Attorneys General in 40 US states urge FDA to regulate e-cigarettes.

The Wall Street Journal (9/25, Esterl, Subscription Publication, 5.91M) is among numerous media outlets that report on a joint call by Attorneys General in 40 US states for the FDA to heavily regulate access by young people to e-cigarettes and to meet an Oct. 31 deadline for proposing the regulations. The group expressed concern about an array of issues, from e-cigarette advertising on TV with cartoon-like characters to the sweet flavors used in some e-cigarettes. The group, which includes large states such as California and New York, wrote to FDA Commissioner Margaret Hamburg.

        The Los Angeles Times (9/24, Li, 3.07M) reports that Ohio AG Mike DeWine asked the FDA to regulate e-cigarettes like other tobacco products. “Unlike traditional tobacco products, there are no federal age restrictions that would prevent children from obtaining e-cigarettes, nor are there any advertising restrictions,” he said in a statement.

        The AP (9/25, Pratt) reports that the letter, co-sponsored by DeWine and Massachusetts AG Martha Coakley, “said 1.8 million middle and high school students said they had tried e-cigarettes in 2012,” which mirrors increases in adult usage of the products. “People, especially kids, are being led to believe that e-cigarettes are a safe alternative, but they are highly addictive and can deliver strong doses of nicotine,” Coakley said.

        The Boston Globe (9/24, Lazar, 1.75M) “White Coat Notes” blog reports that “many health advocates worry that with big tobacco’s deep pockets, the marketing will become more aggressive, and even more youth-oriented, creating a young generation of e-cigarette smokers hooked on nicotine before researchers fully understand what risks the product may pose.”

        Reuters (9/25, Clarke) notes that the letter comes less than a week after 15 public health organizations sent a letter to President Barack Obama asking him to pressure the FDA into issuing the rules.

Obesity May Be a Frequent Barrier to Living Kidney Donation

New research suggests obesity may be a frequent barrier to living kidney donation. In a single center, retrospective analysis of 104 potential living kidney donors between 2008 and 2012, a total of 23 individuals (22%) were moderately or morbidly obese (BMI > 35), and of these only three (13%) succeeded at losing weight and donating. The Clinical Transplantation study found 82% of individuals were overweight (37%) or obese (BMI 30–34.9 [23%], 35– 39.9 [16%], and > 40 [6%]).

BMI and Waist Circumference Linked with Left Ventricular Mass in Hypertensive Predialysis CKD Patients

In a study of 206 hypertensive predialysis CKD patients whose BMI and waist circumference were assessed annually for 3 years, both BMI and waist circumference were associated with left ventricular mass in CKD stage 1 to 3 but not in CKD stage 4 or 5, after adjusting for age, sex, primary renal disease, smoking and history of cardiovascular disease. In a longitudinal analysis, both an increase in BMI and waist circumference were associated with an increase in left ventricular mass. The findings are published inNephrology Dialysis Transplantation.

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For Immediate Release: Monday, June 17, 2013

NIH launches Dietary Supplement Label Database

Searchable collection contains product information and ingredients from labels of dietary supplements sold in U.S.

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Researchers, as well as health care providers and consumers, can now see the ingredients listed on the labels of about 17,000 dietary supplements by looking them up on a website. The Dietary Supplement Label Database, free of charge and hosted by the National Institutes of Health, is available atwww.dsld.nlm.nih.gov.

The Dietary Supplement Label Database provides product information in one place that can be searched and organized as desired. "This database will be of great value to many diverse groups of people, including nutrition researchers, healthcare providers, consumers, and others," said Paul M. Coates, Ph.D., director of the NIH Office of Dietary Supplements (ODS). “For example, research scientists might use the Dietary Supplement Label Database to determine total nutrient intakes from food and supplements in populations they study."

For consumers, the My Dietary Supplements (MyDS) app from ODS is already available, at https://myds.nih.gov. The app is an easy way to keep track of vitamins, minerals, herbs, and other products you take, and has science-based, reliable information on dietary supplements.

