<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_3252"
                     title="Growth of Employer Plans Forseen With Health Reform"
                     score="0.01"
                     href="http://www.medpagetoday.com/Washington-Watch/Reform/tb/22013?impressionId=1283456205452"
                     
      &lt;p&gt;WASHINGTON  --  Employer-sponsored insurance will not only remain a cornerstone of the American healthcare system, but it will increase in prevalence in the post-healthcare reform environment, according to several researchers.&lt;/p&gt;
&lt;p&gt;The Affordable Care Act (ACA) likely will result in a large increase in employer-offered insurance, according to a Perspective article published in the Sept. 1 issue of the &lt;em&gt;New England Journal of Medicine&lt;/em&gt; (NEJM).&lt;/p&gt;
&lt;p&gt;In the article, researchers from the RAND Corporation used a simulation model to predict how the healthcare market will change because of healthcare reform. The researchers took a number of factors into consideration to predict the decisions workers are likely to make regarding health insurance.&lt;/p&gt;
&lt;p&gt;First, under the ACA, firms with more than 50 employees that do not offer insurance will be penalized. Firms with fewer than 100 workers have the choice of offering insurance through an insurance exchange. In those small firms, individuals with an income of between 100% and 400% of the federal poverty level who do not have an affordable offer of insurance from their employer will receive a government subsidy to help them purchase a plan through the exchange.&lt;/p&gt;
&lt;p&gt;In addition, ACA expands Medicaid to include those with incomes up to 133% of the federal poverty level, which will mean some workers might switch from employer-sponsored coverage to Medicaid.&lt;/p&gt;
&lt;p&gt;The researchers, led by Christine Eibner, PhD, predicted that the number of workers offered coverage post-reform will increase from the current 115 million workers, or 85% of the U.S. work force, to about 129 million workers, or 95% of the work force.&lt;/p&gt;
&lt;p&gt;The increase will be even more pronounced among workers who are employed by a small company. Currently, just 60% of employees at firms that have 50 or fewer employees have an offer of coverage. That proportion is projected to increase to 86% after all the major elements of reform are implemented, the researchers wrote.&lt;/p&gt;
&lt;p&gt;The driving factors that will increase the prevalence of employer-sponsored insurance are the threat of being penalized and the greater availability of lower-cost plans, the researchers said.&lt;/p&gt;
&lt;p&gt;Reform will have less of an effect on large businesses, the authors said. Of the 13.6 million workers who will be offered insurance who were not offered it before reform, just about three million will be employed at firms that are large enough to be subject to penalties for failing to offer insurance.&lt;/p&gt;
&lt;p&gt;The authors point out that a few assumptions  --  such as that reform will create administrative savings that will translate to cheaper plans  --  are not guaranteed to happen.&lt;/p&gt;
&lt;p&gt;&quot;Although these caveats will influence the proportion of workers who are offered exchange-based versus traditional employer-sponsored insurance, our prediction that employer-sponsored insurance will remain an important source of coverage is very robust [in response] to variations in modeling assumptions,&quot; the authors conclude.&lt;/p&gt;
&lt;p&gt;Employer-sponsored insurance will remain popular partly because of an increased demand by workers for health insurance, and also because companies will &quot;frequently choose to offer insurance rather than to drop coverage and allow their workers to buy individual coverage,&quot; the authors wrote. These companies will choose to offer insurance in part because of the tax-advantaged treatment of employer plans.&lt;/p&gt;
&lt;p&gt;While the employer-sponsored structure is likely to remain in solid, the authors of the &lt;em&gt;NEJM&lt;/em&gt; article said the nature of employer-sponsored coverage may change and more employers may opt to offer their employees plans through the exchanges.&lt;/p&gt;
&lt;p&gt;&quot;Many employers will find that offering coverage through the exchanges is an attractive option, owing to wider risk pooling, low administrative costs, and expanded choices,&quot; they conclude.&lt;/p&gt;
