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British-Swedish drugmaker AstraZeneca has been approved by the FDA for its once-a-day Xigduo XR extended-release tablet to treat adults with type 2 diabetes mellitus in the United States.
The Xigduo FDA approval gives the two anti-hyperglycaemic agents, dapagliflozin and metformin, a green light to be used as a once-daily oral tablet. SGLT2 inhibitors are a new class of medicines that remove glucose from the body through the kidneys. However, safety worries have thus far limited uptake for the SGLT2 class, as the treatments have been linked to increased rates of genital and urinary tract infections, plus kidney damage and cardiovascular issues.
LGM Pharma provides the two anti-hyperglycaemic agents dapagliflozin and metformin hydrochloride for research and development purposes, and offers clients continued support throughout the R&D process. Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1).
This entry was posted in Anti-Diabetic, Blood Glucose Regulator, FDA Approved 2014, OTC and Compounding Product, Therapeutic Classification and tagged Australia, type 2 Diabetes by admin.
Diet, exercise, and education remain the foundation of any type 2 diabetes treatment program. Ultimately, many patients will require insulin therapy alone or in combination with other agents to maintain glucose control.
The American Diabetes Association and the European Association for the Study of Diabetes have updated guidelines on the management of hyperglycemia in nonpregnant adults with type 2 diabetes. The novel position statement on the management of hyperglycemia in type 2 diabetes was necessary because since the last similar treatment algorithm, which is more than 3 years old, a lot of new insights have been generated that required an update. According to the ADA, to reduce the incidence of macrovascular disease, HbA1c should be lowered to less than 7% in most patients. For strong recommendations in favour (or against) certain diabetes medications, the evidence is not strong enough; choices and preferences will differ with different patients, their characteristics and attitudes.
Several therapeutic options were discussed, including lifestyle interventions to change physical activity levels and food intake; oral agents and noninsulin injectables, as well as insulin. The second step can be a dipeptidyl peptidase-4 inhibitor, it can be a glucagon-like peptide-1 (GLP-1) receptor agonist, it can be a thiazolidinedione, it can be a sulfonylurea agent, or it could be basal insulin. If a patient needs a more intensive insulin regimen, then it is recommended to add 1 or 2 - maybe even 3 - doses of mealtime insulin. The position statement lists all commonly used medications with all their properties (positive and negative), and gives all the information to make good choices based on priorities (ie, avoiding hypoglycemia at all costs) and preferences. Overall, comparative evidence for antihyperglycemic treatment of type 2 diabetes is lacking, and there is a considerable need for high-quality, comparative-effectiveness research on costs and outcomes important to patients, including quality of life and the avoidance of life-limiting complications such as cardiovascular disease. Because of the rapid change in lifestyle in China, there is concern that diabetes may become epidemic. A nationally representative sample of 46,239 adults, 20 years of age or older, from 14 provinces and municipalities participated in the study. These results indicate that diabetes has become a major public health problem in China and that strategies aimed at the prevention and treatment of diabetes are needed.
In an editorial comment in the European Heart Journal, some opinion leaders indicate what might be the reasons for the failure of the dal-HEART programme.Both the on-treatment vascular effects and the underlying molecular mechanism causing increased HDL-c are important in determining the vascular effects of an HDL-c raising therapy.
The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study assessed how to manage diabetes in children and adolescents.
The China National Survey of Chronic Kidney disease was a cross-sectional study to evaluate the prevalence of CKD and associated factors in Chinese adults between 2007 and 2010.CKD has become an important public health issue in China, maybe as a consequence of increased diabetes and hypertension. DPP-4 inhibitors can be used as second line treatment in patients with type 2 diabetes who do not achieve their glycaemic targets with metformin alone. The study was set up to determine all cause mortality and deaths from cardiovascular events related to intensive glucose lowering treatment in people with type 2 diabetes. In GPRD data, current use of sulphonylureas only (with active or inactive metabolites) was associated with an increased risk of hypoglycaemic events, as compared with current use of metformin.
Recent outcome trials of novel antidiabetic drugs shed new light on why diabetes patients develop heart disease. Out of 18 biomarkers, Lp-PLA2 and adiponectin were independently associated with a decreased risk for T2DM. In females with gestational diabetes, the future risk of developing type 2 diabetes depends on certain pregnancy-related and maternal factors that could be used for postnatal counselling. Please note: If you have a promotional code you'll be prompted to enter it prior to confirming your order. If you subscribe to any of our print newsletters and have never activated your online account, please activate your account below for online access.