A screen shot of The Dietary Supplement Label Database

Dietary supplements, taken regularly by about half of U.S. adults, can add significant amounts of nutrients and other ingredients to the diet. Supplements include vitamins, minerals, herbals and botanicals, amino acids, enzymes, and more. They come in many different forms, including tablets, capsules, and powders, as well as liquids and energy bars. Popular supplements include vitamins D and E; minerals like calcium and iron; herbs such as echinacea and garlic; and specialty products like glucosamine, probiotics, and fish oils.

By law, any product labeled as a dietary supplement must carry a Supplement Facts panel that list its contents and other added ingredients (such as fillers, binders, and flavorings). The Dietary Supplement Label Database includes this information and much more — such as directions for use, health-related claims, and any cautions — from the label.

The Dietary Supplement Label Database offers these features:

• Quick Search: Search for any ingredient or specific text on a label.
• Search for Dietary Ingredients: An alphabetical list of ingredients is also provided.
• Search for Specific Products: An alphabetical list of products is also provided.
• Browse Contact Information: Search by supplement manufacturer or distributor.
• Advanced Search: Provides options for expanding a search by using a combination of search options including dietary ingredient, product/brand name, health-related claims, and label statements.

Hundreds of new dietary supplements are added to the marketplace each year, while some are removed. Product formulations are frequently adjusted, as is information on labels. “The Dietary Supplement Label Database will be updated regularly to incorporate most of the more than 55,000 dietary supplement products in the U.S. marketplace,” said Steven Phillips, M.D., director of the National Library of Medicine’s Division of Specialized Information Services.

The Dietary Supplement Label Database is the result of collaboration between ODS and NLM, with input from federal stakeholders who participate in a federal working group on dietary supplements. These include representatives from most NIH institutes and centers, as well as the Food and Drug Administration, Agency for Healthcare Research and Quality, Administration for Community Living, Centers for Disease Control and Prevention, Office of Disease Prevention and Health Promotion, Consumer Product Safety Commission, Department of Defense, Department of Veterans Affairs, Federal Trade Commission, Health Resources and Services Administration, National Aeronautics and Space Administration, National Institute of Standards of Technology, and Department of Agriculture.

The Office of Dietary Supplements, ODS http://ods.od.nih.gov, seeks to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.

The National Library of Medicine (NLM) is the world's largest library of the health sciences, and collects, organizes, and makes available biomedical science information to scientists, health professionals, and the public. For more information, visit http://www.nlm.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH...Turning Discovery Into Health®

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Quality Campaign Cuts Dialysis Deaths

Published: Sep 17, 2013

By Crystal Phend, Senior Staff Writer, MedPage Today

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A national quality improvement initiative cut 1-year mortality among new dialysis patients by 13.6%, an independent analysis showed.

While that reduction from 2009 to 2012 didn't reach the 20% target, further declines are expected based on the bigger 25% reduction in 90-day mortality, Vincent Mor, PhD, of Brown University School of Public Health, and colleagues wrote in a report released from the PEAK campaign.

"It did not achieve that bold goal, but it was a fairly ambitious goal to begin with," Mor told MedPage Today. "We actually do anticipate a continued drop in 1-year mortality over the next 5 or 6 months because of the 90-day mortality."

He served as project director for the independent data analysis commissioned by Kidney Care Partners, the amalgam of professional, industry, and advocacy groups that organized the initiative.

Overall end-stage renal disease mortality has been on the decline for a decade, whereas deaths in the first year have remained stubbornly high at an annualized rate of about 30%, the PEAK (Performance Excellence and Accountability in Kidney Care) websiteexplained as the reason for its focus.

The campaign included a number of voluntary "best practices" aimed at reducing catheter use in favor of arteriovenous fistulas, improving cardiovascular outcomes, managing nutrition and inflammation, handling anemia, and optimizing dialysis, along with depression screening, patient education, and social support.

The analysis couldn't pinpoint the reason for the decline seen during the campaign, but did hint at longer dialysis sessions as a contributing factor.

Case mix didn't change over the study period for albumin levels at dialysis initiation or other clinical and demographic characteristics, except for a small but steady decline in baselinehemoglobin levels and a possible increase in baseline creatinine among older age groups, suggesting slightly worse kidney function over time when starting dialysis.