&lt;p&gt;Another research group  --  the Commonwealth Fund  --  released a report Thursday that also predicts employer-based coverage will remain solid and that tax credits available to small businesses will spur increased coverage for 16.6 million small business employees.&lt;/p&gt;
&lt;p&gt;The tax credits  --  which were mandated by the ACA  --  will equal 35% of the employer&apos;s premium contribution in 2010, and increase to 50% in 2014.&lt;/p&gt;
&lt;p&gt;In the Commonwealth Fund report  --  called &quot;Realizing the Potential of Health Reform: Small Businesses and the Affordable Care Act of 2010&quot;  --  the authors wrote that the tax credits from small businesses are sorely needed.&lt;/p&gt;
&lt;p&gt;While nearly all firms with 200 or more employees currently offer health benefits, just 46% of firms with fewer than 10 employees offer insurance. In addition, more than half of all workers at companies with fewer than 50 employees are uninsured or underinsured, wrote the authors.&lt;/p&gt;
&lt;p&gt;On average, small firms pay up to 18% more in premiums than large firms do for the same health insurance policy, the authors wrote.&lt;/p&gt;
&lt;p&gt;Over the next 10 years, small businesses and organizations could receive an estimated $40 billion in federal support through the premium credit program, the report concluded.&lt;/p&gt;
&lt;p&gt;&quot;The ACA will provide both immediate and long-term relief for millions of small businesses that have long struggled to provide health insurance to their workers and who are now coping with a severely weakened economy,&quot; wrote the authors.&lt;/p&gt;
&lt;p&gt;Under reform, small businesses will be better equipped to offer health benefits to their workers, which will reduce the &quot;considerable disadvantage&quot; that small firms have had in the labor market, enabling them to compete for high-quality employees, the authors said.&lt;/p&gt;
&lt;p&gt;&quot;The ACA will also benefit millions of workers in small firms who have lost their health benefits over the past decade and have been unable to buy affordable coverage on the individual market,&quot; the authors concluded.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The authors report that their Comprehensive Assessment of Reform Efforts (COMPARE) microsimulation model is funded by a number of companies and foundations, including AARP, Abraxis BioScience, Aetna Foundation, Alcoa, Amgen Foundation, Blue Cross Blue Shield of Massachusetts, Business Roundtable, California HealthCare Foundation, The Funari Family Foundation, General Motors Foundation, Johnson &amp;amp; Johnson, The Martin Foundation, Pacific Business Group on Health, Pfizer, Robert Wood Johnson Foundation, The Suzanne Nora Johnson and David G. Johnson Foundation, United Health Foundation, and Wellpoint Foundation.&lt;/p&gt;&lt;p&gt;RAND also receives funding from the U.S. Department of Labor.&lt;/p&gt;&lt;p&gt;The Commonwealth Fund report contained no conflict of interest disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_3251"
                     title="Rapid TB Test Shows High Accuracy (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/InfectiousDisease/Tuberculosis/tb/22011?impressionId=1283456205452"
                     
      &lt;p&gt;A two-hour molecular diagnostic test detected tuberculosis bacteria, including rifampin-resistant strains, with sensitivity and specificity well over 90%, researchers found.&lt;/p&gt;
&lt;p&gt;Sensitivity exceeded 98% in samples from patients with smear-positive &lt;em&gt;Mycobacterium tuberculosis&lt;/em&gt; infections and the false positive rate was 0.8%, according to Catherina C. Boehme, MD, of the Foundation for Innovative New Diagnostics (FIND) in Geneva, Switzerland, and colleagues.&lt;/p&gt;
&lt;p&gt;The automated Xpert MTB/RIF test yielded false-negative or indeterminate results in about 27.5% of samples from smear-negative, culture-positive patients. But running the test three times on such samples increased the sensitivity to 90.2%, the researchers reported online in the &lt;em&gt;New England Journal of Medicine&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Nearly all samples from patients with rifampin-resistant &lt;em&gt;M. tuberculosis&lt;/em&gt; infection were also tested accurately with the molecular diagnostic, with sensitivity of 97.6% in 205 patients.&lt;/p&gt;
&lt;p&gt;Less than 4% of results (192 of 5,190 tests in total) yielded indeterminate results, which dropped to 1.2% for repeat tests. &quot;No patient had indeterminate results on all samples tested,&quot; Boehme and colleagues reported.&lt;/p&gt;
