Preclinical Studies Show Promise For Novel Antibody Therapy To Treat Acute Myeloid Leukemia (AML)

CSL Limited, Australia’s leading
biopharmaceutical company, has presented data at the American Society
of Hematology (ASH) 49th annual meeting, which demonstrate the promising
pre-clinical activity of a novel monoclonal antibody, in the potential
treatment of acute myeloid leukemia (AML).

AML is an aggressive cancer of white blood cells and most commonly
occurs in adults. It is usually treated with chemotherapy but the cure rate
in adults is only about 30%. About 9,000 deaths from AML occur each year in
the United States(1). The novel antibody specifically targets the “core
cell” of AML, called the leukemic stem cell (LSC) which was first
identified in the laboratory of Professor John Dick, one of the key authors
of the study(2). It is currently thought that the resistance of leukemic
stem cells to chemotherapy is a major reason for the inability to cure most
AML, and that improving the outlook for patients with AML will require
elimination of these cells.

The antibody used in the research, called 7G3, was first created by Dr
Angel Lopez at the Hanson Centre for Cancer Research in Adelaide, South
Australia. It hones in on CD123 (IL-3 receptor alpha chain) on the surface
of the LSC, blocking its function, growth and survival. CD123 is found on
the surface of normal blood stem cells much less frequently, and 7G3 should
therefore have no effect on normal blood cell development.

The research presented at the ASH meeting by key investigator Associate
Professor Richard Lock of Children’s Cancer Institute Australia for Medical
Research in Sydney, describes the results of treatment with 7G3 of
irradiated immune-deficient mice with AML.

Two central experiments were undertaken; firstly human AML stem cells
were treated with 7G3 and then injected into the mice, which were compared
with a control group of mice injected with untreated AML stem cells. The
overall survival of treated engrafted mice was significantly improved with
the median survival of control group 11.5 weeks versus 24 weeks for the
antibody-treated group.

Secondly, 7G3 was administered to mice with established AML.
Administration of the antibody to these mice reduced AML dissemination
around the body of the mice. The ability of leukemic stem cells from mice
treated in this way to reestablish leukemia as secondary transplants into
other animals was markedly reduced.

In contrast, exposure to 7G3 had little effect on normal human bone
marrow stem cells.

“These results show that 7G3 is able to target LSC’s to prevent them
from moving around and proliferating in the mice, while at the same time
having little effect on normal blood cells,” said Dr Lock at the ASH
meeting today.

“This is a very exciting finding because it is one of the first drugs
that has been designed to specifically target the LSC, rather than simply
attacking the cancer cells proliferating in the blood and bone marrow.
Hopefully this means that it can fight leukemia without many of the side
effects of current drugs. It opens up an exciting new option for the
treatment of AML,” he said.

CSL wishes to acknowledge the contribution of the University Health
Network in Toronto, Canada, The Institute of Medical and Veterinary
Science/Hanson Institute for Cancer Research in South Australia, Children’s
Cancer Institute Australia for Medical Research in Sydney, Australia and
the Queensland Institute for Medical Research, Australia, its key
collaborators in this important project.

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Violent Video Games Fire Up Kids’ Brains

Teenagers’ brains are fired up by violent video games, while at the same time areas of the brain associated with self control become subdued, say researchers from the Indiana University School of Medicine.

Dr. Vincent Mathews, head researcher, explained that this study shows, for the first time, that violent video games affect the physiology of the brain and the way it functions. He said the teenagers had increased activity in the amygdala, an area of the brain involved in emotional arousal. “At the same time, they had decreases in activity in parts of the brain which are involved in self-control,” he said.

Video games are big business – in the USA alone sales hit over $10 billion in 2005.

44 teenagers were randomly asked to either play a violent video game or a non-violent one, for half-an-hour, after which they underwent an fMRI (functional magnetic resonance imaging). An fMRI measures changes that take place in the active brain in real time. The teenagers of either group did not differ in age, IQ or gender.

They found that those who had played the violent games had more activity going on in the amygdala, as opposed to the teenagers who played the non-violent games (who did not have more activity there). Those playing the violent games also had lower activity in prefrontal areas of the brain – these areas are associated with self control, inhibition and focus (concentration), compared to the non-violent game players (who did not have lower activity there).

The researchers said further studies are needed to determine whether these physiological changes make individuals behave more violently.

Dr. Mathews presented the findings at the Annual Meeting of the Radiological Society of North America.

