Europe Trip

A New Gout Drug. Febuxostat wins marketing approval in the European Union

October 23, 2014 | Comments Off on A New Gout Drug. Febuxostat wins marketing approval in the European Union

It has taken a very long time for a major new gout drug to be developed and approved. Probably the best gout news in over 40 years, is that Febuxostat, which has been given the trade/brand name of Adenuric, has been approved by the European Medicines Agency for marketing in European Union (EU) countries.

This approval applies only to EU countries. Febuxostat has not yet been approved in the United States. If you are reading this from a non-EU country, or the US, you can check with your doctor to find out whether, or when, Febuxostat will be approved in your country.

Approval in one country does not mean approval in another, but the fact that the European Medicines Agency has approved it will carry weight when the medical authorities in other countries consider its approval.

BENEFITS

In large trials Febuxostat (Adenuric) has outperformed Allopurinol, the most common gout medication for long term treatment. Like Allopurinol, it works to lower uric acid production by inhibiting xanthine oxidase, an enzyme required to produce uric acid. In two major studies it reduced uric acid (UA) in more gout sufferers, and more patients reached the target 6.0 mg/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 around 51%. Allopurinol at a 300 mg dosage in most participants achieved this is 22% of study patients. Hence the excited buzz in rheumatology circles since these kinds of results became apparent in its trials. At or below 6.0 mg/dL gout is more likely to be cured or managed better.

Generally, Febuxostat has been more effective when UA levels are below 10.0 mg/dL (595 mmol/mol). However, even if they have been 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’S NOT PERFECT

In trials its success rate in reducing UA levels down to the important 6.0 mg/dL (357 mmol/mol) level was not 100%. About 35% of trial patients did not achieve the target. This may have been partly because so many gout sufferers are not UA over-producers, the problem Febuxostat addresses, but under-excretors of uric acid.

And it may cause side effects of course. See the bottom of this article.

Febuxostat (Adenuric) is not unfortunately a treatment for gout pain. It won’t be used instead of NSAIDS like Indomethacin, Colchicine, and corticosteroids.

It is recommended that NSAIDs or Colchicine are used along with Adenuric. This is because, as with Allopurinol, on a course of Febuxostat, there may be an initial increase in gout flares. If this happens you must battle through the attacks and continue taking Adenuric.

It will also only be used in gout patients who have chronic hyperuricemia (high UA levels) and gout.

So if you’re a gout sufferer who lives in a European country that’s a member of the EU, you can ask your doctor’s opinion about whether Febuxostat is suitable for you.

WHO WILL BE PRESCRIBED IT?

The recommended dose is one 80 mg daily tablet. If after two weeks there is no reduction in UA levels, your doctor may increase the dose to 120 mg daily. Patients will need another serum UA test after two weeks treatment to find out how well it’s doing. In trials it has usually worked quickly, within a couple of weeks.

Your uric acid levels will have to be high. If you have gout but normal or slightly raised uric acid levels as some do, it is unlikely to be prescribed.

Tophi If you have tophi, it’s heartening to know that Febuxostat has been shown to have success against tophi. Measured tophi areas reduced in many patients with tophi. The presence of tophi 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, and more good news 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. 44% of patients achieved the target at an 80 mg dosage, more at higher dosages. Better results than Allopurinol. If you have mild kidney disease (renal impairment) or mild liver problems (hepatic impairment) your doctor will judge whether Adenuric/Febuxostat can be taken safely.

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 or children.

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.

NB. The contents of this article contain medical information not medical advice. Please always discuss remedies with your doctor or other health care professional, before implementing any treatment.

John Mepham has lost track of the number of hours he has spent researching gout treatments. His best tip for curing gout naturally? Get to your ideal weight whatever the sacrifices may be. Learn more about natural gout treatment at www.gout-smashers-guide.com It’s an e-book with an emphasis on natural gout treatment