Authoritative Gout Answers
Countless questions occur to anyone afflicted with gout. An Internet search provides a million answers, but it’s often hard to know what’s right and what’s hokum. Dr. Theodore Fields, Professor of Clinical Medicine at Weil-Cornell Medical College, and Director of the Rheumatology Faculty Practice Plan at the Hospital for Special Surgery, was kind enough to throw light on a few of those questions.
Gout Cured? Whattya Mean, Cured?
Is gout something that can really be cured, or is it something where, once you get it, you can only hope to manage it? “If you define ‘cured’ as meaning that gout episodes can completely stop happening forever, the great majority of gout patients can be ‘cured’ as long as they stay on their medicine that keeps their uric acid less than 6. Although a ‘cure,’ defined in this way, is very possible for most people with gout, people need to know that in the early stages of treatment with medication to lower uric acid they can still get attacks. It may take 6 months, or sometimes a year or more, to get things under control. Gout is due to crystals in the joints, not just the blood level of uric acid. Thus, even though medication can get the uric acid below 6 within weeks, it can take a long time to gradually remove the crystals from the joints. For this reason, patients starting medications to lower their uric acid should plan with their doctor in advance what to do if an attack comes. Also, in addition to the uric-acid-lowering drug, people should discuss with their doctor about taking a medication for the first 6 months, such as colchicine, that can help prevent those early gout flares. Also, in most people, just keeping to a good diet isn’t enough for a ‘cure,’ since diet most often isn’t enough to get the uric acid less than 6.”
Choice of Medication vs. Uric Acid Level.
Does the choice of medication or treatment for gout change with the blood level of uric acid, and if so, how? “In general, whether using allopurinol, probenecid or febuxostat to lower uric acid, we start with a low dose and then see how low the uric acid goes. Our goal is to get the patient to less than 6 mg/dL, and we raise the dose of the medication until we get to goal.”
Gout and Uric Acid Levels.
“There are many patients with an elevated uric acid and no gout. This probably relates to how the patient’s immune system reacts to the gout crystals. Some people get more inflammation from the crystals. Also, a number of people who have high uric acid and no gout will at some future time develop gout. In general, guidelines recommend treatment of elevated uric acid in patients with gout when they have had two attacks within a year, or have a tophus (visible lump under the skin with uric acid crystals) or imaging studies that show joint damage due to gout.”
“Until about four years ago, to lower uric acid we had only allopurinol and probenecid. Susbequently, febuxostat (Uloric®) became available as an alternative, and subsequent to that the intravenous agent pegloticase (Krystexxa®) came on the market. These give more ways to get patients to the goal of uric acid less than 6. There are additional medications under study which work either to decrease production or increase excretion of uric acid.”
Why Does Gout Appear (or increase) with Age?
What is it about aging that brings on gout. You go along fine for decades and then suddenly you find yourself afflicted by it. “As people get older, if the uric acid in their blood is high then gradually more uric acid crystals deposit in the body, such as in the cartilage and joint lining of joints such as the big toe or ankle. The more crystals deposited, the more likely a gout attack will occur. This is why the incidence of gout increases with age. However, men can certainly get gout in their 20s. Gout is much less common in women until they reach menopause.”
Side Effects of Colchicine?
Colchicine seems like a very commonly prescribed drug for controlling gout inflammation and pain, but how often is there a problem with side effects? “When used in high dose, colchicines does have a tendency to cause diarrhea. Fortunately, a recent study confirmed that a lower dose of colchicines, two pills followed by one an hour later, and then no more for at least 12 hours, is just as good as the older dosing, which was much higher. In that study, none of the patients taking the low dose had severe diarrhea.”
Get Diet-Serious with Gout Cookbooks
A lot more has been learned about the effects of what we eat and drink on giving us gout, “but those things are so tied in with obesity that you can’t separate those things out,” says Dr. Eric Matteson, Professor of Medicine at the University of North Carolina. “If there’s one single thing we can concentrate on,” he says, “it would be reducing obesity.”
And hey, one of the best ways to reduce obesity is to make healthy recipes, and there is a horde of great gout cookbooks out there that not only help one eat healthy but also specifically to manage gout. Check out this Amazon page, wow! Of course, a gout-recipes search on the Web turns up plenty of recipes, but it’s nice to have a cook book and, each time you do a recipe, write on the page the date you had it and how good it was (or wasn’t). Fun to just work your way through a cookbook. Keeps you going.
When Your Gout Regimen Isn’t Working
Advice from Dr. Theodore Fields, Professor of Clinical Medicine at Weil-CornellMedicalCollege, and Director of the Rheumatology Faculty Practice Plan at the Hospital for Special Surgery:
“It’s important when your regimen for gout isn’t working to get back to your doctor as soon as possible. In addition to colchicines and NSAIDs, some patients benefit from oral corticosteroids, such as prednisone, or local injection of the joint with crystalline steroids. There is also a medicine called anakinra, which is a subcutaneous injection, which is sometimes used in cases that don’t respond to any of our treatments. Anakinra isn’t approved by the FDA specifically for gout, so it’s generally only used by rheumatologists and only when all other options fail. If you are presently not being treated by a rheumatologist and having great trouble getting your gout under control, you might benefit from rheumatology consultation.”