“Short-term Effects of Violent Video Game Playing: An fMRI Study”
Vincent Mathews, M.D., Yang Wang, M.D., Andrew J. Kalnin, M.D., Kristine M. Mosier, D.M.D., Ph.D., David W. Dunn, M.D., and William G. Kronenberger, Ph.D
Click here to view abstract online

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Single Reader With CAD More Efficient, Yields Fewer False Positives, And Possibly More Sensitive Than Double Reading Of Mammograms

Single reading of screening mammograms with computer-aided detection (CAD) is more efficient than double reading and yields a higher sensitivity than the first reader in a double reading program, according to a study conducted by researchers at Charlotte Radiology in Charlotte, NC. In addition, the readings with CAD had a significantly lower recall rate than double reading.

The double reading method consisted of the mammogram being first read by sub-specialized mammographers, with the second reading performed by either a specialist or a general radiologist who is certified in mammography. Single reading with CAD was performed by sub-specialized mammographers.

The study compared the recall rate, sensitivity, positive predictive value (PPV), and cancer detection rate of single reading with CAD to double reading and to the first reader in the double reading program in 231,221 mammograms from 2001-2005. The study shows that single reading with CAD was as effective at finding cancers as double reading and had a lower recall rate.

“Because double reading is time consuming and not generally reimbursed, CAD has become increasingly popular in the United States as an alternative way to increase sensitivity,” said Matthew Gromet, JD, MD, author of the study.

According to the study, statistically significant results included a lower recall rate with CAD compared to double reading (10.6% vs. 11.9%), increased sensitivity with CAD compared to the first reader (90.4% vs. 81.4%), and increased recall rate with CAD compared with the first reader (10.6% vs. 10.2%). The sensitivity of single reading with CAD was slightly higher than double reading (90.4% vs. 88.0%), although this difference did not reach statistical significance.

“With manpower and cost constraints limiting the use of double reading, CAD appears to be an effective and more widely accessible alternative that provides a lower recall rate and equal or possibly higher sensitivity,” said Dr. Gromet.

The full results of this study will appear in the April 2008 issue of the American Journal of Roentgenology.

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Prize4Life Launches $1 Million Prize For Finding Novel Treatment Candidates For ALS

Prize4Life, a non-profit organization, today launched its latest prize, a one million dollar ($1M) award for finding a treatment candidate that reliably and significantly increases the lifespan in mouse models of ALS (amyotrophic lateral sclerosis), commonly known in the US as Lou Gehrig’s disease. This prize, called the “Avi Kremer ALS Treatment Prize,” is open to all interested researchers worldwide with the goal of accelerating the discovery of treatments and cures for ALS.

ALS is a rapidly progressing neurodegenerative disease that typically steals the life of patients within 2-5 years of diagnosis. It is caused by the degeneration of motor neurons, the nerve cells in the central nervous system that control voluntary muscle movement. It most commonly strikes people between the ages of 40 and 70, and affects men slightly more than women. ALS is the most common motor neuron disease worldwide, and as many as 30,000 Americans struggle with the disease at any given time. There is no known cure for ALS and only one FDA-approved treatment for the disease.

“An effective treatment for ALS is desperately needed, and the existing mouse model is the primary gateway to clinical trials. The identification of a treatment capable of meeting the high survival bar set forward in this prize should attract the attention of those with the resources necessary to move a potentially effective ALS therapy into the clinic,” said Dr. Tom Maniatis, the Jeremy R. Knowles Professor of Molecular and Cellular Biology at Harvard University, who is a prominent ALS researcher and member of Prize4Life’s Scientific Advisory Board. “The Kremer prize will only be awarded for a therapy that makes a major difference in the disease, the kinds of therapies that ALS patients really need.”

With the launch of the ALS Treatment Prize, Prize4Life is hoping to increase the number of novel ALS treatments in the drug development pipeline. As a critical first step to expanding the pipeline of potential new therapies, the ALS treatment prize will encourage the testing of a wide variety of potential therapies in ALS mouse models, a critical scientific and regulatory hurdle for the development of new drugs. In addition to posting the million-dollar prize, Prize4Life has also pledged to spend up to $500,000 additional dollars for independent validation of therapies that meet the bar set by the treatment prize, which is a 25% extension of lifespan in two different animal models of ALS.

Prize4Life was the first disease-oriented organization to utilize the incentive prize model to address neurodegenerative disease — specifically finding treatments and cures for ALS. “There are challenges to this model, to be sure,” noted Dr. Maniatis, “but if Prize4Life succeeds, the payoff could be huge. This effort could have major implications not just for ALS patients, but for any group looking to bring new ideas to the table for solving a biomedical problem.”