Use of a catheter instead of an arteriovenous fistula when starting dialysis changed little over the study period, though patients may have gone on to get a fistula later in treatment, the researchers pointed out.

The one striking trend was more patients initially prescribed dialysis for at least 4 hours' duration.

That proportion rose 10 percentage points from before the initiative in 2008 through 2011, from just under 65% to nearly 75%, and then spiked up to almost 80% by the end of 2012.

While that shift was associated with a drop in mortality, Mor cautioned that the association could not be determined as causal based on the available data and that there was no data on what happened to prescribed dialysis duration later in the course of treatment.

His group pulled national data from the same Centers for Medicare and Medicaid Services (CMS)'s Renal Management Information System used by the United States Renal Data System (USRDS).

The decline in first-year mortality from 0.25 deaths per person-year when the campaign launched in June 2009 to less than 0.22 per person-year by the end of 2012 came out almost identical whether calculated by USRDS methods or by the PEAK method.

The proportion of patients dying within 1 year of starting dialysis fell by 13.7%, from about 21% to less than 19% over the same period.

Early deaths in the first 90 days declined from around 8% to about 6% by the end of 2012. That was a 22.5% improvement since the beginning of the program after adjustment for demographic, clinical, and treatment characteristics at baseline.

Notably, more than 60% of that decline occurred in those starting dialysis in 2012, "suggesting that the impact of PEAK may not have completed its impact on reductions in 1-year mortality," as early survival typically predicts 1-year survival, the report pointed out.

While the report was considered final, there are plans to follow mortality rates for another 6 months to see if that is the case, Mor said.

"Given the findings, now the important thing is to try to find out why," he suggested.

The USRDS has additional, more detailed data available, which should clarify the factors most closely related to the declining mortality so that those components can be applied more uniformly across practices, Mor noted.

Also, there were variations within regions that could be informative, he pointed out.

New score predicts likelihood of good outcome after in-hospital CPR

Researchers have developed a simple score, useful in discussing do-not-resuscitate orders, which can identify patients who aren't likely to benefit from a resuscitation attempt if they experience in-hospital cardiac arrest.

Study participants were 51,240 inpatients with an index episode of in-hospital cardiac arrest (IHCA) between 2007and 2009 in 366 hospitals participating in the Get With the Guidelines-Resuscitation registry. Researchers created several candidate decision models, and used a test data set to choose the model that best classified patients with very low (<1%), low (1% to 3%), average (>3% to 15%) or higher-than-average (>15%) likelihood of surviving with good neurologic status after resuscitation for IHCA. The main outcome was a Cerebral Performance Category score of 1, meaning the patient could lead a normal life and have only minimal neurologic or psychologic deficits, like mild dysphagia. They checked the final model with a validation data set.

The best model used a simple point score based on 13 pre-arrest variables available at the time of admission: neurologically intact or with minimal deficits at admission, major trauma, acute stroke, metastatic or hematologic cancer, septicemia, medical noncardiac diagnosis, hepatic insufficiency, admitted from skilled nursing facility, hypotension or hypoperfusion, renal insufficiency or dialysis, respiratory insufficiency, pneumonia and older age. Results were published online September 9 by JAMA Internal Medicine.

The resulting clinical prediction rule, the Good Outcome Following Attempted Resuscitation (GO-FAR) score, had a C statistic of 0.78 when applied to the validation set. Overall, the score identified more than a quarter of patients as having low or very low likelihood of surviving to discharge neurologically intact or with minimal deficits after IHCA. Specifically, the score identified 9.4% and 18.9% of patients, respectively, as having very low or low likelihood of a good outcome. Fifty-four percent were identified as having average likelihood of a good outcome and 17.7% as having an above-average likelihood of a good outcome.

The score could be helpful when counseling patients about their "do not resuscitate" (DNR) orders, the authors wrote, adding that past research has found most patients significantly overestimate their post-CPR survival chances. The score could be built into the admission process, they added, and integrated with patient values and expectations to optimize decision making about DNR orders. To this end, the researchers said they are creating a web-based tool to give patients general information about CPR, provide individual estimates of outcomes, and to help them specify their treatment preferences.

