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    <recommendedItem id="20100101_19_3195"
                     title="ESC: Hot Line Actually Only Lukewarm"
                     score="0.014"
                     href="http://www.medpagetoday.com/MeetingCoverage/ESCCongress/tb/21936?impressionId=1283458690683"
                     
      &lt;p&gt;STOCKHOLM  --  Intracoronary bone marrow cell transplantation extended survival in patients with chronic heart failure due to ischemic cardiomyopathy  --  that was the good news. The bad news was that the finding was not &quot;new&quot; at all  --  it had already been published.&lt;/p&gt;
&lt;p&gt;Late today the European Society of Cardiology said it would sanction the researcher who reported the stem cell study by barring him from presenting research at ESC congresses for two years.&lt;/p&gt;
&lt;p&gt;The ESC guidelines for Hot Line trials specifically state that the information submitted should be new, unpublished data. Yet, the STAR trial was accepted for presentation as a Hot Line trial at the ESC annual meeting here.&lt;/p&gt;
&lt;p&gt;When asked by &lt;em&gt;MedPage Today&lt;/em&gt; to point out the &quot;news&quot; in the Hot Line presentation, STAR lead investigator Bodo-Eckehard Strauer, MD, of the Heinrich Heine University of D&amp;#252;sseldorf, Germany, said the news was that bone marrow cell therapy significantly improved survival in patients with chronic cardiomyopathy, which he illustrated with a slide showing a Kaplan-Meier curve  --  the same graph that was published in the July issue of the &lt;em&gt;European Journal of Heart Failure.&lt;/em&gt; Moreover, every data slide in Strauer&apos;s presentation matched the tables in the published paper.&lt;/p&gt;
&lt;p&gt;Late today, the ESC acknowledged the breach of congress rules in a statement saying that it &quot;acknowledges that significant information pertaining to the results of the STAR Heart Study, presented today at ESC Congress 2010 as novel had already been published prior to [the] ESC Congress.&quot;&lt;/p&gt;
&lt;p&gt;The presentation therefore, &quot;clearly breaks ESC rules for Hot Line Sessions, which state that information must be first presented at ESC Congresses in order to qualify for presentation in a Hot Line session.&quot;&lt;/p&gt;
&lt;p&gt;The ESC said it was not informed of the publication before the meeting. As a result of the violation, the ESC said it would &quot;not accept abstracts from this investigator for a period of two years.&quot;&lt;/p&gt;
&lt;p&gt;According to information in the journal, Strauer and colleagues submitted their paper in February, revised it in April, and the journal accepted it in late April.&lt;/p&gt;
&lt;p&gt;It should be noted that the &lt;em&gt;European Journal of Heart Failure &lt;/em&gt;is a journal of the ESC.&lt;/p&gt;
&lt;p&gt;Immediately after the press briefing &lt;em&gt;MedPage Today&lt;/em&gt; asked Fausto Pinto, MD, PhD, the ESC program chair, and ESC President Roberto Ferrari, MD, why they had accepted the STAR paper as a Hot Line presentation. They said &quot;we thought there were new data.&quot;&lt;/p&gt;
&lt;p&gt;Ferrari then added, &quot;We were snookered.&quot;&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_3235"
                     title="ESC: New Anticoagulants Create Buzz"
                     score="0.011"
                     href="http://www.medpagetoday.com/MeetingCoverage/ESCCongress/tb/21988?impressionId=1283458690683"
                     
      &lt;p&gt;STOCKHOLM  --  After years of waiting for an alternative to warfarin (Coumadin), there are now three wending their way through the regulatory process. In this exclusive InFocus video report we review each of these new agents.&lt;/p&gt;
&lt;p&gt;Two factor Xa inhibitors  --  apixiban and rivaroxaban  --  along with the direct thrombin inhibitor, dabigatran, are competing to be the first warfarin alternatives to gain FDA approval and that is good news according to Fausto Pinto, MD, PhD, the program chair at this year&apos;s European Society of Cardiology congress, where the new agents were featured in a number of sessions.&lt;/p&gt;
&lt;p&gt;Ralph L. Sacco, MD, president of the American Heart Association agreed that the news was good, but noted that, as the agents come to market, developing new guidelines for their use will be a critical task for the AHA and the ESC.&lt;/p&gt;