When it comes to preventing and treating high blood pressure, one often-overlooked strategy is managing stress.
Low back pain has many different causes, including the normal wear and tear that comes with aging.
Mobility — the ability to move purposefully around your environment — is vitally important to health and well-being. If a growth or mole looks like a melanoma, the doctor will take a biopsy to confirm the diagnosis. An overactive bladder (also known as urge incontinence) causes a sudden urge to urinate, even when your bladder isn't full. It might seem like retirement is a time to take it easy and devote yourself to gardening, golfing, and napping.
Sleep shortfalls can lead to a range of health problems, from being more likely to catch a cold or gain weight to increased risk of developing heart disease or diabetes.
Subscribe to Harvard Health Online for immediate access to health news and information from Harvard Medical School. As man crosses the prime sexual period, 30 years in many cases, the male organ undergoes some significant changes.
As men age, the testosterone level falls, and when this hormone level falls in the body, it takes more time to achieve erection and orgasm.
Oh my gosh, are you seriously teaching something medical when you don’t even know about the foreskin? When i was child then i don’t know disadvantage of Hand Practice, I do so much hand practice, Now my penis goes down and it is bent towards left, It is not straight, Veins also appears on my penis, Please tell me how can i see it in straight form.
SGLT-2 inhibitors are the first class of drugs to target renal glucose reabsorption as a means of reducing hyperglycemia in type 2 diabetes mellitus. Developed by a faculty of renowned, international diabetes experts led by Julio Rosenstock, MD, this 2-part educational activity will provide clinicians with an interpretation of recent clinical data, and explore the potential role of SGLT-2 inhibitors in diabetes care.

This continuing medical education activity is jointly sponsored by Albert Einstein College of Medicine of Yeshiva University and Haymarket Medical Education and supported by an educational grant from Bristol-Myers Squibb.
The first component of this 2-part educational activity, the clinical monograph will provide endocrinologists, cardiologists, and general practitioners who manage the care of patients with type 2 diabetes with the latest data on the SGLT-2 inhibitors.
Four international diabetes experts will further elucidate the future role of the SGLT-2 inhibitors in the T2DM treatment arsenal. A scientific team from the Center for Nanoparticle Research at IBS has created a wearable GP-based patch that allows accurate diabetes monitoring and feedback therapy by using human sweat. Insulin is produced in the pancreas and regulates the use of glucose, maintaining a balance in blood sugar levels.
KIM Dae-Hyeong, a scientist from the Center for Nanoparticle Research, describes the vast array of components: "Our wearable GP-based device is capable of not only sweat-based glucose and pH monitoring but also controlled transcutaneous drug delivery through temperature-responsive microneedles. The device shows dramatic advances over current treatment methods by allowing non-invasive treatments. Living with Type 1 diabetes requires constant monitoring of blood sugar levels and injecting insulin daily. Diabetic patients have to monitor blood glucose regularly and frequently, but conventional method of taking blood sample for measuring glucose level is painful.
It is now feasible to make a prized material for spintronic devices and semiconductorsa€”monolayer graphene nanoribbons with zigzag edges. Extraordinary things happen to ordinary materials when they are subjected to very high pressure and temperature.
Rice University scientists who analyze the properties of materials as small as a single molecule have encountered a challenge that appears at very low temperatures. Extremely thin stacks of two-dimensional materials, which could deliver applications fine-tuned to the demands of industry, are set to revolutionise the world in the same way that graphene will. Next week is shaping up to be an important week for earnings, with a huge percentage of the S&P 500 companies reporting their results. Januvia is a blockbuster therapy for Merck, and it's responsible for about $6 billion in sales annually. Eli Lilly (NYSE:LLY) and Boehringer Ingelheim's co-developed SGLT-2 inhibitor, Jardiance, really turned heads in August when the partners reported that a long-term cardiovascular outcomes trial (EMPA-REG OUTCOME) showed that it was superior to the current standard of care in terms of lowering the risk of a cardiovascular event in high-risk CV patients. In the second quarter, Keytruda closed the sales gap between it and Opdivo in a big way, but it's possible Opdivo may have outsold Keytruda by a substantive amount thanks to its added NSCLC indication in Q3. Whereas some companies are going for the gusto when they make an acquisition, Merck's strategy has been (to steal a sports term) to "dink-and-dunk" its way to success.