&lt;p&gt;In an accompanying editorial, two global public health experts said the DNA-based technology could point the way toward better worldwide control of TB.&lt;/p&gt;
&lt;p&gt;&quot;If an improved rapid nucleic acid&amp;#8211;amplification test is adopted globally, it could help avert more than 15 million tuberculosis-related deaths by 2050,&quot; wrote Peter Small, MD, of the Institute for Systems Biology in Seattle, and Madhukar Pai, MD, PhD, of McGill University in Montreal.&lt;/p&gt;
&lt;p&gt;Gold-standard culture methods for diagnosing active TB usually take weeks. The only rapid test now feasible in poorer nations is sputum-smear microscopy, which &quot;routinely misses half of all cases,&quot; Small and Pai wrote.&lt;/p&gt;
&lt;p&gt;But they pointed out that the Xpert platform remains relatively expensive for developing countries and has other limitations.&lt;/p&gt;
&lt;p&gt;The Xpert platform, developed by California-based Cepheid and already available in reference laboratories for other types of infectious disease testing, uses polymerase chain reaction (PCR) technology to amplify DNA sequences that are unique to a given organism.&lt;/p&gt;
&lt;p&gt;For &lt;em&gt;M. tuberculosis&lt;/em&gt;, it requires little hands-on operation  --  just a few minutes of sample preparation that can be performed by a minimally trained technician. All other functions are automated, with results available within two hours.&lt;/p&gt;
&lt;p&gt;The evaluations reported by Boehme and colleagues included samples from 609 individuals who did not have TB, 561 patients with smear-positive TB, and 171 with smear-negative TB.&lt;/p&gt;
&lt;p&gt;Patients came from Peru, South Africa, Azerbaijan, and India. Culture methods were the definitive test for TB infection. All tests were performed in well-equipped reference laboratories.&lt;/p&gt;
&lt;p&gt;Rifampin resistance was also assessed with traditional phenotypic drug-susceptibility testing as well as the Xpert test, which detects certain mutations in the bacterium&apos;s &lt;em&gt;rpoB&lt;/em&gt; gene that confer resistance to rifampin, a first-line TB drug in much of the world.&lt;/p&gt;
&lt;p&gt;The following sensitivities were reported for single-sample analyses of patients with culture-confirmed TB: &lt;ul&gt; &lt;li&gt;Smear-positive, 98.2% (95% CI 96.8% to 99.0%)&lt;/li&gt; &lt;li&gt;Smear-negative, 72.5% (95% CI 65.4% to 78.7%)&lt;/li&gt; &lt;li&gt;All culture-positive, 92.2% (95% CI 90.0% to 93.9%)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;When three samples were tested for each patient, the sensitivities increased  --  to 99.8% (95% CI 99.0% to 100%) in smear-positive samples and 90.2% (95% CI 84.9% to 93.8%) in smear-negative samples.&lt;/p&gt;
&lt;p&gt;Single-sample analysis in the non-TB participants showed specificity of 99.2% (95% CI 98.1% to 99.6%), which worsened only slightly when three samples per patient were tested (98.1%, 95% CI 96.6% to 98.9%).&lt;/p&gt;
&lt;p&gt;When it came to identifying rifampin-resistant infections, the molecular test appeared more accurate than conventional phenotypic susceptibility testing.&lt;/p&gt;
&lt;p&gt;When the latter was used as the reference, the Xpert test showed sensitivity of 97.6% and sensitivity of 98.1%. But the Xpert test&apos;s sensitivity and specificity were higher when discrepancies were resolved by sequencing the &lt;em&gt;rpoB&lt;/em&gt; gene, bringing the sensitivity to 99.1% and specificity to 100%.&lt;/p&gt;
&lt;p&gt;The test was similarly accurate for identifying patients with multidrug-resistant TB although the test itself only analyzes rifampin resistance, Boehme and colleagues reported.&lt;/p&gt;
&lt;p&gt;Both the investigators and the editorialists noted that the use of reference laboratories to perform the evaluations was a significant limitation. The ultimate goal of FIND, the nonprofit group that has sponsored the research, is to have a test platform that can be deployed widely in TB-endemic areas across Africa, Asia, and South America.&lt;/p&gt;
&lt;p&gt;&quot;It is not certain that our findings would be replicated in microscopy centers, health posts, and other point-of-treatment settings where temperature and electricity supply will be more variable,&quot; Boehme and colleagues cautioned. They also noted that the Xpert technology is more expensive than sputum smear microscopy, even with &quot;concessionary pricing for public-sector programs,&quot; although it is also potentially less costly than culture methods.&lt;/p&gt;
