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March 21, 2012 — New Infectious Diseases Society of America (IDSA) guidelines state that most cases of acute rhinosinusitis are caused by viruses and should not be treated with antibiotics. According to a written release accompanying the guidelines, up to 98% of cases are caused by viruses, and therefore would not be responsive to antibiotics. The guidelines, authored by an 11-member panel chaired by Anthony W. Chow, MD, professor emeritus of infectious diseases at the University of British Columbia, Vancouver, Canada, included contributions from experts from the US Centers for Disease Control and Prevention, the American College of Physicians, and the Society of Academic Medicine. "There is no simple test that will easily and quickly determine whether a sinus infection is viral or bacterial, so many physicians prescribe antibiotics 'just in case,' " noted Dr. Chow in a news release. However, the use of antibiotics with viral infections may increase antibiotic res...

March 23, 2012 (Hollywood, Florida) — Information on 2 new systemic therapies for metastatic disease and a reduced emphasis on testing for metastases in early-stage disease headline the changes to the melanoma guidelines from the National Comprehensive Cancer Network (NCCN). The guidelines were discussed here at the NCCN 17th Annual Conference. In his opening remarks to the NCCN audience, Daniel Coit, MD, from the Memorial Sloan-Kettering Cancer Center in New York City, highlighted the recently approved vemurafenib ( Zelboraf , Plexxikon/Roche) and ipilimumab ( Yervoy , Bristol-Myers Squibb), calling them "very exciting new agents for the treatment of systemic disease." Last year during the NCCN annual meeting, ipilimumab was on the cusp of being reviewed by the US Food and Drug Administration (FDA). Upon its approval, it was integrated into the NCCN guidelines. More recently, a footnote was added to the section in the guidelines on metastatic disease concerning the use...

March 21, 2012 — Roughly 165 young children in the U.S. are treated in the emergency departments every day after getting into medications, says a new report from Safe Kids Worldwide. That's more than 60,000 kids a year ages 5 and under who unintentionally take a medicine or overdose on it. Over the last 25 years, the poisoning death rate among American children ages 14 and under has steadily dropped. But during this same time period, the number of poisoning deaths linked to accidental medication poisoning has almost doubled from 36% in 1979 to about 64% in 2006. With more medications than ever available in homes, whether it's prescription drugs, over-the-counter medicines, vitamins, herbs, and dietary supplements, this increases the chances a young person might accidentally swallow one of these products. It's not only that a child might see medicine bottles around the house more often. Our fast-paced lifestyles may also be at fault: Family members might forget to prop...

March 16, 2012 — Estradiol valerate and estradiol valerate/dienogest ( Natazia , Bayer HealthCare Pharmaceuticals Inc) oral contraceptive tablets were approved March 14 for the treatment of heavy menstrual bleeding (HMB). According to a company press release, this agent is the first and only oral contraceptive indicated for the treatment of HMB. The drug was approved in May 2010 for the prevention of pregnancy. The current approval was based on results from 2 multicenter, randomized, double-blind, placebo-controlled clinical trials including 421 women. Women in the study were at least 18 years of age and were diagnosed with dysfunctional uterine bleeding, described as heavy, prolonged and/or frequent, and without organic pathology. HMB was defined as "menstrual blood loss of 80 mL or more in at least 2 bleeding episodes during a 90-day run in phase." Patients were randomly assigned to receive either treatment or placebo for 7 menstrual cycles. Complete symptom relief dur...

March 19, 2012 — The US Food and Drug Administration (FDA) today approved the first generic versions of ibandronate ( Boniva , Genentech), a once-a-month tablet to treat or prevent osteoporosis in postmenopausal women. Three companies (Apotex, Orchid Healthcare, and Mylan Pharmaceuticals) received a green light to make generic 150-mg ibandronate tablets. Ibandronate belongs to the bisphosphonate drug class, which help boost bone mass and reduce the risk for spinal fracture. The National Institutes of Health estimates that more than 40 million men and women have osteoporosis or are at high risk for it because of low bone mass. "Men as well as women are affected by osteoporosis, a disease that can be prevented and treated," said Keith Webber, PhD, deputy director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research, in an agency press release. "For people who must manage their health conditions over time, it is important to h...

