Wang T, McNeill A M, Chen Y, Senderak M, Shankar R R
Merck & Co. Inc., Kenilworth, NJ, USA.
J Clin Pharm Ther. 2016 Apr;41(2):229-36. doi: 10.1111/jcpt.12379. Epub 2016 Mar 9.
Metformin is the only oral antihyperglycemic agent approved for use in adolescents with type 2 diabetes mellitus (T2DM). There are reports of metformin used to treat conditions such as obesity, hyperinsulinemia, prediabetes, metabolic syndrome and polycystic ovarian syndrome (PCOS). It is important to understand metformin prescription patterns and underlying diagnoses in adolescents as it can provide estimates of the extent of on-label (i.e. treatment of T2DM) and off-label use of metformin in this population. Our study sought to assess metformin prescription patterns among US adolescents from 2009 to 2013.
Data from the National Disease and Therapeutic Index (NDTI) database, the MarketScan(®) Commercial Claims and Encounters database and the Multi-State Medicaid database were analysed. The proportion of diagnoses associated with metformin that was recommended during a clinical visit was identified in the NDTI database. In the MarketScan(®) Commercial and Medicaid databases, adolescents with at least one metformin prescription with ±6 months continuous enrolment from the date of the index metformin prescription were included in the analyses. All diagnosis and procedure codes were extracted within ±6 months of the index metformin prescription. The proportion of T2DM was calculated irrespective of any other medical conditions, whereas all other prespecified conditions were classified as positive only if no concurrent T2DM diagnosis codes were present.
In the NDTI database, the most common diagnoses associated with metformin use were diabetes (34·9%), followed by metabolic syndrome (20·9%), PCOS (17·2%) and obesity (6·5%). In the MarketScan(®) Commercial database, T2DM was the most common diagnosis among girls aged 10-14 years (22·8-23·6%), boys aged 10-14 years (20·5-24·5%) and boys aged 15-19 years (37·1-43·1%), whereas PCOS (24·1-28·3%) was the most common diagnosis among girls aged 15-19 years. In the Medicaid database, T2DM was the most common diagnosis among all four groups and the proportions were higher than their counterparts in the Commercial database.
Analyses from three separate US data sources suggest that off-label prescribing of metformin is common among US adolescents aged 10-19 years. To avoid potential overestimation, caution should be exercised when utilizing metformin prescription as a proxy measure to estimate the burden of T2DM in adolescents.
二甲双胍是唯一被批准用于青少年2型糖尿病（T2DM）的口服降糖药。有报道称二甲双胍可用于治疗肥胖、高胰岛素血症、糖尿病前期、代谢综合征和多囊卵巢综合征（PCOS）等病症。了解青少年二甲双胍的处方模式及潜在诊断很重要，因为这可以估算该人群中二甲双胍标签内使用（即治疗T2DM）和标签外使用的程度。我们的研究旨在评估2009年至2013年美国青少年的二甲双胍处方模式。
分析了来自国家疾病与治疗指数（NDTI）数据库、MarketScan®商业索赔与诊疗数据库以及多州医疗补助数据库的数据。在NDTI数据库中确定临床就诊期间推荐使用二甲双胍的相关诊断比例。在MarketScan®商业和医疗补助数据库中，分析纳入了从索引二甲双胍处方日期起至少有一张二甲双胍处方且连续注册±6个月的青少年。在索引二甲双胍处方的±6个月内提取所有诊断和程序代码。T2DM的比例不考虑任何其他医疗状况进行计算，而所有其他预先指定的状况仅在不存在并发T2DM诊断代码时才分类为阳性。
在NDTI数据库中，与二甲双胍使用相关的最常见诊断是糖尿病（34.9%），其次是代谢综合征（20.9%）、PCOS（17.2%）和肥胖（6.5%）。在MarketScan®商业数据库中，T2DM是10 - 14岁女孩（22.8 - 23.6%）、10 - 14岁男孩（20.5 - 24.5%）和15 - 19岁男孩（37.1 - 43.1%）中最常见的诊断，而PCOS（24.1 - 28.3%）是15 - 19岁女孩中最常见的诊断。在医疗补助数据库中，T2DM是所有四个年龄组中最常见的诊断，且比例高于商业数据库中的对应比例。
来自美国三个独立数据源的分析表明，二甲双胍的标签外处方在10 - 19岁美国青少年中很常见。为避免潜在的高估，在将二甲双胍处方用作估算青少年T2DM负担的替代指标时应谨慎。