&lt;p&gt;Pinto and Sacco discussed the potential benefits  --  and challenges  --  of the new agents with &lt;em&gt;MedPage Today&lt;/em&gt; executive editor Peggy Peck.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_3223"
                     title="ESC: EINSTEIN DVT Data Positive for Factor Xa Inhibitor (CME/CE)"
                     score="0.011"
                     href="http://www.medpagetoday.com/MeetingCoverage/ESCCongress/tb/21976?impressionId=1283458690683"
                     
      &lt;p&gt;STOCKHOLM  --  An investigational oral anticoagulant appears to be as effective and safe as treatment with enoxaparin (Lovenox) plus warfarin (Coumadin) to prevent recurrent deep vein thrombosis, researchers reported.&lt;/p&gt;
&lt;p&gt;In a study conducted in the Netherlands among more than 3,400 older adults with symptomatic DVT, 2.1% (n=36) of the rivaroxaban patients experienced recurrent DVT versus 3.0% (n=51) of controls  --  a difference that was statistically significant for noninferiority (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001 one-sided)  --  said Harry R. Buller, MD, of the Academic Medical Center in Amsterdam.&lt;/p&gt;
&lt;p&gt;Moreover, the net clinical benefit  --  the primary efficacy endpoint of symptomatic DVT (a composite of recurrent DVT, nonfatal pulmonary embolism, or fatal PE) plus major bleeding  --  also favored rivaroxaban, HR 0.67 (95% confidence interval 0.47 to 0.95), Buller reported at the European Society of Cardiology Congress here.&lt;/p&gt;
&lt;p&gt;The safety endpoint  --  a combination of major and minor clinically-relevant nonmajor bleeding  --  was the same in both arms, 8.1% (&lt;em&gt;P&lt;/em&gt;=0.77).&lt;/p&gt;
&lt;p&gt;Buller said there was &quot;no evidence of liver toxicity and no cardiovascular signal.&quot; Liver toxicity has been a concern with factor Xa inhibitors because the first agent to reach clinical trials, ximelagatran, failed to receive FDA approval due to liver toxicity.&lt;/p&gt;
&lt;p&gt;The appeal of rivaroxaban is its simplicity  --  a pill that doesn&apos;t require a special diet or blood tests to confirm clotting time, both of which are required with warfarin, said Clyde Yancy, MD, of Baylor Medical Center in Dallas.&lt;/p&gt;
&lt;p&gt;Yancy told &lt;em&gt;MedPage Today &lt;/em&gt;that it is the simplicity of the new agents that has him concerned because there is a possibility that they will be used universally &quot;for indications that have not been studied simply because they are easier than warfarin.&quot;&lt;/p&gt;
&lt;p&gt;Elliot Antman, MD, a senior investigator with the TIMI group at Brigham and Women&apos;s Hospital and professor of medicine at Harvard Medical School, said the EINSTEIN DVT results were encouraging, but he noted that there is a concern with all of the new anticoagulants, &quot;how to reverse the anticoagulant effect?&quot;&lt;/p&gt;
&lt;p&gt;Vitamin K is an antidote for warfarin, but there is at present no antidote for drugs like rivaroxaban and other new oral anticoagulants, he said.&lt;/p&gt;
&lt;p&gt;Antman used a scenario to illustrate his point: &quot;Suppose you have patient on rivaroxaban for DVT, and that patient develops acute cholecystitis, and he or she needs immediate gall bladder surgery? What do you do?&quot;&lt;/p&gt;
&lt;p&gt;The possible options would be fresh frozen plasma or wait until the drug clears, &quot;but that might be 12, 24, 36 hours.&quot;&lt;/p&gt;
&lt;p&gt;He said that every company that is developing an oral anticoagulant is looking at ways to reverse the drugs, including Daiichi Sankyo, which is developing edoxaban, an oral factor Xa inhibitor. Antman is the principal investigator of phase III trial of edoxaban.&lt;/p&gt;
&lt;p&gt;But the concern about reversibility &quot;should not dampen the enthusiasm for these agents,&quot; Antman said.&lt;/p&gt;
&lt;p&gt;The EINSTEIN DVT trial randomized 1,731 patients to rivaroxaban 15 mg twice daily for three weeks followed by 20 mg maintenance dose. Patients were treated for three, six, or 12 months, at the discretion of the investigator.&lt;/p&gt;
&lt;p&gt;The trial design did not allow for identification of an ideal treatment duration said discussant Harald Darius, MD, of Vivantes Klinikum Neuk&amp;#246;lln Hospital in Berlin. Darius said it looked like treatment wasn&apos;t needed after six months, but it wasn&apos;t clear.&lt;/p&gt;
