Further results from the initial clinical trial of the ClariVein(TM) catheter, used in a new minimally invasive treatment for varicose veins, will be delivered on Friday, September 25, at the 23rd Annual Meeting of the Eastern Vascular Society in Philadelphia. The device combines mechanical and chemical modalities to accomplish vein treatment in an in-office setting.

Speaking is Steve Elias MD FACS FACPh, Associate Professor of Surgery at Mount Sinai Hospital, NY and the Director of The Centers for Vein Disease at Mount Sinai and Englewood Hospitals. Dr. Elias is the principle investigator of the trial, which was conducted at Englewood Hospital and Medical Center, NJ. Thirty patients were studied in this IRB-regulated trial.

“Initial results were very encouraging, and the success rates continue to be excellent as we follow patients over a longer period,” Dr. Elias states. “The success rates are equal to the early results of radiofrequency or laser treatment of great saphenous vein disease. The main advantage is that the technique does not require tumescence anesthesia infusion, thus saving significant time and decreasing patient discomfort. In addition, no generator is required and capital and maintenance cost is reduced. This in-office procedure takes about 15 minutes to perform and patients resume normal activity that day. All patients would recommend the procedure to others.”

The ClariVein(TM) catheter is a product of Vascular Insights LLC of Madison, CT. The company engages in the design, development, manufacture, and marketing of medical devices for the minimally invasive treatment of peripheral vascular disease. The company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market ClariVein(TM) for infusion of physician-specified agents in the peripheral vasculature.

Dr. Elias is scheduled to speak at the 10:00 am scientific session at the Loews Philadelphia Hotel.

Source: Vascular Insights LLC

Myelodysplastic syndromes (MDS), a group of blood disorders that can lead to acute myeloid leukemia (AML) in some patients, often cause severe anemia (when the body lacks a sufficient number of functional red blood cells). While certain treatments can help manage the symptoms of anemia, some studies have suggested that they may lead to complications. A new study, however, demonstrates that MDS patients with anemia may benefit from treatment with an erythropoietin (EPO)-based regimen plus supportive care without added complications as compared with those receiving supportive care alone. The study appears in the September 17 issue of Blood, the official journal of the American Society of Hematology.

The phase III prospective, randomized trial, conducted by research teams of the Eastern Cooperative Oncology Group, was designed to evaluate the efficacy and safety of EPO with or without myeloid growth factor treatment (G-CSF, or granulocyte colony-stimulating factor) and supportive care (SC) with red blood cell transfusions for patients with early-stage MDS (n=53), in comparison to supportive care alone (n=57).

For the study, the researchers followed MDS treatment and dosing guidelines recommended by the National Comprehensive Cancer Network, which include managing anemia with erythropoiesis-stimulating agents (ESAs) such as EPO. EPO is a drug that imitates the action of the hormone erythropoietin, which stimulates the body to produce more red blood cells. Generally, therapy with G-CSF interacts with EPO treatment synergistically to improve erythroid (red blood cell) responses, especially in MDS patients that do not respond to EPO alone.

“EPO is a recommended treatment for MDS, but the combination with G-CSF and supportive care required comparative studies in this patient population,” according to lead study author Peter Greenberg, MD, Professor of Medicine, Stanford University Cancer Center. “Our goal was to manage anemia while not increasing the risk of transformation to leukemia, and we undertook this study to understand if this combination might be successfully utilized in these patients.”

The results of the study proved successful for this group of patients with lower-risk MDS and anemia. After the first course of therapy, 36 percent of patients in the EPO arm responded to treatment, compared with only 9.6 percent in the SC alone arm. After subsequent courses, 47 percent responded in the EPO arm. Researchers then followed both patient groups for a median of 5.8 years to determine their long-term response to treatment. Responders to EPO experienced increased survival in comparison to the non-responders (5.5 vs. 2.3 years) and significantly improved physical, emotional, and functional well-being, reduced fatigue, and improved overall quality of life. The research team otherwise found no statistically significant differences in overall survival of patients between the EPO and SC arms (3.1 vs. 2.6 years) or the incidence of transformation to AML (7.5 vs. 10.5 percent of patients, respectively), suggesting long-term safety of the EPO treatment regimen.

