Rosiglitazone Risk Analysis

This article discussed a 54-year-old patientspatient diagnosed with type 2 diabetes (T2DM). She was overweight by 225 pounds and had a body mass index of 35.2. She started with Metformin medication with poor control. Within two months, glimepiride was added to the regimen. Six months later Hemoglobinhemoglobin A1C (HA1C) was above 8%. Normal range is less than 6%. Her endocrinologist added Exenatide. One month later, she developed abdominal pain, anorexia, and 20-pound weight loss. Her blood glucose became extremely high. After a few days, she was admitted to the ER with severe abdominal pain and difficulty

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

Current FDA regulations my have rendered pharmaceutical companies to be cautious of citing unbranded studies that provide additional information about a particular disease or condition in their marketing materials.

The drug corporation place profit above human life while the drug cause complexion of issues relates clinical data on Avandia with a bias report that the medication was safe. Consequently, the Avandia drug many adverse side effects that were generating heart trouble and death to the many of the diabetic patients taking the drug. Therefore, we will learn how the first step in research is essential that there is no bias and that the formulation of the investigation will determine failure or success, the drug companies imply that the study is valid as true, without proof that leads to bias in the pharmaceutical companies that are manufacturing medicinal drugs. The Know bias that I, as a customer how the drug industry money influences over research.

The evidence-based practice should be the force behind changes in medical and nursing practice especially when it is advantageous to patient's health. Moreover, this principle should always be the first requirement despite the financial hurdles we face these days. With that in mind, one of the obstacles which we are trying to overcome in my department is for the leaders to realize that treating diabetic patients with GLP-1 drugs has been proven to be cost-effective while providing greatest HbA1c and weight reductions comparing to other hypoglycemic agents ( ). Besides, those patients would ultimately have higher life expectancy and less microvascular and macrovascular complications leading to considerably improved lifestyle. Although our case

I have chosen the above topic because the guidelines are very vague in recommending this combination therapy even though we have clear cut guidelines recommending the use of individual agents in the treatment in Type II Diabetes patients. American diabetes association (1) guidelines recommend advising lifestyle modifications like healthy eating, increased physical activity and weight control, and if the patient fails to meet the target HbA1C levels on lifestyle changes, Metformin is added and over a period of three months, if the patient does not reach the target A1C levels, patient can be started on two drug combinations and we have several options to do this, from sulfonylureas, TZDs ,GLP-1 Analogues, DPP-4 inhibitors and insulin. A search of literature for this combination (2) shows that there are very few clinical studies conducted with the combination of GLP 1 analogues and Insulin and in these studies it was more common to find short-acting GLP-1 RA (exenatide twice daily, liraglutide once daily, lixesanatide once daily) treatment added to an existing insulin regimen (with or without concomitant OAMs) rather than insulin added to existing GLP-1 RA therapy.

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

There is growing concern that intense glucose lowering or the use of certain agents may be associated with adverse cardiovascular outcomes.

The provider’s focus becomes more directed at protecting the liver. A patient might see a change in their medications to that could cause liver damage, inflammation, or increase fibrosis (Neuschwander-Tetri, 2017). The goal for the patient is to decrease the amount of changes in the liver by living a more active and healthy lifestyle. If a person has type 2 diabetes, it will also be vitally important to control their numbers and improve their A1C to decrease the workload on the

Avastin was initially approved by the Food and Drug Administration (FDA) as a treatment for different types of cancer. Its use to treat eye disease is considered an “off-label” use. The FDA allows the use of drugs for conditions other than those for which it is approved if doctors are well informed about the product and proof has been shown of the drug’s positive

Title: FDA Drug Safety Communication: FDA Warns About Prescribing and Dispensing Errors Resulting From Brand Name Confusion with Antidepressant Brintellix (Vortioxetine) and Antiplatelet Brillinta (Ticagrelor).

Pioglitazone was also introduced in 1999 for treating type 2 diabetes mellitus. It improves glycaemic control and LDL cholesterol and also high-density lipoprotein (HDL) cholesterol ratio compared the placebo. It does not cause hepatotoxicity. There is no evidence that pioglitazone causes adverse cardiovascular effects. In fact, it has shown a beneficial effect on cardiovascular disease. Its combination with aliskiren (direct rennin inhibitor) is being considered as a possible therapeutic intervention for cardiovascular injury

The FDA tried to look past the evidence and public FDA’S don’t take the desired actions and taking stuff very backwards.

On March 29, 2013, Canagliflozin (InvokanaTM) was approved by the FDA for the improvement of glycemic control for adults with type 2 diabetes. In 2013, Elkinson and Scott estimated that there were approximately 220 million people worldwide affected by type 2 diabetes. Despite having multiply classifications of drugs and typically multiple drugs to each classification, more than have of patient being treated do not have adequate control of their diabetes (Elkinson & Scott, 2013). As mentioned before with so many medication types already on the market, is Canagliflozin a beneficial addition to the market. First we need to understand how Canagliflozin work, next must analyze if it is effective, then what are some of the side effects or restricts, and finally what is the cost analysis.

Differences in type 2 diabetes management guideline and the study settings might also be the possible reasons. For example, nearly 10% of type 2 diabetes patients with hypertension comorbidity in our set up received hydrochlorothiazide or Amilodipine while guidelines recommend the use angiotensin converting enzyme inhibitors, angiotensin recptor blockers or nondihydropyridine clacium channel blockers. This is because these class of drugs have renoprotective effect and reduce protein uria (41).The rate of ineffective drug therapy in our study is slightly lower than the study in Indonesia (42)where ineffective drug therapy was identified in 50% of the participants.