Pecere Alessandro, Caputo Marina, Sarro Andrea, Ucciero Andrealuna, Zibetti Angelica, Aimaretti Gianluca, Marzullo Paolo, Barone-Adesi Francesco
Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.
Endocrinology, Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.
J Clin Endocrinol Metab. 2020 Dec 1;105(12). doi: 10.1210/clinem/dgaa544.
A warning has been recently issued by the European Medicine Agency (EMA) regarding a potential increased risk of acute pancreatitis (AP) in methimazole (MMI) users.
To investigate the association between MMI and the diagnosis of AP in a population-based study.
A retrospective analysis of administrative health databases was conducted (2013-2018). Relevant data were obtained from: (1) inhabitants registry, (2) hospital discharge records (ICD-9-CM 577.0), and (3) drug claims registry (ATC H03BB02). We evaluated AP risk in MMI users in 18 months of treatment, stratifying results by trimester. Poisson regression was used to estimate the age- and sex-adjusted rate ratios (RR), and the relative 95% confidence intervals (CI), comparing rates of AP between MMI users and nonusers. The absolute risk of AP in MMI users was also calculated.
A total of 23 087 new users of MMI were identified. Among them, 61 hospitalizations occurred during the study period. An increase in AP risk was evident during the first 3 trimesters of therapy (RR 3.40 [95% CI: 2.12-5.48]; RR 2.40 [95% CI: 1.36-4.23]; RR 2.80 [95% CI: 1.66-4.73]), but disappeared thereafter. The AP absolute risk in MMI users during the first 18 months of treatment was less than 0.4% in all sex and age classes.
Our results support the EMA warning, suggesting an increased risk of AP associated with MMI use. However, such an increase seems limited to the first months of MMI treatment. Moreover, in absolute terms, the probability of AP is low among patients, well below 1%.
欧洲药品管理局（EMA）最近发布了一项警告，指出使用甲巯咪唑（MMI）的患者急性胰腺炎（AP）风险可能增加。
在一项基于人群的研究中调查MMI与AP诊断之间的关联。
对行政卫生数据库进行回顾性分析（2013 - 2018年）。相关数据来自：（1）居民登记册，（2）医院出院记录（ICD - 9 - CM 577.0），以及（3）药品报销登记册（ATC H03BB02）。我们评估了MMI使用者在18个月治疗期间的AP风险，并按孕期分层结果。采用泊松回归估计年龄和性别调整后的率比（RR）以及相对95%置信区间（CI），比较MMI使用者和非使用者之间的AP发生率。还计算了MMI使用者发生AP的绝对风险。
共识别出23087名MMI新使用者。其中，研究期间有61人住院。治疗的前3个孕期AP风险明显增加（RR 3.40 [95% CI：2.12 - 5.48]；RR 2.40 [95% CI：1.36 - 4.23]；RR 2.80 [95% CI：1.66 - 4.73]），但此后消失。在所有性别和年龄组中，MMI使用者在治疗的前18个月发生AP的绝对风险均低于0.4%。
我们的结果支持EMA的警告，表明使用MMI会增加AP风险。然而，这种增加似乎仅限于MMI治疗的最初几个月。此外，从绝对值来看，患者发生AP的概率较低，远低于1%。
