PHARM.D

FDA approves combination therapy Juvisync First combination drug to treat type 2 diabetes and high cholesterol in one tablet The U.S. Food and Drug Administration today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin. About 20 million people in the United States have type 2 diabetes, and they often have high cholesterol levels as well. These conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness, among other chronic conditions, particularly if left untreated or poorly treated. Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body's own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Simvastatin is an HMG-CoA r...

 Recurrent Stroke Risk Higher in Type 2 Diabetes Megan Brooks Patients with type 2 diabetes, but without frank cardiovascular disease, are at higher risk for recurrent stroke and cardiovascular events than patients without diabetes or without metabolic syndrome. However, statin therapy appears to cut the risk in both groups and to the same degree as in people without these conditions. The findings come from a post hoc analysis of the Stroke Prevention by Aggressive Reduction of Cholesterol Levels (SPARCL) trial published online June 13 in the Archives of Neurology . "The take-home message from this paper would be that patients with type 2 diabetes and stroke or TIA [transient ischemic attack] without known heart disease have increased risk of future events compared to those without type 2 diabetes or with metabolic syndrome," first author Alfred Callahan, MD, from Vanderbilt University, Nashville, Tennessee, told Medscape Medical News . "This increased risk is...

  FDA Warns of Serious Risks Associated With Liraglutide Mark Crane The US Food and Drug Administration (FDA) today warned healthcare professionals to closely monitor patients with diabetes receiving liraglutide injections ( Victoza , Novo Nordisk) for thyroid C-cell tumors and acute pancreatitis. Novo Nordisk said in a letter that a recent assessment showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza. First approved by the FDA in January 2010, liraglutide is the first once-daily human glucagon-like peptide 1 analog indicated for the treatment of type 2 diabetes. The treatment is indicated in conjunction with diet and exercise to improve blood glucose control in adults with type 2 diabetes failing first-line therapy. Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both sexes of rats and mice, according to an alert sent today f...

Fewer Side Effects for Partial PPAR-Gamma Agonist Balaglitazone By Rob Goodier  Balaglitazone, an experimental thiazolidinedione derivative, was slightly less effective than pioglitazone but had fewer side effects in patients with type 2 diabetes in a recent phase III trial. Both agents stimulate PPAR (peroxisome proliferator-activated receptor)-gamma. Full PPAR-gamma agonists, like pioglitazone (Actos) and rosiglitazone (Avandia), are linked with bone loss, heart failure, edema and weight gain. But balaglitazone is a partial PPAR-gamma agonist. This study was the first to assess of the safety of this type of agent. Adverse effects were less frequent with balaglitazone, "especially at the level of edemas, weight gain and bone loss," said Dr. Kim Henriksen, who led the research at Nordic Bioscience A/S, in Herlev, Denmark, in an email to Reuters Health. The research team randomized 409 patients with type 2 diabetes on stable insulin therapy to four groups that ...

Colesevelam Effective as Add-On Therapy in Type 2 Diabetes Colesevelam ( Welchol , Daiichi-Sankyo Pharmaceuticals) might not be a first choice for many clinicians in the treatment of type 2 diabetes; however, a post hoc analysis of 3 large randomized controlled trials reveals that it might be a good option as an add-on therapy for patients with both type 2 diabetes and high cholesterol. In the analysis of 696 patients receiving colesevelam, the medication reduced mean low-density-lipoprotein cholesterol by 16.5%, total cholesterol by 5.8%, and apolipoprotein B levels by 7.6% when used along with metformin background therapy and when compared with placebo ( P  < .0001), according to researchers here at the American Association of Clinical Endocrinology 20th Annual Meeting and Clinical Congress. Elevations in triglycerides — a known adverse effect of colesevelam, particularly when used in combination with sulfonylureas or insulin — were also modest in the tr...

         FDA approves new treatment for Type 2 diabetes The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes. People with Type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood. Over time, high blood glucose levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage. "This approval provides another treatment option for the millions of Americans with Type 2 diabetes," said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “It is effective when used alone or when added to existing treatment regimens.” Type 2 diabetes is the most common form of the disease, affecting between 90 percent and 95 percent of the 2...