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FDA Approves Enzalutamide for a Type of Late-Stage Prostate Cancer

The U.S. Food and Drug Administration today approved Xtandi (enzalutamide) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Approved for prostate cancer patients previously treated with docetaxel, another anti-cancer treatment, Xtandi was reviewed under the FDA’s priority review program. The program provides for an expedited six-month review for drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists. Xtandi received FDA approval three months ahead of the product’s prescription drug user fee goal date of Nov. 22, 2012. “The need for additional treatment options for advanced prostate cancer continues to be important for patients,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient’s life.” Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 241,740 men will be diagnosed with prostate cancer and 28,170 will die from the disease in 2012. The safety and effectiveness of Xtandi was evaluated in a study of 1,199 patients with metastatic castration-resistant prostate cancer who had received prior treatment with docetaxel. The study was designed to measure overall survival (the length of time before death) in men receiving Xtandi compared with men receiving a placebo (sugar pill). The median overall survival for...

FDA Approves Linzess to Treat Certain Cases of IBS and Constipation

The U.S. Food and Drug Administration today approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults. According to the National Institutes of Health, an estimated 63 million people are affected by chronic constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and do not respond to standard treatment. Additionally, an estimated 15.3 million people are affected by IBS. IBS-C is a subtype characterized mainly by abdominal pain and by hard or lumpy stools at least 25 percent of the time and loose or watery stools less than 25 percent of the time. Linzess is a capsule taken once daily on an empty stomach, at least 30 minutes before the first meal of the day. Linzess helps relieve constipation by helping bowel movements occur more often. In IBS-C, it may also help ease abdominal pain. “No one medication works for all patients suffering from these gastrointestinal disorders,” said Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition.” The safety and effectiveness of Linzess for the management of IBS-C were established in two, double-blind studies. A total of 1,604 patients were randomly assigned to take 290 micrograms of Linzess or a placebo for at least 12 weeks. Results showed Linzess was more effective in reducing the amount of abdominal pain and increasing the number of complete spontaneous bowel movements compared with placebo. The safety and effectiveness...

Zynex Receives FDA 510(k) Clearance for InWave Medical Device

Zynex, Inc, a provider and developer of non-invasive medical devices for electrotherapy, stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced that it received FDA 510(k) clearance on its InWave medical device. The InWave device is the newest product in the Zynex portfolio, and will be manufactured, marketed and sold through our Zynex Medical subsidiary. This device is used primarily for treating female urinary incontinence. Incontinence is defined as the involuntary loss of bladder or bowel control. According to the National Association for Continence, urinary incontinence affects 200 million people world-wide, and it is believed that 80% of those sufferers are women. Zynex’s CEO, Thomas Sandgaard, commented; “We are very excited about the introduction of this new product. The InWave adds to our already broad product line and is reimbursed by health insurance. We believe it will provide our expanding sales force an additional tool to fuel revenue generation in our rapid growing Zynex Medical subsidiary.” About Zynex Zynex (founded in 1996), operates under three primary business segments; Zynex Medical, Zynex NeuroDiagnostics and Zynex Monitoring Solutions. Zynex Medical engineers, manufactures, markets and sells its own design of electrotherapy medical devices for electrotherapy, used for pain management and rehabilitation. Zynex Medical’s product lines are fully developed, FDA-cleared and commercially sold world-wide. Zynex NeuroDiagnostics, sells the company’s proprietary NeuroMove device designed to help stroke and spinal cord injury patients and is currently expanding into markets for EMG, EEG, sleep pattern, auditory and nerve conductivity neurological diagnosis devices through product development and acquisitions. Zynex Monitoring Solutions, currently in the development stage, has been established to develop and market medical devices for non-invasive cardiac...

