Afrezza® in the Treatment of Type 1 and Type 2 Diabetes Mellitus
34.2 million people. Within the United States, that is 10.5% of the population, and these individuals all have Diabetes Mellitus (DM). 26.8 million people have been diagnosed with DM; however, nearly 7.4 million individuals remain undiagnosed with a condition that is alarmingly increasing at such a rate ranking it as the seventh contributing or underlying cause of death. Out of the diagnosed population, 1.6 million individuals have Type 1 DM, affecting 5.2% of the population.
Pathophysiology of Type 1 and Type 2 Diabetes Mellitus
Type 1 DM is an autoimmune disorder that leads to absolute insulin deficiency due to destruction of beta cells that normally produce insulin within the pancreatic islets. On the other hand, Type 2 DM has multiple contributing factors such as: insulin deficiency due to progressive loss of pancreatic beta cells that produce insulin, insulin sensitivity that has decreased, and an increase of gluconeogenesis in the liver.
Clinical presentation of Type 1 and Type 2 Diabetes Mellitus
Symptoms include:
· Polydipsia
· Polyphagia
· Polyuria
Signs: hyperglycemia
Patient presentation of the above symptoms or a confirmed case of a hyperglycemic or hypoglycemic event warrant conclusive testing to determine the diagnosis of Type 1 or Type 2 DM in order to improve patient outcomes as this condition is associated with various comorbidities and can lead to death when not properly managed.
Diagnosis of Type 1 and Type 2 Diabetes Mellitus (American Diabetes Association: ADA 2020 Guidelines)
· An 8 hour Fasting Blood Glucose (FBG) that yields =/> 126 mg/dL.
OR
· A 75-gram Oral Glucose Tolerance Test with a 2-hour plasma glucose reading that yields =/> 200 mg/dL.
OR
· A Hemoglobin A1C that yields=/> 6.5%.
OR
· A Random Plasma Glucose that yields =/> 200 mg/dL with classic symptoms of hyperglycemia. **
** Two abnormal readings from the same sample or in two separate samples are required to confirm diagnosis.
Afrezza® Mechanism of Action and Dosing
In June 2014, Afrezza® was FDA approved for adults as a bolus rapid-acting inhaled insulin intended to be utilized with meals. The inhaled insulin enters the bloodstream in less than 1 minute, has a peak effect of 30 minutes — 1 hour, and its duration of action is 1.5–3 hours. The insulin is then able to regulate metabolism of carbohydrates, fats, and proteins and promote glucose absorption in the liver, adipose tissue, and skeletal muscle. There are color coated cartridges (blue = 4 units, green = 8 units, and yellow = 12 units) that are inserted into the inhaler to achieve the desired prandial insulin dose. Patient specific dosage must be individualized to avoid hypoglycemia and to promote glucose control; however, an estimated </= 4 units of injectable insulin dose per meal is equivalent to 4 units of inhaled Afrezza® dose per meal.
Afrezza® Safety Profile
Some common side effects of Afrezza® may include sore throat, cough, throat pain, and weight gain. Other serious side effects of the medication include persistent cough, trouble breathing, wheezing, slurred speech, vision changes, dizziness, and severe fatigue. Furthermore, the use of Afrezza® is contraindicated in patients who have hypersensitivity to insulin and those who have Asthma or COPD as there is an increased risk of bronchospasm.
Benefits of Afrezza®
Patients with Type 1 DM have the option to utilize Afrezza® in combination with their long-acting basal insulin to maintain glycemic control; however, it is important to note that Afrezza® does not serve as a replacement for long-acting insulin. Patients with Type 2 DM may utilize Afrezza® concomitantly with long-acting basal insulin when glycemic control at mealtimes is inadequate. Afrezza® may be beneficial to patients as the inhaler serves as an alternative to reduce the amount of needlesticks that must be given at mealtimes. Not only are inhalers less painful than needlesticks, patients may feel that they are more discrete and sanitary when dinning out as a sterile environment with alcohol pads are required to administer subcutaneous insulin. Furthermore, the insulin dose may be inhaled moments before food is ready — with that in mind, patients have better mealtime flexibility. Lastly, the shelf-life for the Afrezza® inhaler is longer than that of opened vials or pens of insulin as the latter has a shelf life of approximately 28 days before they must be thrown away.
Conclusion
The incidence rate of Diabetes within the United States population is increasing quickly, and many individuals appear to go undiagnosed. This can result in poor management of either Type 1 or Type 2 DM which may lead to serious outcomes or even death. Insulin-dependent patients must encounter numerous needlesticks per day which can be painful and lead to bruising at the injection site with improper technique. In addition to the pain from the prandial or long-acting basal insulin needlesticks, there are lancet pricks to the finger that can also be painful for patients. With the utilization of Afrezza® — prandial doses of insulin may now be administered via inhalations from an inhaler to reduce the amount of daily needlesticks that a patient receives. The incorporation of Afrezza® into a patient’s lifestyle allows one to have more mealtime flexibility as inhalation of the drug into the lungs generates rapid systemic circulation with an onset of action that takes approximately twelve minutes. Overall, Afrezza® appears to have a generally tolerable safety profile and shows promise to reduce the number of needlesticks, especially for those patients who may be fearful of injections.
References
Afrezza. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Hudson, OH. Available at: https://online-lexi-com.libaccess.fdu.edu/lco/action/doc/retrieve/docid/patch_f/5477154?cesid=5RIKwtt2dtS&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dafrezza%26t%3Dname%26va%3Dafrez. Accessed May 19, 2020.
Diabetes Statistics. https://www.diabetesresearch.org/diabetes-statistics. Accessed May 19, 2020.
Take Control with Afrezza®. Afrezza. https://afrezza.com/?gclid=EAIaIQobChMIu9XxndfA6QIVD4_ICh3lzgO2EAAYASAAEgL0r_D_BwE. Accessed May 19, 2020.
