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alogliptin 25 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

New labels warn of new risks for diabetes drugs Nesnia, Onglyza

The safety labels for the type 2 diabetes drugs Nesnia (alogliptin) and Onglyza (saxagliptin) have been updated to include new warnings for pancreatitis and heart failure. Nesnia and Onglyza are in a newer class of type 2 diabetes drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. Other drugs in this class include Januvia (sitagliptin) and Tradjenta (linagliptin). The “Warnings and Precautions” section for both Nesnia and Onglyza now include a warning that in post-marketing settings and/or randomized clinical trials, patients have been diagnosed with acute pancreatitis. Pancreatitis is a painful inflammation of the pancreas that can increase the risk for more ... 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

Study clears Nesina of heart risk; cancer risk still questionable

The type 2 diabetes drug Nesina (alogliptin) does not increase the risk of heart failure or cardiovascular risk, according to a new study published in the journal The Lancet. Death and disability from heart disease is rampant among individuals with type 2 diabetes. Concerns have been raised over the years about how some diabetes medications affect cardiovascular health after the drug Avandia was severely restricted when studies linked the medication to fatal heart attacks. As a result, Food and Drug Administration (FDA) now requires that a comprehensive evaluation of the cardiovascular safety profile be conducted on all new diabetic therapies. ... Read More

Takeda gives up on diabetes drug candidate due to liver damage risk

Takeda Pharmaceuticals, Asia’s largest drug maker, has halted development of its new diabetes treatment, known as TAK-875 or fasiglifam, because the drug was linked to liver damage. Takeda tried to find a silver lining in the cloud of data, hoping that the drug’s efficacy profile would outweigh the liver risks. However, after consulting with three independent panels on clinical trials results, the writing was on the wall. “The company has reached the conclusion that, on balance, the benefits of treating patients with fasiglifam do not outweigh the potential risks,” Takeda said. “Takeda is working with trial investigators and local regulatory ... 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

Some type 2 diabetes medications linked to increased risk of heart failure

New studies suggest two type 2 diabetes drugs do not increase the risk of heart attack, but may increase the risk of heart failure. A heart attack occurs when blood flow to part of the heart is blocked for a long enough time to cause damage or death to part of the heart muscle. Heart failure is a condition in which the heart cannot pump enough blood to the rest of the body. Both conditions can be deadly. Cardiovascular risks with diabetes medications have made headlines in recent years since the blockbuster diabetes drug Avandia was linked to fatal heart ... Read More

UK drug regulators close to approving risky type 2 diabetes treatments

European drug authorities are close to approving new treatments for type 2 diabetes. The European Medicines Agency (EMA) issued a favorable opinion for Takeda Pharmaceuticals drug alogliptin as a stand-alone drug, in combination with metformin, and in combination with pioglitazone. The drugs will be sold under the brand names Vipidia, Incresync, and Vipdomet, respectively. The three drugs were launched last month in the United States under the brand names Nesina, Oseni and Kazano. Alogliptin is in a class of medications known as dipeptidyl peptidase 4 (DPP-4) inhibitors. They work by slowing the inactivation of the incretin hormones that regulate blood ... Read More

Lawsuits filed against makers of several type 2 diabetes drugs

Last month, the Food and Drug Administration (FDA) announced that it was investigating cases of pancreatitis and precancerous cellular changes called pancreatic duct metaplasia in patients taking a class of type 2 diabetes drugs known as incretin mimetics. Lawsuits against manufacturers of several of these drugs have been underway for years. Incretin mimetic drugs include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). The FDA’s inquiry is based on unpublished findings from a group of academic researchers who examined a small number of pancreatic tissue ... Read More

FDA investigates cases of pancreatitis, precancerous pancreatic cancer with type 2 diabetes treatments

An increased risk of pancreatitis, or inflammation of the pancreas, and other precancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics is being evaluated by the Food and Drug Administration (FDA). The investigation is based on unpublished findings by a group of academic researchers who examined a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. Incretin mimetic drugs include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin ... Read More