Gout attacks must be endured. Why you may have to break through the pain barrier





This page, about the nature of gout attacks, was last reviewed or updated on 19 July 2010

The distasteful fact about gout treatment is that gout flares (attacks) may be caused by the gout drugs designed to lower down uric acid to those levels where it's likely you can cure them. Below 6.0 mg/d, a bit lower in women.

In other words, the medication to lower uric acid levels may cause a gout flare. You'll be delighted to know this is not inevitable. However, these flares are the reason why many gout sufferers give up on medication.

But giving up may be premature and, if they had continued the treatment, eventually the attacks would cease.

Because it is the falling uric acid levels that can cause attacks, treatment with natural remedies may cause them too, although there aren't any studies about this. Some people report natural remedies halted attacks immediately or quickly, without a repeat one before they made their testimonial. Lucky them!

These attacks are the reason doctors prescribe a medication (an NSAID or colchicine) for what they and academic medical researchers call prophylaxis, medical jargon for advance attack prevention - along with uric acid lowering drugs such as allopurinol or febuxostat. Colchicine suppresses the immune system's response so that the attack subsides. NSAIDS often stop or lower pain, sometimes they don't. Among the NSAIDS, indomethacin (indometacin, indocin) is reckoned to be the most effective.

How long will prophylaxis drugs be prescribed for preventing gout attacks? Because of their side effects, six months is usually the maximum. In your case it may well be less.

FACTS ABOUT THE FACT STUDY

The reports released by the European Medicines Agency (EMEA)when it approved febuxostat contained results and analysis of the phase 3 febuxostat studies. These were large gout-patient-number studies. So what happened to patients whilst trialing febuxostat (and allopurinol) gives a reasonable picture of what is likely to happen to you, if you are taking febuxostat or allopurinol. Remember though, your case may be different. Prophylaxis may have to be stopped before gout flares cease.

There's some statistics here, but it's worth understanding them. They show how many gout sufferers suffered attacks during febuxostat's major trials and how many suffered attacks in the last trial period.

Febuxostat went through two major phase 3 trials. Phase 3 trials are the last major trials that have to be completed before a pharmaceutical can be submitted for approval. They were called APEX and FACT (febuxostat v allopurinol controlled trial).

In both studies prophylaxis treatment lasted from week one to week eight and then generally stopped, with exception cases determined by the assessors.

In both studies, in the measurement period after prophylaxis to prevent gout attacks was stopped, gout flares rose but in subsequent measurement periods they declined.

Will you suffer a gout attack whilst on uric acid lowering medication?

The odds are that you will. In the FACT trial period (weeks 8 -52) the number of patients suffering gout flares who required treatment (some may have had flares but did not require treatment) was:

Febuxostat 80 mg daily
Number of patients with flares 147.
Number of patients in group 228.
% suffering flares 64%.

Febuxostat 120 mg daily
Number of patients with flares 150.
Number of patients in group 215.
% suffering flares 70%.

Allopurinol 300 mg daily
Number of patients with flares 150.
Number of patients in group 234.
% suffering flares 64%.

How long might you suffer gout attacks whilst on treatment with Febuxostat or Allopurinol?

In the final FACT trial period (weeks 49 – 52) numbers, and percentages of patients suffering attacks were:

Febuxostat 80 mg daily
Number of patients with flares 13.
Number of patients in group 167.
% suffering flares 8%.

Febuxostat 120 mg daily
Number of patients with flares 9.
Number of patients in group 153.
% suffering flares 6%.

Allopurinol 300 mg daily
Number of patients with flares 20.
Number of patients in group 185.
% suffering flares 11%.

APEX

During the last period of APEX (weeks 24-28) the percentage of patients suffering gout attacks had fallen to 15% for febuxostat (both groups) and 14% for allopurinol.

So it's likely, but not inevitable, that with these medications you will suffer gout attacks en route to the end of them. And that it may take up to a year to beat them, but perhaps two more years. (See the extension trial below).

BETTER IN EXTENSION TRIALS

Many of the patients who had been on the APEX or FACT trial then went onto an extension trial called Cxx-021. i.e. after febuxostat and allopurinol for 28 weeks or 52 weeks, and then two more years of treatment with febuxostat. It is still ongoing. 

Combined data for the 80 mg/120 mg febuxostat groups was that only 2.7% suffered flares after two years of the extension study. (6/8% after a year).There was no data on drop out rates, but the figures show that the longer you treat gout with febuxostat the more likely you are to cure gout attacks.
Summary  After about six months of APEX 15% on febuxostat and 14% on allopurinol had flares; after one year on FACT 6-8% febuxostat and 11% on allopurinol had flares; after two years of an extension trial 2.7% on febuxostat had flares. (No extension trial figures for allopurinol).

So more patients cleared up flares in the extension trials. And the longer you stay the course, the more likely you are to end gout attacks.

FEBUXOSTAT AVAILABILITY

Febuxostat is  available in the EU, U.S. and some Asian countries. (e.g. South Korea).It may have been approved in some other countries - please check with your doctor. This means that allopurinol will still be prescribed, and there is also the consideration of whether febuxostat is suitable for a patient. It is also much more expensive than allopurinol.

Read more about febuxostat here

So, many readers will be prescribed allopurinol. To repeat its results. After one year of allopurinol (FACT trial) 11% of those on allopurinol 300 mg daily, still suffered flares. 89% did not.

Read more about allopurinol here

ETHNICITY AND GOUT ATTACKS

Figures above are not adjusted for ethnicity, described in the study as Caucasians v non Caucasians. For the combined APEX and FACT trials the EMEA background information report said:

"Efficacy (i.e. effectiveness in producing the desired effect) in the combined pivotal phase 3 studies (i.e APEX and FACT): serum uric acid levels <6 mg/dL (less than 6 mg/dL) was significantly greater in Caucasians compared to non Caucasians (not further specified) in the 120 mg treatment group (68% v 46%)."

Although these percentages do not refer to the gout attack numbers above, but are for lowering uric acid levels, lowering uric acid to 6 mg/dL is reckoned to be the level at which gout sufferers may cure gout attacks.

In the APEX study the report said that Caucasians, Asians and other sub groups performed about the same. But at 80 mg febuxostat and 120 mg febuxostat, the response rate of Blacks and Hispanics was smaller, but not in the 240 mg groups. Febuxostat at 240 mg was not approved for EU nations.

The assessors said it was difficult to draw a correct conclusion about different ethnic groups due to the small numbers in the non Caucasian sub groups.

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.

Why flying can cause gout flares. And what you can do if you've forgotten your medicine for gout attacks, but have an attack of gout on a flight.

You can read more about Febuxostat (Uloric, Adenuric) on this page at the European Medicines Agency website.





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