&lt;p&gt;Another 1,718 patients were enrolled in the control arm, which received enoxaparin 1 mg/kg/bid &amp;#8805;5 days, followed by warfarin.&lt;/p&gt;
&lt;p&gt;Patients were in their mid-50s and more than half were men.&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 Bayer AG.&lt;/p&gt;&lt;p&gt;B&amp;#252;ller disclosed grants for clinical research from: Bayer HealthCare Pharmaceuticals, Daiichi Sankyo, Merck Sharpe &amp;amp; Dohme, Pfizer, and sanofi-aventis. He also served as a consultant for Bayer HealthCare Pharmaceuticals, Daiichi Sankyo, Merck Sharpe &amp;amp; Dohme, Pfizer, and sanofi-aventis.&lt;/p&gt;&lt;p&gt;Darius said he had no relevant disclosures.&lt;/p&gt;&lt;p&gt;Yancy said he had no conflicts.&lt;/p&gt;&lt;p&gt;Antman is a principal investigator of ENGAGE AF-TIMI 48 a phase III trial of the oral factor Xa inhibitor edoxaban which is being developed by Daiichi Sankyo.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_3203"
                     title="Vitamin A Hikes HIV Loads in Breast Milk (CME/CE)"
                     score="0.011"
                     href="http://www.medpagetoday.com/HIVAIDS/HIVAIDS/tb/21944?impressionId=1283458690683"
                     
      &lt;p&gt;HIV-positive mothers may be more likely to infect infants via breast milk if they take vitamin A and beta-carotene supplements, researchers have found.&lt;/p&gt;
&lt;p&gt;In two analyses of a cohort of HIV-positive Tanzanian women, those who took the vitamins had significantly higher viral loads in their breast milk than those who didn&apos;t take them (&lt;em&gt;P&lt;/em&gt;=0.02), according to Eduardo Villamor, MD, PhD, of the University of Michigan, and colleagues.&lt;/p&gt;
&lt;p&gt;They also had a higher risk of subclinical mastitis, an inflammatory response that causes tight junctions in the mammary epithelium to open, allowing extracellular fluid to flow from plasma to milk. Villamor said this could be the mechanism explaining the association with viral load.&lt;/p&gt;
&lt;p&gt;&quot;Daily supplementation with these nutrients at the doses tested in the trial should probably not be given to HIV-infected lactating women,&quot; Villamor told &lt;em&gt;MedPage Today&lt;/em&gt; in an e-mail.&lt;/p&gt;
&lt;p&gt;The analyses were published in separate papers in the &lt;em&gt;American Journal of Clinical Nutrition&lt;/em&gt; and the &lt;em&gt;Journal of Nutrition&lt;/em&gt;, respectively.&lt;/p&gt;
&lt;p&gt;Both come from a randomized, controlled trial of 1,078 HIV-infected women in Dar es Salaam, Tanzania, who received one of four regimens: vitamin A and beta-carotene (5,000 IU and 30 mg, respectively); B-complex vitamins along with vitamins C and E; a multivitamin plus vitamin A and beta-carotene; or placebo.&lt;/p&gt;
&lt;p&gt;The &lt;em&gt;American Journal of Clinical Nutrition&lt;/em&gt; study looked at 594 of these women who were infected with HIV and had breast milk samples taken.&lt;/p&gt;
&lt;p&gt;The researchers found that the proportion of breast milk samples with detectable viral load was significantly higher in women who received regimens with vitamin A and beta-carotene than in the other groups (51.3% versus 44.8%, &lt;em&gt;P&lt;/em&gt;=0.02).&lt;/p&gt;
&lt;p&gt;The effect was apparent at least six months postpartum, they said, with a 34% increased risk of HIV shedding in milk at that time (relative risk 1.34, 95% CI 1.04 to 1.73).&lt;/p&gt;
&lt;p&gt;There were no significant differences between women who received multivitamins and those who took placebo, they added.&lt;/p&gt;
&lt;p&gt;They also found that breast milk concentrations of beta-carotene were related to increased detectable viral load in milk.&lt;/p&gt;
&lt;p&gt;One mechanism by which this occurs may be subclinical mastitis, assessed in the &lt;em&gt;Journal of Nutrition&lt;/em&gt; study.&lt;/p&gt;
&lt;p&gt;A subset of 674 participants had subclinical mastitis assessed, measured by sodium-to-potassium ratio in breast milk.&lt;/p&gt;
&lt;p&gt;The researchers found that those on vitamin A and beta-carotene had a 45% increased risk of severe subclinical mastitis (&lt;em&gt;P&lt;/em&gt;=0.03), with nonsignificant trends toward greater risk of moderate subclinical mastitis or any degree of the condition.&lt;/p&gt;
