School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia.
Charles Perkins Centre and School of Pharmacy, The University of Sydney, Sydney, Australia.
Pharmacoepidemiol Drug Saf. 2022 Oct;31(10):1039-1045. doi: 10.1002/pds.5508. Epub 2022 Jul 27.
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.
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.
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).
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.
澳大利亚和英国的国家监管机构于 2011 年 7 月发布了关于吡格列酮使用与膀胱癌之间关联的安全性公告。澳大利亚的公告指出，男性患膀胱癌的风险高于女性，而英国的公告则强调了一项新建议，即由于年龄增长风险增加，建议老年人谨慎考虑。本研究考察了这些公告中的差异在两国是否具有不同的年龄和性别影响。
使用中断时间序列分析比较了 2011 年 7 月安全公告前后 24 个月（研究期间为 2009 年 7 月至 2012 年 6 月）澳大利亚和英国的吡格列酮使用量（每 10 万人的处方数）。分别使用两国的性别和年龄组（≥65 岁与<65 岁）的单独模型进行比较。
在发布安全公告后，澳大利亚（17%）和英国（24%）的吡格列酮使用量下降。在澳大利亚，男性（18%）的吡格列酮使用量下降幅度大于女性（16%），而在英国，女性（25%）的吡格列酮使用量下降幅度大于男性（23%）；然而，这些差异均无统计学意义（澳大利亚 p=0.445，英国 p=0.462）。在英国，老年人与年轻人相比，吡格列酮的使用量下降幅度相似（23%比 26%，p=0.354），而在澳大利亚，两个年龄组之间无差异（均为 18%，p=0.772）。
结果表明，澳大利亚和英国安全公告中的差异导致两国人口水平的吡格列酮使用量大幅减少，但未观察到亚组之间的差异。