Asthma: Prevalence, Healthcare Use, & Mortality

Data from 2001 to 2010 indicate that the prevalence of asthma in the United States appears to have increased from 7.3% to 8.4%. Healthcare visits per 100 persons with asthma declined in primary care settings during the study period, but asthma-related visits to the emergency room and hospitalizations for the disease remained stable. Children with asthma had lower rates of asthma-associated mortality than adults. African Americans with asthma had higher mortality rates than Caucasians. Source:...

Web-Based Intervention Gets Women Moving

A team of American researchers has found that a 12-week, web-based physical activity (PA) intervention appears to improve measures of PA and quality of life (QOL) among adult women. In the study, women aged 18 and older received 12 weekly PA modules and completed surveys on PA, QOL, and readiness for PA at registration. Significant improvements were observed in PA, stage of readiness for PA, BMI, and composite scores for energy and well-being. Among participants who reported no PA at baseline, 54.6% achieved some PA and another 9.1% achieved total compliance with PA guideline recommendations. Overall, guideline compliance increased from 15.8% to 21.4%. Abstract: American Journal of Cardiology, June 15,...

20-Year Hospitalization Trends for Stroke

The rate of hospitalizations for stroke per 10,000 population increased from 32.4 in 1989 to 34.9 in 1999, but then decreased to 31.8 in 2009, according to new data from the CDC. Throughout these 2 decades, more than two-thirds of stroke-related hospitalizations occurred among patients aged 65 and older. A 20% decrease in stroke hospitalization was observed in patients aged 65 to 74 and 85 and older. A 24% decrease in stroke hospitalization rates was seen in patients aged 75 to 84 during the study period. Source:...

Benefits of Adjunctive Acupuncture for COPD

Results of a small, 12-week study indicate that acupuncture appears to be a useful adjunctive therapy for reducing dyspnea on exertion (DOE) in patients with COPD. Patients who underwent acupuncture in addition to standard medication experienced improvements in a 6-minute walk for distance test, a sign of increased exercise tolerance and reduced DOE. Abstract: Archives of Internal Medicine, June 11,...

Analyzing Distress Screening in Cancer Care

The utility of distress screening appears to vary among cancer clinicians, according to findings from a British investigation. Researchers found that clinicians believed screening was useful in 43% of patient assessments but not useful in 35.9% of assessments. More than half of respondents felt distress screening helped with communication, but about one-third (37.5%) felt it was impractical for routine use. Abstract: Cancer, June 6, 2012...

Type of Atrial Fibrillation Matters in Post-AMI Treatment

Permanent atrial fibrillation (AF) appears to be the only form of AF that independently predicts death among patients with acute myocardial infarction (AMI) who are treated invasively. When compared with a control group, more than half of AMI patients with permanent AF (54.3%) had significantly higher long-term mortality. The long-term mortality rate for new-onset AF was 35.8%. Abstract: American Journal of Cardiology, June 15,...

Analyzing Physician Salaries

Salaries among mid-career academic physicians appear to vary between men and women, according to an American study. The average salary for men was $200,433, compared with $167,669 for women. Gender differences persisted after adjusting for specialty, institutional characteristics, academic productivity and rank, work hours, and other factors. Abstract: JAMA, June 13,...
Social Media Empowers Afib Patients and Others

Social Media Empowers Afib Patients and Others

Atrial fibrillation can be bewildering for patients, especially when they’re first diagnosed. After all, their own hearts have betrayed them, beating out of rhythm, often leaving them exhausted, frustrated, and searching for answers. Increasingly, patients are finding these answers — along with treatment options and support — through social media. For example, Jason Mattingly, a father of three and sales man­ager from Dallas, was diagnosed with afib when he was 34. Because he wanted a treatment option that would allow him to maintain his active lifestyle, he scoured the Internet for information. After participating in conversations at the AFIBsupport Forum in Yahoo! Groups), he received numerous recommendations to seek out an ablation. After the ablation and a follow-up procedure, his heart is back to normal rhythm. Social media helped guide him to afib-free living, and it can help your patients, too. Social Media Patient Empowerment When you think of how social media relates to afib, think of it as a problem-solver. Do you have patients who are clueless about afib, making them more difficult to manage and less likely to adhere to medications? Research shows that community support works better than medication for some. The Pew Research Center’s Internet & American Life Project recently found that social media creates empowered patients who participate in their care. September is National Atrial Fibrillation Awareness Month. What better time to share some examples of how the afib patient community uses social media with patients and colleagues? (Many of these ideas can be used to empower patients with other health conditions as well.) 1. Discussion forums. Forums, such as the AFIBsupport Forum, are...