The ALS Treatment Prize will have a rolling deadline. If no winning solutions are submitted, the prize will be closed to further submissions in October 2010. Interested researchers can learn more about the prize and register to compete at prize4life.

About Prize4Life and the Avi Kremer ALS Treatment Prize

Prize4Life was founded by a group of Harvard Business School students when one of them, Avi Kremer, was diagnosed with ALS at the age of 29. The founders sought to attract new minds, media, and money to the battle against ALS to expand upon existing efforts and increase the resources available to researchers. Several years later, even as the disease takes its inexorable toll, Mr. Kremer continues to lead and drive the organization which has garnered a significant amount of attention for its pioneering model and has helped inject a newfound hope in ALS patients and their families. The funding for the latest prize was given by an anonymous donor whose only request was that this prize be named the “Avi Kremer ALS Treatment Prize” in honor of Prize4Life’s founder and CEO. The Avi Kremer ALS Treatment Prize is the second major prize launched by this non-profit organization.

The organization’s first prize, a $1 million award for the discovery of a clinically relevant biomarker, released in November 2006, has already attracted over 50 competing teams from around the world, including a number of researchers outside the field of ALS who have sought to apply novel solutions to the biomarker challenge. The deadline for submissions to this first prize challenge is November 6, 2008.

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UNC Researchers Receive $100,000 Grand Challenges Exploration Grant To Develop Male Contraceptive

The University of North Carolina at Chapel Hill has received a $100,000 Grand Challenges Explorations grant from the Bill & Melinda Gates Foundation. The grant will support an innovative global health research project conducted by James Tsuruta, PhD, and Paul Dayton, PhD, titled “Ultrasound as a long-term, reversible contraceptive.”

Tsuruta is an assistant professor in the Laboratories for Reproductive Biology in UNC’s Department of Pediatrics. Dayton is associate professor and director of graduate studies in the Department of Biomedical Engineering, which is jointly housed at UNC and N.C. State University.

Tsuruta and Dayton’s project is one of 78 grants announced by the Gates Foundation in the fourth funding round of Grand Challenges Explorations, an initiative to help scientists around the world explore bold and largely unproven ways to improve health in developing countries. The grants were provided to scientists in 18 countries on six continents.

To receive funding, Tsuruta and Dayton showed in a two-page application how their idea falls outside current scientific paradigms and might lead to significant advances in global health. The initiative is highly competitive, receiving almost 2,700 proposals in this round.

“Our long-term goal is to use ultrasound from therapeutic instruments that are commonly found in sports medicine or physical therapy clinics as an inexpensive, long-term, reversible male contraceptive suitable for use in developing to first world countries,” said Tsuruta.

“We think this could provide men with up to six months of reliable, low-cost, non-hormonal contraception from a single round of treatment,” Tsuruta said. Tsuruta notes that the initial idea to re-examine the effects of ultrasound on sperm production came from another private foundation. “The financial support of the Parsemus Foundation was instrumental in forming a team to study ultrasound’s effect on the testis. Our pilot studies would not have been possible without the support of Elaine Lissner (Parsemus), David Sokal (Family Health International), Michael Streicker (Integrated Laboratory Systems) and Michael O’Rand (UNC-CH).

Tsuruta and Dayton have successfully depleted testicular sperm using therapeutic ultrasound instruments. Once the testis has stopped producing sperm and all “sperm reserves” have been depleted, it is impossible to be fertile. Their Grand Challenges Exploration Grant project is aimed at fine-tuning this technique for maximum effect and safety.

“The winners of these grants show the bold thinking we need to tackle some of the world’s greatest health challenges,” said Dr. Tachi Yamada, president of the Gates Foundation’s Global Health Program. “I’m excited about their ideas and look forward to seeing some of these exploratory projects turn into life-saving breakthroughs.”

About Grand Challenges Explorations

Grand Challenges Explorations is a five-year, $100 million initiative of the Gates Foundation to promote innovation in global health. The program uses an agile, streamlined grant process – applications are limited to two pages, and preliminary data are not required. Proposals are reviewed and selected by a committee of foundation staff and external experts, and grant decisions are made within approximately three months of the close of the funding round.

Applications for the current round of Grand Challenges Explorations are being accepted through May 19, 2010. Grant application instructions, including the list of topics for which proposals are currently being accepted, are available here.