The U.S. Food and Drug Administration (FDA) is clarifying dosing and warning recommendations for the antidepressant Celexa (citalopram hydrobromide; also available in generic form). In August 2011 , FDA issued a Drug Safety Communication (DSC) stating that citalopram should no longer be used at doses greater than 40 mg per day because it could cause potentially dangerous abnormalities in the electrical activity of the heart. Citalopram use at any dose is discouraged in patients with certain conditions because of the risk of QT prolongation, but because it may be important for some of those patients to use citalopram, the drug label has been changed to describe the particular caution that needs to be taken when citalopram is used in such patients. The revised drug label also describes lower doses that should be used in patients over 60 years of age. Changes in the electrical activity of the heart (specifically, prolongation of the QT interval of the electrocardiogram ...

March 27, 2012 (Chicago, Illinois) — A small pilot study of a lower, "safe" dose of thrombolytic--around half the standard dose of tPA conventionally used--has shown promise as an acute treatment for moderate pulmonary embolism (PE). This dose of tPA effectively dissolved the blood clot and led to earlier hospital discharge and less pulmonary hypertension and recurrent PE, without causing bleeding or other major side effects, said Dr Mohsen Sharifi (Arizona Cardiovascular Consultants, Mesa), who presented the findings of the Moderate Pulmonary Embolism Treated with Thrombolysis (MOPETT) trial during the late breakers at the American College of Cardiology (ACC) 2012 Scientific Sessions today. Sharifi says he is offering this treatment option to patients presenting to the emergency room with a moderate PE in his institution, but others said the work would require verification in much larger randomized trials before physicians could even consider adopting this approach. ...

March 27, 2012 (Updated March 29, 2012) (Chicago, Illinois) — The coronary computed-tomography angiography (CCTA)-based strategy for screening chest-pain patients in the emergency department is safe and reduces overall patient time in the hospital but costs about the same overall as the current standard approach, the Rule Out Myocardial Infarction Using Computer Assisted Tomography II (ROMICAT II) results show. Dr Udo Hoffman (Massachusetts General Hospital, Boston) presented results of the randomized ROMICAT II trial today at the American College of Cardiology (ACC) 2012 Scientific Sessions . The study randomized 1000 chest-pain patients with suspected acute coronary syndrome on a 1:1 ratio to either a CCTA screening approach or standard care left to the discretion of the physician. ROMICAT II was designed following the completion of the observational ROMICAT study, which showed that about 8% of patients screened for ACS in emergency departments are actually suffering ACS. The ...

March 27, 2012 (Updated March 29, 2012 ) (Chicago, Illinois) — Adjusted four-year all-cause mortality was about 20% lower after CABG than after PCI in an observational study of about 190 000 patients in the US who underwent nonemergent revascularization for two- or three-vessel coronary disease [1]. Mortality at one year was similar for the two procedures. Dr William S Weintraub Based on patients > 65 years of age taken from two huge society-sponsored databases, the analysis used several methods to control for risk levels and other influences on outcomes. It found the long-term advantage for CABG was independent of age, sex, diabetes, renal function, and lung disease and was evident "even among patients whose propensity scores were most consistent with selection for PCI," write the authors, led by Dr William S Weintraub (Christiana Care Health System, Newark, DE), in a report published today in the New England Journal of Medicine . "That was one of the majo...

