Diabetes Metab J.  2012 Oct;36(5):371-378. 10.4093/dmj.2012.36.5.371.

The Risk of Bladder Cancer in Korean Diabetic Subjects Treated with Pioglitazone

• Song SO
• Kim KJ
• Lee BW
• Kang ES
• Cha BS
• Lee HC

• KMID: 2174396
• DOI: http://doi.org/10.4093/dmj.2012.36.5.371

Abstract

BACKGROUND
There is growing concern regarding the increased incidence of bladder cancer in diabetic patients using pioglitazone. This study aimed to investigate the association between bladder cancer and the use of pioglitazone in Korean diabetics.
METHODS
This retrospective, matched case-control study included a case group (n=329) of diabetic patients with bladder cancer who presented at the Severance Hospital from November 2005 to June 2011. The control group consisted of patients without bladder cancer (1:2 ratio matching for sex and age, n=658) who were listed on the Severance Hospital diabetes registry.
RESULTS
The percentage of subjects who had ever used pioglitazone was significantly lower in the case group than in the control group (6.4% vs. 15.0%, P<0.001). Multivariate conditional logistic analysis revealed that independent factors affecting bladder cancer were smoking (odds ratio [OR], 11.64; 95% confidence interval [CI], 6.56 to 20.66; P<0.001), coexisting cancer (OR, 6.11; 95% CI, 2.25 to 16.63; P<0.001), and hemoglobin levels (OR, 0.78; 95% CI, 0.69 to 0.88; P<0.001). The OR of the history of pioglitazone use was 2.09 and was not significantly different between the two groups (95% CI, 0.26 to 16.81; P=0.488).
CONCLUSION
A relationship between pioglitazone use and incidence of bladder cancer was not observed in Korean diabetic patients. This suggests that the risk for bladder cancer in Korean diabetic subjects treated with pioglitazone might be different from that of Caucasian populations. Large-scale, well-designed and multi-center studies are needed to further evaluate this relationship.

Keyword

Diabetes mellitus, type 2; Korea; Pioglitazone; Urinary bladder neoplasms

MeSH Terms

Case-Control Studies
Diabetes Mellitus, Type 2
Hemoglobins
Humans
Incidence
Korea
Retrospective Studies
Smoke
Smoking
Thiazolidinediones
Urinary Bladder
Urinary Bladder Neoplasms
Hemoglobins
Smoke
Thiazolidinediones

Figure

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  Fig. 1 Study design: matched case-control.

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  Fig. 2 Proportion of anti-diabetic medication use. SU, sulfonylurea; DPP-4, dipeptidyl peptidase-4.

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  Supplementary Fig. 1 Frequency of bladder cancer and pioglitazone market in Korea. (A) Both. (B) Male. (C) Female. The crude rate (CR), a rate based on the frequency of cancer in the entire population, is calculated as follow: CR (per 100,000 person-years)=(Number of events/Corresponding person-years of observation)×100,000. The an age-standardized rate (ASR) is a weighted average of crude age-specific rates, where the CRs are calculated for different age groups and the weights are the proportions of persons in the corresponding age groups of a standard population.

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