Detecting Intimate Partner Violence More Quickly

Published research indicates that nearly one-third of women reported that they were presently experiencing some form of intimate partner violence (IPV) when they were asked about these occurrences during an ED visit. When questioned about their past, nearly 50% of women reported being victims of IPV. In addition, other research has demonstrated that 56% of victimized female patients presenting to the ED also report perpetration behaviors. Studies that have focused on detecting perpetrators of IPV in the ED suggest that screening is effective, but few of these individuals are actually identified in medical settings despite frequently being in attendance. Testing a Shorter Screening Tool for IPV The gold standard for detecting perpetrators of IPV in the ED has historically been the 25-question Physical Abuse of Partner Scale (PAPS). Although the PAPS is an effective, validated questionnaire, the length of time needed to administer it is not practical for a short visit in the ED. In the February 2012 Journal of Emergency Medicine, my colleagues and I had a study published in which we developed a shorter IPV screening alternative to the PAPS. We developed the PErpetration RaPid Scale (PERPS) by validating a shortened version of the PAPS consisting of three questions: 1. Have you ever forced your partner to have sex or hurt your partner during sex? 2. Have you ever pushed or shoved or poked your partner violently? 3. Have you ever hit or punched your partner’s arms, body, head, or face? Unlike the PAPS, which uses a Likert scale for its 25 questions, PERPS has the potential to be administered more quickly because it uses only “yes/no”...

Comorbidities in Hip Fracture: Costs & Improving Care Delivery

More than 250,000 hip fractures occur annu­ally in the United States, and the incidence is expected to increase among the elderly as society continues to outlive previous generations. Hip fractures have a significant impact on health-related quality of life and are a major source of healthcare expenditures, and almost all result in hospitalization and surgery. They also often result in nursing home admission, long-term dis­ability, and extended periods of rehabilitation. Patients with hip fractures frequently present with comorbid illnesses, including many chronic diseases. “In addition to increasing resource uti­lization, the presence of several comorbidities has been identified as a strong preoperative risk factor for death in patients with hip fractures,” says Kevin P. Black, MD. A New Large-Scale Analysis of Hip Fracture Previous research has examined comorbidities and hospitalization costs for hip fracture in the elderly, but these studies have been conducted on a small scale. In the January 4, 2012 Journal of Bone and Joint Surgery, Dr. Black and colleagues had a larger-scale study published that aimed to gain a better understanding of the coexist­ing medical conditions that impact the cost of treating patients with hip fractures. “A better understanding of the impact of comorbidities on inpatient costs and length of stay may advance the discussion on appropriate reimbursement for patients with hip fractures and multiple comor­bidities,” says Dr. Black. “It may also lead us to the development of strategies to better manage comorbidities in this patient population.” Hospital discharge information was gathered from an AHRQ report that included data from more than 1,000 hospitals in 40 states. For the more than 32,000 patients involved in the study,...

