Real-globe data, or data collected from “real-life” patient experiences, can easily give additional assistance in to treatment plans in timetable clinical practice. These data can easily complement or supplement clinical trial findings, which evaluate a medicine’s safety and efficacy in a much more controlled setting.
A full list of Takeda-sponsored abstracts to be presented at the American Diabetes Association’s 76th Scientific Sessions, all of which are embargoed until 10:00 a.m. Central Time on Saturday, June 11, 2016, follows:
Alogliptin Abstracts Accepted As:
Oral Presentation:
- Abstract # 2016-A-3107-Diabetes: Optimal Management of Glycaemia in Older Type 2 Diabetes Patients: Partnership Between Treatment Choice, HbA1c manage and Event Incidence (Gordon J., McEwan P., Evans M., et al.)
Moderated Posters:
- Abstract # 2016-A-2307-Diabetes: Mortality Findings from the EXAMINE Trial (Kupfer S., Cannon C., Mehta C., et al.)
- Abstract # 2016-A-2395-Diabetes: Hypoglycemia is Associated along with Increased Risk of Cardio Events: Results from the EXAMINE Trial (Bergenstal R., Cannon C., Kupfer S., et al.)
Posters:
- Abstract # 2016-A-4160-Diabetes: Alogliptin in Triple Therapy along with Metformin and Sulfonylureas Provides Considerable Reductions in HbA1c and is Well Tolerated: an Analysis from the EXAMINE Trial (Cannon C., Howitt, H. Khunti K. et al.)
- Abstract # 2016-A-3512-Diabetes: Renal Outcomes Associated along with Alogliptin vs. Placebo in Patients along with Type 2 Diabetes Mellitus and Recent Acute Coronary Syndrome: Results from the EXAMINE Trial (White W., Charytan D., Wilson C., et al.)
- Abstract # 2016-A-3109-Diabetes: Validating Prescribing Choice in Older Patients along with Type 2 Diabetes: an Economic Assessment of Patient Outcomes Using Routinely Collected Primary Care Data (Gordon J., McEwan P., Evans M., et al.)
- Abstract # 2016-A-6040-Diabetes: Growth Differentiation Factor (GDF)-15 and Long-term Outcomes in Patients along with Diabetes Mellitus in the EXAMINE Trial (Cannon C., Jarolim P., Bakris G., et al.)
Abstract Only:
- Abstract # 2016-A-2067-Diabetes: Comparison of Alogliptin/Pioglitazone Fixed Dose Combination (APC) along with DPP4 Inhibitor Monotherapy in Reducing HbA1c (Szymanki K., Klink A., Visaria J., Dybala C.)
About Takeda’s Diabetes Business
Takeda’s heritage in diabetes globally involves Considerable contributions towards scientific discovery and exchange, starting along with the discovery of the thiazolidinedione (TZD) pioglitazone, the much more recent developments of alogliptin and the fixed-dose combinations (FDC) alogliptin and pioglitazone, and alogliptin and metformin HCl. The company’s diverse diabetes portfolio prove to Takeda’s ongoing commitment to advancing patient care and assisting to meet the specific requires of this growing patient population.
About the EXAMINE Trial
EXAMINE, a large, randomized, double-blind, placebo-controlled outcomes study, was completed as a result of the U.S. FDA 2008 Guidance, titled “Suggestions for Industry: Diabetes Mellitus – Evaluating Cardio Risk in Brand-new Antidiabetic Therapies to Treat Type 2 Diabetes,” for all Type 2 diabetes treatments under development because the issuance of the guidance.1,2 The EXAMINE trial was made to evaluate CV safety complying with treatment along with alogliptin in addition to standard of care, versus placebo in addition to standard of care, in patients along with Type 2 diabetes that were at higher risk for major side Cardio events (MACE) as a result of recent acute coronary syndrome (ACS).1 The trial’s primary goal was to evaluate non-inferiority of CV risk based on a primary composite endpoint of CV death, nonfatal myocardial infarction (MI) and nonfatal stroke.
EXAMINE randomized 5,380 patients in 49 countries along with Type 2 diabetes along with an ACS within the previous 15-90 days.1 The EXAMINE primary endpoint of non-inferiority compared to placebo in addition to standard of care was met, showing no Boost in CV risk in a Type 2 diabetes patient population at higher risk for CV events based on the primary composite endpoint of CV death, nonfatal MI and nonfatal stroke. The primary endpoint occurred at similar rates in the alogliptin (n=305) and placebo (n=316) groups (in 11.3 percent of patients vs. 11.8 percent of patients throughout a median follow-up period of 18 months; hazard ratio (HR), 0.96; upper boundary of the one-sided repeated CI, 1.16). These data, demonstrate that alogliptin does not Boost CV risk in Type 2 diabetes patients at high-risk for MACE as a result of a recent ACS.
