Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.
Diabetes is a complex and multifactorial disorder that affects a large portion of the population. Therefore, it is imperative for health care professionals to continue to increase awareness about diabetes, the risk factors associated with the disease, as well as the importance of obtaining continual medical care and the crucial role that self-management plays in reducing or preventing the complications associated with managing diabetes. As more treatment options and tools become available for making the management of diabetes easier, a collaborative effort between health care professionals and patients, coupled with patient education, are still fundamental in effectively controlling this condition.
According to statistics from the National Institute of Diabetes and Digestive and Kidney Diseases, an estimated 23.6 million individuals in the United States have diabetes. Of this total, 17.9 million individuals have been formally diagnosed, while an estimated 5.7 million individuals remain undiagnosed.1 An estimated 5% to 10% of cases are classified as type 1 diabetes, while the remainder are attributed to type 2 diabetes.1 Furthermore, at least 57 million individuals are considered to have prediabetes, and the prevalence has significantly increased in recent years.2,3 In 2007, 1.6 million new cases of diabetes were diagnosed in individuals aged 20 years and older.1,3 In 2004, the World Health Organization (WHO) projected that by 2030, the worldwide prevalence of diabetes could actually double, thus affecting an estimated 366 million individuals, representing 4.4% of the world’s population.4
Diabetes is considered to be the sixth leading cause of death.3 Due to the many complications associated with uncontrolled diabetes, such as macrovascular complications (eg, coronary artery disease, peripheral arterial disease, and stroke), microvascular complications (eg, retinopathy, neuropathy, and nephropathy), hypoglycemia or hyperglycemia, periodontal diseases, and increased risk of developing infections, the overall risk of death for individuals with diabetes is twice as high when compared with those without diabetes.1,4 Individuals with diabetes are 2 to 4 times more likely to develop cardiovascular disease.5 Cardiovascular disease is considered to be the major cause of morbidity and mortality among individuals with diabetes, and the cardiovascular risks associated with diabetes account for 65% of deaths among individuals with diabetes.6,7 Diabetes is considered the leading cause of blindness in individuals between the ages of 20 and 74, end-stage renal disease, and the most frequent cause of nontraumatic lowerlimb amputations.1
In January 2009, the American Diabetes Association released their 2009 Standards of Medical Care for Diabetes, which is intended to provide health care professionals with essential information regarding diabetes care, its treatment, and tools to evaluate and manage diabetes.8 Additionally, in October 2008, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) published a consensus statement regarding the management of hyperglycemia in patients with type 2 diabetes. The primary goal of the updates to the consensus algorithm is to assist health care providers in managing the progressive nature of type 2 diabetes. The algorithm provides guidelines for selecting the most therapeutically effective treatment options, while also taking into consideration the most cost-effective treatment.9,10
The revised guidelines stress the importance of obtaining and maintaining a hemoglobin A1C (HbA1C) level of less than 7%.9,10 The consensus also states that when patients have HbA1C levels of 7% or more, medication therapy should be changed to achieve desired levels. While the guidelines also stress the importance of treating A1C, weight should not be undervalued—80% to 90% of patients with type 2 diabetes are overweight or obese.9,10 Modest weight loss (~4 kg) has beneficial effects on glucose levels and improves cardiovascular risk factors.9,10
Patients should routinely visit their primary health care providers to enable timely assessments of the patient response to therapy and make adjustments. Because type 2 diabetes is a complex disorder that, without proper treatment, can cause multiple longterm complications, effective management of blood glucose levels, as well as prevention or reduction of potential complications, may often require combination therapy. The ADA/EASD algorithm describes a stepped care approach to treat the elevated levels of blood glucose and HbA1C levels. The updated guidelines are divided into 2 tiers of recommended treatment.
Tier 1, which is divided into 3 steps, involves well-validated core therapies and is considered to be the best established and most cost-effective therapeutic strategy for achieving optimal glycemic goals.9,10 Step 1 involves lifestyle interventions and metformin. If targeted glycemic goals are not achieved or maintained, then Step 2 involves adding another medication such as insulin or a sulfonylurea. If lifestyle interventions, metformin, and sulfonylurea or basal insulin do not result in achievement of target glycemia, the next step should be to initiate or intensify insulin therapy.10
Traditionally, insulin therapy in patients with type 2 diabetes was not considered until diet, exercise, and treatment with oral antidiabetes agents had failed to maintain normal glycemic control.11 Increasing evidence supports using insulin therapy early on in the treatment of diabetes to normalize glycemic control and emulate normal physiologic insulin secretion. Attaining glycemic control has been shown to delay or prevent diseaseassociated complications.11
Tier 2 of the consensus algorithm consists of therapies that are not as well confirmed as those in tier 1 and may be used for patients within selected clinical settings, such as when hypoglycemia is undesirable, as in individuals with hazardous jobs. Recommended therapies include the use of the newer agent, exenatide, which is a glucagon-like peptide-1 (GLP-1) agonist, or thiazolidinedione (TZD). The TZD specifically named in the algorithm is pioglitazone. The new guidelines do not recommend the use of rosiglitazone.9,10 Exenatide also may be considered if promotion of weight loss is needed and the hemoglobin A1C level is close to target (<8%).
The addition of a sulfonylurea may be considered if these interventions are not effective in achieving optimal HbA1C levels or not tolerated. Alternatively, the tier 2 interventions should be stopped and basal insulin initiated. Currently, exenatide is the only GLP-1 agonist on the market; however, other GLP-1 agonists are under development and in various phases of clinical studies. The guideline states that although there is far less published data on exenatide, it appears to lower HbA1C by 0.5 to 1 percentage points, primarily by lowering postprandial blood glucose levels.10 Exenatide suppresses glucagon secretion and slows gastric motility. It is not associated with hypoglycemia, but has a high incidence of gastrointestinal side effects.10
Various clinical studies have demonstrated the impact that glycemic control has on preventing or reducing complications of diabetes. Routine monitoring of blood glucose levels has been shown to be important for controlling diabetes.12 The updated algorithm for the management of hyperglycemia will assist health care providers with effective care and individualized treatment plans for patients. The early initiation of insulin and the use of newer agents like the GLP-1 agonist demonstrate that the treatment options for diabetes are changing. As more treatments emerge, so do the opportunities to help patients better manage diabetes.
Over the past decade, the emergence of new treatment options, including oral antidiabetes agents and other agents such as the GLP-1 agonist and insulin analogs, have been advantageous to achieving blood glucose control.13
Pharmacists are in a pivotal position to be a valuable resource for patients with diabetes, especially those who are newly diagnosed, because the diagnosis may be overwhelming. Pharmacists also can identify patients at risk for type 2 diabetes (eg, obesity, having a sedentary lifestyle, history of gestational diabetes, those with elevated triglycerides, etc) and encourage them to get tested since a late diagnosis can lead to an increased risk of complications and may require more intensive therapy.
During counseling, pharmacists can use this opportunity to reiterate that diabetes requires continuing medical care and self-monitoring to prevent further complications. Pharmacists can encourage patients, especially those on multiple medications, to use medication reminder devices to prevent missed doses and enroll in automatic refill programs for medications. To increase patient compliance, when appropriate, pharmacists can make clinical recommendations to physicians about prescribing combination oral antidiabetes agents with once- or twice-a-day dosing intervals, including GLP-1 agonists or a longacting insulin. Health care professionals can empower patients with the tools needed to effectively manage diabetes, and assist patients in taking control of their diabetes before it takes control of them. A proactive and aggressive approach to treating diabetes increases the likelihood of successful management.