An editorial note praised the score but cautioned it should be used "in conjunction with, not as a replacement for, clinical judgement" since such scores "often do not identify subtle patient characteristics … that may render the patient's chance of a good outcome either better or worse than that predicted by the index." The note added that doctors should get a clear sense of patients' wishes as "many patients would accept CPR if it allowed survival with more moderate or even severe forms of disability."

Severe Hypoxic Events in OSA May Lead to Kidney Damage

MedPage Today reported that research presented at the European Respiratory Society meeting suggests that “severe hypoxic events in obstructive sleep apnea (OSA) might lead to kidney damage, though the sleep disorder appeared to be only a minor contributor overall.” Researchers found that “the lowest oxygen saturation level reached at night modestly but significantly predicted chronic kidney disease as indicated by a below-normal estimated glomerular filtration rate (eGFR).” The study indicated that “mean oxygen saturation wasn’t a significant predictor overall in the multivariate analysis, nor were there consistent correlations between eGFR and Apnea-Hypopnea Index.”

Tests May Help Identify Patients Who Retain Sodium

By getting a second urine sample and blood pressure measure, researchers found that eight out of 19 adolescents visiting a pediatric nephrologist were sodium retainers and seven of these were already hypertensive. The amounts of sodium retained ranged from a few milligrams to hundreds of milligrams over the course of a doctor’s visit. The findings (9/13) were presented at the American Heart Association’s High Blood Pressure Research 2013 Scientific Sessions. Retaining too much sodium increases fluid retention and blood pressure levels. The team is now using the method to try to identify sodium retainers among adults seeing a general internist.

Cinnamon May Benefit Patients with Type 2 Diabetes

n Annals of Family Medicine meta-analysis of 10 randomized controlled trials evaluating the effects of cinnamon in 543 patients with type 2 diabetes at doses of 120 mg/day to 6 g/day for 4 to 18 weeks found that consumption reduced levels of fasting plasma glucose (-24.6 mg/dL), total cholesterol (-15.6 mg/dL), LDL cholesterol (-9.4 mg/dL) and triglycerides (-29.6 mg/dL). Cinnamon also increased levels of HDL cholesterol (1.7 mg/dL). No significant effect was seen on hemoglobin A1c levels. High degrees of heterogeneity were present for all analyses except HDL cholesterol, which limits the potential application of the results to patient care.

New rules for opioid painkiller labeling announced by FDA.

Many of the nation’s most widely circulated papers, as well as several websites, covered the Food and Drug Administration’s Tuesday announcement altering opioid painkiller labeling requirements. All of these sources quote agency officials such as FDA commissioner Margaret Hamburg and Dr. Douglas Throckmorton, deputy director for regulatory programs at the FDA Center for Drug Evaluation and Research. The Washington Post(9/10, Dennis, 4.39M) reports that on Tuesday, FDA detailed its new tougher warning label requirements for opioid painkillers “as part of an effort to combat the rampant addiction and misuse that lead to thousands of deaths each year.” The stricter requirements apply to all opioid painkillers, both long-acting and extended-release varieties. Speaking with reporters on Tuesday, Hamburg said, the “FDA is extremely concerned about the inappropriate use of opioids, which has reached epidemic proportions in the United States and has become a major public health challenge,” but she added that the medical benefit the drugs provide patients in pain cannot be ignored. Hamburg said that a balance must be struck “between their benefit in treating patients with pain and the risks associated with misuse, abuse, addiction, overdose and death.”

        The heart of the changes are “a modification of the language on what kind of pain the drugs are supposed to be prescribed for,” the New York Times (9/11, Tavernise, Subscription Publication, 9.44M) reports. Currently, labels indicate “the drugs should be used for moderate to severe pain,” which Dr. Throckmorton said was not right. According to Throckmorton, “What is moderate to me could be severe to you,” and the labeling change “will say that the drugs should be reserved for use in patients who do not have other treatment options, and be used for management of pain that is ‘severe enough’ to require round-the-clock treatment.”

