Division of Pharmacotherapy, University of Texas at Austin College of Pharmacy, UT Health San Antonio, 7703 Floyd Curl Drive MC 6220, San Antonio, TX, 78255, USA.
Clin Drug Investig. 2019 Aug;39(8):757-763. doi: 10.1007/s40261-019-00799-0.
Metformin (MET) is used as first-line treatment for type 2 diabetes mellitus but has been shown to have pleiotropic effects that have expanded its use to various conditions. Limited current data exist regarding unconventional use within various patient populations.
The aim of this study was to evaluate US FDA-approved and off-label MET utilization in the US from 2000 to 2015.
We performed a retrospective analysis of outpatient MET prescribing in the US from 2000 to 2015. Data from the Medical Expenditure Panel Survey (MEPS) administered by the Agency of Healthcare Research and Quality were analyzed. Demographic characteristics, including age, sex, socioeconomic status, comorbidities, and region, were analyzed using the MEPS Household Component (HC). Prescription rates were defined as the annual number of MET prescriptions divided by the corresponding population estimate. Population denominators were derived using the MEPS HC. The MEPS estimates US populations based on sampled persons in the target population (civilian, non-institutionalized) for an entire year. MET prescribing is represented by population per 1000 persons. We determined if changes of MET prescribing were uniform across five age groups: < 18 years, 18-29 years, 30-49 years, 50-64 years, and 64 years and older.
An estimated 553,291,094 MET prescriptions were dispensed in the US from 2000 to 2015. Prescribing rates steadily increased from 2000 to 2015. FDA-approved MET prescription rates increased from 2.27 per 1000 persons in 2000 to 235 per 1000 persons in 2015, while off-label MET prescription rates increased from 0.74 per 1000 persons in 2000 to 20.3 per 1000 persons in 2015. The top indications for off-label MET use were endocrine disorders (45.8%), cardiovascular disorders (18.2%), female reproductive disorders (12.9%), and metabolic disorders (10.9%). MET prescribing rates for FDA-approved indications increased across all age groups in 2000 and 2015, with the most substantial increase seen in adults aged 50-64 years and > 65 years (1.7 per 1000 persons to 20.6 per 1000 persons, and 2.3 per 1000 persons to 18.7 per 1000 persons, respectively). While off-label MET increased across all age groups from 2000 to 2015, a tenfold increase (< 1.0 to 10.6) was seen in adults aged 30-49 years of age.
Overall, MET use has substantially increased within the past 15 years, which was mainly driven by older adults. Our study highlights the emerging prevalence of MET use in both FDA-approved and off-label indications.
二甲双胍（MET）被用作 2 型糖尿病的一线治疗药物，但已显示出具有多种治疗作用，已将其应用扩展到各种病症。目前关于在各种患者人群中非常规使用的有限数据。
本研究旨在评估 2000 年至 2015 年美国 FDA 批准和非标签 MET 的使用情况。
我们对 2000 年至 2015 年美国门诊 MET 处方进行了回顾性分析。分析了医疗支出面板调查（MEPS）的数据，该调查由医疗保健研究与质量局管理。人口统计学特征，包括年龄、性别、社会经济地位、合并症和地区，使用医疗支出面板调查家庭成分（HC）进行了分析。处方率定义为每年 MET 处方数除以相应的人口估计数。人口除数来自医疗支出面板调查 HC。MEPS 根据目标人群（平民、非机构化）全年抽样人员估计美国人口。MET 处方表示每 1000 人中有多少人。我们确定了在五个年龄组中，MET 处方的变化是否均匀：<18 岁、18-29 岁、30-49 岁、50-64 岁和 64 岁及以上。
2000 年至 2015 年，美国共开出了 553291094 张 MET 处方。处方率从 2000 年到 2015 年稳步上升。FDA 批准的 MET 处方率从 2000 年的每 1000 人 2.27 上升到 2015 年的每 1000 人 235 人，而非标签 MET 处方率从 2000 年的每 1000 人 0.74 上升到 2015 年的每 1000 人 20.3。非标签 MET 使用的主要适应症是内分泌疾病（45.8%）、心血管疾病（18.2%）、女性生殖疾病（12.9%）和代谢疾病（10.9%）。FDA 批准的 MET 适应证的处方率在 2000 年和 2015 年在所有年龄组中均有所增加，其中 50-64 岁和>65 岁的成年人增幅最大（每 1000 人从 1.7 增加到 20.6，每 1000 人从 2.3 增加到 18.7）。虽然非标签 MET 在 2000 年至 2015 年期间在所有年龄组中均有所增加，但 30-49 岁成年人的增加了十倍（<1.0 至 10.6）。
总体而言，过去 15 年中 MET 的使用量大幅增加，主要是由老年人推动的。我们的研究强调了 FDA 批准和非标签适应证中 MET 使用的新兴流行趋势。
