Division of Endocrinology and Metabolism, School of Medicine, University of California, San Diego, San Diego, CA
Veterans Affairs Medical Center, San Diego, CA.
Diabetes Care. 2017 Nov;40(11):1425-1432. doi: 10.2337/dc16-1974. Epub 2017 Aug 11.
Despite U.S. Food and Drug Administration (FDA) approval of over 40 new treatment options for type 2 diabetes since 2005, the latest data from the National Health and Nutrition Examination Survey show that the proportion of patients achieving glycated hemoglobin (HbA) <7.0% (<53 mmol/mol) remains around 50%, with a negligible decline between the periods 2003-2006 and 2011-2014. The Healthcare Effectiveness Data and Information Set reports even more alarming rates, with only about 40% and 30% of patients achieving HbA <7.0% (<53 mmol/mol) in the commercially insured (HMO) and Medicaid populations, respectively, again with virtually no change over the past decade. A recent retrospective cohort study using a large U.S. claims database explored why clinical outcomes are not keeping pace with the availability of new treatment options. The study found that HbA reductions fell far short of those reported in randomized clinical trials (RCTs), with poor medication adherence emerging as the key driver behind the disconnect. In this Perspective, we examine the implications of these findings in conjunction with other data to highlight the discrepancy between RCT findings and the real world, all pointing toward the underrealized promise of FDA-approved therapies and the critical importance of medication adherence. While poor medication adherence is not a new issue, it has yet to be effectively addressed in clinical practice-often, we suspect, because it goes unrecognized. To support the busy health care professional, innovative approaches are sorely needed.
尽管自 2005 年以来，美国食品和药物管理局 (FDA) 已批准了 40 多种治疗 2 型糖尿病的新方案，但从全国健康和营养检查调查的最新数据来看，达到糖化血红蛋白 (HbA) <7.0% (<53 mmol/mol) 的患者比例仍约为 50%，在 2003-2006 年和 2011-2014 年期间几乎没有下降。医疗保健效果数据和信息集的报告甚至显示出更令人震惊的比率，只有约 40%和 30%的商业保险 (HMO) 和医疗补助人群中的患者分别达到 HbA <7.0% (<53 mmol/mol)，而且在过去十年中几乎没有变化。最近一项使用美国大型索赔数据库的回顾性队列研究探讨了为什么临床结果没有跟上新治疗方案的步伐。该研究发现，HbA 降低的幅度远低于随机临床试验 (RCT) 报告的幅度，药物依从性差是导致脱节的关键驱动因素。在本观点中，我们结合其他数据研究这些发现的含义，以突出 RCT 结果与现实世界之间的差异，所有这些都指向 FDA 批准的治疗方法的未充分实现的承诺和药物依从性的至关重要性。虽然药物依从性差并不是一个新问题，但它在临床实践中尚未得到有效解决——通常，我们怀疑，是因为它没有被认识到。为了支持忙碌的医疗保健专业人员，迫切需要创新方法。