        The Los Angeles Times (9/11, Girion, Healy, 3.07M) adds that Hamburg said that “drug manufacturers will also have to conduct new research aimed at identifying what doses and modes of use are most likely to harm patients.” The FDA is hoping to change the practice of prescribing the opioids to patients for use on an “as needed” basis. The new guidelines are not formal prescribing restrictions on physicians, but agency “leaders made clear they wanted to discourage physicians from prescribing the medications for anything other than ongoing, intractable pain,” encouraging physicians and patients to not only focus on subjective pain levels, “but on how long pain persists and on other treatment options” as well. The Times notes that physicians will retain “broad latitude to prescribe the drugs ‘off-label’ where they” believe it’s medically warranted.

        New boxed warnings on the risks surrounding taking the drugs while pregnant will also be included, reports the Wall Street Journal (9/11, Catan, Martin, Subscription Publication, 5.33M). The FDA has taken action, Hamburg said, “to combat the crisis of misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities.” The new warnings do not affect immediate-release painkillers.

        Bloomberg News (9/11, Edney, 1.41M) includes data from the Centers for Disease Control and Prevention that notes the involvement of prescription painkillers in “14,800 overdose deaths in 2008, more than cocaine and heroin combined.” Drug manufacturers will also be required “to conduct new post-market studies on the abuse potential of their drugs and on the possibility that users develop an increased sensitivity to pain.” One year ago the agency started “requiring risk mitigation strategies of extended-release and long-acting opioids.”

        The AP (9/11, Perrone) notes that in a statement, Throckmorton said the changes describe “the risks and safety concerns associated with `extended release and long-acting’ opioids” more clearly, and they “will encourage better, more appropriate, prescribing, monitoring and patient counseling practices.” Also reporting on the FDA announcement are the CBS News (9/11, Castillo, 5.42M) website, CNN (9/10, Kounang, 11.58M), the NPR (9/11, Stein, 405K) “Shots” blog, Time (9/10, Szalavitz, 13.36M), CQ (9/11, Adams, Subscription Publication, 530), HealthDay (9/11, Reinberg, 2K), MedPage Today (9/11, Fiore, 185K), Medscape (9/11, Lowes, 187K), and the Fayetteville (NC) Observer (9/10, Ramsey, 141K).

Good Attitude Helps Heart to Heal

Published: Sep 10, 2013 | Updated: Sep 11, 2013

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By Cole Petrochko, Staff Writer, MedPage Today

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

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Ischemic heart disease patients who had positive attitudes were more likely to exercise and were less likely to die from any cause at 5-year follow-up, researchers found.

Action Points

• Ischemic heart disease patients who had positive attitudes were more likely to exercise and were less likely to die from any cause at 5-year follow-up.
• Note that positive affect was more common in patients who were male, had higher education, and were employed, and was associated with lower likelihood of diabetes and COPD.

High positive affect was associated with a significantly reduced risk of all-cause mortality (unadjusted hazard ratio 0.58, 95% CI 0.37-0.92) and a significant chance of exercising (unadjusted odds ratio 1.99, 95% CI 1.44-2.76) among 607 Danish ischemic heart disease patients, according to Susanne Pedersen, PhD, of Tilburg University in the Netherlands, and colleagues.

Additionally, patients who exercised were 50% less likely to die by the 5-year follow-up (HR 0.50, 95% CI 0.31-0.8, P=0.004), they wrote online in Circulation Cardiovascular Quality Outcomes.

"Interventions aimed at increasing both positive affect and exercise may have better results with respect to patients' prognosis and psychological well-being than interventions focusing on one of these factors alone," the authors said.

Patients with ischemic heart disease commonly present with depression, anxiety, and "other negative affective states," which have been tied with other major adverse cardiac events and death, despite advances in treatment of ischemic heart disease that have reduced mortality, they wrote.

Positive affect has been associated with lower risks for 10-year cardiovascular events, though the underlying mechanisms of the association between affect and health outcomes has not been established.

The study measured whether positive affect was predictive of time to first cardiac-related hospitalization and all-cause mortality, and if exercise was tied to the relationship between affect, hospitalization, and mortality among heart disease outpatients.

Participants completed the HeartQoL questionnaire, an international cross-sectional survey of health-related quality of life.