About Alogliptin
Alogliptin is a DPP-4 inhibitor for the treatment of Type 2 diabetes in adults as an adjunct to diet regimen and exercise. DPP-4 inhibitors are made to slow the inactivation of incretin hormones GLP-1 (glucagon-enjoy peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased quantity of energetic incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby helping in the management of blood glucose levels.
Alogliptin is approved as a monotherapy and likewise in fixed-dose combination (FDC) along with pioglitazone and metformin HCl for the treatment of Type 2 diabetes in adults as adjuncts to diet regimen and exercise. These therapies are not for treatment of Type 1 diabetes or diabetic ketoacidosis.
Takeda launched alogliptin in Japan in 2010. because that time alogliptin and/or its FDC therapies have actually been approved in over 30 countries across the globe including Brazil, China, the European Union, Mexico, Russia, South Korea and the United States. Diabetes prevalence continues to grow worldwide, along with much more compared to 415 million people impacted by diabetes.3 As the disease becomes increasingly prevalent, Takeda remains focused on expanding access of alogliptin, especially in emerging markets.
INDICATIONS
Alogliptin
Alogliptin is indicated in adults aged 18 years and older along with type 2 diabetes mellitus to improve glycaemic manage in combination along with various other glucose lowering medicinal products including insulin, as quickly as these, with each other along with diet regimen and exercise, do not give adequate glycaemic control.
Alogliptin/Metformin
Alogliptin/Metformin is indicated in the treatment of adult patients aged 18 years and older along with type 2 diabetes mellitus: as an adjunct to diet regimen and physical exercise to improve glycaemic manage in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated along with the combination of alogliptin and metformin; in combination along with pioglitazone (i.e., triple combination therapy) as an adjunct to diet regimen and physical exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone; in combination along with insulin (i.e., triple combination therapy) as an adjunct to diet regimen and physical exercise to improve glycaemic manage in patients as quickly as insulin at a steady dose and metformin alone do not give adequate glycaemic control.
Alogliptin/Pioglitazone
Alogliptin/Pioglitazone is indicated as a second or third line treatment in adult patients aged 18 years and older along with type 2 diabetes mellitus: as an adjunct to diet regimen and physical exercise to improve glycaemic manage in adult patients (particularly over weight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate as a result of contraindications or intolerance; in combination along with metformin (i.e., triple combination therapy) as an adjunct to diet regimen and physical exercise to improve glycaemic manage in adult patients (particularly over weight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. In addition, Alogliptin/Pioglitazone can easily be used to replace divide tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older along with type 2 diabetes mellitus already being treated along with this combination.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS – for Alogliptin, Alogliptin/Metformin and Alogliptin/Pioglitazone
Acute Pancreatitis – Postmarketing events of acute pancreatitis have actually been reported for alogliptin and have actually been associated along with DPP-4 inhibitors. After initiation of alogliptin, patients must be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, Alogliptin/Metformin or Alogliptin/Pioglitazone must be promptly discontinued and proper management must be initiated.
Hypersensitivity Reactions – Postmarketing events of serious hypersensitivity reactions in patients along with alogliptin such as angiodema and severe cutaneous side reactions including Stevens-Johnson syndrome have actually been reported and have actually been associated along with DPP-4 inhibitors. If a serious hypersensitivity reaction is suspected, Alogliptin/Metformin or Alogliptin/Pioglitazone must be discontinued.
Hepatic Effects – Postmarketing reports of hepatic dysfunction including hepatic failure, sometimes fatal, have actually been received. Baseline liver test panel is recommended. Patients must be observed closely for feasible liver abnormalities. Perform liver examinations promptly in patients that report symptoms that might indicate liver injury. If an abnormally is found and an alternative etiology is not established, think of discontinuation of Alogliptin/Metformin or Alogliptin/Pioglitazone.
Hypoglycemia – Insulin and insulin secretagogues are known to induce hypoglycemia. Therefore, a lower dose of insulin or insulin secretagogue could be called for to minimize the risk of hypoglycemia as quickly as used in combination along with alogliptin, Alogliptin/Metformin or Alogliptin/Pioglitazone.
WARNINGS AND PRECAUTIONS – for Alogliptin/Metformin
Lactic Acidosis – Lactic Acidosis is fairly rare, yet serious and potentially fatal metabolic complication that can easily occur as a result of metformin accumulation. Reported cases have actually occurred primarily in diabetic patients along with Considerable renal failure. The incidence of lactic acidosis can easily and must be low by assessing various other associated risk factors such as excessive alcohol intake, hepatic insufficiency and any type of condition associated along with hypoxia. In particular, elderly patients have actually a tendency to have actually decreased renal function; hence treatment of the elderly must be accompanied by careful monitoring of renal function (creatinine clearance). If renal acidosis is suspected, treatment along with Alogliptin/Metformin must be discontinued.