March 27, 2012 ( Chicago, Illinois) — Long-term data from the Balloon-Pump Assisted Coronary Intervention Study (BCIS)-1 suggests that the use of an intra-aortic balloon pump (IABP) in patients with low ejection fraction undergoing high-risk angioplasty procedures is associated with a lower long-term risk of mortality. Researchers report that the elective use of IABP during PCI was associated with a 34% reduction in the risk of death after a median follow-up of 51 months. The mortality benefit contrasts with the overall negative results of BCIS-1, a study that showed there was no difference in the risk of major adverse cardiac and cerebrovascular events (MACCE) at the time of hospital discharge among patients treated with IABP when compared with those who did receive counterpulsation. The results of the newest analysis were presented this week at the American College of Cardiology (ACC) 2012 Scientific Sessions by Dr Divaka Perera (St Thomas' Hospital, London, UK). To heart wi...

March 26, 2012 — Don't take this sitting down, but spending too much time in a chair is bad for your health -- really, really bad. New research published in the Archives of Internal Medicine shows that people who spend a lot of time sitting may be up to 40% more likely to die from any cause, compared to people who don't sit as long. The study tracked nearly 222,500 Australian adults for about three years. During that time, people's odds of dying dovetailed with how much time they spent sitting. Compared to people who spent less than four hours per day sitting, the odds of dying were: 15% higher for people who sat for at least eight hours 40% higher for people who sat for 11 or more hours a day “Our findings add to the mounting evidence that public health programs should focus not just on increasing population physical activity levels, but also on reducing sitting time,” the researchers write. Alpa V. Patel, PhD, has published studies on the health risks associated...

March 27, 2012 — The US Food and Drug Administration (FDA) today announced it has approved the new erythropoiesis-stimulating agent (ESA) peginesatide to treat anemia in patients receiving dialysis who have chronic kidney disease (CKD). Peginesatide, which was developed by Affymax in partnership with Takeda Pharmaceutical Co, will be marketed as Omontys . It works by stimulating the bone marrow to produce more red blood cells, thus increasing hemoglobin levels and reducing the need for transfusions in patients with CKD. Injected subcutaneously once a month, the new anemia drug is expected to be a robust rival to epoetin alfa ( Epogen , Amgen Inc). Affymax may also price peginesatide more competitively , which will be an advantage in an era of streamlined healthcare costs. "Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001," Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for ...

March 27, 2012 — Temporary treatment with combination antiretroviral therapy (cART) for people first infected with HIV can defer the start of long-term cART, according to the results of a randomized clinical trial published online March 27 in PLoS Medicine . Under current practices, such treatment is often not started until a person's CD4 cell count falls below a certain level or clinical conditions call for treatment. "From a clinical perspective, an important question is whether patients who are treated during PHI remain off treatment longer than patients in whom treatment is deferred until indicated based on their CD4 cell count or clinical condition," the researchers write. To find out, Marlous L. Grijsen, MD, from the Center for Infection and Immunity at the Academic Medical Center of the University of Amsterdam, the Netherlands, and colleagues analyzed the records of 168 patients with primary HIV infection (PHI) who were randomly assigned to 1 of 3 groups in a c...

March 28, 2012 (New York, New York) — In the United States, testing for hepatitis C virus (HCV) infection is happening most often in the people least likely to be infected with the virus, according to a study presented here at the International Conference on Viral Hepatitis 2012. "Hepatitis C is primarily a disease of older men, but they aren't the ones actually getting tested. The majority of testing is happening in young women. I'm not sure anyone has ever shown this before," study presenter Camilla S. Graham, MD, MPH, from Vertex Pharmaceuticals in Cambridge, Massachusetts, told Medscape Medical News . There is a need for targeted age-based guidelines for HCV testing, Dr. Graham said. Roy M. Gulick, MD, from Weill Cornell Medical College in New York City, agrees. "Focused testing for hepatitis C makes sense," he told attendees during his keynote address. HCV testing recommendations are currently being developed by the US Centers for Disease Control and...

