Non-antiarrhythmic drugs prolonging the QT interval: considerable use in seven countries
Non-antiarrhythmic drugs prolonging the QT interval: considerable use in seven countries
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DOI：
10.1046/j.1365-2125.2002.01617.x
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发表时间：
2002-08-01
影响因子：
3.4
通讯作者：
Montanaro, N
中科院分区：
文献类型：
--
作者：
De Ponti, F;Poluzzi, E;Montanaro, N
目的：属于不同治疗类别的许多药物似乎都有一个潜在的致命副作用：与QT延长相关的室性快速性心律失常。本研究的目的是通过对所有非抗心律失常药物按QT延长证据的类型进行分组并分析其销售数据，来评估这一问题在7个国家的相关性和严重性。方法我们将所有非抗心律失常药物按临床相关性从高到低分为以下类别：A组，已公布QT延长临床或临床前证据或相关官方警告的药物；B组，已公布临床或临床前证据的药物；C组，已公布临床证据的药物；D组，已公布的尖端扭体或室性心律失常与QT延长相关的临床证据；E组，D组药物，已公布临床证据或与QT延长相关的室性心律失常。我们检索了7个国家(澳大利亚、丹麦、英国、德国、希腊、意大利和瑞典)社区药店1998年的销售数据。个别制剂的数据以每天每1000名居民的限定日剂量(DDD/1000/天)表示。计算了每组药物在每个国家的总体使用量。结果在102种符合至少一个纳入标准的非抗心律失常药物中，33种药物的销售数据大于或等于1 DDD/1000/d，71种药物在至少一个国家/地区的使用大于或等于0.1 DDD/1000/d。在37种报道与QT延长相关的室性心律失常的非抗心律失常药物中，有12种化合物的销售数据大于或等于1DDD/1000/天。A组为51.9~94.7 DDD/1000/天；B组为51.6~92.7 DDD/1000/天；C组为37.1~76.6 DDD/1000/天；D组为12.9~29.1 DDD/1000/天；E组为5.8~15.3 DDD/1000/天。大量使用D和E类药物应促使对每种药物进行仔细的风险/益处评估。
Aims Many drugs belonging to different therapeutic classes appear to share a potentially fatal side-effect: ventricular tachyarrhythmias associated with QT prolongation. The aim of this study was to assess the relevance and the magnitude of the problem in seven countries by grouping all nonantiarrhythmic drugs according to the type of evidence on QT prolongation and analysing their sales data.Methods We divided all nonantiarrhythmic QT-prolonging agents into the following categories (in increasing order of clinical relevance): group A, drugs with published clinical or preclinical evidence on QT prolongation or with relevant official warnings; group B, drugs with published clinical or preclinical evidence; group C, drugs with published clinical evidence; group D, drug with published clinical evidence on torsades de pointes or ventricular arrhythmias associated with QT prolongation; group E, drugs belonging to group D with official warnings. We retrieved 1998 sales data from community pharmacies in seven countries (Australia, Denmark, England, Germany, Greece, Italy and Sweden). Data for individual agents were expressed as defined daily doses per 1000 inhabitants per day (DDD/1000/day). Overall use in each country was calculated for each drug group. Groups D and E were considered as the most clinically relevant.Results Among the 102 nonantiarrhythmic agents meeting at least one of the inclusion criteria, 33 drugs had sales data greater than or equal to1 DDD/1000/day and 71 drugs had a use greater than or equal to0.1 DDD/1000/day in at least one country. Among the 37 nonantiarrhythmic agents with published reports of ventricular arrhythmias associated with QT prolongation, 12 compounds had sales data greater than or equal to1 DDD/1000/day. Total consumption in each country ranged: from 51.9 to 94.7 DDD/1000/day for group A; from 51.6 to 92.7 DDD/1000/day for group B; from 37.1 to 76.6 DDD/1000/day for group C; from 12.9 to 29.1 DDD/1000/day for group D; and from 5.8 to 15.3 DDD/1000/day for group E.Conclusions In spite of wide variations in the sales of individual agents, the overall extent of use of nonantiarrhythmic QT-prolonging drugs was of the same order of magnitude in all countries. The significant use of drugs belonging to categories D and E should prompt careful risk/benefit assessment of each agent.