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Onglyza 19 articles

Large analysis of three clinical trials links diabetes drugs gliptins to acute pancreatitis

An analysis of three large clinical trials looking at the cardiovascular safety of three type 2 diabetes drugs known as gliptins has found that the medications significantly increase the risk of acute pancreatitis. The study, conducted by Ivan Tkac, M.D., Ph.D., from Pasteur University Hospital in Kosice, Slovakia, and Itamar Raz, M.D., from Hadassah Hebrew University Hospital in Jerusalem, combined incidence of acute pancreatitis from randomized controlled trials. The trials included SAVOR-TIMI 53, involving the medication Onglyza (saxagliptin); EXAMINE, involving the drug Nesina (alogliptin); and TECOS, involving the drug Januvia (sitagliptin). Combined, the studies involved 18,238 gliptin-treated patients and 18,157 ... Read More

Type 2 diabetes drugs linked to cancer spread

Two widely used type 2 diabetes drugs, which are also antioxidants, appear to stimulate cancer metastasis in laboratory mice, a new study has found. The research narrowed in on antioxidants and the popular notion that adding them to the diet can prevent cancer, slow aging as well as a slew of other health benefits. Granted, antioxidants found in foods like fruits and vegetables have been found to neutralize free radicals that can damage DNA, which can lead to cancer. This idea has fostered the belief that antioxidants can also prevent cancer. But, studies on antioxidant pills sold as dietary supplements ... Read More

Some type 2 diabetes drugs linked to heart failure

Drugs from a new class of type 2 diabetes treatments, including Onglyza, Kombiglyze XR and Nesina, have been linked to heart failure, and patients with heart or kidney disease are even more susceptible to this risk, the Food and Drug Administration (FDA) warned in a Safety Alert. The risk was seen with the drug ingredient saxagliptin (found in Onglyza and Kombiglyze XR) and alogliptin (found in the brands Nesina, Kazano and Oseni). Both saxagliptin and alogliptin are in a newer class of type 2 diabetes drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. The new warning comes after an FDA review ... Read More

Alarming number of pancreatitis, pancreatic cancer cases with diabetes drugs

Pancreatitis is a painful inflammation of the pancreas that can increase the likelihood of a patient developing pancreatic cancer, a health problem that type 2 diabetics are already at greater risk of developing. Interestingly, a study of drug adverse event reports reveals that common type 2 diabetes drugs have been associated with side effects that include acute pancreatitis and pancreatic cancer. Health informatics firm AdverseEvents scoured through post-marketing reports filed with the Food and Drug Administration (FDA) and found 1,900 cases of pancreatitis with AstraZeneca’s Byetta injection, 1,284 cases in patients taking Novo Nordisk’s Victoza, and 1,296 cases in patients ... Read More

FDA panel recommends heart failure warning for Type 2 diabetes drugs

The Type 2 diabetes drugs Onglyza and Kombiglyze should carry warnings that use of the medication may cause heart failure and death, a Food and Drug Administration (FDA) advisory panel warned. The recommendation is based on the expert panel’s review of a 16,000-patient study that looked at heart health among patients taking either Onglyza or Kombiglyze. Panel members voted 14-1 to recommend that the drugs’ safety labels should include information to alert patients that using the drugs could lead to an increased risk of hospitalization for heart failure and death from any cause. Despite this risk, panel members voted 13-1, ... Read More

Newer type 2 diabetes drugs carry serious side effects, pancreatic cancer risks

The newest classes of type 2 diabetes drugs may help diabetics manage their disease, but it can come at a great price. Diabetes drugs known as GLP-1, DPP-4, and SLGT2 have been associated with serious side effects including acute pancreatitis, pancreatic cancer, thyroid cancer, urinary tract infections, gastrointestinal issues, and renal and gallbladder problems, according to AdverseEvents (AE), a company that analyzes post-market side effects data. According to DrugWatch.com, Glucagon-like peptide-1 receptor (GLP-1) agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors both affect levels of the incretin hormone, which helps to control blood sugar. Sodium-glucose co-transporter 2 (SGLT2) inhibitors (glucuretics) block glucose reabsorption ... Read More

Some diabetes drugs may be linked to more serious side effects than initially thought

Type 2 diabetes drugs known as DPP-4 inhibitors may be linked to more serious side effects than generally believed, according to an analysis from AdverseEvents. AdverseEvents, a health care informatics company, analyzed data on 11 of the newer type 2 diabetes drugs to conclude which were the safest and which may need closer watch. The drugs included in the study involved GLP-1 receptor agonists, such as Bydureon, Byetta, and Victoza, and DPP-4 inhibitors, such as Janumet, Januvia, Tradjenta and Nesina. AdverseEvents examined data from the Food and Drug Administration’s (FDA) Adverse Event Reporting System, FAERS, and then identified suspect cases ... Read More

FDA opens investigation into heart failure risk with diabetes drugs Onglyza, Kombiglyze

The Food and Drug Administration (FDA) has opened an investigation into the safety of the type 2 diabetes drug saxagliptin after a recent study published in the New England Journal of Medicine (NEJM), reported an increased rate of hospitalizations for heart failure in patients taking the drug. Heart failure occurs when the heart does not efficiently pump blood throughout the body. It can lead to more serious and life threatening problems. Saxagliptin is sold in the United States under the brand names Onglyza and Kombiglyze XR. Patients currently taking saxagliptin should talk with their health care providers about any questions ... Read More

Clinical trials to begin on novel new type 2 diabetes drug

Zydus Cadila Healthcare has been given approval by the Food and Drug Administration (FDA) to begin phase I clinical trials of ZYDPLA1, a novel next generation orally active small molecule DPP-4 inhibitor to treat type 2 diabetes. ZYDPLA1 is a New Chemical Entity (NCE), a classification given to a drug that contains no active functioning group that has been approved by the FDA in any other application. The drug was discovered and developed by the Zydus Research Center. It is a novel compound in the Gliptin class of diabetes medications, also known as DPP-4 inhibitors. ZYDPLA1 works by blocking the enzyme ... Read More

Diabetes drugs may not increase heart problems but could pose cancer risk

Studies involving different type 2 diabetes drugs show no evidence that the medications cause heart attacks and strokes, however they do not improve cardiovascular outcomes in patients either. Some medications also pose cancer risks. The first study compared the drug saxagliptin, marketed in the United States as Onglyza, with a placebo in patients who had type 2 diabetes and were considered at high risk for a cardiovascular event. Another study pitted the drug alogliptin, marketed as Nesina, against placebo. Researchers recorded incidences of cardiovascular death, heart attack or ischemic stroke as well as hospitalizations for unstable angina, coronary revascularization or ... Read More