A new gout drug - Febuxostat is approved in the European Union

At long last there's a new gout drug - Febuxostat. For long suffering gout patients, perhaps the best gout news in 45 years is that febuxostat has been approved for marketing in those European countries that are members of the European Union (EU). In the EU at least, it has been given the brand/trade name of Adenuric. Marketing authorization was announced in early May 2008.

This approval applies only to the EU, although if you are reading this from another country, you can check with your doctor to find out whether, or when, febuxostat will be approved in your country. It has not yet been approved in the United States.

THE GOOD NEWS ABOUT THIS NEW GOUT DRUG

It's good news for gout sufferers because in large trials febuxostat has outperformed allopurinol, the most common gout medication for long term treatment. Like allopurinol, it works to lower uric acid production. In two major studies it reduced uric acid (UA) in more gout sufferers, and more patients reached the target 6mg/dL level more quickly, than did those on allopurinol.

At 120 mg it has reduced UA levels to the target of 6.0 mg/dL in over 60% of study patients. At 80 mg the numbers were about 51%. This compares with 22% for allopurinol at a 300 mg dosage in most participants.

As with allopurinol, this new gout medicine works by inhibiting xanthine oxidase, an enzyme required in uric acid production.

NOT A WONDER DRUG, BUT A STEP FORWARD IN GOUT TREATMENT

In trials its success rate in reducing UA levels down to the important 6 mg/dL (357 mmol/µmol) level was not 100%. About 35% of trial patients did not achieve the target. And it has been less successful in patients who have UA levels above 10 mg/dL, (595 mmol/µmol).

But even when they are above this level it has reduced UA levels down to the target in about 40% of study patients at an 80 mg dosage, and by more at higher dosages.

It can cause side effects of course (see the bottom of this article).

Febuxostat (Adenuric) is not a treatment for gout pain – so it won't be used instead of NSAIDS, colchicine and corticosteroids such as prednisone. But it's recommended that NSAIDs or colchicine are used along with Adenuric.

It will also only be used in gout patients who have chronic hyperuricemia (high UA levels) and gout. It does not work to improve uric acid excretion, so under-excretors may not benefit from it. Under-excretors are often treated with urosuric drugs.

If you're a gout sufferer who lives in a European country that's a member of the EU, and not all countries in geographical Europe are members, you can ask your doctor's opinion about whether it is right for you, and find out when s/he will be able to consider prescribing it.

WHO WILL GET IT AND WHAT'S THE DOSAGE?

This new gout drug is taken orally as a tablet. The recommended dosage is 80 mg daily. If after two weeks there is no reduction in UA levels, the dose may be increased to 120 mg daily. In trials as much as 240 mg daily has been taken, but this is not a recommended amount for routine treatment. Patients will need another serum (blood) UA test after two weeks treatment on febuxostat to find out how well it's doing.

It also shares one of the benefits of allopurinol. Because it has to be taken just once daily, it's simpler to take and easier not to forget. The more often a drug has to be taken each day, the more likely it is that patients forget to take it.

Your uric acid levels will have to be high, so if you have gout but normal or slightly raised uric acid levels this is unlikely to be prescribed, and you must have gout crystals.

The presence of tophi If you have tophi, note it has been shown to have success against tophi, and this will be an additional factor in favour of a decision to prescribe febuxostat (Adenuric). You will not need to be on a low purine diet. Good news too is that it can be prescribed for the elderly.

Kidney and liver disease In trials it has performed quite well with patients who have mild kidney disease and much better than allopurinol which did not reduce UA levels in patients with mild/moderate kidney disease. 44% achieved the target at an 80 mg dosage of Febuxostat, more at higher dosages. If you have mild kidney disease (renal impairment) or mild liver problems (hepatic impairment) your doctor can determine whether Adenuric/febuxostat is right for you.

If you have severe kidney or liver problems Febuxostat is not recommended since it has not been tested in these patient groups. It is not recommended for people with heart disease.

Noted possible side effects dizziness, drowsiness, diarrhoea, rashes, headaches, hypertension and liver function abnormalities – considered mild ones. In trials none of these side effects were reported in more than 3.5% of trial patients. The most common were liver function abnormalities.

On a course of this new gout medicine, there may be an initial increase in gout flares, in which case you must "grin-and-bear-it" and continue taking Adenuric. This problem is also common in allopurinol treatment.

FEBUXOSTAT (ADENURIC) DOWNLOADS

If you want to read more detail about this new gout drug, visit the website of the European Medicines Agency where you can download the Public Summary, Public Assessment Report and Product Information for Adenuric.

A complete list of noted side effects is in the Public Assessment report as are detailed summaries of the studies. The shortest and easiest read is the Public Summary which is just a couple of pages. The other reports are about 50 pages.

For possible side effects the easiest way to understand these is to read the package leaflet details which are shown on the Public Assessment Report, pages 45-48. On these pages the contact details of the local representative of the marketing authorisation holder for each EU country is also shown. You can download the Summary for the Public, the Public Assessment report, and background information on Febuxostat here. This is the website of the European Medicines Agency. Click on the available documents link that arrives on screen

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