&lt;p&gt;Those taking multivitamins without vitamin A and beta-carotene had a 33% greater risk of subclinical mastitis (&lt;em&gt;P&lt;/em&gt;=0.005) and a 75% greater risk of severe subclinical mastitis (&lt;em&gt;P&lt;/em&gt;=0.0006) than women on placebo.&lt;/p&gt;
&lt;p&gt;The researchers called these findings &quot;unexpected,&quot; attributing their effects to an increased inflammatory response.&lt;/p&gt;
&lt;p&gt;Women taking multivitamins plus vitamin A and beta-carotene had trends toward increased risks, but again they were not significant.&lt;/p&gt;
&lt;p&gt;The researchers also found that among women with CD4+ T-cell counts of 350 or greater, multivitamin intake resulted in a 49% increased risk of any subclinical mastitis (&lt;em&gt;P&lt;/em&gt;=0.006).&lt;/p&gt;
&lt;p&gt;However, multivitamins had no effects among those with lower counts.&lt;/p&gt;
&lt;p&gt;The analyses were limited because they lacked details on clinical breast symptoms and on breast-feeding practices.&lt;/p&gt;
&lt;p&gt;Villamor told &lt;em&gt;MedPage Today&lt;/em&gt; that the findings about vitamins other than vitamin A and beta-carotene are not immediately concerning, because in previous studies, these nutrients have shown benefits in terms of disease progression, child growth, diarrhea, and anemia.&lt;/p&gt;
&lt;p&gt;But vitamin A and beta-carotene do seem clearly problematic, he said.&lt;/p&gt;
&lt;p&gt;There are now &quot;strong arguments to consider the implications of supplementation to pregnant or lactating women who are HIV-positive. It does not look like it&apos;s a safe intervention for them,&quot; Villamor 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;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_3191"
                     title="ESC: It&apos;s Not Butter and It&apos;s Not Better (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/MeetingCoverage/ESCCongress/tb/21921?impressionId=1283458690683"
                     
      STOCKHOLM  --  Adding margarine enriched with omega-3 fatty acids as a dietary intervention did not prevent second heart attacks in older men and women at risk for worsening heart disease, researchers said here.&lt;br&gt;
&lt;br&gt;The study results are doubly disappointing since the margarine intervention did initially reduce events, but by 30 months the evidence of that benefit had disappeared, said Daan Kromhout, MPH, PhD, of Wageningen University in the Netherlands.&lt;br&gt;
&lt;br&gt;After more than 40 months, consumption of the omega-3 fatty acid fortified margarines &quot;had no effect on the rate of major cardiovascular events,&quot; he reported at a Hot Line session today at the European Society of Cardiology meeting. The findings were simultaneously published online by the &lt;em&gt;New England Journal of Medicine.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;The ALPHA-OMEGA trial randomized 4,837 MI survivors, 60 to 80 years old, to margarine supplemented with a combination of eicosapentaenoic acid and docosahexaenoic acid (EPA and DHA), or with 2 grams of the plant-derived fatty acid alpha-linolenic acid (ALA), or a third supplemented with all three versus a placebo margarine.&lt;/p&gt;
&lt;p&gt;The primary endpoint was the combined rate of fatal and non-fatal cardiovascular events and cardiac interventions.&lt;/p&gt;
&lt;p&gt;Neither EPA-DHA nor ALA reduced this endpoint, the researchers reported (hazard ratio with EPA-DHA, 1.01; 95% confidence interval 0.87 to 1.17, &lt;em&gt;P &lt;/em&gt;=0.93).&lt;/p&gt;
&lt;p&gt;A prespecified subgroup analysis in women found that use of the ALA-fortified margarine reduced the rate of cardiovascular events compared with placebo or with the EPA-DHA margarine, but the difference failed to reach statistical significance (HR 0.73, 95% CI 0.51 to 1.03, &lt;em&gt;P&lt;/em&gt;=0.07).&lt;/p&gt;
&lt;p&gt;Alfred Bove, MD, of Temple University in Philadelphia, said the findings surprised him &quot;because most of the data on omega-3 fatty acids come from epidemiologic studies and those were positive.&quot;&lt;/p&gt;
&lt;p&gt;He likened the situation to hormone therapy, which had been widely recommended to reduce cardiovascular risk in postmenopausal women based on data from epidemiologic studies.&lt;/p&gt;
&lt;p&gt;That hypothesis was initially questioned when a randomized controlled trial (Estrogen/Progestin Replacement Study [HERS]) linked hormones to increased risk of events. The HERS finding was confirmed in the landmark Women&apos;s Health Initiative trial in which ischemic events were more common among women randomized to estrogen/progestin.&lt;/p&gt;
