Gout Pal Interactive

When you ask the bank manager for your account balance, does “OK, Nothing to worry about?” make you happy? Do you accept “Normal” and rush out on a spending spree?

Of course not. You need the number. And here is why.

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As part of the approval submission, URL Pharma have done dosage tests and conclude that lower doses than the “traditional” 4.8mg per day are just as effective. They suggest that 2 tablets (1.2mg) followed by a further .6mg tablet one hour later is the best dose.

You can read more patient information about colchicine dosing and side effects in Read the rest of this entry »

Pegloticase has been shown to be effective in lowering uric acid in clinical trials, and is aimed at those gout patients who cannot tolerate allopurinol. It uses a genetically engineered form of uricase to breakdown uric acid in the body. This enzyme is common in many animals, but not humans.

The failure of Krystexxa to gain FDA approval means that it will be unavailable to help gout patients for some time, though there may still be access through ongoing clinical trials.

Apparently, Savient have changed the manufacturing process for pegloticase. Resubmission will require either a return to the previous method, or rerunning the clinical trials with the output from the changed process. It is expected that Savient will revert to the original process.

Approval is also dependent on Savient providing:

• A Medication Guide for using Krystexxa safely and effectively.
• A Communication Plan for Savient to correctly notify healthcare providers about infusion risks, life threatening allergic reactions, and risks for patients who also have Glucose-6-phosphate dehydrogenase deficiency (G-6-PD), or heart problems.
• An Assessment Plan for ensuring that the other 2 plans ensure that the risks o Krystexxa are properly communicated to doctor and patient.

OK, I have not gone mad. First, let me remind you why managing uric acid levels is much more important than managing gout pain, then I will explain why I say “lowering uric acid is useless.”

Gout Pain And Tooth Decay

There is no link between gout and tooth decay, but regular readers will recognize my oft-vaunted (overused?) analogy.

When you visit a dentist to treat toothache, you expect an examination for decay, treatment of that decay, and pain relief to help you endure the treatment and associated soreness and gum inflammation.

Treatment for gout, ignoring complications such as allergies, and other health conditions, should be just as simple. Take allopurinol (or some other uric acid lowering therapy) and support this with pain relief, such as colchicine, until the allopurinol has removed the excess uric acid threat.

But what should be simple, rarely is.

Tooth decay treatment starts with drilling, and you know this is going to hurt. Do you know that, as with any uric acid lowering therapy, including diet, allopurinol treatment for gout can hurt? Many gout patients do not understand this, and so they stop taking the uric acid lowering treatment. The equivalent of leaving the dentist’s chair half way into the drilling process.

All dentists, and most of their patients, understand that all the decay must be drilled out before the cavity can be filled. Almost no gout patients, and very few healthcare practitioners understand that uric acid levels must be maintained below 6mg/dL (preferably below 5) to get rid of existing uric acid crystals. Frequent uric acid tests during uric acid lowering treatment are just as vital as frequent checks to see if all decay is removed.

Tooth decay treatment ends with agreeing an appointment for the next inspection. Nobody assumes that one dentist visit fixes everything. We continue with daily teeth cleaning and return to check all is well. The gout patient who has lowered uric acid long enough for all existing crystals to dissolve must continue with a daily maintenance dose of allopurinol (if necessary) and return for a uric acid test every three to six months. Even when symptom free, it is unwise to go longer than 12 months without testing blood for uric acid.

You can stop being a gout sufferer, but you can never stop being a gout patient.

Once you have had a gout attack, you have changed. You have lost your gout virginity. You can never become a person who has never had gout, but you do not need to return to being a gout sufferer. You just need to manage your uric acid level, and never let it rise above 6mg/dL again. Standard uric acid tests might declare you “normal” at 7 or even 8 mg/dL.

You are not standard. You are not a gout virgin. You must not let uric acid rise above 6mg/dL.

Managing uric acid

So if I feel so strongly about the importance of uric acid, why do I say “Lowering uric acid is useless?”

Because “Lowering” is not enough – you need to manage it.

Lowering uric acid from 9mg/dL to 7mg/dL is pointless. It might slow down the rate at which new uric acid crystals form, but it will do nothing for the existing urate deposits that are eating into your bones.

Lowering uric acid to below 6mg/dL, then letting it rise back up to 7 is worse than pointless. You will get pain from old crystals dissolving, then pain from new ones forming. You will be in a mess.

Lowering uric acid is simply not enough. Here is how to manage it.

Phase 1

Get uric acid down to Phase 1 Target Level (usually 5mg/dL – agree something lower than 6 with your doctor). It does not matter how you do it, just do it. Allopurinol is the obvious choice, but there are medical alternatives.

You may be tempted to rely on dietary / lifestyle changes – this is fine, as long as you definitely lower uric acid, and not just seek to stop the pain. In practice, dietary and lifestyle changes are not quick enough to get uric acid levels down immediately, so it is better to support your lifestyle plan with immediate allopurinol support. I call this my allopurinol / gout diet Combination Therapy.

Phase 2

Maintain uric acid below the Phase 1 target level until you achieve six consecutive months without a gout flare. During this phase, you will experience gout flares, but they will become less frequent, and less intense.

These gout flares are due to your immune system reacting to old uric acid crystals as they dissolve. I know it is hard to convince you that such pain should bring you joy, but each time you experience a gout flare when uric acid is permanently below 6mg/dL, you are getting better. Compare this with occasional gout flares from new crystals when your uric acid level is higher – every day moving nearer and nearer becoming crippled.