&lt;p&gt;Editorialists Small and Pai noted that future testing in point-of-care settings in endemic regions would be &quot;critical&quot; in determining whether the Xpert platform is feasible in those locations.&lt;/p&gt;
&lt;p&gt;In the U.S., the Xpert MTB/RIF test is currently available for research use only.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The work was funded by FIND, the National Institutes of Health, Cepheid, and the Bill and Melinda Gates Foundation.&lt;/p&gt;&lt;p&gt;Boehme reported no potential conflicts of interest. Other authors reported various relationships with Cepheid, including employment. Boehme and several authors were employees of study sponsor FIND.&lt;/p&gt;&lt;p&gt;Small holds a position in the Bill and Melinda Gates Foundation. He also reported owning stock in Johnson &amp;amp; Johnson. Pai had no disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_3250"
                     title="Attitudes More than Growth Response Drive Growth Hormone Therapy (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/Endocrinology/GeneralEndocrinology/tb/22010?impressionId=1283456205452"
                     
      &lt;p&gt;While a physician&apos;s decision to start a child on growth hormone is usually consistent with evidence-based guidelines, continuation or intensification of therapy is strongly influenced by factors other than treatment response, according to a new survey.&lt;/p&gt;
&lt;p&gt;Doctors&apos; attitudes and other factors, such as parent preference, exerted more influence on continuation decisions than did the growth response to therapy, Leona Cuttler, MD, of Case Western Reserve University, in Cleveland, and colleagues reported in &lt;em&gt;Pediatrics&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;&quot;At minimum, the results underscore the need for more emphasis and guidance on criteria for discontinuing growth hormone and perhaps other similar medications,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;Growth hormone is one of the fastest-growing classes of pharmaceuticals: biologicals, many with &quot;controversial indications and unclear endpoints for treating chronic conditions,&quot; Cuttler and colleagues wrote.&lt;/p&gt;
&lt;p&gt;Initiation and continuation of treatment is decided solely by the physician, but the determinants of those decisions are unclear.&lt;/p&gt;
&lt;p&gt;So to examine how physicians decided to begin growth hormone therapy among patients with idiopathic short stature, as well as how they decided to continue, the researchers assessed data from a survey questionnaire of 727 pediatric endocrinologists. The structured survey included different case scenarios;&lt;strong&gt; &lt;/strong&gt;the response rate was 90%.&lt;/p&gt;
&lt;p&gt;The researchers found that in previously untreated children, recommendations to initiate growth hormone were largely consistent with guidelines and were also influenced by family preferences and physician attitudes &lt;em&gt;(P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;For instance, 93% of endocrinologists said they would likely initiate growth hormone for a very short child with very low predicted adult height (PAH), very slow growth velocity, and a family wishing treatment.&lt;/p&gt;
&lt;p&gt;On the other end of the spectrum, 74% said they wouldn&apos;t initiate treatment for the child when growth parameters were less impaired and the family was neutral about treatment.&lt;/p&gt;
&lt;p&gt;Physicians ranked PAH as the most important parameter for initiating treatment, followed by baseline height and growth velocity.&lt;/p&gt;
&lt;p&gt;Family preference had almost as strong an influence as growth velocity, the researchers said.&lt;/p&gt;
&lt;p&gt;Compared with decisions on initiating therapy, decisions about continuation or intensification of treatment were more divergent.&lt;/p&gt;
&lt;p&gt;Overall, physicians demonstrated a preference for continuation (47.3%) and intensification (36.7%) versus discontinuation (16%).&lt;/p&gt;
&lt;p&gt;Those decisions were driven by nonphysiologic and contextual factors including physician attitude, family preference, and initiation recommendations (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001 for all).&lt;/p&gt;
&lt;p&gt;The combination of family preference and low response to treatment was particularly powerful in increasing dose, the researchers said (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;Also, factors present at initiation significantly influenced continuation decisions independent of the child&apos;s response to treatment. Doctors were likely to increase the dose of growth hormone if baseline PAH was very short, and decisions were also influenced by baseline height, growth velocity, and family preference.&lt;/p&gt;