&lt;p&gt;R. Scott Wright, MD, of the Mayo Clinic in Rochester, Minn., told &lt;em&gt;MedPage Today&lt;/em&gt; that the trial design was faulty, in that margarine was a bad choice of vehicle for omega-3 fatty acids.&lt;/p&gt;
&lt;p&gt;&quot;It needs to be combined with another food  --  bread,&quot; he said. &quot;So this not a good option for Americans because it would mean eating more bread, which is likely to lead to weight gain and bread is high in sodium, so blood pressure would be a factor.&quot;&lt;/p&gt;
&lt;p&gt;Wright noted that the ALPHA-OMEGA study did not include information on weight or blood pressure, so he considered the findings at best incomplete.&lt;/p&gt;
&lt;p&gt;All of the patients received &quot;state-of-the-art antihypertensive, antithrombotic, and lipid-modifying therapy,&quot; according to Kromhout and colleagues, in addition to margarine, and it may have been that optimal therapy that limited the potential for an omega-3 benefit.&lt;/p&gt;
&lt;p&gt;Statin therapy, along with other improvements in cardiovascular care, means &quot;a beneficial effect of low doses of EPA-DHA is difficult to prove,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;Wright said he wasn&apos;t persuaded by that explanation since, even after optimal therapy, there is about a 30% residual risk. &quot;There is plenty of room to show a benefit,&quot; he declared.&lt;/p&gt;
&lt;p&gt;Most of the patients in ALPHA-OMEGA were men (78%) and 24% were obese, but they differed from the typical high-risk American in at least one way: at baseline they consumed about three times more fish than does the typical American, a median of 15 grams a day.&lt;/p&gt;
&lt;p&gt;According to a report from the Environmental Protection Agency, average fish consumption in the U.S. works out to 4.58 &amp;#177; 0.42 grams a day.&lt;/p&gt;
&lt;p&gt;The authors conducted a post hoc exploratory analysis in patients with diabetes, finding significant reductions in events among patients in the EPA-DHA group. But the authors noted that &quot;[the] results with respect to patients with diabetes are only hypothesis-generating and do not permit definitive conclusions to be drawn.&quot;&lt;/p&gt;
&lt;p&gt;Bove, a former president of the American College of Cardiology, added that the results from the subset analysis in diabetics was reassuring, since patients with diabetes and elevated triglycerides are the patients that &quot;we have believed would be most likely to benefit&quot; from omega-3 fatty acids.&lt;/p&gt;
&lt;p&gt;The margarines used in the trial were supplied by Unilever, an international maker of food and consumer goods, and included the well-known &quot;I Can&apos;t Believe It&apos;s Not Butter,&quot; which contains 420 mg of ALA per serving.&lt;/p&gt;

&lt;p&gt;In a statement released after the ALPHA-OMEGA trial findings were presented, Unilever said the &quot;study outcome for EPA and DHA is surprising considering the weight of evidence published to date. This could be the result of methodological issues such as the relatively low daily dosage compared with previous studies or the fact that in this study serious cardiovascular events were much lower than in studies performed in the past. This is probably due to extensive drug treatment that is nowadays applied. The finding needs further study, but given the totality of evidence does not immediately impact the current advice on fish and fish oil consumption for prevention of cardiovascular disease.&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 trial was supported by the Netherlands Heart Foundation, the National Institutes of Health, and Unilever.&lt;/p&gt;&lt;p&gt;Kromhout reported that his institution received grant support form Unilever to cover distribution of the trial margarines to patients. His institution also received a grant from the Product Board for Margarine Fats and Oils to support research on polyunsaturated fats and cardiovascular diseases done by a PhD student.&lt;/p&gt;&lt;p&gt;Bove said he had no financial conflicts.&lt;/p&gt;&lt;p&gt;Wright said he consults for Roche and Genentech and conducts trial work for 3M/Littman.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
</recommendedContent>