Interpreters in the ED: A Look at Errors & Consequences

According to recent United States Census estimates, more than 25 million Americans have limited English proficiency (LEP), and many of these individuals are school-age children. Language barriers affect multiple aspects of healthcare for LEP patients, including access to care, health status, use of health services, and patient safety. LEP patients often defer needed medical care, have higher risks of leaving hospitals against medical advice, and are less likely to have a regular healthcare provider. They’re also more likely to miss follow-up appointments and to be non-adherent with medications. “Medical interpreters are an essential component of effective communication between LEP patients and healthcare providers.” Federal policy requires that hospitals provide adequate language assistance to LEP patients. Medical interpreters are an essential component of effective communication between LEP patients and healthcare providers. Professional interpreters are hired specifically to provide language services to LEP patients, but all too often, language services are provided by ad hoc interpreters. These individuals—who range from family members and friends to hospital/clinic employees and strangers from waiting rooms—are untrained in medical interpretation. A New Comparison of Interpretation Methods Previous studies have shown that family members and untrained bilingual people who provide ad hoc interpretation can commit many errors of interpretation. No investigation, however, has been conducted comparing these errors and their potential consequences in encounters with a focus on professional interpreters versus ad hoc interpreters or no interpreters. In the March 2012 Annals of Emergency Medicine, my colleagues and I had a study published in which we performed a cross-sectional error analysis of audiotaped ED visits during a 30-month period in the two largest pediatric EDs in...

A Closer Look at Violence in the ED

The stressful nature of an ED visit has been shown to increase the likelihood of violent acts for many reasons. Common reasons include a high frequency of pain among patients, long wait times to be seen by physicians or to receive treatment for pain, and a general overall frustration with the healthcare system. Furthermore, the patients who present to the ED are often those who have a tendency toward violence, including people who are using or seeking drugs, are under the influence of drugs or alcohol, and/ or have underlying dementia or psychosis. “All of these factors increase the possibility of violent acts occurring in the ED,” says Roger D. Tillotson, MD. “Considering the escalating trend of violence toward healthcare workers, it’s important to examine the nature of these risks so that we can develop new strategies to mitigate workplace violence.” Intriguing New Data on ED Violence Most ED personnel are aware that violence continues to be problematic, but the literature on the topic is scarce. In the May 2011 Journal of Emergency Medicine, Dr. Tillotson and colleagues had a study published that sought to estimate the overall incidence of violence experienced by faculty and resident physicians working in academic EDs in the United States. “Our specific goal was to estimate the proportion of physicians who had experienced at least one type of violent act while working in the ED,” adds Dr. Tillotson. “We also sought to obtain information on violence prevention strategies that have been implemented by EDs.” The analysis involved 263 emergency medicine residents and attending physicians who reported 271 different types of violence experienced in the...

FDA Approves New Treatment for Severe Neutropenia in Certain Cancer Patients

The U.S. Food and Drug Administration today approved Sicor Biotech’s tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils. Tbo-filgrastim is intended for use in adults who have cancers other than blood or bone marrow cancers (non-myeloid malignancies) and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone marrow. This reduction in neutrophils may lead to infection and fever (febrile neutropenia). Tbo-filgrastim stimulates the bone marrow to increase the production of neutrophils. It is administered as an injection beginning 24 hours after chemotherapy treatment. “Supportive care products, such as tbo-filgrastim, reduce or allow for more rapid recovery from side effects of cancer treatments,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. Tbo-filgrastim was evaluated in a clinical study of 348 adult patients with advanced breast cancer receiving treatment with the anti-cancer drugs doxorubicin and docetaxel. Patients were randomly assigned to receive tbo-filgrastim, a placebo, or a non-U.S.-approved filgrastim product, a drug that also stimulates neutrophil production by the bone marrow. The effectiveness of tbo-filgrastim was determined based on study results that showed that patients receiving tbo-filgrastim recovered from severe neutropenia in 1.1 days compared with 3.8 days in those receiving the placebo. Tbo-filgrastim’s safety was evaluated in three clinical studies composed of 680 adults with breast cancer, lung cancer, or non-Hodgkin’s lymphoma who received high-dose chemotherapy that reduces bone marrow cells (myeloablative chemotherapy). The most common side effect observed in those receiving tbo-filgrastim was...

