Archive for Mayo, 2009

Younger Men With Advanced Prostate Cancer Have Shorter Survival Times

Mayo 23rd, 2009 | Category: prostate

While young men with prostate cancer have a low risk of dying early, those with advanced forms of cancer do not live as long as older men with similar forms of the disease. That is the conclusion of a new study published in the July 1, 2009 issue of CANCER, a peerreviewed journal of the American Cancer Society. The paradoxical findings indicate that there may be biological differences between prostate cancers that develop in younger men and those that develop in older men, and that uncovering these differences may help tailor screening and treatment strategies for patients based on age.

In general, a younger cancer patient has a better prognosis than an older patient with the same type of cancer. Few studies have analyzed the health of younger vs. older men after diagnosis and treatment for prostate cancer, though.

To investigate the impact of age on prostate cancer prognosis, Daniel Lin, M.D., of the University of Washington and colleagues designed a study to examine the association between age at diagnosis and health outcomes in men diagnosed with prostate cancer in the United States. Mining the National Cancer Institutes Surveillance, Epidemiology, and End Results (SEER) database, the investigators identified 318,774 men diagnosed with prostate cancer between 1988 and 2003. Men aged 35 to 74 years were stratified by age at the time of diagnosis, and the researchers examined differences in tumor characteristics, treatment, and survival within each age group.

The analysis revealed that, over time, men are being diagnosed with prostate cancer at younger ages, likely due to more extensive screening. Also, younger men are more likely to be treated with prostatectomy, have less aggressive cancers, and have a better chance of survival after 10 years compared with older men. However, among men with advanced prostate cancers, the youngest men (aged 35 to 44 years) have a particularly poor prognosis compared with older men. These young men are more likely to die from cancer or another cause sooner than older men with similar forms of cancer.

While the reasons for this unexpected finding are not clear, the researchers suspect that young men with advanced prostate cancer may have biologically more aggressive forms of the disease than the forms that are diagnosed in older men. Additional studies are needed to determine what, if any, underlying differences exist between advanced prostate cancer found in young men vs. those found in older men. These studies may help clinicians improve screening in young men and could ultimately lead to the development of better treatment strategies for these patients.

Article “Treatment and survival outcomes in young men diagnosed with prostate cancer a population based cohort study.” Daniel W. Lin, Michael Porter, and Bruce Montgomery. CANCER; Published Online May 22, 2009 (DOI 10.1002/cncr.24324); Print Issue Date July 1, 2009.

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David Sampson

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Rexahn Achieves 50% Enrollment Milestone In Serdaxin™ Phase IIa Clinical Trial For Depression

Mayo 22nd, 2009 | Category: depression

Rexahn Pharmaceuticals, Inc. (NYSE Amex RNN), announced that it has enrolled 50% of the total projected enrollment required for its Phase IIa trial to evaluate the safety and preliminary efficacy of Serdaxin™ as a central nervous system based treatment for Major Depressive Disorder (MDD). The complete trial calls for the enrollment of up to 80 patients at multiple clinical trial sites in the United States.

“This patient enrollment milestone in the Serdaxin clinical trial is an exciting step forward. We anticipate that enrollment will continue to move quickly, and preliminary study results may be available by year end. Serdaxin is of particular importance in meeting unmet needs in depression, because it appears to have fast onset of action in animal models and lacks the serious side effects associated with existing antidepressant drugs, including nausea, vomiting, insomnia, weight gain and sexual dysfunction.” Said Dr. Chang Ahn, CEO of Rexahn

The Serdaxin Phase IIa clinical trial is designed as a randomized, double blind, placebo controlled and dose ranging study. Main endpoints include clinically validated depression rating scales, and quality of life surveys. The Serdaxin Phase IIa study in MDD was initiated February 2009, and the Company anticipates completion of enrollment by July 2009.

Rexahn will be presenting at the BIO 2009 International Convention at the Georgia World Congress Center (Room 314, Building A, Level 3) in Atlanta, GA on Wednesday, May 20, 2009 at 300 PM ET.

