Incretin based drugs have proven to be effective glucose-lowering agents (Butler et al, 2013). But there have been concerns with respect to the long-term consequences of using such therapies. The issues raised were regarding their causal relationship with acute pancreatitis (AP). There are clearly conflicting evidence that have been presented in preclinical studies and in epidemiologic studies which suggest an association which may or may not be a causal relationship between these drugs and AP. (Butler et al, 2013)
In order to have better understanding, data from the manufacturers is reviewed below which will also show whether the manufacturers of these products behaved ethically as well as what needs to be reconsider with respect to the use of incretin-based therapies because of the growing concern of potential risk of AP. Hence risk management plans will be discussed below. (Butler et al, 2013) CLINICAL PERSPECTIVES OF ACUTE PANCREATITIS AND INCRETIN BASED DRUGS
Meier & Nauck (2014) reported meta-analyses for the available data describing pancreatitis events in phase 3 trials for DPP-4 inhibitors and GLP-1R agonists. The odds ratio for acute pancreatitis with a GLP-1R agonist was 1.39, whereas for exposure to a DPP-4 inhibitor, it was 1.07, however the total number of patients studied and absolute event rates were small (2.1 events of pancreatitis per 1,000 patient years), greater numbers of subjects followed for longer periods of time would be required to increase the
With the level of technology at where it is today there are many risks involved with many treatments. What the companies tend to do is advertise products and try to make the risks seem small. Every time you watch TV nowadays there is a commercial on there about a treatment that has
This author appreciates the researcher’s effort in determining a cause-and-effect between the variables. Many references were offered to support the hypotheses. The NICE-SUGAR STUDY (2009) was also referenced. It showed the efficacy of using intermediate glucose management (SSI) in lowering the blood glucose level in the acute setting. (Finfer, Chittock, Blair, Foster & Ronco, 2009). More importantly though, was the need to determine the relevance of SSI dose and the timing of meal intake.
The Pharmaceutical industry has been in the spotlight for decades due to the fact that they have a reputation for being unethical in its marketing strategies. In The Washington Post Shannon Brownlee (2008) states, “We try never to forget that medicine is for the people. It is not for the profits. The profits follow.” This honorable statement is completely lost in today’s world of pharmaceutical marketing tactics. These tactics are often deceptive and biased. Big Pharma consistently forgets their moral purpose and focuses primarily on the almighty dollar. Big Pharma is working on restoring their reputation by reforming their ethical code of conduct.
Everyone wants the miracle drugs to be approved faster and get to market quicker; however the safety of the consumer needs to be a priority. Oversight of the manufacturing and approval process is a necessity to ensure the safety of the
Inflectra was not approved for Ulcerative Colitis and Crohn’s because of the deference between inflectra and its reference product (Remicade). This difference could have an impact on the safety and efficacy of Inflectra in patients with Crohn’s disease and Ulcerative colitis. This further resulted in that the benefit/risk assessment of Inflectra in patients with Ulcerative Colitis and Crohn’s disease could not be completed.
- As the article mentioned, it is important for us to get our products into the clinic before others do.
Annual incidence of Acute Pancreatitis ranges from 13 to 45/100,000 persons, and Chronic Pancreatitis is 5 to 12/100,000; the prevalence of Chronic Pancreatitis is about 50/100,000 persons (Banks PA. Epidemiology 2002)
In life, there are many obstacles that get in your way. Some obstacles can be overcome. Some are harder to overcome. This is the story of a woman I know who had three obstacles of her own: pancreatitis, cancer and a stroke.
Pancreatitis is the most common and feared complication of ERCP. The pathology of acute pancreatitis relates to inappropriate activation of trypsinogen to trypsin and a lack of prompt removal of active trypsinogen inside the pancreas. The clinical diagnosis of acute pancreatitis is based on characteristic abdominal pain and nausea, combined with elevated serum levels of pancreatic enzymes (Cheng, et al., 2006). When caring for a patient suffering from acute pancreatitis it is important to monitor fluid balance and pulse oximetry (Whitcomb, 2006). This is especially true when a patient’s pain is being treated with narcotic analgesics. The respiratory depression affects of the narcotics coupled with the pain of breathing due
The table below displays the mean permeability surface area product values in patients with mild acute pancreatitis and severe acute pancreatitis for each anatomical division of the pancreas.
Hi, my name is Anna and I am 71 years old born on May 28, 1943. I was born and raised in Rochester New York. I formerly worked at Kodak as an executive secretary and retired in 2005. I live at home with my husband who is also retired, in a one-story ranch located in Greece, New York. This is my second marriage as I lost my first husband to a traumatic car accident. We have been married for thirty-one years now with four children, a son and three daughters. I have 10 grandchildren who keep me busy. I enjoy taking long walks, reading books, and spending quality time with my family. My medical history consists of hypothyroidism, biliary tract disorder, anxiety, depression and migraines. I take levothyroxine 0.075mg every morning for my
I was admitted to a hospital due to an acute pancreatitis attack. While there, I was instructed that I should set up an appointment with my physician two weeks after my release, and that they would be taking over my treatment planning and health services. A couple days after my release, I received a call from group health instructing me that my physician Czechowski wanted me to come in for an appointment as soon as possible. Following that I set up the next available appointment, which was on 5/29/2015. As a result, I went in for my appointment on that date and as soon as Czechowski came storming through the door you could tell he was upset and he immediately became verbally aggressive and absolutely unprofessional. At no point in his verbal
Mr. P.M. is a forty-seven-year-old African Canadian who came to emergency with complains of vomiting and severe abdominal pain. He stated that he finished a heavy meal accompanied with 3-4 glasses of wine when his pain began. He usually consumes 2-3 cans of beer per day. Based on clinical findings and tests, he was diagnosed with acute pancreatitis and admitted to the medical-surgical unit. I was assigned to care for Mr. P. M. during day shift following his admission.
There is growing concern that intense glucose lowering or the use of certain agents may be associated with adverse cardiovascular outcomes.
Smart-Bio is a successful company that devote to develop new drugs and increase the life quality of Australian. At present, Smart-Bio has successfully developed several pharamceutical and has a good reputation in the sector. Alogliptin is a oral taken drug that targeting the incretin pathway, serving as a potent and selective inhibitor of the serine protease dipeptidyl peptidase IV (DPP-4). Alogliptin can be used alone or in combination with other antidiabetic agents to increase the efficacy of both drugs. The clinical trials results suggested that Alogliptin is a promising new drug for type 2 diabetes mellitus (T2D) showing little or no side effects like its counterparts.