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31st International Conference on Pharmacoepidemiology and
Therapeutic Risk Management
Abstract Number: 751217
Submission Type: Oral/Poster
Presenting/Contact Author: Pasi Korhonen, PhD
Department/Institution: EPID Research
Address: Metsänneidonkuja 12
City/State/Zip/Country: Espoo, FIN, 02130, Finland
Phone: +358503652990 Fax: Finland E­mail: [email protected]
Subfield within pharmacoepidemiology: Safety End Point Studies
Secondary Subfield within pharmacoepidemiology: Does your abstract focus on a specific exposure? Yes
Alimentary tract and metabolism therapeutic area
Does your abstract focus on a specific outcome? Yes
Choices:
Cancer
Does your abstract focus on a specific population? No
Does your abstract fit with the interests of one of the SIGs? Yes
Choices:
Database
Keywords: no keyword selected
Presentation format: Oral presentation preferred
Disclosure: Yes: Authors PK, FH, SC and MM are employed by EPID Research, which is a contract research
organization that performs commissioned pharmacoepidemiological studies and thus its employees have been
and currently are working in collaboration with several pharmaceutical companies including Takeda
Development Centre Europe. Authors EMH, IB and LH are employed by the Pharmo Institute for Drug Outcomes Research, which performs
financially supported studies for several pharmaceutical companies including Takeda Development Centre
Europe. Authors SB and ML are employed by the Centre for Pharmacoepidemiology (CPE) at Karolinska Institute, which
has contracts with several pharmaceutical companies and performs research for them through research grants.
In this study EPID Research and the Centre for Pharmacoepidemiology at Karolinska Institute have a research
contract for CPE to perform the study in Sweden. Authors RW, HS and TW are employed by the Clinical Practice Research Datalink Group, which performs
financially supported studies for several pharmaceutical companies including Takeda Development Centre
Europe. Author PD is employed by Takeda Development Centre Europe.
Presentation Release ­ I give ISPE permission to post my presentation, which will be given at ICPE
in the Members Only section of the ISPE website after the ICPE. Yes
Student Award: No
Title: Preliminary results of bladder cancer risk in relation to exposure to pioglitazone among patients with
T2DM in the Pan European Multi­Database Bladder Cancer Risk Characterisation Study
Pasi Korhonen, PhD1, Edith M Heintjes, PhD2, Rachael Williams, MSc3, Fabian Hoti, PhD1, Solomon Christopher,
MSc1, Maila Majak, MSc1, Irene Bezemer, PhD2, Leanne Houweling, MSc2, Helen Strongman, MSc3, Timothy
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ISPE 2015 : Abstract # 751217 Preview
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Williams, PhD , Marie Linder, PhD , Paul Dolin, DPhil5 and Shahram Bahmanyar, PhD4. 1EPID Research, Espoo,
Finland; 2Pharmo Institute for Drug Outcomes Research, Utrecht, Netherlands; 3The Clinical Practice Research
Datalink Group, The Medicines and Healthcare products Regulatory Agency, London, United Kingdom; 4Centre
for Pharmacoepidemiology, Karolinska Institute, Stockholm, Sweden and 5Takeda Development Centre Europe,
London, United Kingdom. Background: This observational cohort study was conducted at the request of the European Medicines Agency
in Finland, Netherlands, Sweden and United Kingdom.
Objectives: The objectives were to evaluate the bladder cancer risk in T2DM patients in relation to exposure
to pioglitazone.
Methods: A common study protocol and pooled analysis plan was used across countries. Linked prescription,
hospital, general practitioner, cancer and death registration records were used to build the study database
from the country specific datasets. To limit channelling bias, pioglitazone exposed (n=56,337) and non­
exposed were matched based on treatment history and propensity scores accounting for variables affecting
pioglitazone initiation. The hazard ratios (HR) with 95% confidence intervals (CI) were estimated using Cox’s
model with adjustments for relevant confounders. Follow­up was from cohort entry until first incident bladder
cancer, death, start of other TZDs, diagnosis of secondary malignant neoplasm of bladder, leaving from
database, end of database coverage or 30 June 2011 whichever occurred first.
Results: A total of 283 bladder cancer cases occurred: 130 in the exposed group during a mean follow­up
time of 2.9 years and 153 in the non­exposed group during a mean follow­up time of 2.8 years. The pooled
adjusted HR (exposed vs. non­exposed) was 0.99 (95% CI: 0.75, 1.30). The dataset specific HRs varied from
0.60 (95% CI: 0.33, 1.08) for the Finnish dataset to 4.10 (95% CI: 1.21, 13.87) for the Swedish dataset.
Increasing duration and dose were not associated with increasing risk of bladder cancer. The adjusted HRs
varied from 1.11 (95% CI: 0.82, 1.49) to 0.81 (95% CI: 0.42, 1.56) for <18 months and >48 months of
exposure,and from 1.05 (95% CI: 0.77, 1.42) to 0.61 (95% CI: 0.32, 1.20) for 1­14,000 mg and >48,000 mg
of exposure, respectively when compared to the never exposed group.
Conclusions: This large pan European study found that pioglitazone use was not associated with increased
risk of bladder cancer. Further analyses are needed to explore the observed heterogeneity between datasets.
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