Quarterly earnings results are certainly important to help investors understand what type of outlook to expect from a company, but rarely does a single earnings report alter your investing thesis in a company. AstraZeneca’s once-daily tablet is indicated as an adjunct therapy to diet and exercise to improve glycaemic control. Dapagliflozin is an inhibitor of sodium-glucose cotransporter 2 (SGLT2) and metformin hydrochloride is a biguanide, which decreases glucose production and improves the body’s response to insulin.
As a result, peak sales estimates for the class of drugs have been erratic, with some pegging their potential north of $5 billion and others expecting cumulative revenue more in line with $2 billion a year. Type 2 diabetes is the most common form of diabetes affecting patients globally, and the United States alone has over 23 million people suffering from this condition. Combination therapy with an additional 1–2 oral or injectable agents is reasonable, aiming to minimize side effects where possible. The update is based on new evidence of risks and benefits of glycemic control, evidence on safety and efficacy of new drug classes, the withdrawal and restriction of other drug classes and the increasing need for a more patient-centered approach to care.
However, data from type 2 diabetes cardiovascular trials have demonstrated that not all patients benefit from aggressive glucose maintenance, again pointing toward a more individualized approach to treatment. In contrast to previous statements, the present one is based on a patient-centered approach. According to the guidelines, when it comes to prescribing oral agents and noninsulin injectables, agent- and patient-specific properties, such as dosing frequency, side effect profiles, cost and other benefits, are often used to guide drug selection. Anticipated glucose-lowering effects should be balanced with the convenience of the regimen, in the context of an individual’s specific therapy goals. We conducted a national study from June 2007 through May 2008 to estimate the prevalence of diabetes among Chinese adults. The penis head gradually loses its color due to reduced blood flow, and pubic hair loss can be observed in some cases. One, the slow deposition of fatty substances (plaques) inside tiny arteries in the penis, which impairs blood flow to the organ. In the image on the left, the flaccid penis, there should be foreskin hanging over the glans.
Emerging data strongly suggest that this novel drug class will, in the very near future, have a role to play in diabetes management.
A detailed explanation of the unique mechanisms of action and the safety and tolerability profiles of this drug class will be provided, and the results of key clinical trials will be discussed.
Schematic and corresponding images of the GP-hybrid electrochemical devices and thermoresponsive drug delivery microneedles.
The researchers improved the device's detecting capabilities by integrating electrochemically active and soft functional materials on the hybrid of gold-doped graphene and a serpentine-shape gold mesh.
Diabetes causes an imbalance: insufficient amounts of insulin results in high blood glucose levels, known as hyperglycemia.
Precise measurement of sweat glucose concentrations are used to estimate the levels of glucose in the blood of a patient.
During the team's research, two healthy males participated in tests to demonstrate the sweat-based glucose sensing of the device. A graphene-based electrochemical device with thermoresponsive microneedles for diabetes monitoring and therapy, Nature Nanotechnology (2016). Instead of placing too much emphasis on Merck's headline sales and profit results, dig below the surface by keeping these key points in mind.
One such company that's bound to garner a lot of attention, which also happens to be a component of the Dow Jones Industrial Average, is Big Pharma Merck (NYSE:MRK). However, a new class of type 2 diabetes drugs could wind up placing a lot of pressure on Januvia going forward.
It may be a bit early to see an effect on Januvia's total sales given that Eli Lilly and Boehringer Ingelheim didn't release the magnitude of the outperformance until Sept.
I'd suggest investors really hone in on Keytruda's growth in metastatic melanoma and listen closely to early estimates regarding its NSCLC prescriptions, which should be available when Merck reports.

Instead of looking at large-cap drugmakers, Merck believes in bolting on smaller but complementary drug developers in areas where it's looking to secure its leadership. Merck's current yield of 3.5% is well above the market average, and it tends to attract long-term-minded investors to the stock, which also keeps volatility at a minimum. Thus, if you're currently a Merck shareholder I foresee no reason to jump out of your position before the report, and I don't see any particular reason why those on the sidelines should be diving into Merck, either.
