Safety/Efficacy of Inhaled Insulin AFREZZA
Daniel Jo, Pharm D Candidate May 2016
University of Oklahoma College of Pharmacy
PPOK/MaxCare rotation June 2015
Introduction
Diabetes mellitus (DM) is a group of metabolic diseases characterized by consistently elevated blood glucose levels resulting from defects in insulin secretion or action, or both. 1 Chronic hyperglycemia is associated with long term organ damage, especially the heart, eyes, nerves, kidneys, and blood vessels. 2
The importance of tight glycemic control has been shown to prevent and/or delay long-term complications of diabetes.3 The success of insulin therapy, however, depends on its physiologic properties as well as on its proper use. Barriers to patient use of subcutaneous insulin include anticipated pain, anxiety, inconvenience, fear of hypoglycemia, and concern about weight gain. Evidence suggests that patients may be reluctant to start insulin when prescribed or to delay starting treatment.4
All patients with type 1 diabetes (T1DM) and many patients with type 2 diabetes (T2DM) require insulin therapy at some point to adequately manage their disease state.5 Traditional treatment of DM therapy, which ultimately includes subcutaneous injection of insulin, is often met with apprehension among diabetic patients due to the inconvenience and discomfort of injecting oneself. Administration of insulin by methods other than injection has been investigated since the discovery of insulin in the 1920s.6One such
Diabetes Mellitus is the metabolic disorder characterized by high levels of blood glucose that is caused by deficiency of production of insulin, action of insulin, or may be both of them. The uncontrollable output of hepatic glucose and reduced uptake of glucose by the skeletal muscle with reduced synthesis of glycogen lead to hyperglycaemia. Diabetes is a complicated disease; it can affect mostly every organ of our body and causes devastating consequences.
In a 52 week randomized clinical study, patients with either type 1 diabetes or type 2 diabetes were treated using insulin glargine or insulin degludec. The study focus was on the effectiveness, safety and how well the patients tolerated the insulin degludec. One area of the study that was of particular interest was the occurrence of hypoglycemic events and mainly nocturnal hypoglycemia. The results of this study were then analyzed and the findings interpreted to compare insulin glargine and insulin degludec.
Insulin is a hormone, produced in the pancreas, responsible the metabolism of glucose in the body. Ultimately, insulin maintains homeostasis of blood glucose levels. Patients with altered insulin function or production may develop diabetes. Type 1 diabetes mellitus is characterized by insulin deficiency. Type 2 diabetes mellitus develops from a patient’s resistance to insulin function. Exogenous insulin is used in replacement therapy for diabetes management, restoring levels of insulin for use in glucose metabolism. A variety of insulin preparations are currently FDA approved and on the market. Different insulin are classified by time
It is necessary to consider changing from an oral diabetes medication to insulin injections after
Treatment of diabetes is important to minimize the harm that is done to the body by diabetes. In addition to exercise and a special diet, type 1 diabetes patients need regular insulin injections to lower the blood sugar levels, while people with type 2 diabetes usually don’t need insulin shots, most of them require insulin tablets in addition to healthy diets and regular exercise and a few don’t even need the insulin tablets. (2, 7)
This will be emphasize on the implementation phase of the audit, which aim to educate and create awareness amongst the treating doctors and nursing staff about hypoglycemia prevention. This might be a very challenging task especially in the elderly patients with inconsistent and poor food intake, swallowing difficulties, progressive sarcopenia, or behavioral management issues related to cognitive impairment. More than one third (75%) of patient in our audit is on premixed insulin, which required a fixed dose to be given in the morning and evening. It is impossible to reserves the insulin if patient were to miss a meal after the dose is given, resulting in hypoglycemia. Other alternatives would be using rapid-acting insulin after meals, so the insulin can match the amount of carbohydrate intake. (ilvio E. Inzucchi, 2012) However, it will increase the amount of subcutaneous
Rapid-acting insulin— Three injected rapid-acting insulin analogs—insulin lispro, insulin aspart and insulin glulisine – are commercially available. The rapid-acting insulins permit more physiologic prandial insulin replacement because their rapid onset and ealrly peak action more closely mimic normal endogenous prandial insulin secretion than does regular insulin and they have the additional benefit of allowing insulin to be taken immediately before the meal without sacrificing glucose control.
