Pioglitazone use in Australia and the United Kingdom following drug safety advisories on bladder cancer risk: An interrupted time series study

Anna Kemp-Casey; Barbara Mintzes; Richard L. Morrow; Colin R. Dormuth; Patrick C. Souverein; Elizabeth E. Roughead

doi:10.1002/pds.5508

Pioglitazone use in Australia and the United Kingdom following drug safety advisories on bladder cancer risk: An interrupted time series study

Anna Kemp-Casey^*, Barbara Mintzes, Richard L. Morrow, Colin R. Dormuth, Patrick C. Souverein, Elizabeth E. Roughead

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Purpose: National regulators in Australia and the United Kingdom issued safety advisories on the association between pioglitazone use and bladder cancer in July 2011. The Australian advisory noted that males were at higher risk of bladder cancer than females, while the UK advisory highlighted a new recommendation, suggest careful consideration in the elderly due to increasing risk with age. This study examined whether these differences in the advisories had different age- and sex-based impacts in each country. Methods: Interrupted time series analysis was used to compare pioglitazone use (prescriptions/100000 population) in Australia and the United Kingdom for the 24 months before and 11 months after the July 2011 safety advisories (study period July 2009–June 2012). Separate models were used to compare use by sex and age group (≥65 years vs. <65 years) in each country. Results: Pioglitazone use fell in Australia (17%) and the United Kingdom (24%) following the safety advisories. Use of pioglitazone fell more for males (18%) than females (16%) in Australia, and more for females (25%) than males (23%) in the United Kingdom; however, neither difference was statistically significant (Australia p = 0.445, United Kingdom p = 0.462). Pioglitazone use fell to a similar extent among older people than younger people in the United Kingdom (23% vs. 26%, p = 0.354), and did not differ between age groups in Australia (both 18%, p = 0.772). Conclusions: The results indicate that differences in the Australian and UK safety advisories resulted in substantial reductions in pioglitazone use at the population level in both countries, however, differences by sub-groups were not observed.

Original language	English
Pages (from-to)	1039-1045
Number of pages	7
Journal	Pharmacoepidemiology and Drug Safety
Volume	31
Issue number	10
DOIs	https://doi.org/10.1002/pds.5508
Publication status	Published - Oct 2022

Bibliographical note

Funding Information:
This work was supported by an Australian National Health and Medical Research Council Project Grant (1122332) and a Canadian Institutes of Health Research (PJT‐153275). Open access publishing facilitated by University of South Australia, as part of the Wiley ‐ University of South Australia agreement via the Council of Australian University Librarians.

Funding Information:
This work was supported by an Australian National Health and Medical Research Council Project Grant (1122332) and a Canadian Institutes of Health Research (PJT-153275). Open access publishing facilitated by University of South Australia, as part of the Wiley - University of South Australia agreement via the Council of Australian University Librarians.

Publisher Copyright:
© 2022 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

Funding

This work was supported by an Australian National Health and Medical Research Council Project Grant (1122332) and a Canadian Institutes of Health Research (PJT‐153275). Open access publishing facilitated by University of South Australia, as part of the Wiley ‐ University of South Australia agreement via the Council of Australian University Librarians. This work was supported by an Australian National Health and Medical Research Council Project Grant (1122332) and a Canadian Institutes of Health Research (PJT-153275). Open access publishing facilitated by University of South Australia, as part of the Wiley - University of South Australia agreement via the Council of Australian University Librarians.

Keywords

adverse drug reaction reporting systems events
diabetes mellitus
patient safety
pharmacovigilance

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Pharmacoepidemiology and Drug - 2022 - Kemp‐Casey - Pioglitazone use in Australia and the United Kingdom following drug (1)Final published version, 747 KBLicence: CC BY

Cite this

@article{84c87b795c7640178e11fbc3b36a5495,

title = "Pioglitazone use in Australia and the United Kingdom following drug safety advisories on bladder cancer risk: An interrupted time series study",

abstract = "Purpose: National regulators in Australia and the United Kingdom issued safety advisories on the association between pioglitazone use and bladder cancer in July 2011. The Australian advisory noted that males were at higher risk of bladder cancer than females, while the UK advisory highlighted a new recommendation, suggest careful consideration in the elderly due to increasing risk with age. This study examined whether these differences in the advisories had different age- and sex-based impacts in each country. Methods: Interrupted time series analysis was used to compare pioglitazone use (prescriptions/100000 population) in Australia and the United Kingdom for the 24 months before and 11 months after the July 2011 safety advisories (study period July 2009–June 2012). Separate models were used to compare use by sex and age group (≥65 years vs. <65 years) in each country. Results: Pioglitazone use fell in Australia (17\%) and the United Kingdom (24\%) following the safety advisories. Use of pioglitazone fell more for males (18\%) than females (16\%) in Australia, and more for females (25\%) than males (23\%) in the United Kingdom; however, neither difference was statistically significant (Australia p = 0.445, United Kingdom p = 0.462). Pioglitazone use fell to a similar extent among older people than younger people in the United Kingdom (23\% vs. 26\%, p = 0.354), and did not differ between age groups in Australia (both 18\%, p = 0.772). Conclusions: The results indicate that differences in the Australian and UK safety advisories resulted in substantial reductions in pioglitazone use at the population level in both countries, however, differences by sub-groups were not observed.",

keywords = "adverse drug reaction reporting systems events, diabetes mellitus, patient safety, pharmacovigilance",

author = "Anna Kemp-Casey and Barbara Mintzes and Morrow, \{Richard L.\} and Dormuth, \{Colin R.\} and Souverein, \{Patrick C.\} and Roughead, \{Elizabeth E.\}",

note = "Funding Information: This work was supported by an Australian National Health and Medical Research Council Project Grant (1122332) and a Canadian Institutes of Health Research (PJT‐153275). Open access publishing facilitated by University of South Australia, as part of the Wiley ‐ University of South Australia agreement via the Council of Australian University Librarians. Funding Information: This work was supported by an Australian National Health and Medical Research Council Project Grant (1122332) and a Canadian Institutes of Health Research (PJT-153275). Open access publishing facilitated by University of South Australia, as part of the Wiley - University of South Australia agreement via the Council of Australian University Librarians. Publisher Copyright: {\textcopyright} 2022 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley \& Sons Ltd.",