After 6 months without a gout flare, you can be certain all existing gout crystals have gone, and you are no longer a gout sufferer.

Phase 3

No longer a gout sufferer, but still a gout patient. Uric acid tests every 6 months to stay below 6mg/dL.

Pegloticase is a generic name for PEG-uricase – a genetically engineered form of uricase. Uricase is an enzyme present in some animals that breaks down uric acid in the body. Humans do not produce uricase, so techniques have been developed to produce a type of uricase that humans can use.

Various versions of this treatment are being developed. The one that is most advanced is expected to be approved soon under the brand name Krystexxa, in the USA.

This was recommended for approval in June this year, and the FDA are expected to give final approval on August 1st.

So does this mean you can rush out and buy some in August?

Absolutely not.

Even when production gets up to speed, this is not a gout medication for self-administration. You need to go to your doctor, a clinic, or hospital for pegloticase to be given by intravenous infusion.

I suggest that you discuss this now with your doctor. There may be perfectly acceptable uric acid lowering therapies available to you. We have certainly discussed many other options in the gout forum, from the ubiquitous allopurinol to the newly launched febuxostat (Uloric / Adenuric). Surprisingly, even some blood pressure and cholesterol lowering medicines can have uric acid lowering effects.

If the discussion with your doctor reveals that you are a candidate for pegloticase, then he is in the best position to find a source of the medicine, or refer you to a suitable specialist. He may even know of clinical trials in your area, where you gain access to the treatment prior to it being on general release.

This study involves 9 visits to the test center over 24 weeks.

To qualify for the study you must have a confirmed diagnosis of gout with at least 2 acute attacks in the last 12 months. You will need to consent to a physical exam, EKG, height and weight, blood pressure and pulse, and fasting lab tests. You will need to complete a daily diary during a gout flare.

There is no cost to you and you will be compensated at $40.00 per completed visit. In order to determine if you qualify for this research study, please complete the gout study application form.

Rochester Clinical Research is located at 500 Helendale Road Rochester, NY 14609. GoutPal has no association with this organization, and I provide this information solely to keep you informed of current gout research.

FDA review has been postponed from February to give time for additional analysis of cardiovascular risks.

You can find full details of the meeting, including Savient’s briefing submission on the FDA site.

So what does this mean for gout sufferers?

Assuming approval is given, do not be thinking that you have a newer, easier option for controlling your uric acid.

Krystexxa cannot be taken orally. You get dosed up every two weeks with 8mg delivered by intravenous injection.

As well as being inconvenient, there are fairly high documented reaction rates. On a positve side, it is good that severe gout sufferers have an alternative if they cannot tolerate allopurinol.

So expect plenty drug company stimulated hype over the next few weeks. In fact a gout forum regular has spotted early signs of the latest outbreak of gout hype.

It is such a pity that similar money and exposure does not go into fixing the two great fallacies inherent in healthcare regimes throughout the world:

1. Gout sufferers need better diagnosis. Too many patients are dismissed without gout because “normal” uric acid range is set too high.
2. Allopurinol is rarely prescribed properly. Most gout patients do not get the right dose, the right monitoring, or the right support.

Back in May,

zip2play said:

My research has shown one antihypertensive regimen that lowers uric acid.  I will repeat it here.

It involves the use of two antihypertensive drugs, furosemide and losartan, (Lasix and Cozaar) but they must be taken in a particular way: first take the Lasix (which causes brisk diuresis) and then several hours later, take the Cozaar which causes uric acid elimination. Dosage of both drugs is titrated to get reasonable blood pressure control. Needless to say, people with NORMAL BP should not use this regimen.

The study confirming this regimen is small but rather convincing, but studies showing the uricosuric effect of losartan are all over the net. It;s the ONLY antihypertensive with this capability but used alone its effect is not large.

The name of the study is “Effects of the uricosuric action by losartan on the patients taking furosemide”, and the results show clearly in the chart above.

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Allopurinol Drug Recall For Europharm’s Purinol

The Department of Health in Hong Kong has withdrawn Purinol from sale, and is investigating other drugs manufactured by Europharm. Please note that this only affects Europharm Laboratories in Hong Kong.

The contamination appears to have occurred due to delays in the process of converting the active ingredients mixture into tablet form. It does not affect other manufacturers of allopurinol.

Patients receiving Purinol are urged to seek alternative allopurinol supplies from the clinics where there drugs where dispensed. It is vital that you do this immediately, as suspected medicines should never be used, but allopurinol should not be discontinued without the advice of your doctor.

Please check your allopurinol packaging immediately. You only need to take action if the medicine was manufactured by Europharm Labs of Hong Kong. Note that you should do this even if you live outside Hong Kong, as the drug is exported from there to other countries.

All gout sufferers should be happy to have this choice. Allopurinol intolerant gout patients must be euphoric.

I know many GoutPal visitors suffer reactions to allopurinol that make it impossible, or uncomfortable to maintain crucial uric acid lowering treatment. These are a minority of allopurinol users as most people can take allopurinol without problems. Patients with kidney problems are common in allopurinol-intolerant groups.

If you have this intolerance, please see your doctor today and discuss Uloric for your gout. If you live outside the US, febuxostat may well be approved in your country, but it might be sold as Adenuric.