&lt;p&gt;&quot;This is particularly striking because their influence persisted even after new evidence on growth response and family preference was known,&quot; the researchers wrote. &quot;This suggests that physicians may continue to be influenced by perceived disability associated with short stature, rather than guided primarily by evidence of the child&apos;s response to treatment.&quot;&lt;/p&gt;
&lt;p&gt;Physicians&apos; personal beliefs were also powerful influences on continuation of treatment. Concerns about emotional well-being and belief in the use of individualized growth hormone trials increased the likelihood of intensifying treatment and reduced the&lt;strong&gt; &lt;/strong&gt;likelihood of discontinuation (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;Those who believed that drug companies provide useful information were less likely to discontinue growth hormone (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;Together, attitudinal and contextual factors exerted more influence on continuation decisions than did the growth response to therapy, the researchers said.&lt;/p&gt;
&lt;p&gt;The study was limited by the use of scenarios and potential response bias although 96% of respondents said the questionnaire resembled cases in their practice, and the scenarios were vetted in advance.&lt;/p&gt;
&lt;p&gt;Still, the researchers concluded that the results may hold insights into medication management for chronic conditions treated with drugs that have unclear endpoints.&lt;/p&gt;
&lt;p&gt;The findings also underscore need for more evidence-based guidance for discontinuing growth hormone therapy, the researchers wrote.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by the National Institutes of Health.&lt;/p&gt;&lt;p&gt;The researchers reported no conflicts of interest.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_3249"
                     title="ESC: Novel Agent Blocks Hyperkalemia in Heart Failure (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/MeetingCoverage/ESCCongress/tb/22009?impressionId=1283456205452"
                     
      STOCKHOLM  --  An investigational potassium binder prevented hyperkalemia in at-risk patients with heart failure, a randomized, placebo-controlled trial showed.&lt;br&gt;
&lt;br&gt;Through four weeks, the compound  --  RLY5016  --  resulted in a drop in mean serum potassium levels from 4.69 to 4.48 mEq/L (a change of -0.22), Bertram Pitt, MD, of the University of Michigan in Ann Arbor, reported at the European Society of Cardiology congress here.&lt;br&gt;
&lt;br&gt;In the placebo group, potassium levels increased from 4.65 to 4.93 mEq/L (a change of +0.23). The between-group difference at the end of treatment was 0.45 mEq/L (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;br&gt;
&lt;br&gt;The drug was generally well tolerated; the most common side effects were gastrointestinal.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;Because of three cases of hypokalemia in the treatment group, Pitt said additional studies are needed to determine whether a lower dose retains the benefits without dropping potassium too low. Ongoing studies suggest a lower dose does just that, he added.&lt;/p&gt;
&lt;p&gt;The drug could alleviate some of the concern clinicians have had regarding the use of renin-aldosterone-angiotensin-system (RAAS) blockers, which have been shown to reduce mortality in patients with heart failure but have been associated with hyperkalemia.&lt;/p&gt;
&lt;p&gt;&quot;If future studies bear out what we&apos;ve seen over the longer term... then we think we have the opportunity of taking a number of very high-risk patients and a relatively large number of them and making available to them life-saving therapy with multiple RAAS blockers, including aldosterone blockers, which we think will have tremendous effect on outcome,&quot; Pitt said at a press briefing.&lt;/p&gt;
&lt;p&gt;The PEARL-HF trial randomized 55 patients to receive 30 g a day of the new drug and 49 to receive placebo for four weeks.&lt;/p&gt;
&lt;p&gt;Most of the patients (about 98%) had relatively mild heart failure  --  New York Heart Association class II or III.&lt;/p&gt;