FDA is clarifying dosing and warning recommendations for the antidepressant Celexa (citalopram hydrobromide; also available in generic form). In August 2011, FDA issued a Drug Safety Communication (DSC) stating that citalopram should no longer be used at doses greater than 40 mg per day because it could cause potentially dangerous abnormalities in the electrical activity of the heart. Citalopram use at any dose is discouraged in patients with certain conditions because of the risk of QT prolongation, but because it may be important for some of those patients to use citalopram, the drug label has been changed to describe the particular caution that needs to be taken when citalopram is used in such patients. The revised drug label also describes lower doses that should be used in patients over 60 years of age.

March 28, 2012 — An estimated 71% of all cancer deaths in India occur in people 30 to 69 years of age, according to a study published online March 28 in the Lancet . This is a "landmark study" because it is a "nationally representative sample," according to an accompanying comment . The study provides adequate coverage of often neglected rural areas where three quarters of Indians live, write Rengaswamy Sankaranarayanan, MD, from the International Agency for Research on Cancer in Lyon, France, and Rajaraman Swaminathan, PhD, from the Cancer Institute in Chennai, India, in their comment. It "represents notable progress in obtaining direct estimates of the cancer burden, particularly in regions that are not covered by cancer registration," they write. "Verbal autopsy" — and not systematic medical certification — was used to determine the cause of death in the study. Such autopsies, which rely on relatives' accounts of illness, are used i...

March 27, 2012 — Ultrasound-guided surgery appears to be better able to completely excise breast tumors and spare healthy tissue than standard palpation-guided surgery. A new study, presented at the 8th European Breast Cancer Conference (EBCC-8), held in Vienna, Austria, found that ultrasound-guided surgery can prevent the unacceptably high rate of tumor-involved resection margins seen in palpable breast cancer excision, and can reduce the amount of healthy breast tissue removed to optimal volume resection. "Ultrasound for palpable breast cancer excision is highly accurate, and results in high rates of tumor-free resection margins and less need of additional treatment for the patients," said lead author Nicole Krekel, MD, a PhD student in the Department of Surgical Oncology and a resident in plastic and reconstructive surgery at the VU University Medical Center in Amsterdam, the Netherlands. The technique is noninvasive, simple, safe, and effective, she explained. Not Re...

March 27, 2012 (New York, New York) — When a suburban New York hospital was audited to investigate billing for implantable cardioverter defibrillator (ICD) implants that violated national coverage determination (NCD) directives, a careful review found that only 15% of questioned implants failed to have an acceptable explanation [1]. This represented only 1.3% of patients who received the ICDs at that institution during the audit period. Dr Jonathan Steinberg (Columbia University College of Physicians and Surgeons, New York) and Dr Suneet Mittal (Valley Hospital, Ridgewood, NJ) describe the audit and "lessons learned" in an article in the April 3, 2012 issue of the Journal of the American College of Cardiology . "Most implantable defibrillators are done appropriately and have a very great track record of reducing the risk of cardiac death," Steinberg told heart wire . "Physicians who are involved in the care of patients who may need an ICD need to be aware...

March 27, 2012 (Chicago, Illinois) — In a talk on the new oral anticoagulants entitled "Putting it all together: What should we do now?" Prof John Camm (St Georges Hospital, London) attempted to make some recommendations on how these new drugs should be incorporated into clinical practice. Noting that dabigatran (Pradaxa, Boehringer Ingelheim) is now available worldwide, rivaroxaban (Xarelto, Bayer) is starting to reach the market, and apixaban (Eliquis, Pfizer/Bristol-Myers Squibb) is awaiting approval, Camm told a packed session on the last day of the American College of Cardiology (ACC) 2012 Scientific Sessions : "It is a difficult task to put together all the data in a field that is so highly dynamic." Prof John Camm He stressed that warfarin was an extremely effective drug for stroke prevention in AF patients, reducing stroke by 68% and mortality by 26%. But about 60% of patients never get warfarin, around half of patients who do get it stop takin...