Trasylol Studies Continue to Assess Kidney Failure Risk

Boston, MAThere have been a number of studies conducted on the anti-bleeding drug Trasylol that is used during heart bypass surgeries that suggests that it is responsible for kidney failure in patients after their surgery. In fact, one third of patients are believed to have received it during the procedures.

However, a 2006 study that was led by Dr. Dennis Mangano was published in the New England Journal of Medicine and revealed results that Trasylol doubled the risk of renal failure and increased the chances of heart attack. After a second study was conducted showing the same results, Trasylol marketing was suspended in November 2007. To make matters worse, Bayer had conducted their own study that revealed similar results and had not notified the FDA of their findings.

But now there is an even newer study that has been conducted that makes the suggestion that kidney failure is more apt to happen in those with a preexisting condition. The study that can be found in the Journal of Thoracic and Cardiovascular Surgery says that the effect that was published in the New England Journal of Medicine by Dr. Mangano was pure artifact because it did not take into account that the patients being studied were even sicker from the beginning. This is despite previous studies and even a study by Bayer that showed an increased risk of kidney failure.

In the study conducted by Pagano and colleagues, it is stated that the results are at odds with those found by Mangano and his colleagues because Mangano's study consisted of patients with a poor risk profile. They allege that the patients in the study had a higher risk for such conditions as congestive heart failure, renal disease, pulmonary disease, concomitant valvular disease, and carotid disease.

However, in Mangano's paper it is said that there was also no balance of baseline characteristics because covariate interactions proved unnecessary to achieve that balance. There were several factors taken into account in Mangano's study, but it seems that Pagano and his colleagues were not impressed by what they read although Mangano's study states that the methods used did not target any particular group.

In February 2008, there was a study published in the American Journal of Nephrology regarding the use of Trasylol and its association with kidney failure. This was actually the first study that was conducted to evaluate the type of effect Trasylol has on urinary neutrophil gelatinase-assocated lipocalin or NGAL. NGAL is said to be able to detect renal injury caused by Trasylol.

The study consisted of 369 patients given either aminocraproic acid or Trasylol during their heart surgery. 205 of those patients received Trasylol while the remaining 164 were given aminocraproic acid. The study's results showed that those given Trasylol had a risk that increased twofold when it came to developing kidney failure compared to the group that received the aminocraproic acid. 51 out of the 205 patients that were given the Trasylol developed kidney failure after their surgery. This study proved to be in favor of the 2006 study conducted by Dr. Mangano.

However, studies do continue on the drug to figure out what factors make a person at higher risk or if there are any factors at all increasing that risk. Bayer claims on their Trasylol website that kidney failure was more likely to happen in those who were already sicker, which coincides with the Pagano study. The Mangano study did not target people who were sicker or healthier than others. But at this point, Bayer faces lawsuits because of alleged negligence stemming from not revealing their own study results to the FDA sooner. Yet only time will tell what really caused the drug to lead patients to kidney failure.

By Ginger Gillenwater