Then after a long battle, Eli Lilly and Boehringer Ingelheim finally won approval for empagliflozin. Continued research and development of new and innovative treatments to combat this ever growing patient population is not only prudent, but also extremely necessary. The authors recommend combination therapy with the addition of one to two oral or injectable agents, with the goal of reducing side effects when possible. The prevalence of diabetes was higher among urban residents than among rural residents (11.4% vs.
When levels of glucose in the blood rise (for example, after a meal), the pancreas produces more insulin. Whether single, married, healthy or unhealthy, a man’s body will eventually go through some changes.
This process, known as atherosclerosis, is the same one that contributes to blockages inside the coronary arteries — a leading cause of heart attack. As men reach 40, semen production start getting lower, and the erection quality also starts going down. Thus, it is important that health care providers who treat patients with diabetes are aware of the most recent data on these agents and the implications for clinical practice. The device's pH and temperature monitoring functions enable systematic corrections of sweat glucose measurements as the enzyme-based glucose sensor is affected by pH (blood acidity levels) and temperature. The device retains its original sensitivity after multiple uses, thereby allowing for multiple treatments. Glucose and pH levels of both subjects were recorded; a statistical analysis confirmed the reliable correlation between sweat glucose data from the diabetes patch and those from commercial glucose tests. Microneedles pierced the skin of the mouse and released Metformin, an insulin regulating drug, into the bloodstream. For that, we need to dig below the surface into the meat and potatoes of a company's quarterly earnings results. 21, but it'll be important to monitor how Merck plans to mitigate what could be weak Januvia sales moving forward.
This is potentially a $5 billion per-year drug at its peak, so a lot of attention should be given to this budding immunotherapy giant. Areas of interest for future acquisitions could include infectious diseases, oncology, and cardiovascular, although I wouldn't count on any acquisitions being limited to just these therapeutic indications.
Following four consecutive quarters with a dividend payment of $0.45, shareholders are probably going to be eager to see Merck boost its dividend once more. Merck definitely has some growth challenges to face, and its Q3 results will likely help address some of its issues.
We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors.
You'll often find him writing about Obamacare, marijuana, drug and device development, Social Security, taxes, retirement issues and general macroeconomic topics of interest. Meanwhile, Pfizer and Merck are still working through late-stage trials with the competing ertugliflozin. Insulin therapy, whether alone or in combination, will ultimately be required to maintain glucose control for many patients. In many cases, the prostate enlarges which weakens the urine flow and may cause other complications. It affects some 3 million Koreans with the figure increasing due to dietary patterns and an aging society. If abnormally high levels of glucose are detected, a drug is released into a patient's bloodstream via drug loaded microneedles. The group treated with microneedles showed a significant suppression of blood glucose concentrations with respect to control groups.
Whereas Merck's top line has been mostly hit-or-miss when it comes to Wall Street's forecasts, it's surpassed the Street's EPS estimates in 10 of the past 11 quarters. When Merck does release its results in a matter of days, I'd suggest paying close attention to how it addresses the following questions.
SGLT-2 inhibitors work in the kidneys, as opposed to liver and pancreas, and block the absorption of glucose, allowing the patient to excrete excess blood sugar through their urine. Shareholders should consider closely examining any commentary from Merck's management pertaining to its acquisition strategy.
Although Merck's top line is still struggling, inclusive of negative currency translation, its substantial cash flow should allow it to hike its dividend.
The prevalence of isolated impaired glucose tolerance was higher than that of isolated impaired fasting glucose (11.0% vs. There is nothing to worry about if you notice the reduction in the size, since it simply happens due to reduced blood flow.
The current treatments available to diabetics are painful, inconvenient and costly; regular visits to a doctor and home testing kits are needed to record glucose levels. The malleable, semi-transparent skin-like appearance of the GP device provides easy and comfortable contact with human skin, allowing the sensors to remain unaffected by any skin deformations. This doesn't necessarily mean Merck is in line to beat on its EPS numbers, but the trend has certainly been that way for nearly three years. Pay close attention to any comments made in Merck's press release concerning its intentions to boost shareholder payouts. Treatment with Metformin through the skin is more efficient than that through the digestive system because the drug is directly introduced into metabolic circulation through the skin," commented KIM Dae-Hyeong.
There is a significant need for non-invasive, painless, and stress-free monitoring of important markers of diabetes using multifunctional wearable devices. The IBS device facilitates this and thereby reduces the lengthy and expensive cycles of visiting doctors and pharmacies.

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