Herdeiro Maria T, Soares Sara, Silva Tânia, Roque Fátima, Figueiras Adolfo
Department of Medical Sciences and Institute for Biomedicine - iBiMED, University of Aveiro, Campus Universitário de Santiago, 3810-193, Aveiro, Portugal.
CESPU, Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde, Rua Central de Gandra, 1317 4585-116, Gandra, Portugal.
Fundam Clin Pharmacol. 2016 Oct;30(5):440-9. doi: 10.1111/fcp.12207. Epub 2016 Jul 6.
Pharmacovigilance systems are important to monitor the safety of on-market drugs after approval. The aim of this study was to assess the impact of rosiglitazone safety alerts on trends in the sale of rosiglitazone and other oral antidiabetic drugs. An ecological study was conducted, using temporally aggregated data and linking safety alerts to countrywide sales of all oral antidiabetic drugs in Portugal from January 2002 to December 2012. Sales figures for oral antidiabetic drugs marketed in Portugal were supplied by IMS Health Portugal with a breakdown by active substance and fixed combinations. The number of defined daily doses per 1000 inhabitants per day (DIDs) of each oral antidiabetic drug sold to the estimated diabetic population using oral antidiabetic drugs in Portugal was calculated. Particular attention was paid to the case of rosiglitazone, with the results being adjusted for changes in rosiglitazone reimbursement policies. A total of four safety alerts were issued about rosiglitazone. Rosiglitazone sales registered an increase of 32.9% (0.202 DIDs; P < 0.001) after the first alert (risk of macular oedema or worsening of pre-existent macular oedema) in January 2006. After subsequent alerts about cardiovascular risks, this trend was not, however, repeated and sales fell. Following the January 2006 and January 2008 safety alerts, rosiglitazone sales described a long-term downward trend, with decreases of 3.75% (-0023 DIDs; P > 0.05) and 0.24% (-0.001 DIDs; P > 0.05), respectively. It is important to promote the dissemination and publication of drug safety alerts.
药物警戒系统对于监测已批准上市药物的安全性至关重要。本研究的目的是评估罗格列酮安全警示对罗格列酮及其他口服抗糖尿病药物销售趋势的影响。我们开展了一项生态学研究，使用时间上汇总的数据，并将安全警示与2002年1月至2012年12月葡萄牙全国所有口服抗糖尿病药物的销售情况相联系。葡萄牙IMS Health提供了在葡萄牙上市的口服抗糖尿病药物的销售数据，按活性物质和固定组合进行了细分。计算了向葡萄牙使用口服抗糖尿病药物的估计糖尿病患者群体销售的每种口服抗糖尿病药物的每千居民每日限定日剂量数（DIDs）。特别关注了罗格列酮的情况，结果针对罗格列酮报销政策的变化进行了调整。关于罗格列酮共发布了四项安全警示。在2006年1月首次发布警示（黄斑水肿风险或已有黄斑水肿恶化）后，罗格列酮销售额增长了32.9%（0.202 DIDs；P < 0.001）。然而，在随后发布关于心血管风险的警示后，这一趋势并未重复，销售额下降。在2006年1月和2008年1月发布安全警示后，罗格列酮销售额呈现长期下降趋势，分别下降了3.75%（-0.023 DIDs；P > 0.05）和0.24%（-0.001 DIDs；P > 0.05）。促进药物安全警示的传播和发布很重要。