About SerdaxinTM

SerdaxinTM is a potential market leading CNS neuroprotective agent and antidepressant. Among lead indications, we are investigating Serdaxin for depression in Phase II clinical trials. Serdaxin may achieve greater and broader therapeutic coverage, and appears to have no serious side effects such as nausea, vomiting, insomnia, weight gain, sexual dysfunction, cognitive deficit or motor impairment that are linked to existing antidepressant drugs. Serdaxin has wellestablished and excellent human safety. In preclinical studies, Serdaxin had onset of action in less than two days. Based on its novel mechanism as a dual serotonin and dopamine enhancer, it is a potential treatment for multiple CNS disorders where these neurotransmitters are depleted or implicated in CNSbased illnesses, such as Parkinsons disease (PD). Serdaxin has the potential to address both nonmotor and motor events of PD by serving as a neuroprotective agent and addressing loss of dopaminergic neurons that lead to loss of control of movements; and further, enhancing serotonin and dopamine levels that are involved in depression and mood disorders. Rexahn has multiple clinical programs planned for Serdaxin including depression and anxiety disorders, Parkinsons disease, Alzheimers and neurodegenerative illnesses, neuroprotection and biodefense uses.

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Care For School Children With Diabetes May Be Improved By Telemedicine

Mayo 21st, 2009 | Category: diabetes

Type 1 diabetes is the most common chronic childhood disease. The management of this serious medical condition includes regular fingerstick glucose measurements, multiple daily injections of insulin, and frequent insulin dose adjustments. Because children spend a great deal of their time in school, school nurses often supervise medical decisions and diabetes care. Some researchers believe that the use of telecommunication technology may make diabetes care easier for some children. A new study soon to be published in the Journal of Pediatrics explores the effectiveness of telemedicine in helping school nurses and children manage diabetes care.

Dr. Roberto Izquierdo and colleagues from SUNY Upstate Medical University in Syracuse, NY, studied 41 children between the ages of 5 and 14 years with type 1 diabetes. All of the children received routine care, and 23 of the 41 children were also enrolled in a telemedicine intervention program. As a part of routine care, letters containing instructions for each childs diabetes care were sent to the school nurses, who also attended an annual diabetes education program. Additionally, all children visited the diabetes center at SUNY Medical University every three months, and parents, children, and school nurses communicated with the center via phone as needed. In addition to receiving regular care, the 23 children enrolled in the telemedicine intervention program attended video conferences with the school nurse and the diabetes center monthly to discuss treatment orders. Their glucose readings were sent to the center via the telemedicine unit, and the diabetes nurse practitioners at the center made adjustments to insulin treatments as needed.

During the initial six month period of use, the telemedicine group experienced improved blood sugar control and fewer visits to the Emergency Department and/or hospitalizations due to their diabetes. The telemedicine program was well accepted by the participants, with more than 90% stating they would use the program again. According to Dr. Izquierdo, “Children in the telemedicine treatment group were more apt to feel better about their diabetes.” He also notes that the children who used the telemedicine program were more likely to complete the prescribed diabetes care related tasks, which can lead to improved management of the disease. Dr. Izquierdo and his colleagues are hopeful that school telemedicine programs could improve diabetes care in the future.

The study, reported in “SchoolCentered Telemedicine for Children with Type 1 Diabetes Mellitus” by Roberto Izquierdo, MD, Philip C. Morin, MS, CCRP, Kathleen Bratt, PNP, CDE, Zoryana Moreau, FNP, CDE, Suzanne Meyer, RN, CDE, Robert PloutzSnyder, PhD, Michael Wade, MS, and Ruth S. Weinstock, MD, PhD, appears in The Journal of Pediatrics, DOI 10.1016/j.jpeds.2009.03.014, published by Elsevier.

Source
Brigid Huey

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New Target In Fight Against Osteoporosis, Periodontitis Identified By Dental Researchers

Mayo 20th, 2009 | Category: diabetes

Osteoporosis and periodontitis are common diseases whose sufferers must cope with weakness, injury and reduced function as they lose bone more quickly than it is formed. While the mechanism of bone destruction in these diseases is understood, scientists have had less information about how bone formation is impaired.

Now, researchers at the UCLA School of Dentistry, working with scientists at the University of Michigan and the University of California, San Diego, have identified a potential new focus of treatments for osteoporosis, periodontitis and similar diseases.

In a paper published May 17 in the online edition of the journal Nature Medicine, CunYu Wang, who holds UCLAs NoHee Park Endowed Chair in the dental schools division of oral biology and medicine, and colleagues suggest that inhibiting nuclear factorkB (NFkB), a master protein that controls genes associated with inflammation and immunity, can prevent disabling bone loss by maintaining bone formation.