The study results also indicated that the combination of EPO plus G-CSF was beneficial for patients who either did not respond initially to EPO or who experienced a delayed response. Furthermore, higher doses of EPO seemed to prove valuable for a proportion of patients who initially failed to respond. Importantly, the outcomes suggested long-term tolerance to the treatment combination, with a low overall incidence of adverse events. Specifically, the researchers found no significant treatment-related increase in incidence of either cardiovascular or thrombotic (clotting) events or transformation to AML in the patients who received EPO alone or with G-CSF, as compared with those in the SC arm.

Recently, the FDA has issued alerts regarding the use of ESAs, noting increased mortality, possible tumor promotion, and thromboembolic events that have been observed in some studies of non-MDS patients receiving ESAs. However, other studies of patients with solid tumors receiving chemotherapy did not demonstrate an adverse effect of ESAs on survival.

“We believe the data suggest that the negative effects of cytokines, like ESAs, demonstrated in some studies of other diseases may relate to biologic and clinical features or the specific treatments associated with the differing disorders studied,” said Dr. Greenberg. “Findings from this study demonstrate the relative safety and efficacy of EPO plus G-CSF for treating anemic lower-risk MDS patients and may be considered as part of future treatment recommendations for the use of this class of therapies.”

Source:
Patrick C. Irelan

American Society of Hematology

The National Community Pharmacists Association (NCPA) and the American Association of Diabetes Educators (AADE) announced a partnership that will expand counseling options for patients while offering community pharmacies a path to be compensated by diabetes management.

Traditionally, Diabetes Self-Management Education/Training (DSME/T) services have been limited to hospital settings, but falling reimbursements have created an access void for patients. Community pharmacists already play an active role in helping patients cope with diabetes, such as through prescription management or dispensing of glucose meters and therapeutic shoes. DSME/T is the next logical step.

The NCPA-AADE partnership will allow community pharmacists to obtain the training to conduct intensive, comprehensive educational classes targeted to diabetes patients to ensure every measure is being incorporated to improve their health outcomes and ultimately lower costs. The training will be provided by AADE, the recognized leader in DSME/T, and NCPA.

After fulfilling the 16 hours of certified training, comprised of online and live training, the community pharmacist will be eligible to serve as an instructor within an accredited diabetes education program. It also provides the pharmacist with the opportunity to accumulate enough hours providing DSME/T to be eligible to take the certified diabetes educator exam.

Additionally, training will be provided on how to apply to become an accredited DSME/T program, which is necessary for reimbursement. In order to offer DSME/T, community pharmacists should have sufficient room for conducting classes. These can either be within their pharmacy or in a community setting such as senior centers and assisted living homes.

“With each passing year the number of Americans with diabetes grows, along with the urgency to find proven solutions,” said Bruce T. Roberts, RPh, NCPA executive vice president and CEO. “In that vein, NCPA is excited to join with AADE to train community pharmacists to provide comprehensive and structured diabetes self-management services that will positively affect the lives of patients.”

“We are pleased to have formed a partnership with the National Community Pharmacists Association,” said Lana Vukovljak, MA, MS, AADE chief executive officer. “By working together to provide critical diabetes self-management education at the community level, more people with diabetes will receive the training they need to maintain optimal health.”

Besides differentiating themselves from chain pharmacists or mail order distributors, participating community pharmacists will have access to another revenue stream and raise their profile as clinically-trained health care professionals. Diabetes affects 23.6 million Americans (with 57 million having pre-diabetes) at a cost of $174 billion, according to 2007 data compiled by the Centers for Disease Control and Prevention. As part of this effort, NCPA and AADE are pursuing additional sponsorships to measure the effectiveness of the DSME/T program. Armed with that information the program can expanded.

The two associations introduced NCPA members to the DSME/T offering in a conference call yesterday. The accreditation process is available on a limited basis and will be offered no more three times a year. The first opportunity will occur at NCPA’s 111th Annual Convention held October 17 - 21 in New Orleans, Louisiana.

To register for the first session go here or call 1-866-575-4134.

“NCPA’s expectation is that many of our members will seize on this opportunity, because they know a better educated diabetes patient can avoid the more debilitating, but preventable aspects that come from the disease,” added Roberts.

Source
The National Community Pharmacists Association