&lt;p&gt;In addition to heart failure, patients were also required to have stage 3 or 4 chronic kidney disease or a recent history of hyperkalemia that resulted in the discontinuation of RAAS blocker therapy. At baseline, all had a serum potassium level of 4.3 to 5.1 mEq/L.&lt;/p&gt;
&lt;p&gt;Use of RAAS blocker therapy was similar in the placebo and treatment groups at baseline, with indications that numerous patients were undertreated.&lt;/p&gt;
&lt;p&gt;All patients were given spironolactone 25 mg/day at the beginning of the study. At day 15, the dose was increased to 50 mg/day in patients whose serum potassium level was below 5.1 mEq/L.&lt;/p&gt;
&lt;p&gt;In addition to the significant drop in serum potassium in the treatment group, there was also a significant reduction with the new compound in the number of patients who had hyperkalemia at any point in the study (7% versus 25%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.05). The benefit was seen across all levels of kidney function.&lt;/p&gt;
&lt;p&gt;Bertram noted that only 19% of patients with normal kidney function in the placebo group (and who entered the study because of a history of hyperkalemia resulting in stopping RAAS inhibitors) developed hyperkalemia during the study, which suggests that they should retry recommended doses of RAAS inhibitors before abandoning use or reducing the doses.&lt;/p&gt;
&lt;p&gt;The number of patients who were able to increase th spironolactone dose to 50 mg/day was greater in the treatment group (91% versus 74%, &lt;em&gt;P&lt;/em&gt;=0.019).&lt;/p&gt;
&lt;p&gt;There were few serious adverse events (two in each group), and one death (in the placebo group).&lt;/p&gt;
&lt;p&gt;The gastrointestinal adverse effects were all mild and transient, except for one case of severe flatulence, according to Pitt.&lt;/p&gt;
&lt;p&gt;Serving as a discussant at Pitt&apos;s presentation, Henry Dargie, a consultant cardiologist at Golden Jubilee National Hospital in Glasgow, Scotland, said the risks and benefits of the new compound need to be carefully explored in future studies.&lt;/p&gt;
&lt;p&gt;He noted that the patient population in PEARL-HF likely had milder heart failure and renal impairment than would be expected in patients taking RAAS inhibitors, which are indicated for severe heart failure.&lt;/p&gt;
&lt;p&gt;&quot;So the target population perhaps isn&apos;t exactly the one we would be using in clinical practice,&quot; he said.&lt;/p&gt;
&lt;p&gt;Future studies should target those with more severe heart failure and renal impairment, and should be able to evaluate the effect on mortality, considering the seriousness of hypokalemia, he said.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;Pitt reported serving as a consultant to and holding stock options in Relypsa, which is developing the compound evaluated in this study. He reported additional relationships with Abbott, AstraZeneca, AuraSense, Bayer, BG Medicine, Boehringer Ingelheim, Forest Labs, GE Healthcare, Medtronic, Merck, Novartis, Pfizer, and Takeda.&lt;/p&gt;&lt;p&gt;Dargie said he had no conflicts of interest.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_3248"
                     title="Increased Cardiac Events Seen With Sibutramine (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/Cardiology/MyocardialInfarction/tb/22008?impressionId=1283456205452"
                     
      &lt;p&gt;Overweight patients with cardiovascular risks who took the weight-loss drug sibutramine (Meridia) had a 16% increased likelihood of experiencing a cardiac event, a large randomized trial found.&lt;/p&gt;
&lt;p&gt;The overall hazard ratio for a fatal or nonfatal cardiovascular event was 1.16 (95% CI 1.03 to 1.31, &lt;em&gt;P&lt;/em&gt;=0.02) among patients receiving sibutramine compared with those receiving placebo, according to W. Philip T. James, MD, of the London School of Hygiene and Tropical Medicine, and colleagues.&lt;/p&gt;
&lt;p&gt;Specifically, the hazard ratio for nonfatal myocardial infarction was 1.28 (95% CI 1.04 to 1.57, &lt;em&gt;P&lt;/em&gt;=0.02), and the hazard ratio for nonfatal stroke was 1.36 (95% CI 1.04 to 1.77, &lt;em&gt;P&lt;/em&gt;=0.03), the researchers reported in the Sept. 1 &lt;em&gt;New England Journal of Medicine&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;A &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/17147&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/17147&quot; target=&quot;_blank&quot;&gt;preliminary analysis&lt;/a&gt;&lt;a target=&quot;_blank&quot;&gt; &lt;/a&gt;of data from the SCOUT (Sibutramine Cardiovascular Outcomes) trial previously suggested this increased risk, and the FDA required stronger &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/18088&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/18088&quot; target=&quot;_blank&quot;&gt;cautionary language&lt;/a&gt; in the drug&apos;s labeling.&lt;/p&gt;