The findings could offer new hope to millions who struggle with osteoporosis and periodontitis each year. The National Institutes of Health estimates that in the United States alone, more than 10 million people have osteoporosis, and many more have low bone mass, putting them at risk for the disease, as well as for broken bones. According to the American Academy of Periodontology, mild to moderate periodontitis affects a majority of adults, with between 5 and 20 percent of the population suffering from a more severe stage of the disease.

The NFkB protein, a culprit in inflammatory and immune disorders, plays a major role in both osteoporosis and periodontitis, disrupting the healthy balance of bone destruction and formation. It is this balance that Wang and his fellow scientists seek to restore, and perhaps even improve upon, by finding new ways to promote net bone accumulation.

“Most studies focus on the part that NFkB plays in the regulation of osteoclasts boneresorbing cells. For the past five years, we looked closely at the effect of NFkB on osteoblasts boneforming cells,” said Wang, the studys principal investigator and a member of UCLAs Jonsson Comprehensive Cancer Center. “We knew that NFkB promoted resorption. What we discovered in our in vitro and in vivo studies is that this protein also inhibits new bone formation, giving us a fuller picture of its role in inflammation and immune responses.”

“This landmark paper by Dr. Wang and his colleagues is not only topnotch molecular science, but it also holds promise for clinicians trying to provide the most enlightened treatment of women with postmenopausal osteoporosis,” said John Adams, a UCLA professor of orthopedic surgery. “The paper shows how the molecular manipulation of a previously unsuspected proinflammatory pathway in the boneforming cell, the osteoblast, can regulate the capacity of that cell to make new bone.”

Many currently available treatments work to prevent further bone loss but are not able to increase bone mass. Wangs research results support the idea that a new drug that prevents the action of NFkB in cells may represent a major therapeutic advance.

“Although it has been known for some time that inflammation inhibits bone formation, the groundbreaking work by Dr. Wang and his colleagues elucidates the critical role of NFkB in the mechanism that underlies this phenomenon,” said Philip Stashenko, a professor at the Harvard School of Dental Medicine and president and CEO of the Forsyth Institute, an oral health treatment and research organization. “Many drugs that block NFkB are in development, and these findings suggest that new treatments to preserve bone in periodontitis, osteoporosis and related bone diseases are imminent.”

As a next step, Wang and his research team are planning to test small molecules that inhibit the specific boneresorption and boneinhibition actions of NFkB in osteoporosis and periodontitis.

The study was supported by grants from the National Institute of Dental and Craniofacial Research and the National Institute of Diabetes and Digestive and Kidney Diseases.

Source
Sandra Shagat

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Alastair Campbell Gets Majority Vote! Mind Champion Of The Year 2009

Mayo 20th, 2009 | Category: mental health

Alastair Campbell has won Minds Champion of the Year Award for his significant contribution to raising awareness of mental health. He beat fellow nominee and chat show host Paul OGrady, among other mental health campaigners, to the prestigious award announced yesterday evening.

Winning 52% of the vote, Alastair has clearly won public confidence and support for speaking openly and candidly about his experience of mental health. His nomination for the award recognised his tireless campaigning to improve attitudes towards mental health.

In the last year, as well as fronting the current major antistigma campaign Time to Change, Alastair produced a BBC2 documentary Cracking Up exploring his own experiences of a psychotic breakdown, and his book All in the Mind, the semiautobiographical story of a troubled psychotherapist.

Mind Champion 2009 Alastair Campbell said “Change is happening, and I really feel we are close to the tipping point in terms of peoples greater understanding and societys greater openness about mental illness. I am pleased and proud that people think I have played a part in that. This award recognises that I have used my voice, and taken it to the public platform that I can, to raise awareness of the fantastic work that charities like Mind carry out.”

Paul Farmer, Minds Chief Executive said “I am very happy that we did not need to select the winner for this award and that it was down to a public vote! This years shortlist was of an exceedingly high level and saw a very eclectic mix vie for the accolade. Alastair has offered tremendous support through his public discussion of his experiences of mental distress. He has done so much for the mental health movement and this award expresses the appreciation of the public for his hard work.”

The other people on the shortlist were Anne Savage, who fought and won a historic legal battle for the rights of mental inpatients, MP Lynne Jones, cochair of the All Party Parliamentary Group on Mental Health, and the Hearing Voices Networks Chair Jacqui Dillon. Paul OGrady, better known for his alter ego Lily Savage, was also nominated for dedicating an entire series of his talk show to mental health, and speaking out about his experience of depression.