The three most common ways to have insulin administers there are the syringes, an insulin pen, or an insulin pump. When injecting insulin you inject the insulin into the fat (not muscle) just under the skin. The abdomen is most common area because it is where the insulin is most quickly and evenly adsorbed. Insulin syringes are available today to make it easier to draw up the proper amount and smaller needles make the injections easier and try not to be painful. Automatic injectors can insert the needle and some will evenly insert the insulin for you. Insulin pumps are a computerized device that looks like a pager and is usually worn on your waistband, pocket, or belt. It releases steady doses of fast actins insulin throughout the day. More
Because there is no cure, diabetes is controlled be diet, exercise, and medication. Type 2 diabetics can often control the disease process by diet and exercise alone. When the two prove not to be enough oral medication may also be used. Type 1 diabetics need insulin to control their blood glucose. Insulin is administered subcutaneously or into the tissues beneath the skin. Injection sites include the abdomen, thighs, buttocks, and the anterior and posterior parts of the upper arm. If not properly controlled, diabetes can lead to several long-term complications. Examples include retinopathy, neuropathy, and vascular complications.
The term diabetes mellitus describes a metabolic disorder of multiple aetiology characterised by chronic hyperglycaemia with disturbances of carbohydrate, fat and protein metabolism resulting from defects in insulin secretion, insulin action or both. The effects of diabetes mellitus include long term damage, dysfunction and failure of various organs (WHO 1999).
Insulin therapy for patients that are insulin deficient or poor control of their type 2 diabetes
(3) Diabetes mellitus is a serious metabolic disease that results in hyperglycemia as a result of ineffective or total inaction of insulin secretion. This condition is most often the result of a defective pancreas that can lead to damage to the heart, kidneys and blood vessels.
Diabetes mellitus, commonly known as diabetes, is a chronic, lifelong condition that affects your body 's ability to use the energy found in food. There are
Diabetes is a systemic disease caused by a decrease in the secretion of insulin or reduced sensitivity or responsiveness to insulin by target tissue. (Beale, et al., 2011) The incidence of diabetes is growing rapidly in the United States and worldwide. An estimated 347 million people around the world are afflicted with diabetes. (Whalen, et al., 2012) According to World Health Organization (WHO), Diabetes prevalence among adults over 18 years of age has risen from 4.7% in 1980 to 8.5% in 2014. It is the major cause of blindness, kidney failure, heart attack, stroke and limbic amputation. World Health Organization (WHO) projects that diabetes will be the 7th leading cause of death in 2030. It is a complex and costly disease that can affect nearly every organ in the body and result in devastating consequences. The leading cause of non-traumatic lower extremity amputations, renal failure, and blindness in working-age adults, diabetes is also a major cause of premature mortality, stroke, cardiovascular disease, peripheral vascular disease, congenital malformations, perinatal mortality, and disability. (Cefalu, 2000) Insulin therapy and oral hypoglycemic agents have demonstrated improvement in glycaemic control. However, Insulin therapy has some disadvantages such as ineffectiveness following oral administration, short shelf life, of the need for constant refrigeration, and fatal hypoglycaemia, in the event of excess dosage.
For instance, insulin lispro is different to regular insulin in that the reverse positions of lysine and proline at positions 28 and 29 in the B chain. This modification causes more rapid absorption, a quicker onset, and a shorter duration of action due to decreases in hexameric insulin formation after subcutaneous injection. Peak levels of Insulin lispro has peak levels at 30 to 90 minutes. Insulin aspart and insulin glulisine have similar pharmacokinetic and pharmacodynamic properties with insulin lispro. Rapid - or short-acting insulins are provided to mimic the prandial release of insulin during prandial (mealtime) and to control postprandial glucose. They may also be used in cases where swift alteration of elevated glucose to normal is needed. Injection of rapid-acting insulin has been proven to be more effective than regular insulin by which when they are administered pre-meal, having 15-20 minutes onset of action compared to 30 minutes or above respectively. This shorter interval for insulin injection pre-meal is more acceptable for patients and leads to better adherence with prescribed injection timing guidelines. Rapid-acting insulins are commonly used in external insulin pumps and also suitable for IV