TY - JOUR
T1 - Risk of bladder cancer in diabetic patients treated with rosiglitazone or pioglitazone
T2 - A nested case-control study
AU - Hsiao, Fei Yuan
AU - Hsieh, Pei Hua
AU - Huang, Weng Foung
AU - Tsai, Yi Wen
AU - Gau, Churn Shiouh
N1 - Funding Information:
Conflict of interest Pei-Hua Hsieh received a part-time research assistantship from a research project (DOH100-FDA-41100) sponsored by the Food and Drug Administration, Taiwan. Fei-Yuan Hsiao, Weng-Foung Huang, Yi-Wen Tsai and Churn-Shiouh Gau have no conflicts of interest to declare that are directly relevant to the content of this study.
PY - 2013/8
Y1 - 2013/8
N2 - Background: Evidence has emerged that pioglitazone may increase the risk of bladder cancer, but the association has not been confirmed. This potential risk also has not been evaluated in users of rosiglitazone. Objective: Using Taiwan's National Health Insurance Research Database (NHIRD), this large population-based nested case-control study was conducted to explore the relationship between the use of rosiglitazone or pioglitazone and risk of bladder cancer in diabetic patients. Methods: We identified 3,412 cases of newly diagnosed bladder cancer and 17,060 controls (1:5 matched by age and sex) among a diabetic patient cohort from the NHIRD. We defined an index date for each case as the date of first hospitalization for bladder cancer. Each control was assigned the index date of their corresponding case. Multivariable conditional logistic regressions were used to estimate the association between exposure (timing and duration) to rosiglitazone or pioglitazone and bladder cancer. We defined rosiglitazone or pioglitazone exposure as "current" if the prescription duration covered the index date or ended at 90 days before, as "recent" if it ended 91-180 days before the index date, or as "past" if the last prescription ended more than 180 days before. Duration of rosiglitazone or pioglitazone use was defined based on the cumulative days of exposure prior to the index date: <1, 1-2 and ≥2 years. Results: Rosiglitazone and pioglitazone use were associated with risk of bladder cancer and the associations were stronger with a longer term of exposure (pioglitazone <1 year odds ratio [OR] 1.45 [95 % CI 1.12-1.87, p < 0.01], 1-2 years OR 1.74 [95 % CI 1.05-2.90, p = 0.03] and ≥2 years OR 2.93 [95 % CI 1.59-5.38, p < 0.01]; rosiglitazone <1 year OR 0.98 [95 % CI 0.82-1.17, p = 0.81], 1-2 years OR 1.78 [95 % CI 1.31-2.39, p < 0.01] and ≥2 years OR 2.00 [95 % CI 1.37-2.92, p < 0.01]). Conclusions: Long-term exposures to pioglitazone and rosiglitazone were associated with higher odds of bladder cancer, and the highest odds were seen in users with ≥2 years of exposure.
AB - Background: Evidence has emerged that pioglitazone may increase the risk of bladder cancer, but the association has not been confirmed. This potential risk also has not been evaluated in users of rosiglitazone. Objective: Using Taiwan's National Health Insurance Research Database (NHIRD), this large population-based nested case-control study was conducted to explore the relationship between the use of rosiglitazone or pioglitazone and risk of bladder cancer in diabetic patients. Methods: We identified 3,412 cases of newly diagnosed bladder cancer and 17,060 controls (1:5 matched by age and sex) among a diabetic patient cohort from the NHIRD. We defined an index date for each case as the date of first hospitalization for bladder cancer. Each control was assigned the index date of their corresponding case. Multivariable conditional logistic regressions were used to estimate the association between exposure (timing and duration) to rosiglitazone or pioglitazone and bladder cancer. We defined rosiglitazone or pioglitazone exposure as "current" if the prescription duration covered the index date or ended at 90 days before, as "recent" if it ended 91-180 days before the index date, or as "past" if the last prescription ended more than 180 days before. Duration of rosiglitazone or pioglitazone use was defined based on the cumulative days of exposure prior to the index date: <1, 1-2 and ≥2 years. Results: Rosiglitazone and pioglitazone use were associated with risk of bladder cancer and the associations were stronger with a longer term of exposure (pioglitazone <1 year odds ratio [OR] 1.45 [95 % CI 1.12-1.87, p < 0.01], 1-2 years OR 1.74 [95 % CI 1.05-2.90, p = 0.03] and ≥2 years OR 2.93 [95 % CI 1.59-5.38, p < 0.01]; rosiglitazone <1 year OR 0.98 [95 % CI 0.82-1.17, p = 0.81], 1-2 years OR 1.78 [95 % CI 1.31-2.39, p < 0.01] and ≥2 years OR 2.00 [95 % CI 1.37-2.92, p < 0.01]). Conclusions: Long-term exposures to pioglitazone and rosiglitazone were associated with higher odds of bladder cancer, and the highest odds were seen in users with ≥2 years of exposure.
UR - http://www.scopus.com/inward/record.url?scp=84881157625&partnerID=8YFLogxK
U2 - 10.1007/s40264-013-0080-4
DO - 10.1007/s40264-013-0080-4
M3 - Article
C2 - 23797604
AN - SCOPUS:84881157625
SN - 0114-5916
VL - 36
SP - 643
EP - 649
JO - Drug Safety
JF - Drug Safety
IS - 8
ER -