FDA Approves First Drug Formulated for Children With Rare Brain Tumor

The U.S. Food and Drug Administration today approved Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of the anti-cancer drug Afinitor (everolimus) used to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA). Afinitor Disperz is the first approved pediatric-specific dosage form developed for the treatment of a pediatric tumor. Afinitor Disperz is recommended to treat patients ages 1 year and older with tuberous sclerosis complex (TSC) who are diagnosed with SEGA that cannot be treated with surgery. Prior to approval of this new dosage form, Afinitor was recommended for use only in patients ages 3 years old and older. Afinitor was granted accelerated approval in 2010 to treat SEGA in patients with TSC. “Appropriate pediatric dosage forms, such as Afinitor Disperz, help to ensure the safe and effective use of oncology drugs in children,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “In addition, today’s approval demonstrates the value of further studying a drug to better characterize its benefits and how it should be used in pediatric patients.” Afinitor Disperz is available in smaller dose increments than the adult dosage form, Afinitor. Afinitor Disperz also dissolves easily in a small volume of water, making it easy to administer to patients who are unable to swallow whole tablets to take their medication. Afinitor’s manufacturer, Novartis, also provided updated safety and efficacy data from the single-arm study of 28 pediatric and adult patients used to support the drug’s accelerated approval in 2010 for the treatment of SEGA in patients with TSC....

FDA Clears First Vascular Access Product With BioFlo Technology to Reduce Catheter-Related Thrombus

AngioDynamics, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the U.S. Food and Drug Administration has granted 510(k) clearance for its BioFlo peripherally inserted central catheters (PICCs) with Endexo technology designed to reduce the accumulation of catheter-related thrombus on, and in, the catheter. These are the first vascular access products from AngioDynamics to offer BioFlo technology in the U.S. market and an initial launch is expected in the Company’s second quarter of fiscal year 2013. These products are currently CE marked for Europe and are approved in Canada and other international markets. In vitro blood loop model test results show the BioFlo PICC has 87% less thrombus accumulation on its surface on average compared to commonly used PICCs based on platelet count. In addition, side-by-side in vivo test results demonstrate substantially equivalent thromboresistant characteristics as a heparin coated vascular access catheter.* Available with PASV Valve Technology, it is the first catheter that combines all of these properties with AngioDynamics’ patented valve designed to automatically resist backflow and reduce blood reflux on the inside of the catheter. “BioFlo technology provides AngioDynamics with a truly disruptive technology which we believe will drive increased demand for our vascular access products,” said Joseph DeVivo, President and CEO of AngioDynamics. “With 15% of the $375 million U.S. PICC market, AngioDynamics holds a strong second position and BioFlo technology is positioned to help us grow that presence. BioFlo technology shows promise in decreasing the accumulation of catheter-related thrombus without incorporation of heparin, antibiotics, antimicrobials or any other transient materials typically associated with coated...

FDA Approves Nucynta for Pain Associated with Diabetic Peripheral Neuropathy

Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for NUCYNTA® ER (tapentadol) extended-release tablets, an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. NUCYNTA® ER is the first and only opioid approved by the FDA for neuropathic pain associated with DPN. In addition to this new indication, NUCYNTA® ER is currently approved for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Diabetes affects nearly 26 million people in the United States, and approximately 60 to 70 percent of people with diabetes have some form of neuropathy. The most common type of neuropathy is DPN, which causes pain or loss of feeling in the toes, feet, legs, hands and arms; it may also include a persistent burning, tingling or prickling sensation. It is estimated that DPN affects nearly eight million people in the United States. Because the complex pathophysiology of DPN involves both central and peripheral mechanisms, certain patients with DPN may require treatment with multiple agents. “Pain from DPN can be difficult to manage, leaving some patients and healthcare professionals looking for alternative treatments,” said Keith A. Candiotti, M.D., Professor of Anesthesiology and Internal Medicine, University of Miami School of Medicine.* “NUCYNTA® ER is a different option than currently approved medications for the management of painful DPN and may be an important new choice for these...

Cardiology eBook Vol. 3

A collection of interview-based cardiology articles by leading experts. Read some of our top articles on updated guidelines, CHF, and more....
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