Journal Club : Empagliflozin, Cardiovascular Outcomes, And Mortality

Why do we treat diabetes? There are a number of downstream events associated with abnormal blood glucose levels. If glucose levels are managed properly, the complications associated diabetes can be controlled, and sometimes completely prevented. The main problem with having more than the normal amount of glucose circulating in the blood stream is the effect that excess glucose can have on both large and small blood vessels (DTC, 2004). Micro-vascular and macro-vascular problems associated with diabetes can be seen in the heart, eyes, kidney, legs and feet. Diabetic patients are twice as likely to suffer from a mycocardial infaraction, twenty-five times more likely to suffer blindness, and seventeen times more likely to suffer kidney failure compared to a non-diabetic (DTC, 2004). Because of great number of risks associated with abnormal blood glucose levels, diabetes is aggressively treated to improve the quality of life and prevent complications in patients.

Phase 3 clinical studies - Intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

A highly motivated and dedicated analyst with over two years’ experience in start-up Research Office at Huron Consulting Group. Working on developing Medicare Coverage Analysis (MCA) and study budgets for clinical research protocols in various therapeutic areas such as oncology, cardiology, pediatrics, and internal medicine for multiple clients across the country. A meticulous eye for detail in assisting clients with mitigating clinical research billing compliance risks, by interpreting and applying Medicare/Medicaid coverage decisions and national care guidelines to determine correct billing to insurance providers and research study sponsors. A confident communicator with an emphasis on utilizing the strengths of colleagues and creating an

This particular research was driven by the demand of the regulatory guidelines that deals with reduction of risks. The cases of cardiovascular risks among patients are have been reported to increase in the recent days. The regulatory guidance require being presented for the cardiovascular outcomes that can be used in the therapies of type 2 diabetes treatment. However, the

Type-2 Diabetes mellitus (T2DM) is a common disease worldwide. According to the American Diabetes association (ADA), 1808 million people in the United States have been diagnosed with diabetes, and another 7 million are thought to have the disease but have not been diagnosed. (Hilaire, Woods, 2013). This disease has impacted everyone in some way. It is a controllable disease; however many individuals choose not to control it or are uneducated on how to control it. Many people with type 2 diabetes (T2DM) also have hypertension, high cholesterol, obesity, lack of physical activity, poorly controlled blood sugars, and smoking. “Current evidence supports the concept that hyperglycemia significantly contributes to the development of both cardiovascular and microvascular complications of T2DM” (Chittari, McTernan, 2011). Cardiovascular disease (CVD) remains the leading cause of death in patients with diabetes mellitus, accounting for 50% of all deaths (Campbell & Hillman, 2010).

The disclosure of these payments will increase transparency of physicians’ relationship with the manufacturers. Although the Sunshine Act does not prohibit mutually beneficial exchange between health providers and the industry, the amount of money spent by the industry has been gradually declining. “When shared within the appropriate context, the data collected by the Open Payment program helps patients to learn more about industry-physician collaborations and understand how these interactions benefit their health.” Open Payment Act works to ensure that the collaborative interactions between manufacturers and physicians meet high ethical standards; they must be compliance with laws, regulations, and government guidance. With the help of

According to the textbook, “Understanding the research game begins with an identification of the institution supporting the research through funding and hiring researchers as well as granting permission for the research”(Wilkins, 2011). The institution preforming and supporting this research is called BMJ. BMJ is a pair reviewed medical research journal aimed at providing first class information concerning issues. In addition, the BMJ assists medical organizations and clinicians in tacking today’s most critical healthcare challenges. ("Our expertise | BMJ", 2016)

Determine if the addition of ezetimibe to statin therapy will further decrease LDL and adverse cardiovascular events.

Study Objective/ Purpose: The purpose of this study is to determine if ezetimibe added to statin therapy can further reduce the rate of cardiovascular events.

A test contrasted three drug diabetes and determined that the new drug from the company, Avandia, succeeded and effected best. The experiment for the drug, Avandia, was funded by GlaxoSmithKline. The company paid 11 authors from the company. 4 of them were employees while 7 of them were academic experts. 4 years later, the research showed that the drug raised the risk of heart attacks. A Cleveland clinic cardiologist named Steven E. Nissen gave one of the earliest warnings about the drug. Scientists estimated 83,000 heart attacks and deaths in their research. The NEJM published 73 articles on the original studies of new drugs while pharmaceutical companies published 60, drug company employees

In an article written on June 16, 2015 by the U.S. Food and Drug Administration, states that through the examination of scientific evidence they have

Diabetic patients have a major risk of cardiovascular disease leading cause of life threatening and death. The goal of this study is to select drugs that do not increase cardiovascular risk. The US FDA has recommended in its Guidance for Industry for drug developers in year 2008, that type 2 diabetes new drugs for clinical trials should fulfill gycemic benefit and cardiovascular safety, and rule out potentially harmful drug interactions. The European Medicines Agency recommended same. Cautious selection of the drug therapy, specifically cardiovascular safety with controlled diabetes. Patients with diabetes often showing atherosclerosis and are at high risk of morbidity and mortality from cardiovascular disease (CVD). Patients with diabetes have twice threat for stroke, heart related disease, and death from heart disease compared to non diabetic patients. Statics of 2010 showed that 1.9 million people aged 22 years or above in the US were identified with diabetes. Metformin is first choice of the treatment for type 2 diabetes mellitus due to its very effective glucose lowering formula, used from last many years, cheap, no effect on weight, causes least hypoglycemia, taken orally, and has the possible to decrease CV harm. Saxagliptin is basically a Dipeptidyl peptidase 4 (DPP-4) enzyme that reduced 0.6%-0.9% HgA1c by increasing body’s sugar utilization, prevent atherosclerosis and myocardial damage, improving lipid profile and endothelial dysfunction, and lower the blood

This is the first case report on blood glucose management with these conditions in worldwide. Clinical pharmacists assisted physicians in making individualized regimen to improve the therapeutic efficacy and ensure the patient safety.

Banaji, M. R., Bazerman, M. H. & Chugh, D., 2003. How (Un)ethical Are You. Harvard

This protocol is designed for trying a research study on human subjects. Based on this protocol, the trial will be conducted in Canada and on Canadian residents or citizens. All aspects of this study is designed according to Good Clinical Practice part of the International Conference on Harmonization guidelines (ICH/ GCP E6) and Health Canada Regulations (Part C, Division 5) that is mandatory to conduct all the human clinical research in Canada. Metformin is available in Canada as Apo-Metformin but Vildagliptin (Glavus) is not available in this country and is needed some shipping process from United State of America under the Health Canada Regulations (Part c, Division 5).