Rochester Clinical Research have announced a new clinical gout trial to help evaluate a new treatment.
The purpose of this gout research is to examine the safety and effectiveness of different doses of an injectable medication. The medication will be compared to an approved oral medication versus placebo for prevention of acute gout flares. In addition all volunteers will be required to take allopurinol, which will be supplied.
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.
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Krystexxa comes before the FDA Arthritis Advisory Committee Meeting on Tuesday 16th June.
This is the latest stage to try and get approval for the second new gout drug this year.
Hot on the heals of Uloric, the US brandname for febuxostat, pegloticase (formerly known as PEG-uricase) seeks release under Savient’s brand new name of Krystexxa.
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:
- Gout sufferers need better diagnosis. Too many patients are dismissed without gout because “normal” uric acid range is set too high.
- Allopurinol is rarely prescribed properly. Most gout patients do not get the right dose, the right monitoring, or the right support.
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The link between uric acid and blood pressure medication is just one aspect of the relationship between gout and high blood pressure (hypertension).
In fact, hypertension, high blood pressure, or diuretic in the Gout Search Engine (at the foot of every page, and elsewhere throughout the site) will reveal a wealth of information.
You might know that diuretics prescribed for high blood pressure are a common cause of gout. This need not be so.
With the right approach, it is actually possible to lower uric acid with blood pressure medication.
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.
Furosemide alone raises uric acid on average by one third. If it is taken at the same time as losartan, then this increase is reduced to just over one fifth.
Losartan alone gives a slight reduction in uric acid, but as zip2play has pointed out in the gout forum, it is not especially effective at reducing high blood pressure. The correct procedure for gout sufferers with high blood pressure, as described by zip2play, is to take losartan a few hours after taking furosemide. The study shows that this can promote an average 15% drop in uric acid.
If you are not on this regime, discuss it with your doctor today.
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Posted by GoutPal in Gout, tags: gout-forum
I had reason to update this gout blog today, and took the opportunity to add a couple of tweaks to the gout forum.
One change is the ability to change the editor that you use to write your gouty stories. To do this, you first need to register as a member. I always recommend this as it gives so many extra features. In fact, I cannot see any reason for not registering, so if you have a reason, perhaps you could tell me by adding your comments below. Once you register, you can change the editor in your gout forum user profile. Try different options, and see which suits you best.
The second change is the ability for you to let the world know which gout topics you like, and also a chance to give the “thumbs down” to any that do not appeal to you. My main reason for doing this is to allow visitors to vote for improvemnts and research projects that I will start adding soon. More of that in another post soon, but I have already found an excellent use for this voting feature.
There is an excellent thread about some of the iniquities suffered by the gout patient.
There are several interesting points raised, which I hope to summarize later, but for now, I’m pleased to be able to vote for the outstanding contributions.
I am truly amazed and grateful for the depth of feeling expressed by the contributors to this topic. More than I could ever have hoped for, and an inspiration to me. Gout philosophy and life philosophy rolled into a thought provoking and educational discussion.
It doesn’t get better than this.
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Join the forum discussion on this post - (1) Posts
In a recent gout forum post about uric acid, zip2play wondered why there aren’t more people with gout. Or rather, how come so many people have higher than normal uric acid, but never get gout?
This intrigued me also, as it has others, and I found “Growth of monosodium urate monohydrate crystals: effect of cartilage and synovial fluid components on in vitro growth rates.”
In this study, Burt and Dutt found that
“Albumin significantly inhibited MSUM [monosodium urate monohydrate] crystallisation.”
Their findings apparently contradict other studies, which they suggest might be due to the difficulty of studying albumin which can be absorbed by lab equipment.
It is unfortunate that this is not the subject of much more analysis. It seems to me that there are substances (probably including iron), which promote uric acid crystallization. There must be others which inhibit it.
Interestingly, albumin is found in dairy products that have been shown to have a statistical link to lower incidence of gout.
Does anyone know of any current, or more recent, research in this area? The study I refer to was published in 1986.
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Call me a cynic, but I’m always wary about where I get my gout advice from.
A recent report has just hit the gout news network – a survey about how ignorant people are about gout.
The “shocking” statistics reveal that:
- 65% of adults admitted to being “not at all knowledgeable” about gout.
- Over 70% did not know that gout is a form of arthritis.
- 83% said they have not had their uric acid levels checked in the last five years, or weren’t sure if they had.
- 35% of gout sufferers said they have not had their uric acid levels checked in the last five years, or weren’t sure if they had.
- 49% of adults were not aware of the potential crippling effects of gout, such as needing to use a cane or walker, or having to stop working because of limited mobility.
But where did this data come from, and why does it matter?
It matters, because raising gout awareness might push more people into seeking early treatment. By controlling uric acid at the earliest opportunity, people can avoid or reduce the crippling effects of gout.
Such awareness would be good if it encouraged people to get wise advice on managing uric acid and safe alternatives for pain relief until uric acid was correctly controlled. It would be wonderful if the general practice doctor could be relied on for simple proven therapy that will allow gout patients to keep uric acid below 6mg/dL and live a pain free life.
We should praise the Gout & Uric Acid Education Society for pushing confirmed gout sufferers to seek treatment, and unconfirmed gout patients to seek diagnosis.
Unfortunately, experience (and abundant research) tells us that the doctor we rush to has, in many cases, little more knowledge about gout than we do.
Except, of course, they will have been primed by the manufacturers of recently released Uloric (febuxostat) and soon to be released Krystexxa (pegloticase / PEG-uricase / Puricase). They will know all about the new wonder drugs from Takeda and Savient – the very same pharmaceutical companies who sponsor the Gout & Uric Acid Education Society.
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Allopurinol Drug Recall For Europharm’s Purinol
Purinol – a brand of allopurinol manufactured by Europharm Labs of Hong Kong – has been recalled.
Tests have revealed the presence of a fungus called Rhizopus.
Shipments have been refused entry into Macoa.
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.
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Free gout guides to help you understand your doctor and know the right questions to ask. Your free prescription for all the gout answers you need.
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As predicted last November, the final step for febuxostat has just taken place.
Under the name Uloric, febuxostat now has FDA approval for use in the US.
Gout sufferers now have a choice of medicines to regulate uric acid production – the most vital part of gout management.
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.
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Avoid gout confusion – avoid gout.
Easy to say, but harder to do.
Even the experts have areas of gout they do not understand, and as they discover new facts about gout, it is sometimes hard to forget old ideas.
I hate to say it, but I added some gout confusion when I learned new facts about coffee, but failed to remember to change old views about diuretics. Thanks to one reader, I’ve looked into this coffee confusion and made a few changes that hopefully make things clearer.
For information about coffee and gout I’ve added some in depth coffee and gout research to reinforce the overview of how coffee affects gout.
I’ve also updated my advice about fluid intake and gout.
Many people are still skeptical about caffeine – fearing a diuretic effect that may raise uric acid levels through dehydration. There have been several studies recently that rebut the notion that caffeine from coffee causes dehydration. One in particular, “Fluid, electrolyte, and renal indices of hydration during 11 days of controlled caffeine consumption“, concludes that:
Therefore, C0 [placebo], C3 [3mg caffeine], and C6 [6mg caffeine] exhibited no evidence of hypohydration [dehydration]. These findings question the widely accepted notion that caffeine consumption acts chronically as a diuretic.
Simply put, the water from making the coffee drink outweighs any mild diuretic effect from the caffeine, so enjoy it as part of your daily fluid intake.
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