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ORange Wavefront Aberrometer Proves Successful In Determining Refraction In Cataract Patients Who Previously Had LASIK Surgery

WaveTec Vision, the leader in wavefront-guided custom cataract™ surgery, announced today that its ORange® intraoperative wavefront aberrometer has been shown to be more predictable in determining refraction in the post-refractive eye, than any other post-LASIK formula currently available.

“Following LASIK, patients expect a lifetime of quality uncorrected vision. Unfortunately, these same patients are the most difficult to predict the optimal IOL power when they develop cataracts”

Wavefront custom cataract aberrometry with ORange is a breakthrough in modern cataract surgery. The technology has been clinically proven to increase accuracy and improve refractive outcomes: 73 percent of procedures are within 0.5D of intended target, versus 58 percent with traditional cataract surgery using standard method biometry.

“Following LASIK, patients expect a lifetime of quality uncorrected vision. Unfortunately, these same patients are the most difficult to predict the optimal IOL power when they develop cataracts,” Eric Donnenfeld, MD said. “WaveTec’s ORange, in my experience and now documented in studies, is the best technology to improve refractive outcomes and overall patient satisfaction in post LASIK eyes.”

A patented diagnostic breakthrough, ORange allows cataract surgeons – for the first time – to measure refraction during surgery, so they can precisely predict and customize how their patients will see following the procedure.

The new post-LASIK coefficients which are part of the recently released ORange v2.6 software upgrade, will greatly improve post operative cataract refractive outcomes for patients having undergone previous corneal refractive surgery.

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Vitamin-D Enhanced Mushrooms

A new commercial processing technology is suitable for boosting the vitamin D content of mushrooms and has no adverse effects on other nutrients in those tasty delicacies, the first study on the topic has concluded. The technology, which involves exposing mushrooms to the same kind of ultraviolet light that produces suntans, can greatly boost mushrooms’ vitamin D content. It appears in ACS’ Journal of Agricultural and Food Chemistry.

Ryan Simon and colleagues note that many people do not get enough vitamin D in their diets. Few natural foods are high in the vitamin, and there are limits on what foods can be fortified to boost the vitamin D content. Although few people realize it, mushrooms are an excellent natural source of vitamin D. Some producers have embraced results of earlier studies, suggesting that exposing mushrooms to ultraviolet B (UVB) light can significantly boost the vitamin D content.

The scientists set out to answer several questions about commercial-scale UV light processing of mushrooms. Among them: Does it produce consistently high levels of vitamin D and does it adversely affect other nutrients in mushrooms? They compared button mushrooms exposed to UVB light, those exposed to natural sunlight and those kept in the dark. The UVB-exposed mushrooms got a dramatic boost in vitamin D (700 percent more of the vitamin than those mushrooms exposed to no light) and the UVB processing had no effect on levels of vitamin C, folate, riboflavin, niacin and a host of other essential nutrients.

The authors acknowledge funding from the U.S. Mushroom Council. Continue reading

IntelliDOT Announces Fast, Cost-Effective Solution To Comply With New NDC Rule For CMS Outpatient Claims

IntelliDOT Corporation, a leading provider of handheld, barcode point-of-care (BPOC) solutions to hospitals, today announced that IntelliDOT Bedside Medication Administration™ (IntelliDOT BMA™) now enables hospitals to comply with the CMS requirement to report National Drug Code (NDC) numbers for drugs administered in outpatient settings.

“Any CMS 1500 claims for medications administered in outpatient settings will be denied if they do not include the NDC and Healthcare Common Procedure Coding System code,” said David Swenson, RPh and Chief Clinical Officer at IntelliDOT. The rule went into effect after June 30, 2008 (April 1, 2009 for California). “This could end up costing hospitals a significant amount of money per year in lost reimbursements.”

The 1991 Medicaid Drug Rebate Program requires drug manufacturers to enter agreements with the Centers for Medicare and Medicaid Services (CMS) and provide rebates for their products paid for by Medicaid. The Deficit Reduction Act of 2005 further required states to collect drug data in order to expand the program to include drugs dispensed in outpatient settings. In 2007, CMS decided to use NDC numbers to correctly identify the drug and manufacturer, as a way to maximize rebates.

“A barcode scanning system is the only realistic way to collect this data,” said Paul Seelinger, RPh and Sr. Director of Clinical Operations at IntelliDOT. “Many hospitals do not have these systems in place. Manually entering NDC numbers is a difficult, time-consuming process. Our solution is cost-effective, field-proven, and can be implemented in a matter of weeks.”