Information on clinical history up to 10 years before baseline (January 1996 to November 2005) was collected from the National Patient Register. This information included diagnoses and hospital surgeries for a number of conditions including MI, angina, arrhythmias, cardiac arrest, percutaneous coronary intervention, coronary artery bypass graft, renal failure, diabetes, and chronic obstructive pulmonary disease (COPD).

Researchers gathered additional data on mortality and hospitalization, exercise via the patient survey, and Global Mood Scale scores.

Mean patient age was 65.5 and 75.5% of participants were men. Nearly half did not exercise regularly (46%), while the majority engaged in moderate regular exercise (54%).

Positive affect was more common in patients who were male (P=0.002), had higher education (P<0.001), and were employed (P=0.004), and was associated with lower likelihood of diabetes (P=0.039), and COPD (P<0.001). Patients with positive affect were also less likely to have a diuretic prescription (P=0.006) or use psychotropic medications (P≤0.001).

At the 5-year follow-up, 13.2% of patients had died by a mean 4.7 years. A significantly greater number of patients with low positive affect than high positive affect died at follow up, "with the cumulative hazard functions differing significantly between patients wit high versus low positive affect."

Associations between exercise and positive affect remained significant after adjustment (adjusted OR 1.48, 95% CI 1.03-2.13, P=0.036), as did associations between exercise and risks of dying among those with positive affect (adjusted HR 0.41, 95% CI 0.26-0.66, P<0.001).

Patients were also significantly less likely to be hospitalized with positive affect in an unadjusted analysis (HR 0.98, 95% CI 0.97-0.99, P=0.004). Also, patients who exercised were less likely to be hospitalized for cardiac diagnoses when compared with those who did exercise (OR 0.76, 95% CI 0.61-0.95). However, neither the association between positive affect and hospitalization, nor the relationship between exercise and hospitalization, was significant in the mediation model, the authors pointed out.

"The association between positive affect and exercise merits more attention as well because a paucity of studies has considered this relationship," the researchers noted.

One study limitation was that "because positive affect and exercise were both measured at baseline, the design of this study does not permit us to draw conclusions about the direction of causality," the authors said.

Additionally, the study participants were mainly European so the results may not have general application. Finally, the authors did not have information on the type of exercise or exercise intensity.

The study was supported by the Research Council of the Region of Sjaelland, the Danish Heart Foundation, and a VIDI grant from the Netherlands Organization for Health Research and Development.

The authors received support from St. Jude Medical, sanofi-aventis, Medtronic, Cameron Health BV, Boston Scientific, Pfizer, MSD, and AstraZeneca.

From the American Heart Association:

• Circulation: Cardiovascular Quality and Outcomes

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Primary source: Circulation Cardiovascular Quality Outcomes

Source reference: Pedersen SS, et al "Exercise mediates the association between positive affect and 5-year mortality in patients with ischemic heart disease" Circ Cardiovasc Qual Outcomes2013; DOI: 10.1161/circoutcomes.113.000158.

Treatment in Critical Care that Is Perceived to Be Futile Is Common and Costly

Critical care specialists who assessed 1136 ICU patients judged that 80% never received futile treatment, 8.6% received probably futile treatment, 11% received futile treatment, and 1% received futile treatment only on the day they transitioned to palliative care. The most common reason treatment was perceived as futile was because burdens outweighed the benefits (58%), followed by the treatment could never reach the patient’s goals (51%), death was imminent (37%), and the patient would never be able to survive outside an ICU (36%). The average cost for one day of futile treatment was $4004, according to the JAMA Internal Medicine study.

About 20 percent of ICU patients may receive care believed by physicians to be futile.

The Los Angeles Times (9/10, Healy, 3.07M) “Science Now” blog reports that research published in JAMA Internal Medicine suggests that approximately 20 percent of patients in intensive care units may receive “care and treatment judged by the physician in charge to be ineffective, needlessly aggressive or pointless given the patient’s” condition. The research, which was performed at a single “academic medical system in Los Angeles,” indicated “that of 1,125 patients who spent time in the ICU during a three-month period, 98 received treatment that their physicians perceived as ‘possibly futile,’ and 123 received treatment that their physicians considered futile.” What’s more, this care was expensive, “adding up to $2.6 million over a three-month period.”

