A new gout drug - Febuxostat has been approved in the EU - and now the U.S.LATEST MAJOR GOUT NEWS FLASH February 13 2009. The U.S.FDA has approved febuxostat. Its brand name in the U.S.is Uloric.
You can read more here, and download prescribing information.
This page on febuxostat was last reviewed on 19 July 2010 At long last there's a new gout drug. For long suffering gout patients, perhaps the best gout news in 45 years is that this drug has been approved for marketing in those European countries that are members of the European Union (EU). In the EU 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. 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 6.0 mg/dL (0.357 mmol/L) 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 80% of study patients. At 80 mg the numbers were over 70%. This compares with 40% for allopurinol at a 300 mg dosage in most participants who took allopurinol. (Percentages depend precisely on the trial and the number of measurements). As with allopurinol, this new gout medicine works by inhibiting xanthine oxidase, an enzyme required in uric acid production.
In trials its success rate in reducing UA levels down to the important 6.0 mg/dL (0.357 mmol/L) level was not 100%. About 20%-28% of trial patients did not achieve the target at final visit. And it has been less successful in patients who have UA levels above 10.0 mg/dL, (0.595 mmol/L). But even when they are above this level it has reduced UA levels down to the target in about 60%-67% 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). And participants taking it had more gout flares than those who took allopurinol. 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, at least in the early weeks of treatment. 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 usually 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 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 ithas been shown to have success against tophi, and this will be an additional factor in favour of a decision to prescribe febuxostat (Adenuric). Diets You will not need to be on a low purine diet, or any 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. 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 will be for a majority an 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 read more about febuxostat at this page at the European Medicines Agency's website.
Click here to find out whether it is true that higher levels of uric acid, above the level at which hyperuricemia is defined, make it harder to reduce uric acid levels to those at which the MSU crystals dissolve. And what you should do about it.
December 2008 Britain's NICE (National Institute for Health and Clinical Excellence) recommended febuxostat for NHS (National Health Service) use in England and Wales. Scotland and Northern Ireland will probably follow soon. Those British gout patients who will get it from the NHS will have to suffer chronic hyperuricemia (high levels of uric acid), and be intolerant of allopurinol, to be prescribed it. Or they have to be gout patients for whom allopurinol is contraindicated. The recommended dosage is 80 mg daily, but 120 mg daily may be considered. There are warnings and precautions about its use in people with certain kinds of heart disease, which are already well known. If you use Britain's private health sector providers, check to see if they can prescribe febuxostat for you.
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