Why Did Generic Colchicine Dissappear?
You rarely see a generic drug turning into a brand-name drug, so a lot of folks with gout wondered…“WTH?” (what the heck?) when one of their most valued medicines suddenly took that rout and the price skyrocketed from pennies per pill to dollars per pill.
In 2009, the FDA approved the oral colchicine product Colcrys produced by URL Pharma, Inc., and in September 2010, the FDA started taking action against companies manufacturing, distributing and/or marketing “unapproved” colchicine – which was, basically, every company but URL Pharma.
A lot of people went beyond wondering, to outrage. For some two million gout sufferers in the U.S., after all, colchicine is an major assistance against pain. Even many health professionals took issue. “Clinicians generally prescribe colchicines not for acute gout but rather for long-term prophylaxis,” wrote one dissenting doctor, Allen Brett, MD, in a 2010 article. “It’s the cost of long-term prophylaxis — $1800 to $3600 per year at full price – that will likely have patients and clinicians scrambling during the next few years.”
It started in 2006 with the FDA’s “Unapproved Drugs Initiative,” targeting drugs that have been around for a long time and never got FDA approval because they hadn’t gone through the kinds of studies ordinarily done when a new drug comes to market, to scrutinize them for safety and effectiveness. Colchicine is older than the FDA, which has been around since the 1930s, and colchicine had been sort of grandfathered in to acceptance. So it was used for years without FDA approval for information on prescribing, on recommended dosages and on warning of possible interactions with other drugs. Then the FDA zeroed in on cases where colchicine had proven fatal even with standard doses when it interacted with other medications, such as clarithromycin.
So the FDA basically announced that if a company would be willing to approach colchicine as a new drug and do the costly studies, it would reward that company by giving it a monopoly (market exclusivity) for three years. URL Pharma stepped up to the plate. At the end of URL Pharma’s legal market exclusivity, it would still have an effective exclusivity until companies producing older versions of colchicne “updated to conform to FDA’s current approval standards,” as the FDA put it.
At the time of the FDA action, even the American College of Rheumatology had dissented, according to Dr. Brett, that with “responsible prescribing, non-approved colchicine is safe and effective and that patients who cannot afford Colcrys will suffer.”
In 2010, the FDA announced that URL Pharma had “established a Patient Assistance Program (PAP) and a Co-Pay Assistance Program (CAP) to ensure that patients will be able to continue affordable access to colchicine. The company has also informed FDA that it will maintain the programs at a minimum until there is FDA-approved generic competition for Colcrys.”
What’s the Latest in Gout Treatment?
One can point to three important developments that have made a significant difference in recent years, says Dr. Richard Brasington, Director of Clinical Rheumatology and Professor of Medicine at WashingtonUniversity. They’re not necessarily brand new, but “for treatment of a disease that hasn’t changed for about 50 years, it’s pretty significant to have three issues that move us forward,” he says.
“First, the way we use colchicine has changed,” he says. “We know now that we don’t need to give nearly as much colchocine as we thought, so we can use it more safely.”
A recent study confirmed that a much lower dose of colchicines is just as good as the higher dosage that used to be standard practice, reducing the risks of colchicine’s many possible side effects.
Second, Dr. Brasington points to Uloric (generically, febuxostat), a relatively new medicine (approved by the FDA in 2009) that works as an alternative to allopurinol for people who are not able to take allopurinol (Zyloprim, and generics).
Third, Krystexxa (pegloticase), which was FDA approved in September 2010, is not only very effective at lowering uric acid levels but is very effective in shrinking the masses called tophi. These are the uric acid crystal deposits that cause swelling, deformity and chronic pain. “You can shrink the tophi if you give a drug like allopurinol, but it takes a long time, months and sometimes years,” says Dr. Brasington. “But Krystexxa can make this happen a lot faster.”
Krystexxa is expensive and requires intravenous administration, and in some people it can cause anaphylactic reactions (rapid and serious allergic response), “so some doctors are skittish about it, but it really is a major new breakthrough,” Dr. Brasington says.
Gout and Obesity Cool Factoids
As one among millions who fights the battle of the bulge, I hate to bring this up, but here are some great stats which were kindly forwarded to me by Dr. Hyon K. Choi, one of the nation’s leading gout authorities (Google the name for more on that): Of those with gout, 53% are obese, 31% are overweight and just 15.7% are healthy weight. Another perspective on it: Of people who are healthy weight, just 1.88% have gout. Of people who are overweight, 3.47% have gout. Of people who are obese: 6.11% have gout. That’s from the National Health and Nutrition Examination Survey (NHANES) 2007-2008.