        Bloomberg News (9/10, Ostrow, 1.41M) reports that the study was the “first to look at how pervasive futile medical treatments are for critical-care patients and the costs of those treatments, said Neil Wenger, a senior study author.”

        MedPage Today (9/10, Smith, 185K) reports, however, that “the findings should be interpreted with caution, argued Robert Truog, MD...and Douglas White, MD,” who “wrote in an accompanying commentary” that “while the cost of futile care in the study is substantial, it’s unlikely that eliminating such care would save the whole amount because about 85% of intensive care unit (ICU) costs are fixed.”

E-cigarettes may work as well as nicotine patches to help smokers quit.

NBC Nightly News reported that in a study published in the Lancet and presented at a meeting of the European Respiratory Society, researchers “found that E-cigarettes worked as well as nicotine patches in helping smokers kick the habit.”

        The AP (9/8, Cheng) reported that in a study published in the Lancet and presented at a meeting of the European Respiratory Society, researchers found that “electronic cigarettes worked just as well as nicotine patches to help smokers quit.” The study involved more than 650 smokers who wanted to stop smoking. Nearly 300 participants were given “nicotine-containing e-cigarettes while roughly the same number got nicotine patches.” Meanwhile, more than 70 participants were given “placebo e-cigarettes without any nicotine.” Participants used the products they were assigned for 13 weeks.

        The Huffington Post (9/8, Chan, 11.54M) reported that 7.3 percent of those given the e-cigarettes “abstained from smoking during that entire period,” while 5.8 percent of the participants given nicotine patches “had abstained.” Meanwhile, just four percent of those with the “placebo e-cigarettes abstained.”

        On its website, NBC News (9/8, Fox, 6.68M) reported that Dr. Tim McAfee, director of the CDC Office on Smoking and Health, said, “We don’t know much about” e-cigarettes. However, Dr. McAfee “says they could potentially be useful if tobacco companies would stop making products like cigarettes and make e-cigarettes instead – and if those e-cigarettes did indeed turn out to be less harmful than conventional cigarettes.”

        The Time (9/8, Sifferlin, 13.36M) “Healthland” blog pointed out that “the FDA is likely to consider these studies, among others, as it considers what to do about” the devices. Also covering the story were the NPR(9/8, Shute, 405K) “Shots” blog, Bloomberg News (9/8, Kresge, 1.41M), HealthDay (9/8, Preidt, 2K), andMedPage Today (9/8, Phend, 185K).

Blood Test IDs Acute Kidney Injury in ED

MedPage link: http://www.medpagetoday.com/Nephrology/GeneralNephrology/41421

Blood Test IDs Acute Kidney Injury in ED

Published: Sep 6, 2013 | Updated: Sep 6, 2013

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By Salynn Boyles, Contributing Writer, MedPage Today

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Atest that measures blood levels of neutrophil gelatinase-associated lipocalin (NGAL) accurately distinguished between acute kidney injury and reversible transient kidney dysfunction in the ED, researchers reported.

Action Points

• A test that measures blood levels of neutrophil gelatinase-associated lipocalin accurately distinguished between acute kidney injury and reversible transient kidney dysfunction in the ED.
• Point out that higher levels of plasma NGAL were associated with more severe AKI.

Among 616 patients with varying urgent health issues presenting to a hospital emergency department, the highest median levels of plasma NGAL were seen in those with acute kidney injury (146-174 ng/ml at various time points); levels also increased with acute kidney injury (AKI) severity (207-244 ng/ml for AKI Network stage 2 or greater disease).

Plasma NGAL also discriminated between patients with AKI, those with normal kidney function, and those with transient azotemia (area under the curve, 0.85 and 0.73, respectively); a plasma NGAL level of 133 ng/ml or greater was associated with a 10-fold increase in AKI risk, Prasad Devarajan, MD, and colleagues from Cincinnati Children's Hospital Medical Center and the Hospital Fernando Fonseca in Lisbon, Portugal wrote in the Sept. 5 issue of the Clinical Journal of the American Society of Nephrology.

