Evaluation of the relationship between weight change and glycemic control after initiation of antidiabetic therapy in patients with type 2 diabetes using electronic medical record data
Introduction
Weight management, in addition to glycemic control, is a core component of type 2 diabetes management [1], [2]. While weight reduction improves insulin resistance and glycemic control [3], [4], reducing weight by as little as 1 kg also lowers the risk of type 2 diabetes progression and CV disease [5]. Despite the benefits, weight loss is challenging in the type 2 diabetes population. One study found that patients consider adhering to a moderate diet, thus being able to reduce weight, to be as much of a burden as taking insulin [6].
Complicating weight management efforts are the weight effects of anti-diabetic agents. While several newer classes of drugs are considered weight neutral (e.g., DPP-4 inhibitors) or are associated with weight loss (i.e., GLP-1 agonists), other classes of anti-diabetics are associated with weight gain (e.g., insulin, sulfonylureas and thiazolidinediones) [1], [7]. Therefore, clinicians and patients must consider the glycemic control and weight effect benefits and trade-offs when planning a therapeutic course of action. Under ideal circumstances, such decisions are evidence based, and a number of studies have provided evidence associating the benefits of weight loss in patients with diabetes including improved glycemic control. While, the benefits of weight loss in improving cardiovascular events have not been clearly established [8], [9], [10], there is ample evidence that intensive glycemic control is associated with a reduction in microvascular risk [11], [12], [13], [14]. Thus, the benefits of weight loss in diabetes in facilitating improvements in glycemic control should translate into improvement in clinical outcomes.
There is surprisingly little real-world data, however, that indicate whether treatment-emergent weight change and glycemic control go hand in hand or whether these treatment effects are independent. Specifically, numerous clinical trials and retrospective studies have looked at the impact of anti-diabetic medications on weight change and glycemic control as independent outcomes. In addition, a small number of studies have evaluated the impact of weight change on HbA1c levels, but these studies have given little consideration to drug therapy and their weight-effect properties [15], [16], [17]. To our knowledge, no studies have further assessed the influence of anti-diabetic medications on weight and HbA1c outcomes simultaneously, while considering the weight-effect properties of the medications. Our objective was, therefore to begin to close this evidence gap by evaluating the association between weight change and glycemic control in patients with type 2 diabetes, considering the weight-modifying properties of prescribed anti-diabetic therapy.
Section snippets
Study design, timeline, and data
This retrospective cohort study evaluated weight and HbA1c outcomes in patients with type 2 diabetes newly treated with anti-diabetic monotherapy in routine clinical practice.
Patients were identified in the General Electric (GE) Centricity EMR research database from January 1, 2000 through June 30, 2010. The GE EMR contains ambulatory electronic health records for over 15 million patients treated by 15,000 physicians, two-thirds of which practice in a primary care setting. The database contains
Baseline characteristics
Of 1,371,024 patients with type 2 diabetes in the EMR database from January 1, 2000 to June 30, 2010, a total of 527,161 (38.5%) patients received a new order for a study class as monotherapy. The final study population included 28,290 patients (Fig. 1). Of these, 1469 (5.2%) had a new prescription within 30 days of index date and that second prescription was used as the baseline anti-diabetic medication. The majority of the study cohort received MET at baseline (64.8%), followed by SU (22.2%),
Discussion
This observational cohort analyses evaluated HbA1c and weight outcomes in 28,290 newly treated patients with type 2 diabetes in the ambulatory care setting. This is the first in a series of studies evaluating the association between treatment-emergent weight change and glycemic control in patients with type 2 diabetes.
Previous studies have analyzed weight and glycemic control in patients treated with anti-diabetics [15], [16], [17], but these studies evaluated a single or limited number of
Conflict of interest statement
This study was funded through a research grant by Bristol Myers Squibb. JM and UI are employees of Bristol Myers Squibb. CMM receives funding from Award Number KM1CA156723 from the National Cancer Institute. Part of the salaries of S U, B B, and X Y were paid from the research grant. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.
Portions of the results in this
Acknowledgements
The authors would like to thank Brian Oberg of Department of Pharmacotherapy, University of Utah for data management assistance.
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