GoutPal Interactive

Though most gout patients – or at least the ones who read GoutPal.com – understand the importance of lowering uric acid, many are concerned about medication side effects.

To put this into context, the side-effects of NOT lowering uric acid are extensive bone, cartilage, and tendon damage for gout sufferers. This is permanent damage caused by urate crystals, but so slow that you do not notice until it is too late. Another side-effect of high uric acid in the blood is an increased risk of kidney stones. These can cause permanent kidney damage, and they are extremely painful. So, before you dismiss urate lowering therapy for fear of the (often low) risk of side effects, consider carefully the (almost certain) risks of doing nothing.

I’ve written about allopurinol side effects before, but now that we have a new uric acid lowering drug, febuxostat, gout patients are wondering if this has fewer effects.

A clear side-by-side comparison is beyond the scope of this article. There are several comparative studies, but none, as far as I am aware, are a strict comparison of doses at similar uric acid levels.

Febuxostat launched recently in the US under the brand Uloric. Previously, it was launched in Europe under the brand Adenuric. Earlier this month, the European Public Assessment Report for Adenuric was updated, which includes summaries of side effects from trials of febuxostat for gout patients.

Febuxostat Side Effects

Read the rest of this entry »

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.

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.

Allopurinol intolerant gout sufferers in the USA moved one step closer to an alternative gout fixer yesterday.

Though this does not bind the FDA to issuing approval for febuxostat, it represents a highly positive outcome and bodes well for a new treatment sometime in the next few months.

In this part of the approval process, evidence is considered by the committee. I’ll present some of the evidence in detail over the next few weeks. To set the scene, here is the summary, from “Briefing Document for Febuxostat” by Takeda Pharmaceuticals North America, Inc.

Summary and Conclusions

Febuxostat is a potent, nonpurine, selective inhibitor of Xanthine Oxidase (XO), which has been shown to be effective in reducing and maintaining serum uric acid (sUA) <6.0 mg/dL at doses of 40 mg and 80 mg. Maintaining these sUA levels is associated with the clinical benefits of tophi resolution and reduction in gout flare.

Febuxostat 40 mg and 80 mg provide an effective treatment option for patients with hyperuricemia and gout. Based on the clinical data, 40 mg and 80 mg are effective doses with 80 mg providing added benefit for patients with more severe disease.

Febuxostat also provides benefit in this patient population with comorbid conditions and has an advantage over allopurinol of not requiring dose adjustment in patients with mild to moderate renal impairment.

Febuxostat doses of 40 mg and 80 mg are well tolerated and have a similar safety profile as the currently marketed allopurinol. The rates of cardio-vascular (CV) events observed in the febuxostat clinical program were low. The potential CV risk was prospectively evaluated in the CONFIRMS Study and no difference in the rate of CV events was observed between febuxostat 80 mg and allopurinol; whereas, with its known risk of AHS, the risk in terms of severe rash is greater with allopurinol.

Febuxostat 40 mg and 80 mg doses are both recommended for approval to allow clinicians individualized dosing options. The 80 mg dose is more effective than 40 mg, especially in subjects with more severe disease as defined by the presence of tophi or higher sUA levels.

Overall, the benefits of febuxostat 40 mg and 80 mg clearly outweigh the risks and support approval of febuxostat for the treatment of hyperuricemia in patients with gout.