AKI has been increasing in both the hospital and community settings, but diagnosis of the condition remains problematic, the researchers wrote.

Serum creatinine (SCr) is routinely used in emergency departments to diagnose AKI, but it's a delayed marker that rises only after kidney injury has been established, and there are other downsides to the test, Devarajan told MedPage Today.

"Especially in the community-acquired setting, it is very common to see an increase in SCr," he said. "In this setting it is very important to be able to distinguish between true, intrinsic AKI and transient, reversible kidney injury ... [I]n both cases SCr is going to be elevated."

Along with colleagues at Cincinnati Children's Hospital, Devarajan developed the NGAL test as a biomarker of early AKI. In earlier studies, the researchers showed it to be useful in a variety of hospital settings, including adult ICU and heart failure patients.

Devarajan holds patents on the test, which is being commercially developed by the point-of-care diagnostic and services company Alere, Inc. of Waltham, Massachusetts. The test has been approved in parts of Europe and Asia, and the FDA is currently considering Alere's application in the U.S.

In the newly published study, the researchers examined the accuracy of plasma NGAL as a marker of AKI in patients with urgent health issues presenting to the ED.

The study included 616 patients who presented to the ED of Fernando Fonseca Hospital and were admitted for treatment from March to November of 2008. Baseline renal function by SCr, medical history and demographic characteristics were obtained from hospital electronic records.

Prospective renal function assessment was carried out by measuring SCr, serum cystatin C (SCysC), and plasma NGAL at 0, 6, 12, 24, and 48 hours from hospital admission.

Plasma NGAL levels among patients with AKI remained significantly higher than in patients with normal kidney function for all time points (P<0.001). When the combined group of AKI plus transient kidney injury patients was examined, the values of plasma NGAL remained significantly different from patients with normal kidney function (P<0.001 for all time points) and the test was able to differentiate AKI from transient injury (P<0.001 for all time points).

Among the other findings:

• Higher levels of plasma NGAL were associated with more severe AKI using AKI Network classification (median values ranging between 69 and 75, 125.5 and 148, 168 and 195, and 301.5 and 328.5 ng/ml for AKI Network stages 0,1,2, and 3, respectively.

• ROC curves were generated to assess the discriminative ability of the NGAL test for diagnosing AKI. The area under the curves (AUCs) for AKI prediction were 0.77, 0.81, 0.82, 0.79 and 0.78 at 0, 6, 12, 24, and 48 hours, respectively. The AUC for discriminating between patients with AKI and those with normal kidney function was 0.85 (95% CI, 0.81-0.90) at the 12-hour time point.

• The addition of plasma NGAL to the clinical model yielded a net reclassification improvement of 94.3% and an integrated discrimination improvement of 0.122.

• When patients were classified into three grades of risk according to plasma NGAL levels (<97 ng/ml was considered low risk and >133 ng/ml was considered high risk), those in the high risk category were found to have a 10-fold greater risk of AKI (odds ratio, 9.8; 95% CI, 5.6-16.9).

"When pNGAL concentrations are in the gray zone (>97 ng/ml to <133 ng/ml) we propose the recognition of risk factors that are independent predictors of AKI, including age, chronic kidney disease and comorbidities like cardiovascular disease," the researchers wrote. "Thus, patients with these risk factors may be considered at high risk of AKI, even when plasma NGAL levels are in the gray zone."

Devarajan said the findings prove the test could improve the clinical management of patients suspected of having AKI in the emergency treatment setting.

"The incidence of AKI varies from 20% to 40% in critical care patients and it is a significant cause of death," he said. "This test could markedly increase our ability to discriminate between true, intrinsic AKI and other conditions."

Funding for the study was provided by the National Institutes of Health, the Portuguese Nephrology Society, Fernando Fonseca Hospital and Portugal's Fundacao Nacional para a Ciencia e Tecnologia.

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Primary source: Clinical Journal of the American Society of Nephrology

Source reference: Soto K, et al "Plasma NGAL for the diagnosis of AKI in patients admitted from the emergency department setting" Clin J AM Soc Nephrol 2013; DOI: 10.2215/CJN.12181212.