Tuesday, May 29, 2012

Risk of Bladder Cancer for Diabetics Taking Actos Part Two: The Kaiser Permanente Study: Results & Conclusions

This article continues the discussion of the Kaiser Permanente study, conducted over a period of ten years which attempted to determine the risk of bladder cancer in those taking the Type 2 diabetes drug, Actos. Incomplete or missing data were considered potential confounders, or variables which could change the results of the study. These potential confounders, in addition to race/ethnicity and smoking history also included occupational exposures and duration of diabetes. The date in which a patient first developed bladder cancer became a reference date of the patient and the control. The additional data of the potential confounders was garnered through telephone interviews using a standard questionnaire.

Results of the Kaiser Study

After all exclusionary data was applied, 193,099 patients with diabetes ended the study. Among those patients taking Actos in response to their Type 2 diabetes, the median time the drug was taken was 3.3 years. During the follow-up period after the conclusion of the study, a total of 881 cases of bladder cancer were diagnosed. Ninety of those bladder cancer cases were among the group who took Actos—a group which consisted of 30,173 patients or approximately .30%. Patients who had never used Actos yet developed bladder cancer numbered 791 or approximately .48%. Once the numbers were adjusted for age, sex, and other usage of diabetes medications there was a slight elevation associated with the use of Actos. When the study looked at increasing dosages of Actos, the risk of bladder cancer increased slightly, and after adjustments for age and sex only, the risk of bladder cancer was 30% higher among those who took Actos for between twelve and twenty-four months and 50% higher among those who took Actos longer than two years.

Conclusions of the Study

The initial association between Actos and bladder cancer was seen in a study done on male rats. Subsequent research noted a link between the prevention of bladder cancer in the male rats through dietary modifications. Further studies, however, suggested that another diabetes drug, rosiglitazone could be a greater promoter of tumors even in the late stages of bladder cancer advancement while no significant associations between Actos and bladder cancer were noted except in those taking higher dosages or for longer periods of time.

Strengths of the Study

The strengths of the Kaiser study include the fact that a good sampling of diabetes patients was included and that the databases on the patients included diagnoses, lab tests and pharmaceutical data. The database was also used to identify those who developed cancer of the bladder. The ready accessibility of the KPNC data from their own pharmacies was also considered a study strength. Patients who only filled a single Actos prescription or filled more than two prescriptions but not within six months of one another, were not considered to be “exposed” to the drug.

Weaknesses of the Study

The negative aspects of the study were that there was imperfect or absent data on variables believed to be associated with cancer of the bladder such as smoking and occupational exposures. After the first year following the study, there were six cases of bladder cancer in those taking Actos as opposed to three cases among those taking a placebo. Overall, the study concluded that there was no statistically significant increased risk of bladder cancer among those patients taking Actos for less than two years however increased exposure observed a risk.

Author: Sullo & Sullo Attorneys

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