Evaluation of Blood in the Urine (Hematuria)

Speciman BottlesI recently had a long discussion with a diabetic patient about the drug Actos. This very effective and relatively safe diabetic drug has now been implicated as increasing the risk of bladder cancer. While the FDA has not removed the drug from the market, it has been removed from the market in Germany.  My patient wondered if he could continue using Actos but send his urine off for testing and evaluation regularly to detect any indication bladder cancer early. I said I preferred switching medications. 

Chance would have it that the April 11, 2013 edition of Journal Watch addressed the question indirectly.  They looked at whether or not it was safe to send urine off for cytology to look for cancerous cells in the evaluation of blood in the urine. Urine cytology, like the Pap smear, looks at cells in the urine from the bladder and tries to diagnose bladder abnormalities and cancers by identifying abnormal cells. The traditional evaluation of blood in the urine includes doing x-ray and imaging studies as well as performing an invasive procedure called a cystoscope (under anesthesia a fiber optic device is inserted into the bladder through the urethra and advanced into the upper collecting tracts.).

In a study performed in the United Kingdom at a teaching hospital, researchers reviewed the records of patients with blood in the urine. Sixty-five percent of the patients had visible bleeding while 35% had only microscopic bleeding. They all underwent imaging of the upper tract, cystoscopy and urine cytology.

A full evaluation of imaging, cystoscopy and cytology was performed on 2,507 patients. Fourteen percent of the patients were ultimately diagnosed with transitional cell cancers of the bladder. The sensitivity and specificity of abnormal cytology were 45% and 89% making cytology not “good enough” to serve as a first line test for patients with unexplained blood in the urine. More than half the patients with bladder cancers had negative cytology and about 105 of patients with negative cytology had bladder cancers.

The study supports the recommendations of the American Urologic Association’s guidelines that recommend against using urine cytology in the initial evaluation of patients with microhematuria.

Additional Study Discusses Relationship Between ACTOS and Bladder Cancer

Laurent Azoulay, PhD, of McGill University in Montreal presented data linking ACTOS with the development of bladder cancer.  His research specifically implicated ACTOS rather than implicating the class of drugs ACTOS belongs to. His group specifically did not see this effect when looking at Avandia (rosiglitazone).  Avandia has been removed from the US market because of its cardiac toxic effects.

Azoulay and associates looked at 115,727 patients given prescriptions for these antidiabetic medicines in the United Kingdom primary care data base between 1988 and 2009.  The mean age of participants was 64 years old and they were followed for over 4 years.  Patients who had been given a prescription for the thiazolidinediones tended to be more obese, smoked and have worse control of their diabetes.  These are all risk factors for the development of bladder cancer.

ACTOS has been removed from the market in some European countries. The FDA did not restrict it in a recent review.

With the new data it will become necessary to suggest alternatives to ACTOS to my diabetic patients until the matter is completely clarified.