The award was given alongside the highly contended Book of the Year, which was given to Sathnam Sangera for his memoirs The Boy with the Topknot. Journalist of the Year was won by Eleanor Harding from local newspaper Wandsworth Guardian, beating writers for national newspapers The Observer and The Daily Mail to the title. Nottingham Universitys student newspaper Impact saw its journalist, Nicola Byrom, named Student Journalist of the Year.

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Pelleve Receives FDA Clearance For The Treatment Of Mild To Moderate Facial Wrinkles

Mayo 19th, 2009 | Category: dermatology

Ellman International, Inc. announced that the Food and Drug Administration (FDA) has granted clearance to Pelleve(TM), a skin tightening system for the nonablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes IIV. The clearance was granted based on clinical data demonstrating that a single treatment with the high frequency radiowave device can safely and effectively tighten and improve the appearance of skin on the face through six months.

“Todays FDA clearance of the Pelleve system represents a very exciting step in the introduction of nextgeneration high frequency radiowave technology to physicians and patients in the United States,” said Rick Epstein, CEO of Ellman International, Inc. “Pelleve offers safe, noninvasive facial rejuvenation with no need for a local anesthetic and minimal discomfort a significant evolution from previousgeneration technologies in this class.”

Pelleve uses the advanced radiowave technology of the Ellman International Surgitron(R) Dual RF(TM) S5 and a proprietary Pelleve handpiece to precisely deliver energy through the skin to the dermal tissue beneath without damaging the epidermis. This gentle heating of the deeper dermal tissue induces collagen denaturization and contraction. As the dermal tissue recovers, new collagen synthesis occurs, which creates a tightening effect. The result is a noticeable improvement in skin quality and appearance with minimal side effects and healing time for patients.

In a clinical trial conducted to determine the effectiveness of the Pelleve system, 83 women and 10 men were given a single treatment with the Pelleve handpiece. The procedure was performed in an ambulatory (outpatient) setting with no need for skin cooling products or anesthesia and took an average of 15 to 20 minutes, depending on size of the area. More than 87% of patients showed measurable and immediate positive results in a blinded assessment of skin laxity and wrinkle improvement with continued response at six months after treatment. Patients were typically able to return to work and social activities immediately after treatment. Of the study population, two patients experienced small abrasions that healed within three days.

“Our research clearly demonstrates the power of the Pelleve Skin Tightening System. With a single Pelleve treatment, over 87% of our patients experienced an improvement in skin laxity and fewer overall facial wrinkles at six months. The Pelleve Skin Tightening System is an effective, noninvasive, economical and safe tool,” said Dr. Antonio Rusciani, Division of Dermatology, Plastic and Reconstructive Surgery at the University of Rome in Rome, Italy.

Ellmans skin tightening technology has been marketed with a CE Mark in many countries since 2005 under the name Radiage. “We have seen positive results in many patients outside of the United States. Because this unique technology does not require anesthesia or cooling of the skin during the procedure, the physician can safely achieve the look of lifted, tighter skin without surgery, resulting in a more youthful appearance for the patient,” said Dr. Kai Rezai, a noted dermatologist and Radiage user from Munster, Germany.

Designed to work in conjunction with the Surgitron Dual RF S5 platform, Ellmans patented 4.0 MHz radiowave unit, Pelleve handpieces represent just one of hundreds of accessories available for office and clinic environments. The Surgitron Dual RF S5 provides maximum control in precision cutting and energy delivery, with more versatility than other energybased technologies. “Ellmans proven product platform enables medical professionals to perform surgical procedures that produce less tissue damage and pain than the competition. Adding Pelleve offers tremendous value to physicians, as customers ask for the latest in cosmetic correction from their dermatologists, plastic surgeons and other healthcare professionals,” said Epstein. Pelleve will be introduced to the U.S. market this month through dermatologists, plastic surgeons, ENTs and other cosmetic surgery clinics.

About Ellman International

Established in 1959, Ellman International (Oceanside, New York) is a privately held manufacturer of medical devices used to perform a variety of surgical procedures principally requiring cutting, coagulating, tissue ablation and vaporization. The companys products are based on patented and proprietary technologies utilizing high frequency radiowaves to perform traditional scalpel, scissor, electrosurgery and laser procedures.

