Hollywood star --- saying ---"
Traverse Bay Farm are located by the shore of Lake Michigan in the U.S.A.It's obviously easier to order if you live in the U.S. or Canada but they deliver fast to a number of countries. However, the free shipping applies to the 48 continuous U.S. states only. See the cherries page on bgr.com for details.
I have lived in the past in at least two countries in Asia where quality cherry supplements could not be bought. If you live in such a country consider ordering from Traverse Bay Farms. It will cost you more but this is vastly preferable to not finding more options to prevent gout attacks, especially when they tend to increase as you age. I think if you have gout it's better to spend more on treating this well, than spending on any other aspect of your life. But you know your own circumstances of course.
To access the Traverse Bay Farms site go to this page at BGR.com and click on the photo of the cherry trees in the Traverse Bay Farms text. You can also request a free cherry health report, and TBF will find out for you free if there are any importat restrictions in your home country if you ask them. This is a true service and a time saver.
In October, The American College of Rheumatology/Association of Rheumatology Health Professionals held its annual Scientific Meeting, this year in Philadelphia, the home city of that famous gout sufferer, Benjamin Franklin . These sorts of occasions are always ones where the pharmaceutical companies like to present the latest news and reserach on medications they are developing, for obvious reasons. We'll look at the latest research news on two new gout medications next month. But here's some interesting research on water use in gout.
YOU NEED TO DRINK THOSE EIGHT GLASSES
In terms on natural remedies for gout, the most interesting news at this Conference was a study on water use in gout, or rather, the effects of it. So often it's said you must drink at least 8 -10 glasses daily, perhaps less if its alkaline water. Until you get used to this, drinking so much water is a daunting task for just about anyone from any nationality. I'm sure many gout sufferers think they can get away with 4 daily glasses or less. If that's what they think, they have got into bad habits.
The research presented at this Conference says you should not drink just four glasses or less. Researchers from the Boston University School of Medicine surveyed 535 adult (mainly men) gout sufferers. Those who drank 2 -4 glasses of water a day reduced their risk of gout by just 18%. It was not considered statistically significant. Those who drank 5 - 8 glasses a day reduced the risk of another attack by 43%. And those who drank MORE THAN 8 glasses a day reduced the risk of another attack by 48%. 18% compared to 48% is a big difference. Let's hope the respnodents memories were accurate.
Another way of looking at these results is to say, even if you drink eight plus glasses a day you still have a 50/50 (or 52/48, really it's the same) chance of another attack. But is the glass half full or half empty? I would say that when you add in other natural gout remedies - diets, alkaline water, baking soda, exercise, keeping warm, Vitamin C, Potassium Citrate, Cherries, and the rest, the glass is much more than half full. And drinking this amount of water may be preferable to Allopurinol or one of the others.
Before increasing your water intake, check with your doctor.
Next month - The research on two new gout drugs; and the best cherry jam among other items.
NOVEMBER IDEA - Making money from gout shares, plus a plug for Site Build It.
Alcohol is more dangerous than the FOODS THAT CAUSE GOUT ATTACKS - good keywords.
I last wrote about Rilonacept (trade name: Arcalyst)last year in the October issue. It's being developed to deal with the pain of a gout attack (i.e. the job done by NSAIDs and Colchicine) and to prevent an attack whilst a uric acid lowering medication is being taken. As you know falling levels of uric acid can initiate gout attacks which confuses some sufferers who often forget that gout often gets worse before it gets better when it's being treated in this way. Rilonacept (Arcalyst) came though a 16 week trial among 83 gout patients who took Allopurinol for lowering UA levels, quite well. It outperformed, as you'd really expect, those on a placebo (dummy drug). Those on Rilonacept at 16 weeks......
Rilonacept has been approved by the U.S. FDA and the European Medicines Agency (EMEA) for other conditions.
This is a new gout drug under development that I haven't written about before. Its results in an eight week phase 2 trial amongst 191 gout sufferers, compared with triamcinalone acetonide at 40 mg, were presented at the ACR conference. After 72 hours (3 days) those patients suffering an attack and who received a 150 mg dose of Canakinumab got better pain relief than those who received triamcinalone. And it achieved a 50% reduction in pain after a day. Those on triamcinalone took twice as long to get a 50% reduction.
This isn't bad but many gout sufferers can get complete gout pain relief with NSAIDs or Colchicine much faster,although it is being trialed and developed because many can’t tolerate either NSAIDs or Colchicine. And it might be better, side effects wise, than Corticosteroids like Prednisone. What may turn out to be a better use of this drug, when or if it's approved, is to prevent gout attacks whilst uric acid lowering drugs are taken, because only one patient on Canakinumab at 150 mg suffered a gout attack in eight weeks.
For this kind of story, at this stage of a medication's development, I'm really only interested in highlighting the main points really just to let gout patients - those who are stuck for one reason or another - know there are new things coming along they may not have heard of. If you want to read more.....