The manufacturers of the drug Uloric which is prescribed for gout—a specific type of arthritis whose symptoms are typically felt in one to two joints only—recently produced the results of a study comparing this drug to allopurniol, another arthritis medication.

The comparison study was started in 2009 and paid for by Takeda Pharmaceuticals at the insistence of the U.S. Food and Drug Administration (FDA).

Pre-market approval clinical safety trials of the drug Uloric revealed some cardiovascular problems which raised red flags with the federal drug oversight agency.

The small increase in problems was not severe enough to be considered an obstacle to bringing the drug Uloric to the commercial marketplace. The FDA felt the increased risk was worthy of long-range follow-up, however.

The CARES study originally enrolled 6,190 patients with a then-current diagnosis of gout and a medical history with heart conditions or heart events such as myocardial infarctions (heart attacks).

Several participants dropped out over the length of the study without further information as to their whereabouts or health status. At least half of this number remained active for three consecutive study years.

According to the study’s author, Dr. William White, the breakdown between the drug Uloric and the drug Allopurinol doesn’t reflect real-world prescription rates, 50 percent took the drug Uloric and 50 percent took allopurinol for the best comparative analysis.

Dr. White indicates that there are 8 million American citizens alone being treated for gout, but only 7.5 percent are prescribed the drug Uloric by their physicians. Doctors tend to favor treatment with Allopurinol by and large.

The CARES study data was both published online in the New England Journal of Medicine and presented at the annual meeting of the American College of Cardiology in March 2018.

The conclusions drawn from the data generated were as surprising to Dr. White as they were to his medical colleagues. He lacked an easy explanation for the revealed trends.

According to the data, the drug Uloric caused a 34 percent increase in heart-related deaths provided the patients had symptoms of heart disease which preexisted the study. Gout sufferers have a disproportionate chance of having cardiovascular or kidney function issues secondary to the disease.

Additionally, the CARES study found a generalized increase in death risk of 22 percent while taking the drug Uloric. The medication has been in use since 2009 when it was made commercially available by the FDA.

Allopurinol has been in use much longer. It was first introduced in 1966 and has had success in controlling this type of arthritis for fifty years.

What is Gout?

Gout very painfully attacks one to two joints at a time. The joints become inflamed, red, and irritated and these attributes are associated with a deposit of crystallized uric acid in the joint itself. The crystallized acid deposit occurs because blood levels become too high.

Gout is disproportionately diagnosed in men, but women are known to develop it as well. It can have a genetic component but is associated in popular culture with people of means that live the high life with diets rich in red meats, alcohol, and seafood.