Emerging Therapies

Chicago, IL—Previous trials of maintenance therapy for patients with ovarian cancer have failed to show improved survival. A study presented at ASCO 2013 is the first successful phase 3 trial in this setting, showing that the targeted therapy pazopanib (Votrient) extended progression-free survival (PFS) by a median of 5.6 months in women with ovarian cancer. Women who were enrolled in the trial were free of the disease after the initial treatment with surgery and chemotherapy.

Munich, Germany—A total of 16 novel classes of drugs are under development for the management of lipoprotein metabolism toward the prevention of cardiovascular disease (CVD), according to John J.P. Kastelein, MD, PhD, Academic Medical Center, University of Amsterdam, the Netherlands. Dr Kastelein reviewed several of these approaches at the 2012 European Society of Cardiology (ESC) Congress.

Boston, MA—No glucose-lowering regimen has been shown to reduce macrovascular complications, such as myocardial infarction (MI) or stroke, but glucagon-like peptide (GLP)-1 agonism appears to have favorable effects on many surrogate markers for cardiovascular disease (CVD), according to presenters at the 2012 Cardiometabolic Health Congress.

Los Angeles, CA—Reductions in dys­pnea and cardiovascular (CV) death, and improvement in the signs and symptoms of congestion and worsening heart failure (HF), in the RELAX-AHF study were attributed to serelaxin, a novel investigational agent for the treatment of acute HF, which was compared with placebo plus conventional therapy.

Munich, Germany—The first-in-class agent LCZ696, an angiotensin receptor neprilysin inhibitor, was associated with greater reductions of several measures that are associated with worse outcomes in patients who have heart failure with preserved ejection fraction (HFpEF) compared with the angiotensin receptor blocker (ARB) valsartan.

A number of promising oral and injectable agents for diabetes are currently in late-stage development and were featured in posters, oral abstract presentations, and symposia during the 2012 ADA annual meeting. The following is a sampling of new medications with potentially important implications for the treatment of patients with diabetes.

The investigational ultra–long-acting insulin degludec improves long-term glycemic control in patients with type 2 diabetes similar to insulin glargine but with a reduced rate of nocturnal and severe hypoglycemia, and greater weight loss, said Bernard Zinman, MD, Director of the Diabetes Center at Mount Sinai Hospital, Professor of Medicine, University of Toronto, and lead investigator of a randomized head-to-head comparison.

The anti-inflammatory agent salsalate, used for decades as a treatment for rheumatoid arthritis, also has glucose-lowering properties, said Steven Shoelson, MD, PhD, Associate Director of Research at the Joslin Diabetes Center, Boston, and principal investigator of a placebo-controlled study of salsalate in patients with type 2 diabetes.

Salsalate lacks many of the side effects of aspirin; however, in the current study, this drug was associated with weight gain and an increase in low-density lipoprotein cholesterol (LDL-C), said Dr Shoelson.

Several studies related to the GetGoal Program involving the investigational glucagon-like peptide (GLP)-1 agonist lixisenatide were presented at the 2012 ADA annual meeting. Glycemic control was improved in patients with type 2 diabetes with once-daily lixisenatide added to various antidiabetes medications, including basal insulin in the GetGoal-L study, pioglitazone in the GetGoal-P study, and insulin glargine and oral agents in the GetGoal Duo 1 study.

Data presented from a phase 2b study with empagliflozin, a sodium glucose cotransporter-2, which increases renal glucose excretion, showed reductions in hemoglobin (Hb) A1c, fasting plasma glucose (FPG), and body weight in patients with type 2 diabetes at 90 weeks. Hans-Juergen Woerle, MD, Vice President, Boehringer Ingelheim, Germany, presented this randomized, multinational, open-label extension study in a late-breaking abstract session at the 2012 ADA annual meeting.

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