Drug Product Review Of Canagliflozin

Diabetes mellitus (DM) is a pandemic that affects millions of people. The growth rate of unrecognized pre-diabetes in America is expected to rise up to 52% by 2020 (Lorenzo, 2013). As the prevalence of diabetes increases, so will the complications and burden of the disease. One of the leading causes for cardiovascular disease, renal failure, nontraumatic lower limb amputations, stroke, and new cases of blindness is DM (Lorenzo, 2013).

Type 2 Diabetes is the most common form of diabetes in adults. It accounts for approximately 90%-95% of diagnosed diabetes in adults in the United States (cdc.gov, n.d.). Newly diagnose cases of diabetes tripled from 1980-2011 in the United States. It is a costly and deadly disease. Because there are many comorbidities and complications associated with uncontrolled diabetes, it is essential to treat diabetes effectively. Clinicians deal with this ongoing problem on a daily basis. Therefore, new treatment options are needed. Diabetes can be treated and managed by regular physical activity, healthy eating, and by decreasing cardiovascular disease risk factors, such as high lipid levels, high to decrease blood glucose levels are important aspects of disease management. At this time, there are 14 classes of medications currently available to treat type 2 diabetes mellitus, however, only 36 % of the patients achieve glycemic control on their present medications. Also, the prevalence of type 2 diabetes continues to increase which escalates the medical cost to treat the disease. In 2012, the estimates cost of type 2 diabetes was $176 billion. The cost to treat this disease is going to continue to rise. Even though there are drugs available to treat type 2 diabetes, new treatment options with different mechanisms of action are needed to improve patient outcome through better glycemic control (Miller, Nguyen, Jia-Haur, Chihyi, & Nguyen, 2014).

Type 2 Diabetes is a chronic condition, which can cause an individual to face high expenses (Liebl, Khunti, Orozco-Beltran and Yale, 2015). The majority of diabetics require some sort of medication regimen to control their blood glucose. The use of oral antidiabetic drugs is usually the first choice for type 2 diabetics’ medication regimen. “Diabetic drug cost is small compared to the cost of managing type 2 diabetes complications; for example, in the T2ARDIS

Just about every five minutes two people die of diabetes related causes and 16 people are newly diagnosed with the disease (Centers for Disease Control and Prevention [CDC], 2015). Diabetes is becoming an increasingly prevalent disease, especially type 2, due to the fact that the United States population is at high risk for obesity. Type 2 diabetes is when the pancreas suffers a decline in beta cell efficiency therefore disallowing insulin to be produced at the level necessary for its metabolic function (CDC, 2015). As the incidence of diabetes increases, a positive correlation can be observed in increased risk of cardiovascular disease. According to the Centers for Disease Control (2012), in the 2011 population of people diagnosed with diabetes there were five million people with coronary artery disease, about two million who had a stroke, about 4 million diagnosed with another heart disease or condition, and about eight million diagnosed with heart disease or who have had a stroke. A person with diabetes is twice as likely to develop cardiovascular disease than a person who does not have diabetes (National Diabetes Information Clearinghouse [NDIC], 2005). The numbers of people being diagnosed with cardiovascular disease due to increased risk from already having diabetes is alarming and is a major burden of diabetes. Having diabetes affects the patient in many ways but the addition of cardiovascular disease only complicates the disease and the management of it for the

Due to its insulin-independent mechanism of action that produces glucose excretion in the urine, dapagliflozin was known to be very effective when utilized as monotherapy, plus complementary and effective when used in combination with other anti-diabetic drugs; the clinical trial program was aimed to discover this therapeutic potential. Also, the program discovered the persistent calories loss in the

Canagliflozin is prescribed to patients with type 2 diabetes.1 The medication along with proper diet and frequent exercise will improve glycemic control in patients with type 2 diabetes.1 Canagliflozin is in the class of sodium-glucose cotransporter 2 (SGLT2) inhibitor.1,2 This medication reduces reabsorption of filtered glucose by lowering the threshold of glucose and increasing the amount of glucose that will be excreted.2

Each year, at least 1 million people in the United States are diagnosed with diabetes, which makes this disease one of the nation's most serious health concerns that, if left unchecked, could reach epidemic proportions. And it doesn't stop there. Often, people who suffer from diabetes also have to contend with other complications, which not only increase the risk to the patient's health but also add to the rising cost of health care. This makes it necessary for an effective disease management program for diabetes to be in place.

To compare treatment options of type2 diabetes. In reference to this a systematic review and meta-analysis of controlled trials, observation-based studies and published information was carried out in an attempt to investigate the difference of efficacy between pharmacologic treatment in Diabetes type 2, specifically the newer oral class known as the SGLT-2 Inhibitors.

To evaluate the effects of empagliflozin(JARDIANCE), an inhibitor of sodium–glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk.

Sodium-glucose co-transporter 2 (SGLT2), present in the proximal renal tubules, is important for the reabsorption of filtered glucose from the tubular lumen. Canagliflozin acts by inhibiting SGLT2 co-transporter. It diminishes reabsorption of filtered glucose and cuts off the renal limit for glucose (RTG), by additionally expanding the urinary glucose release (UGE).

Diabetes is the eight deadliest disease in the United States (Pietrangelo). As a pharmacy technician, I interact with patients on a daily basis and have observed that the majority of patients take medication for diabetes. I have seen people with diabetes range from ages 10 and up. It is a deteriorating disease that inevitably decreases one’s lifespan. It begins with subtle symptoms like frequent urination and excessive thirst (CDC, 2015). Then symptoms become more severe like sudden vision changes and slow-healing sores (CDC, 2015). Nevertheless, diabetes has a high reaching impact on society.

Diabetes is a disease rapidly increasing throughout the world today, and it is often referred to as the world’s modern epidemic. According to The World Health Organization (WHO) there were 171 million people suffering from diabetes worldwide in 2000. They are expecting this number to be doubled by year 2050 with 366 million diagnosed people. The organization’s most recent “calculations indicate that worldwide almost 3 million deaths per year are attributable to diabetes” (World Health Organization). It is clear that diabetes is a huge problem in the world, and a research called “The burden of Mortality Attributable to Diabetes: Realistic estimates for the year 2000”

Diabetic nephropathy has worldwide prevalence due to diabetes complications crises , according to the united states renal data system reports that most common patients affected with type 2 diabetes were developed to End-Stage Renal Disease (ESRD) for twenty years , although the newly incidence of diabetes have been rising within constant level during the last twenty years until 2000 , the prevalence of diabetic nephropathy expected to rise 70% by 2015 ((Rossing, 2006).data records from Canada , Australia , Japan , Europe , show similar increases in ESRD related to incidence of diabetes (Van Dijk et al,2005) .

Below are data from a Phase 2, randomised, double-blind, placebo-controlled clinical trials, testing the effectiveness of two doses of a new drug designed to lower glucose concentrations in patients suffering from type 2 diabetes. In each trial, patients with Type 2 diabetes were randomised to receive one of two doses of drug or matching placebo once daily for 10 weeks. Whilst the drug has been well tolerated in earlier testing, it has been noted that higher doses are associated with unwanted side effects such as dizziness and nausea.

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.