Monday, May 28, 2012

Risk of Bladder Cancer for Diabetics Taking Actos Part One: The Kaiser Permanente Study: Background Data

This two-part article series will detail a ten-year study between 1997 and 2008 done to determine the relative risk of developing bladder cancer among diabetic patients who were being treated with the drug Actos in an effort to control their diabetic symptoms. After receiving adverse reports regarding the safety of Actos, the FDA requested the manufacturer of Actos, Takeda, conduct a safety study in order to determine whether Actos therapy directly increased the risk of bladder cancer.

The study included over 193,000 patients in the Kaiser Permanente diabetes registry. These patients were forty years old or older at the time of the study, and any patient who had a prior history of bladder cancer was excluded from the study. Actos usage vs. non-Actos usage was adjusted for age, sex, race/ethnicity, other diabetes medications, heart failure, household income, renal function, smoking history and other bladder conditions. Overall, the group treated with Actos contained 30,173 patients.

What is Actos?

Actos is a thiazolidinedione drug used—along with diet and exercise—in the treatment of Type 2 diabetes to improve glycemic control. Actos is typically not used as a first-choice treatment of the symptoms of Type 2 diabetes rather physicians will advise their patients to make lifestyle changes such as losing weight, cutting down on excess fats and sugars, becoming more physically active and quitting smoking. Doctors may also prescribe Metformin as a “starter” drug to see if the lifestyle changes along with the metformin can get the patient’s Type 2 diabetes under control before trying Actos. While some studies have reported a potential association between treatment with Actos and cancer risk, there is a limited amount of data at present to back this up. Most of the data available comes from a study known as the PRO-active study which found a “non-significant” excess of bladder tumors among those taking Actos.

The Kaiser Permanente Data Source

Kaiser Permanente is a Northern California Health Care Facility which provides comprehensive health care to over three million members. The pharmacy database of KPNC includes information regarding each prescription issued on an outpatient basis, and it is estimated that at least 95% of Kaiser’s members have their prescriptions filled at KPNC pharmacies. The KPNC diabetes registry pulls data from various components of patient medical records to build and follow the patients across time.

Patients who met specific criteria were eligible for the KPNC study on the bladder cancer risks of Actos. Patients without prescription benefits at the time the study began were excluded. Cumulative dosage exposure was calculated from the time Actos was first taken along with the specific dosage. Follow-up to the study began on April 30, 2008, the first date when all inclusion data was effectively met, when a gap of greater than four months in membership or prescription benefits occurred, when a new diagnosis of bladder cancer was made or when a death occurred from any cause. The nested case control study and the overall results of the study are detailed in part two of this article.

Author: Sullo & Sullo Attorneys

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