By implementing IntelliDOT BMA in outpatient areas like ER or Radiology, hospitals can achieve 100 percent NDC billing compliance. Upon admittance, each patient is issued a wristband with a unique identifying barcode. All drug packages are also barcoded and those barcodes and corresponding NDCs are stored in the IntelliDOT System drug master file. Before medication is administered, the nurse simply scans the patient’s wristband with one of IntelliDOT’s wireless handheld devices and then scans the medication.

The scan of the medication barcode identifies the exact brand of the medication and the amount being given. The patient information and barcode are sent wirelessly to the IntelliDOT server. The server looks up the barcode’s associated NDC number and includes it in the HL7 DFT billing message sent to the pharmacy information system (or any other system that handles the hospital’s medication billing).

“The drug master in the IntelliDOT System supports a many-to-one relationship between multiple brands of that medication stocked by the pharmacy and the individual formulary line item,” said Swenson. “For example, IntelliDOT BMA can accommodate several different brands of ibuprofen, including generics, and the individual barcodes associated with each brand. In turn, we can associate the corresponding NDC with every unique medication barcode.”

An automatic update feature included in IntelliDOT BMA ensures that NDCs are kept up-to-date in the drug master database.

“Hospital leaders tell us their current pharmacy and billing systems cannot capture the NDC,” said Seelinger. “The IntelliDOT System drug master was designed by pharmacists, which accounts for our preparedness for this requirement. It is the only system today that can meet all of a hospital’s CMS billing requirements for NDC compliance.”

The IntelliDOT System is a best-of-breed wireless, workflow manager that connects caregivers with the information systems they need at the point-of-care. Designed by nurses for nurses, the IntelliDOT System enables clinicians to perform safety checks and safely administer and document medications at the bedside using a lightweight, handheld device. The IntelliDOT System satisfies Joint Commission standards for patient identification and assures accuracy by verifying the five rights of medication administration: right medication, right dose, right route, right patient, right time; as well as ensuring required follow-up documentation, such as pain scale, is performed in a timely manner and accurately recorded.

About IntelliDOT® Corporation

IntelliDOT is a leading provider of wireless, handheld, barcode point-of-care (BPOC) solutions that connect to any healthcare information system to improve patient safety and nurse workflow. When using the IntelliDOT System, nurses can easily manage all tasks associated with five rights medication administration safety checks and related documentation. Additional modules that run on the same handheld device include: IntelliDOT Phlebotomy Specimen Collection™, IntelliDOT Blood Product Administration™, IntelliDOT Mother-Baby Breast Milk Matching™, and IntelliDOT Vital Signs Collection™.

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Third Phase III Study Of Avastin-Based Regimen Met Primary Endpoint In Ovarian Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that OCEANS, a Phase III study evaluating Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and gemcitabine) followed by continued use of Avastin alone until disease progression in women with previously treated (recurrent), platinum-sensitive ovarian cancer, met its primary endpoint.

The study showed that women who received a combination of Avastin and chemotherapy, followed by the continued use of Avastin alone, lived longer without their disease worsening (progression-free survival or PFS), compared to women who received chemotherapy alone. No new safety findings were observed and adverse events were consistent with those seen in previous pivotal trials of Avastin. Full data from the OCEANS study will be submitted for presentation at an upcoming medical meeting.

“We are very pleased with the results of the OCEANS study, as women with ovarian cancer need new treatment options,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “Avastin has now demonstrated a significant improvement in PFS in ovarian cancer in three large Phase III studies, and we look forward to sharing the data at an upcoming medical meeting.”

The results from this trial build on findings from two previous Phase III studies (GOG 0218 and ICON7) in women with newly diagnosed ovarian cancer. Both of these studies demonstrated that front-line Avastin in combination with standard chemotherapy (carboplatin and paclitaxel), followed by the continued use of Avastin alone, significantly increased the time women with ovarian cancer lived without their disease getting worse, compared to those treated with chemotherapy alone. Roche has submitted a European Union marketing authorization application for the use of Avastin in the front-line setting based on the results from GOG 0218 and ICON7 and expects a decision from the Committee for Medicinal Products for Human Use (CHMP) later this year. Genentech plans to submit applications in the United States for the use of Avastin in ovarian cancer in 2011.

About the OCEANS Study

OCEANS is a multicenter, randomized, double-blind, placebo-controlled Phase III study in 484 women with platinum-sensitive recurrent ovarian, primary peritoneal or fallopian tube cancer. Women in OCEANS had received no more than one treatment regimen prior to enrollment in the trial. The trial was designed to evaluate Avastin (15 mg/kg every three weeks) in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin as a single agent until disease progression, compared to placebo in combination with carboplatin and gemcitabine chemotherapy followed by placebo alone. The primary endpoint of the study was PFS. The secondary endpoints of the study included overall survival, objective response, duration of response and safety.

