FDA Panel Leans Against Eliminating PAD Device Access
Noting a significant body of evidence demonstrating the various benefits of paclitaxel-coated devices, an FDA advisory committee recently concluded
that the late mortality signal of the devices used in peripheral artery disease (PAD) should not cause the technology to be removed from the market. The panel unanimously judged that the improved quality of life and reduced need for repeat revascularization for PAD outweigh potential risks. However, while observing the low quality of available data, the panelists did verify the excess mortality risk associated with PAD devices and explained that this risk should be carefully communicated to health care practitioners and the general public. One panelist, Todd Rasmussen, MD, of Walter Reed National Military Medical Center, explained: "Regarding the magnitude, I find these findings statistically significant but not practically significant. As I sit in my office and talk to my patients, I would not underestimate our patients' ability to assess and access data and make their own decision." An additional panelist, Michael Krucoff, MD, of Duke University School of Medicine added: "We need to learn how to communicate a short-term benefit that is certain against a long-term risk that is uncertain."
New Study Evaluates Use of Genetic Variants Related to Antihypertensive Drugs to Inform on Efficacy and Side Effects
A recent study
published in Circulation
observed the benefits and harms related to anti-hypertensive drugs by evaluating the genetic makeup of study participants. The researchers utilized a large genetic database in the United Kingdom to search for specific genes that contain instructions for making proteins targeted by three commonly used blood pressure medicines: ACE inhibitors, beta-blocks, and calcium channel blockers. The researchers then assessed the associated harms and benefits. While the researchers were able to match certain variations in genes with the drug class' effect on lowering heart disease and stroke risk, the genetic variants targeted by calcium channel blockers had a "previously unreported possible side effect." In a statement to the American Heart Association
, Dr. Kiran Musunuru--an Associate Professor of Cardiovascular Medicine and Genetics at the University of Pennsylvania--remarked: "There's no obvious connection that would have led the medical community to suspect a link between calcium channel blockers and diverticulosis, but it appears there might be one after all. The idea of using genetic variants that mimic the effects of medications to get a better sense of whether the drugs will be effective and safe, before the medications are used in people, will be an important element of drug development going forward."
FDA Approves New Treatment for Pediatric Patients with Type 2 Diabetes
The U.S. Food and Drug Administration recently granted approval
for the GLP-1 receptor agnoist liraglutide (Victoza) for use in children ages 10 and older with type 2 diabetes. The approval marks the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. In a public statement, Lisa Yanoff, MD, acting director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research remarked, “The FDA encourages drugs to be made available to the widest number of patients possible when there is evidence of safety and efficacy. Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes. The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease.” Approval relied primarily on the phase III Elipse trial, which found an average HbA1c decline of 0.64% after 26 weeks compared with placebo. At least two additional GLP-1 agonists are currently under study for pediatric patients: duaglutide (Trulicity), and exenatide (Bydureon, Byetta).
Research Suggest BP Guidelines Too High To Prevent CAD in Type 1 Diabetes
presented at the American Diabetes Association suggests that "having blood pressure of more than 120/80 mm Hg combined with HbA1c of more than 8% makes coronary artery disease three times more likely to manifest for those with type 1 diabetes developed during childhood compared with those with lower measures." The researchers examined study participants for for 25 years with biennial surveys and exams at years 2,4,6,8,10,18, and 25, alongside statistic analysis to identify the risk for CAD at different levels of blood pressure. During the presentation, researcher Jingchuan Guo, MD, PhD explained, “Currently, the American Diabetes Association recommends a blood pressure goal of 140/90 [mm Hg] for diabetes individuals with lower heart disease risk and 130/80 [mm Hg] for those with existing heart disease or those with higher risk. There’s no clinical trial data available to guide blood pressure management goals in young adults with type 1 diabetes, " adding, "Our study suggests optimal blood pressure goals need to be lower than current[ly] recommended to further reduce the risk in this group of patients. Young adults with type 1 diabetes should have careful monitoring of their blood pressure [and], because of the absence of direct randomized clinical trial data, our findings should be carefully considered in clinical settings."