Afrezza (Insulin Human) Inhalation Powder Approved for the Treatment of Patients with Type 1 or Type 2 Diabetes.

Field: Medicine (Health Sciences)

Diabetes is a chronic disease that is often accompanied by multiple comorbidities and health complications.1 In the United States, diabetes affects an estimated 29.1 million people—approximately 9.3% of the US population.1 An additional 37% of adults aged ≥20 years are estimated to have prediabetes, based on 2009–2012 data for fasting glucose or glycated hemoglobin (Hb) A1c.1 Furthermore, with the aging of the US population during the next few decades, the prevalence of diabetes is projected to increase from 1 in 10 adults today to a staggering 1 in 3 adults by 2050.2

In 2010, the American Diabetes Association (ADA) adopted the criterion of HbA1c levels ≥6.5% for a diagnosis of diabetes.3 Approximately 5% of all cases of diabetes are type 1 diabetes mellitus, and 90% to 95% of all cases are type 2 diabetes mellitus.1

Diabetes is the seventh leading cause of mortality in the United States. In fact, the death rate for patients with diabetes is 1.5 times higher than for individuals without diabetes.1 Aside from being a major cause of heart disease and stroke, diabetes is the leading cause of kidney failure, nontraumatic lower-limb amputations, and new cases of blindness among US adults.1 Moreover, patients with diabetes have an increased risk for other complications, including nerve disease, nonalcoholic fatty liver disease, periodontal disease, erectile dysfunction, hearing loss, depression, and pregnancy complications compared with individuals without diabetes.1

The annual US healthcare costs attributed to diabetes totaled $245 billion in 2012, including $176 billion in direct medical costs and $69 billion in reduced productivity (eg, increased absenteeism, reduced productivity, lost productivity resulting from early mortality, and the inability to work resulting from disability).4 These 2012 costs represent a 41% increase from the $174 billion in diabetes-related costs in 2007. Overall, the medical expenses for patients with diabetes are 2.3 times higher than expenses for individuals without diabetes.4

The management of diabetes is complex, generally requiring multiple risk-reduction strategies in addition to glycemic control.2 This demands an ongoing approach that considers the whole patient—glycemic control to prevent or reduce microvascular complications, as well as strategies to address obesity and prediabetes as underlying risk factors for diabetes and related macrovascular complications. These approaches often include dietary and other behavioral and lifestyle changes.5

The adequate control of HbA1c levels has been shown to reduce diabetes-associated morbidity and mortality by decreasing chronic complications.6 In fact, a 1% reduction in HbA1c levels is associated with a 35% reduction in diabetes-related microvascular complications, including diabetic neuropathy, nephropathy, and retinopathy.6

The ADA recommends a general target HbA1c level of <7% for adults with diabetes, based on a 2013 position statement on the standards of care for diabetes.6 According to the ADA, the stringency of this goal may need to be adapted based on the patient's duration of diabetes, comorbidities, age, known cardiovascular or advanced microvascular complications, and other patient-specific factors.6

In a 2013 consensus statement, the American Association of Clinical Endocrinologists (AACE) recommended an HbA1c target goal of <6.5% in the majority of patients with type 2 diabetes, acknowledging that this goal may be too aggressive for some patients and not aggressive enough for others (ie, younger patients for whom a lower target may prevent later complications).5 The AACE also states that the goals of lifestyle modification and antihyperglycemic pharmacotherapy should aim to (1) achieve clinical and biochemical glucose targets, (2) avoid hypoglycemia, (3) reduce or avoid increasing cardiovascular risk, and (4) assist with weight loss and minimize weight gain in patients who are obese.5

Although progress has been made in the number of US patients who achieve the target HbA1c level of <7%, there remains a marked need for improvement.7 Ongoing clinical management, patient engagement, education, and the development of novel therapies may help to improve the achievement of glycemic control targets and outcomes for patients with diabetes.