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Notre Dame Controversy, Supreme Court Selection Test Obamas Balancing Act, NYT Reports

Mayo 18th, 2009 | Category: abortion

The New York Times on Friday examined how two events controversy surrounding President Obamas upcoming commencement speech at University of Notre Dame on Sunday and the selection of a replacement for retiring Supreme Court Justice David Souter are testing the “delicate balancing act” the president has pursued on abortion rights. Notre Dames invitation to Obama to deliver the commencement speech and receive an honorary degree has sparked ongoing protests from abortionrights opponents, and Obama is now forced to decide whether he will recognize this opposition in his address on Sunday. According to Anita Dunn, the presidents communication adviser, Obama likely will “make reference to the controversy” in his speech but will not “allow it to become the focus of a day thats actually supposed to be about the graduates.” Meanwhile, the pending Supreme Court vacancy has “galvanized backers of abortion rights,” according to the Times. Although both sides expect that Obama will select a nominee who supports abortion rights, advocates “are taking no chances,” the Times reports.

Obama has attempted to present a nuanced approach to abortionrights issues and expressed that he intends to form consensus around reducing unintended pregnancies and promoting adoption. In addition, his policy moves to date have attempted “to straddle the abortion divide” by creating a dialogue with religious conservatives, avoiding contentious legislative fights and taking a gradual approach to reversing the policies of former President George W. Bush, the Times reports. Obama has named abortionrights supporters to head jobs, such as his nomination of Dawn Johnsen, a former legal director of NARAL ProChoice America, to lead the Justice Departments Office of Legal Counsel. He also repealed the “Mexico City” policy, which prohibited federal funding for international groups that provide abortion services or information; lifted some limits on embryonic stem cell research; proposed decreasing funding for abstinenceonly sex education; and took action to rescind the Bush administrations HHS provider “conscience” rule allowing health care workers to refuse to provide services they find morally or religiously objectionable. However, the president has stepped away from some abortionrelated issues, including the Freedom of Choice Act, which would effectively codify Roe v. Wade. Although Obama said in a 2007 speech to Planned Parenthood that he would sign the bill if elected president, he said in a press conference last month that it is not his “highest legislative priority.”

Meanwhile, Obamas top domestic policy adviser, Melody Barnes, is convening a series of meetings with leaders from both sides of the abortion rights debate to discuss policy ideas, with an aim of drafting recommendations by late summer. David Gushee, a Christian ethics professor at Mercer University who has participated in the talks, said the president is signaling to moderate Catholics and evangelicals that “he clearly knows what the bright red lines are and is trying to avoid stepping over them.” However, some religious conservatives and abortionrights opponents who have not been included in the discussions contend that “Obama is trying to have it both ways,” according to the Times. Charmaine Yoest, president of Americans United for Life, said coming to a consensus would entail the president advocating for restrictions such as parental consent requirements for minors and bans on certain abortion procedures. Sen. Sam Brownback (RKan.), who opposes abortion rights, called Obamas strategy “[m]oderate rhetoric, hardleft policies.”

Polls show that U.S. residents remain “deeply conflicted” over abortion rights, with support declining over the years, the Times reports. About 60% of U.S. residents believed abortion should be legal in all or most cases in a 1995 poll; a recent Pew Research Center poll showed the number declined to 46% (Stolberg, New York Times, 5/15).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

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Perforomist Inhalation Solution Data To Be Presented At American Thoracic Society Conference

Mayo 17th, 2009 | Category: conferences

Dey, L.P., a subsidiary of Mylan Inc. (NYSE MYL), has announced that data from two presentations highlighting the use of Perforomist® (formoterol fumarate) Inhalation Solution will be featured in poster format at the International Conference of the American Thoracic Society on May 19, 2009 in San Diego.

In one analysis, use of Perforomist Inhalation Solution, when added to maintenance tiotropium, resulted in improved pulmonary function, dyspnea (shortness of breath) and rescue medication use versus treatment with tiotropium alone. In a second study, patient satisfaction increased in those treated with Perforomist Inhalation Solution twice daily compared with ipratropium/albuterol metereddose inhaler (MDI) four times daily.

