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Challenges in Diabetes Management: Glycemic Control, Medication Adherence, and Healthcare Costs

Challenges in Diabetes Management: Glycemic Control, Medication Adherence, and Healthcare Costs

The Current State of Diabetes Management: Challenges and Unmet Needs
The Growing Burden of Diabetes
Diabetes affects approximately 29.1 million Americans (9.3% of the US population), according to National Health and Nutrition Examination Survey (NHANES) data from 2012.1 This number accounts for approximately 21.0 million diagnosed and 8.1 million undiagnosed individuals; in other words, 27.8% of people with diabetes in the United States have yet to be diagnosed.1

Healthcare costs associated with diabetes are high. In fact, the average cost of healthcare for patients with diabetes is 2.3 times higher than for patients without diabetes (based on 2012 estimates).1 Direct healthcare expenditures associated with diabetes were estimated at $176 billion in 2012, with additional costs due to loss of productivity related to chronic disability and premature mortality representing an additional $69 billion, for a total of $245 billion in healthcare expenditures attributed to diabetes.1,2

At the 2017 Asembia Specialty Pharmacy Summit, a special presentation addressed key challenges in the current state of diabetes management and considered potential approaches to improve outcomes. Jay Skyler, MD, MACP, professor of medicine, pediatrics, and psychology in the Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Miami Miller School of Medicine, led the discussion. He began by emphasizing the growing prevalence of diabetes: “In the United States, diabetes is projected to affect more than 40 million people by 2034.” Skyler emphasized that complications associated with diabetes are related to poor metabolic control. He alo noted that the increasing prevalence of diabetes in America is “driven by obesity and a sedentary lifestyle.”

Complications and the Importance of Glycemic Control in Diabetes
Diabetes is associated with many complications, notably macrovascular and microvascular diseases, which include cardiovascular disease (CVD) (eg, coronary artery disease, stroke, high levels of low-density lipoprotein cholesterol [LDL-C]) and peripheral vascular disease (PVD), which may lead to amputation.1 Diabetes causes about 60% of nontraumatic lower-limb amputations for individuals 20 years or older.1 Microvascular complications of diabetes also commonly include end-stage renal disease (ESRD) and retinopathy.1 Diabetes was the primary cause of kidney failure in 44% of all new cases in 2011, and in 2005-2008, 4.4% of people with diabetes 40 years or older had advanced diabetic retinopathy, which could lead to severe vision loss.1

Given the prevalence and severity of complications associated with diabetes are associated with imbalanced blood glucose, achieving glycemic control is an important step in diabetes management. During this presentation, barriers to glycemic control and improvements for modifications diabetes management was a key topic of discussion. Glycemic control is typically measured by glycated hemoglobin (A1C) testing. A1C reflects glycemia over a period of approximately 3 months and has strong pre dictive value for diabetes-associated complications—in other words, increased levels of A1C are associated with higher risk of these complications in patients with diabetes.3 As such, the American Diabetes Association (ADA) recommends that A1C testing be performed regularly, every 3 months, in patients with diabetes to determine whether glycemic targets have been reached and sufficiently maintained.3

The ADA-defined target goal for adult patients with diabetes is A1C of <7% (53 mmol/mol).3 However, providers may suggest more stringent target goals (such as <6.5% [48 mmol/mol]) for select patients, such as those with short duration of diabetes, type 2 diabetes managed with lifestyle changes or metformin therapy only, long life expectancy, or no significant CVD.3 In contrast, less stringent A1C goals (such as <8% [64 mmol/mol]) may be appropriate for patients with advanced complications, extensive comorbidities, or difficulty achieving A1C target levels despite appropriate diabetes self-management education, appropriate glucose monitoring, and effective doses of multiple glucose-lowering agents (eg, insulin).3

As mentioned, poor glycemic control in diabetes is strongly correlated with several potentially life-threatening complications, and with higher mortality as well. In a prospective observational study, diabetes-related mortality and all-cause mortality were both strongly associated with glycemia (P <.0001).4 Furthermore, reductions in risk of diabetes complications were associated with a 1% reduction in A1C from baseline. There was a particular reduction in risk for microvascular endpoints, amputation, or death from PVD more so than for heart failure (HF), myocardial infarction (MI), or stroke (Table 14).4

A meta-analysis of observational studies reported a moderate increase in cardiovascular risk with increasing A1C levels in people with diabetes. The pooled relative risk (RR) for total CVD in persons with type 2 diabetes was 1.18 (95% CI, 1.10-1.26) for each 1% increase in A1C. For the studies that examined A1C and stroke risk in people with diabetes, the pooled RR was 1.17 (95% CI, 1.09-1.25). The pooled RR for the studies of A1C and PVD in people with diabetes was 1.28 (95% CI, 1.18-1.39).5

In the United Kingdom Prospective Diabetes Study (UKPDS), an intensive approach was used to study glycemic control in patients with diabetes. Patients achieved median A1c reduction of 11% over the first 10 years, and the frequency of some clinical complications of type 2 diabetes decreased.6 Patients assigned intensive treatment had a significant 25% risk reduction in microvascular end points (which included ESRD and retinopathy; P = .0099) compared with conventional treatment, most of which was due to fewer cases of retinopathy. The reduction in risk for MI was of borderline significance (P = .052).6

Achieving and maintaining glycemic control in patients with diabetes is of paramount importance to their overall health and survival. However, patients with diabetes often struggle to achieve glycemic control and recommended A1C targets. Among adults with diagnosed diabetes included in the NHANES 2007-2010 analysis, half (52.2%) of the study population had achieved the A1C goal of <7%. Even the proportion of patients achieving the less stringent goal of <8% was suboptimal (79.1% of the study population).7 Real-world data from 2015 have also shown that patients with diabetes often fail to achieve glycemic control (Table 29).9 For example, less than 40% of commercially insured patients with diabetes achieved A1C targets of <7%.8

Skyler commented on the data presented above: “Regardless of commercial HMO [health maintenance organization] or Medicaid, 40% or less achieve an A1C goal of <7%. If you raise the target to 8% (which is not ideal, but used for assessment), <60% of patients are reaching the goal. Achievement rates are not changing over time despite these medications. That’s the worry; people are doing something and yet nothing is happening.”

While glycemic control is of great importance in patients with diabetes, Skyler noted that other measures carry significance as well. He stated that it is crucial to “not only consider A1C goals, but goals of blood pressure and LDL-C. We call these the ABC goals.” Patients often struggle to meet these goals as well. According to NHANES 2007-2010 data, one-third to half of participants did not meet the targets for A1C level, blood pressure, or LDL-C level by 2010; only 14.3% of patients met the targets for all of these risk factors.7 Said Skyler, “These are [key] contributors to the 4-fold increase in risk of heart disease among patients with diabetes compared with the general population.”

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