&lt;p&gt;The final publication has now confirmed it, with James and colleagues stating, &quot;On the basis of these results, sibutramine should continue to be excluded from use in patients with preexisting cardiovascular disease.&quot;&lt;/p&gt;
&lt;p&gt;Sibutramine is a norepinephrine and serotonin reuptake inhibitor that has sympathomimetic effects and therefore can increase blood pressure and pulse rate. Because even small increases in blood pressure and pulse rate are associated with an increased likelihood of cardiovascular events, the SCOUT investigators wanted to determine the drug&apos;s long-term cardiovascular risk.&lt;/p&gt;
&lt;p&gt;They enrolled 9,804 obese or overweight patients who were at least 55 years old. All participants had a history of cardiovascular disease and/or type 2 diabetes.&lt;/p&gt;
&lt;p&gt;The study consisted of a six-week lead-in period in which all patients received 10 mg/day of sibutramine, after which they were randomized to the active treatment or placebo.&lt;/p&gt;
&lt;p&gt;Mean duration of treatment was 3.4 years, and slightly more than 40% of patients in both groups discontinued treatment.&lt;/p&gt;
&lt;p&gt;All patients also participated in individualized diet and exercise programs designed for cardioprotection, and blood pressure decreased in both groups during the lead-in phase.&lt;/p&gt;
&lt;p&gt;However, after randomization the sibutramine group had small but consistent increases in blood pressure and resting pulse rate.&lt;/p&gt;
&lt;p&gt;While there were increases in the nonfatal events, there was no between-group difference for cardiovascular death (HR 0.99, 95% CI 0.82 to 1.19, &lt;em&gt;P&lt;/em&gt;=0.90) or death from any cause (HR 1.04, 95% CI 0.91 to 1.20, &lt;em&gt;P&lt;/em&gt;=0.54).&lt;/p&gt;
&lt;p&gt;The investigators noted that fewer than half of the events they had expected at the outset of the trial occurred during its six-year overall duration, and that during that time the incidence of cardiovascular disease decreased in most of Europe and Australia, where most of the study centers were located.&lt;/p&gt;
&lt;p&gt;They also pointed out that the study was limited by the lack of a true placebo group, the inclusion of only high-risk patients, and the longer-than-recommended time of treatment (one to two years).&lt;/p&gt;
&lt;p&gt;In an accompanying editorial, Gregory D. Curfman, MD, executive editor of &lt;em&gt;NEJM, &lt;/em&gt;and colleagues commented that the cardiovascular risk findings of SCOUT need to be considered in light of the potential clinical benefit of the weight loss seen among those on sibutramine.&lt;/p&gt;
&lt;p&gt;Patients on the drug lost 4.3 kg at one year, but regained about 0.5 kg thereafter, for a net loss of less than 4 kg from a baseline average weight of 96 kg.&lt;/p&gt;
&lt;p&gt;In January 2010, after the preliminary analysis of the SCOUT data, the European Medicines Agency suspended marketing authorizations for sibutramine-containing medications throughout the European Union.&lt;/p&gt;
&lt;p&gt;On Sept. 15, an advisory committee of the FDA plans to meet to decide whether additional regulatory action should be taken here as well.&lt;/p&gt;
&lt;p&gt;Curfman and colleagues concluded, &quot;Given that sibutramine has minimal efficacy for weight loss, no apparent benefit for clinical outcomes, a worrisome cardiovascular risk profile, and a plausible mechanism to explain the cardiovascular risk, it is difficult to discern a credible rationale for keeping this medication on the market.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was funded by Abbott Laboratories.&lt;/p&gt;&lt;p&gt;Several of the SCOUT investigators reported serving on advisory boards and receiving fees from multiple pharmaceutical companies, including Abbott, sanofi-aventis, Merck, Johnson &amp;amp; Johnson, Novo Nordisk, GlaxoSmithKline, and Boehringer Ingelheim.&lt;/p&gt;&lt;p&gt;In addition, three of the investigtors were full-time employees of Abbott and had equity interest in the company.&lt;/p&gt;&lt;p&gt;Aside from Curfman&apos;s position with &lt;em&gt;NEJM&lt;/em&gt;, the editorialists had no disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
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