The time between receiving the last dose of platinum-based chemotherapy and disease recurrence is used to help determine the choice of chemotherapy used in the next line of treatment. Patients are said to have ‘platinum-sensitive’ disease if disease recurrence occurred more than six months after completing their initial platinum-based chemotherapy, and ‘platinum-resistant’ disease if recurrence occurred within six months.

About Previous Phase III Studies of Avastin in Ovarian Cancer

The GOG 0218 Study

Results from the GOG 0218 study in 1,873 women with previously untreated advanced epithelial ovarian, primary peritoneal or fallopian tube carcinoma who already had surgery showed that women who received Avastin (15 mg/kg) in combination with chemotherapy (paclitaxel and carboplatin), and continued use of Avastin alone for a total duration of 15 months, had a median PFS of 14.1 months compared to 10.3 months in women who received chemotherapy alone (hazard ratio=0.72, p Continue reading

Use Of Sleep Meds For Patients With Apnea Questioned By Research

Prescription sleep aids may do little to improve the use of continuous positive airway pressure (CPAP) among patients with obstructive sleep apnea (OSA). A new study published in the November issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP), finds that patients with OSA who were given prescription sleep aids were no more likely to use their CPAP machines than patients with OSA taking a placebo.

“CPAP treatment improves daytime alertness and quality of life for most patients with OSA and may prevent some of the long-term complications of this disorder, including heart attacks and strokes,” said the study’s lead author Capt. David A. Bradshaw, MD, FCCP, Naval Medical Center, San Diego, CA. “Yet, many people find CPAP difficult to use. People with a good initial experience are more likely to use CPAP regularly. Our hypothesis was that a sleeping pill might help new CPAP users adjust to sleeping with the equipment and promote long-term usage.”

To determine the effect prescription sleep medications have on CPAP compliance, Capt. Bradshaw and colleagues compared CPAP use among 72 newly diagnosed male patients (mean age 38 ± 7 years) who were referred for CPAP treatment. All patients participated in standardized CPAP training and were randomized to receive the sleeping agent zolpidem (N=24), a placebo pill (N=24), or standard care (N=24) with no sleeping pill or placebo. Patients taking zolpidem or placebo were instructed to take one pill each night, 30 minutes prior to bedtime for the first 14 days of treatment. During the four-week trial, CPAP use was recorded by an internal data chip.

Compared with the placebo pill and standard care groups, the zolpidem group did not show greater CPAP usage in terms of total days used or average time used per night over the course of four weeks. When the initial 14 days of CPAP treatment were analyzed separately, there was also no difference in number of days used or average nightly use. Despite results, researchers believe prescription sleep medications, when used correctly, may prove helpful for a subset of patients with OSA.

“Studies have shown that almost half of patients with OSA have insomnia complaints,” said Capt. Bradshaw. “Our study does not support prescription sleeping pills for all new CPAP users, but OSA patients with insomnia symptoms might benefit.” Still, researchers remain cautious regarding the use of prescription sleep medications for patients with OSA.

“We are concerned, however, about the potential risk for worsening sleep apnea if patients intentionally or inadvertently remove the mask before the effects of the sleeping pill have worn off,” said Capt. Bradshaw. “Also, sleeping pills sometimes have residual daytime effects, such as sleepiness, and can interfere with cognitive function – both of which are already problems for many patients with OSA, even after treatment with CPAP.”

Upon completion of the trial, all patients showed significant symptom improvement on the Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ). Baseline demographics revealed no difference in age, body mass index, ESS, FOSQ, nadir oxygen saturation, or CPAP pressure setting among the three groups. Despite randomization, the standard care group had a higher apnea/hypopnea index than the other two groups.

“When used consistently, CPAP is a highly effective therapy for patients with obstructive sleep apnea,” said Mark J. Rosen, MD, FCCP, President of the American College of Chest Physicians. “More research is needed to determine interventions that can help optimize the initial experience with CPAP and improve long-term usage.”

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CHEST is a peer-reviewed journal published by the ACCP. The ACCP represents 16,500 members who provide clinical respiratory, sleep, critical care, and cardiothoracic patient care in the United States and throughout the world. The ACCP’s mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. For more information about the ACCP, please visit the ACCP Web site at chestnet/.

Contact: Jennifer Stawarz

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