Renal Function – Metformin is known to be substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis Boost along with the degree of impairment of renal function. Thus patients along with raised serum creatinine levels (or serum creatinine levels >135 mcmol/L in males and > 110 mcmol/L in females or creatinine clearance < 60 mL/min) must not receive alogliptin and metformin. proper assessment of renal function is recommended prior to initiation of treatment and periodically thereafter.
WARNINGS AND PRECAUTIONS – for Alogliptin/Pioglitazone
Hepatic Function – Alogliptin/Pioglitazone need to not be used in patients along with hepatic impairment.
Fluid Retention and Cardiac Failure – Pioglitazone, enjoy various other thiazolidinediones, can easily induce fluid retention, which might exacerbate or precipitate heart failure. Patients along with heart failure must be monitored for its signs and symptoms, and discontinuation of pioglitazone must be considered if any type of deterioration in cardiac status occurs.
Edema – Dose-related edema might occur. Use along with caution in patients along with edema.
Bladder Cancer – Data suggest an increased risk of bladder cancer in pioglitazone users. Data likewise suggest that the risk increased along with duration of use. Do not use Alogliptin/Pioglitazone in patients along with energetic bladder cancer. Use caution as quickly as using in patients along with a prior history of bladder cancer. Tell patients to promptly report any type of Authorize of hematuria or various other symptoms such as dysuria urgency as these could be as a result of bladder cancer.
WARNINGS AND PRECAUTIONS – for Alogliptin
Cardiac Failure: Experience of alogliptin use in clinical trials in patients along with congestive heart failure of Brand-new York Heart Association (NYHA) functional class III and IV is limited and caution is warranted in these patients.
CONTRAINDICATIONS
Alogliptin
Alogliptin is contraindicated in patients along with a history of serious hypersensitivity reaction to alogliptin-containing products such as anaphylaxis, angioedema, or severe cutaneous side reactions.
Alogliptin/Metformin
Alogliptin/Metformin is contraindicated in patients along with known hypersensitivity to alogliptin, metformin hydrochloride, or any type of of its components. Additionally, as a result of the metformin hydrochloride component, Alogliptin/Metformin is contraindicated in patients along with the complying with conditions: Renal disease or renal dysfunction and Diabetic ketoacidosis, diabetic coma or pre-coma.
Alogliptin/Pioglitazone
Alogliptin/Pioglitazone is contraindicated in patients along with known hypersensitivity to alogliptin, pioglitazone or any type of of its components. Initiation of alogliptin/pioglitazone treatment is contraindicated in patients along with cardiac failure (NYHA Class III or IV).
DRUG INTERACTIONS
Use along with CYP2C8 sturdy inhibitors (i.e., gemfibrozil or inducers (i.e., rifampin) might require dose adjustment.
ADVERSE REACTIONS
Alogliptin – side reactions include upper respiratory infection, nasopharyngitis, headache, abdominal pain, gastroesophageal reflux disease, pruritis, and rash.
Alogliptin/Metformin – side reactions include gastroesophageal reflux disease, headache, upper respiratory tract infection, pruritis, nasopharangitis, hypersensitivity reactions, hepatic failure and acute pancreatitis, lactic acidosis, decreased vitamin B12, diarrhea, nausea, vomiting, flatulence, abdominal pain, anorexia, rash and taste disorder.
Alogliptin/Pioglitazone – side reactions include upper respiratory tract infections, sinusitis, headache, nausea, dyspepsia, abdominal pain, pruritis, myalgia, oedema peripheral, weight increased.
Please consult along with your local regulatory agency for approved labeling in your country.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, R&D-steered pharmaceutical company committed to bringing much better healthiness and a brighter future to patients by translating science in to life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It likewise has actually personal development programs in specialty Cardio diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and along with partners to remain at the leading edge of innovation. Brand-new innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. much more compared to 30,000 Takeda employees are committed to enhancing quality of life for patients, working along with our partners in healthiness care in much more compared to 70 countries. For much more information, visit http://ift.tt/1RkXc7F.
References
1 White, W.B. et al. (2013) Alogliptin after Acute Coronary Syndrome in Patients along with Type 2 Diabetes. The Brand-new England Diary of Medicine. [online] nejm.org. Last accessed May 4, 2016, available at:
http://ift.tt/171szx6.
2 Meals and Drug Administration (FDA). Suggestions for Industry: Diabetes Mellitus – Evaluating Cardio Risk in Brand-new Antidiabetic Therapies to Treat Type 2 Diabetes 2008. Last accessed May 4, 2016, available at:
http://ift.tt/1Zrz09P.
3 Global Diabetes Federation (IDF). Diabetes Atlas, Seventh Edition 2015. Last accessed May 4, 2016, available at: http://ift.tt/11w56m9.
To view the original version on PR Newswire, visit:http://ift.tt/1Xx3iL1
SOURCE Takeda Pharmaceutical Company Limited