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Pioglitazone use in Australia and the United Kingdom following drug safety advisories on bladder cancer risk: An interrupted time series study. / Kemp-Casey, Anna; Mintzes, Barbara; Morrow, Richard L. et al.
In: Pharmacoepidemiology and Drug Safety, Vol. 31, No. 10, 10.2022, p. 1039-1045.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Pioglitazone use in Australia and the United Kingdom following drug safety advisories on bladder cancer risk

T2 - An interrupted time series study

AU - Kemp-Casey, Anna

AU - Mintzes, Barbara

AU - Morrow, Richard L.

AU - Dormuth, Colin R.

AU - Souverein, Patrick C.

AU - Roughead, Elizabeth E.

N1 - Funding Information: This work was supported by an Australian National Health and Medical Research Council Project Grant (1122332) and a Canadian Institutes of Health Research (PJT‐153275). Open access publishing facilitated by University of South Australia, as part of the Wiley ‐ University of South Australia agreement via the Council of Australian University Librarians. Funding Information: This work was supported by an Australian National Health and Medical Research Council Project Grant (1122332) and a Canadian Institutes of Health Research (PJT-153275). Open access publishing facilitated by University of South Australia, as part of the Wiley - University of South Australia agreement via the Council of Australian University Librarians. Publisher Copyright: © 2022 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

PY - 2022/10

Y1 - 2022/10

N2 - Purpose: National regulators in Australia and the United Kingdom issued safety advisories on the association between pioglitazone use and bladder cancer in July 2011. The Australian advisory noted that males were at higher risk of bladder cancer than females, while the UK advisory highlighted a new recommendation, suggest careful consideration in the elderly due to increasing risk with age. This study examined whether these differences in the advisories had different age- and sex-based impacts in each country. Methods: Interrupted time series analysis was used to compare pioglitazone use (prescriptions/100000 population) in Australia and the United Kingdom for the 24 months before and 11 months after the July 2011 safety advisories (study period July 2009–June 2012). Separate models were used to compare use by sex and age group (≥65 years vs. <65 years) in each country. Results: Pioglitazone use fell in Australia (17%) and the United Kingdom (24%) following the safety advisories. Use of pioglitazone fell more for males (18%) than females (16%) in Australia, and more for females (25%) than males (23%) in the United Kingdom; however, neither difference was statistically significant (Australia p = 0.445, United Kingdom p = 0.462). Pioglitazone use fell to a similar extent among older people than younger people in the United Kingdom (23% vs. 26%, p = 0.354), and did not differ between age groups in Australia (both 18%, p = 0.772). Conclusions: The results indicate that differences in the Australian and UK safety advisories resulted in substantial reductions in pioglitazone use at the population level in both countries, however, differences by sub-groups were not observed.

AB - Purpose: National regulators in Australia and the United Kingdom issued safety advisories on the association between pioglitazone use and bladder cancer in July 2011. The Australian advisory noted that males were at higher risk of bladder cancer than females, while the UK advisory highlighted a new recommendation, suggest careful consideration in the elderly due to increasing risk with age. This study examined whether these differences in the advisories had different age- and sex-based impacts in each country. Methods: Interrupted time series analysis was used to compare pioglitazone use (prescriptions/100000 population) in Australia and the United Kingdom for the 24 months before and 11 months after the July 2011 safety advisories (study period July 2009–June 2012). Separate models were used to compare use by sex and age group (≥65 years vs. <65 years) in each country. Results: Pioglitazone use fell in Australia (17%) and the United Kingdom (24%) following the safety advisories. Use of pioglitazone fell more for males (18%) than females (16%) in Australia, and more for females (25%) than males (23%) in the United Kingdom; however, neither difference was statistically significant (Australia p = 0.445, United Kingdom p = 0.462). Pioglitazone use fell to a similar extent among older people than younger people in the United Kingdom (23% vs. 26%, p = 0.354), and did not differ between age groups in Australia (both 18%, p = 0.772). Conclusions: The results indicate that differences in the Australian and UK safety advisories resulted in substantial reductions in pioglitazone use at the population level in both countries, however, differences by sub-groups were not observed.

KW - adverse drug reaction reporting systems events

KW - diabetes mellitus

KW - patient safety

KW - pharmacovigilance

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U2 - 10.1002/pds.5508

DO - 10.1002/pds.5508

M3 - Article

C2 - 35790047

AN - SCOPUS:85135076162

SN - 1053-8569

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JO - Pharmacoepidemiology and Drug Safety

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IS - 10

ER -

Pioglitazone use in Australia and the United Kingdom following drug safety advisories on bladder cancer risk: An interrupted time series study

Abstract

Bibliographical note

Funding

Keywords

UN SDGs

Access to Document

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