Presentation Details

In COPD, Adding Nebulized Formoterol to Tiotropium Treatment Provides Added Benefits in Pulmonary Function, Dyspnea, and Rescue Medication Use A Pooled Analysis; poster board # J51

Date Tuesday, May 19, 2009
Poster viewing 1030 a.m. to 1245 p.m. PT
Location Area J (Sails Pavilion, Upper Level), San Diego Convention Center

Nebulized Formoterol Improved Efficacy and Increased Patient Satisfaction Compared with Ipratropium/Albuterol MDI; poster board # J50

Date Tuesday, May 19, 2009
Poster viewing 1030 a.m. to 1245 p.m. PT
Location Area J (Sails Pavilion, Upper Level), San Diego Convention Center

About COPD

COPD is a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients. Its pulmonary component is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases.

COPD is the fourth leading cause of death in America, behind heart disease, cancer and stroke. 12 million Americans have been diagnosed with COPD, and at least another 12 million have symptoms but have not been diagnosed. COPD is not well understood or recognized most Americans have not heard of it, not even those who may be living with the condition. The most common cause of COPD is cigarette smoking, which is responsible for an estimated 80 to 90 percent of COPD cases. For patients who smoke, quitting smoking is the single most important step a patient can take to treat or slow down COPD. Estimates of the total incidence of COPD in America range from 24 to 30 million.

About Nebulization

Of the three types of devices used to deliver bronchodilators nebulizers, metereddose inhalers, and dry powder inhalers nebulizers convert medication into a fine liquid mist that the patient inhales through a mouthpiece or facemask. The patient breathes naturally, inhaling the medicine until the complete dosage has been delivered. Nebulization is a very gentle, but also very thorough, method of delivering medicine directly into the lungs.

With Perforomist Inhalation Solution, nebulization may become a more widely used treatment option for many COPD patients at earlier treatment stages who could benefit from twicedaily maintenance dosing of a nebulized longacting beta2adrenergic agonists (LABAs) such as Perforomist Inhalation Solution. For example, this COPD treatment may be a valuable clinical option for many patients whose symptoms are not adequately controlled with their current therapy. COPD patients should consider asking their doctor whether nebulized treatment may be right for them.

About Perforomist® Inhalation Solution

Perforomist Inhalation Solution is indicated for the longterm, twicedaily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Important Safety Information

Perforomist® (formoterol fumarate) Inhalation Solution belongs to a class of medications known as longacting beta2adrenergic agonists (LABAs). LABAs may increase the risk of asthmarelated death. Data from a large placebocontrolled US study comparing the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthmarelated deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a LABA), the active ingredient in Perforomist Inhalation Solution.

Perforomist Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life threatening condition, or to treat acute symptoms. Acute symptoms should be treated with fastacting rescue inhalers. Perforomist Inhalation Solution is not indicated to treat asthma. The safety and efficacy of Perforomist Inhalation Solution in asthma has not been established. Perforomist Inhalation Solution should not be used with other medications containing LABAs. Do not use more than one nebule twice daily. Perforomist Inhalation Solution should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension.

In COPD clinical trials, the most common adverse events reported with Perforomist Inhalation Solution (>2% and more common than placebo) were diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.

Please see full Prescribing Information, including Boxed Warning, at perforomist.com.

Source
Julie Piszczor

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Expert Consensus On Catheter Ablation Of Ventricular Arrhythmias

Mayo 17th, 2009 | Category: conferences

A call to action for more research to be undertaken into catheter ablation in the field of ventricular arrhythmia (VA) has been issued in a joint consensus document from the European Heart Rhythm Association (EHRA) a registered branch of the European Society of Cardiology (ESC) and the US Heart Rhythm Society (HRS). The consensus document launched at Heart Rhythm 2009, the Heart Rhythm Societys 30th Annual Scientific Sessions, being held 13 to 16 May in Boston provides an up to date review of indications, techniques and outcomes of catheter ablation for treatment of ventricular arrhythmias, a technique now being offered to increasing numbers of patients.

“In the last few years there has been a substantial evolution of techniques for catheter ablation in VA. We hope this document will help identify the areas in catheter ablation that require further research, and encourage clinicians to embark on more clinical and registry studies,” says Etienne Aliot, the European cochair from Nancy, France. “It is only by conducting more clinical trials and registries that we can begin to get an idea of exactly how catheter ablation fits into the whole VA treatment paradigm including Implantable Cardio Defibrillators (ICDs) and antiarrhythmic drugs.”

The document authored by 20 leading European and US electrophysiologists recognises there is still “very limited” data establishing the long term impact of catheter ablation on morbidity and mortality.

