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Nesina 11 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

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

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

Type 2 diabetes drug does not reduce risk of heart attack, stroke, death

Diabetes drug Onglyza (saxagliptin) does not reduce the risk of heart attacks, strokes or death from cardiovascular causes compared to a placebo, drug makers Bristol Myers Squibb and AstraZeneca said. The companies had conducted clinical trials to determine if the Type 2 diabetes treatment could help reduce the risk of non-fatal heart attacks and ischemic strokes and death from cardiovascular problems as well as lower blood glucose levels. Onglyza did not perform better than a placebo; however, it was not inferior to the placebo either. The clinical trials involved 16,500 people with diabetes as well as a history of heart ... 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

Newly approved type 2 diabetes drugs come with warnings, requirements

After more than five years of reviews and rejections, the dipeptidyl peptidase IV (DDP-4) inhibitor alogliptin has finally been approved by the Food and Drug Administration (FDA). The new drug was approved in three versions to improve blood sugar control in adults with type 2 diabetes. Nesina contains alogliptin as a single-agent drug; Kazano contains alogliptin with metformin; and Oseni contains alogliptin with pioglitazone. The drugs are to be prescribed in combination with diet and exercise. Alogliptin is the fourth DDP-4 inhibitor to gain FDA clearance. Others include sitagliptin, sold under the brand name Januvia; saxagliptin, sold as Onglyza; and ... Read More

FDA moves back review date for new drug containing Actos

Japanese drug maker Takeda Pharmaceuticals Co. will have to wait even longer to hear if the Food and Drug Administration (FDA) will approve its two experimental diabetes medications. The decision was expected by Jan. 25, 2012, but federal regulators have pushed the date back to April 25, 2012. The FDA is ruling on Takeda’s alogliptin as well as a combination of alogliptin and pioglitazone. Pioglitazone is also known by the brand name, Actos, also manufactured by Takeda. Takeda first sought approval of alogliptin in 2009, but FDA ordered additional cardiovascular safety studies. The application for alogliptin was resubmitted in July ... Read More