National regulators in Australia and the United Kingdom (UK) 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.
Interrupted time series analysis was used to compare pioglitazone use (prescriptions/100,000 population) in Australia and the UK 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.
Pioglitazone use fell in Australia (17%) and the UK (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 UK; however neither difference was statistically significant (Australia P=0.445, UK P=0.462). Pioglitazone use fell to a similar extent among older people than younger people in the UK (23% vs. 26%, P=0.354), and did not differ between age groups in Australia (both 18%, P=0.772).
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. This article is protected by copyright. All rights reserved.
Pharmacoepidemiology and drug safety. 2022 Jul 05 [Epub ahead of print]
Anna Kemp-Casey, Barbara Mintzes, Richard L Morrow, Colin R Dormuth, Patrick C Souverein, Elizabeth E Roughead
University of South Australia, Adelaide, Australia., The University of Sydney, Sydney, Australia., University of British Columbia, Victoria, Canada., Universiteit Utrecht, Utrecht, Netherlands.