Unanswered questions highlighted by the joint document include the long term efficacy of catheter ablation

the comparative success rates of drug and ablative therapies

can ablation slow the progression of ventricular remodelling in structural heart disease?

definition of patients with different underlying cardiac and non cardiac diseases. “Over the past decade there has been great progress with important advances in methods for mapping and ablating ventricular arrhythmias, but there are also many gaps in our knowledge where more work is needed. EHRA and HRS recognized that a document summarizing where we are now, where there is agreement and where we need to go would be timely and important,” says William Stevenson, the US cochair from Brigham and Womens Hospital, Boston, MA USA.

The document is the third joint consensus document to be issued by EHRA and HRS at the Heart Rhythm meeting, with EHRA taking the lead this year.

“Having one document between Europe and the US is vitally important since it gives both clinicians and patients the confidence that they are doing the right thing. Having different documents on both sides of the Atlantic is a recipe for confusion,” says Professor Aliot.

In an area with few clinical trials, but many single centre reports, the consensus document summarised the opinion of task force members based on their own experience of treating patients, in addition to a review of the literature. For each topic, two members of the task force drafted a discussion document that was then considered and edited by all members of the team.

The document examines indications, outcomes, and contraindications of catheter ablation, which are important concerns for physicians and their patients with ventricular arrhythmias that require treatment. In addition, specific technical aspects of ablation procedures important for electrophysiologists are discussed including methods for mapping to identify ablation targets, roles for newer technologies, the use of anticoagulation, analgesia and anesthesia, and antiarrythmic drug management. The knowledge base that physicians need, and the support staff and equipment required, are also considered.

There are two major types of ventricular arrhythmias. Those associated with heart disease are often due to abnormal electrical circuits originating from diseased areas of scar in the ventricular myocardium. A prior heart attack is a common cause. The second type concerns those where there is no structural disease, known as idiopathic ventricular arrhythmias.

Ventricular arrhythmias may cause symptoms such as syncope and palpitations, and in the most severe cases, cause cardiac arrest and sudden death. Many patients with ventricular arrhythmias and structural heart disease have implantable defibrillators that terminate VA when they occur, but these episodes may still cause symptoms and in some cases require painful shocks for termination. Catheter ablation has an important role in preventing or reducing recurrent attacks of symptomatic VA in these situations and can be lifesaving for patients with incessant arrhythmias.

Most idiopathic VA are benign, but careful evaluation is required to distinguish idiopathic from potentially dangerous VA. Ablation is an important alternative to antiarrhythmic drug therapy in many patients with idiopathic VA.

Catheter ablation, the procedure used to selectively eliminate the cells responsible for the arrhythmia, involves inserting catheters (thin flexible wires) into blood vessels, usually in the groin, and threading them through the blood vessels into the heart ventricle under Xray guidance.

The next step is for the electrophysiologist to use the catheter to identify the source of the abnormal electrical activity in a procedure known as mapping. Mapping may involve triggering VA, or identifying abnormal areas that contain the substrate for VA based on findings during sinus rhythm. Radiofrequency energy is then applied through the catheter to destroy the abnormal area. Finally, testing is performed to determine if ablation has been sufficient to prevent the VA. The process of “mapping and ablation” continues until the electrical disturbance can no longer be triggered by catheters or no further substrate can be identified.

Recent innovations in catheter ablation include 3D mapping systems that superimpose electrical maps of the heart on 3D images of the heart from echocardiography, which gives recordings in relation to anatomic locations in the heart and facilitate identification of the arrhythmia substrate during stable sinus rhythm.

Percutaneous epicardial mapping and ablation of ventricular tachycardias that originate from the epicardial surface of the heart.

The delineation of the relation between cardiac anatomy and focal ventricular tachycardia origins in the right and left ventricular outflow tracts and papillary muscles. Source
ESC Press Office

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Washington Post Health Section Highlights Womens Health Issues

Mayo 16th, 2009 | Category: womens health

The Washington Post in its Health Section on Tuesday focused on womens health, including articles on hormone replacement therapy and mammography. Headlines appear below.

~ “Hormone Research Continues” (Washington Post, 5/12).

~ “Mammogram Rates Seem To Be Slipping” (Lunzer Kritz, Washington Post, 5/12).

~ “Weighing the Options Once Again, Scientists are Sharply Divided Over Hormone Therapy for Menopausal Women” (Slomski, Washington Post, 5/12).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

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