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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_449"
                     title="FDA Okays Statin for Primary Prevention"
                     score="0.014"
                     href="http://www.medpagetoday.com/InfectiousDisease/PublicHealth/tb/18380?impressionId=1265793895849"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has approved rosuvastatin (Crestor) for primary prevention of cardiovascular disease, making it the first statin to receive this indication.&lt;/p&gt;
&lt;p&gt;The new labeling, recommended by an FDA advisory panel late last year, also marks the first time that a drug label will include an indication based on the biomarker highly-sensitive C-reactive protein, an inflammatory marker.&lt;/p&gt;
&lt;p&gt;The new indication would be for men 50 or older and women 60 or older who have fasting LDL of less than 130 mg/dL, a highly-sensitive CRP of 2.0 mg/L or greater, triglycerides of less than 500 mg/dL, and no prior history of heart attack or stroke, or coronary heart disease risk.&lt;/p&gt;
&lt;p&gt;The basis for the new labeling was the JUPITER trial, a randomized, placebo-controlled trial of 17,802 men and women with a mean age of 66 and no history of atherosclerosis. All participants had LDL of less than 130 mg/dL and a highly-sensitive C-reactive protein concentration of 2 mg/L or higher.&lt;/p&gt;
&lt;p&gt;Patients were randomized to 20 mg of rosuvastatin for 1.9 years, which reduced median LDL cholesterol to 55 mg/dL, down from a median of 108 mg/dL at baseline. The corresponding relative reduction in the rate of MI, stroke, arterial revascularization, or cardiovascular death was 44% (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.00001).&lt;/p&gt;
&lt;p&gt;The number needed to treat to avoid one cardiovascular event was 25.&lt;/p&gt;
&lt;p&gt;Those results, according to Melvyn Rubenfire, MD, of the University of Michigan, were a &quot;home run for JUPITER,&quot; but it is not clear whether the results would be the same with another statin.&lt;/p&gt;
&lt;p&gt;And there were some risks associated with rosuvastatin, including 13 deaths due to gastrointestinal disorders in the rosuvastatin arm, and 18 patients reported experiencing a &quot;confused state&quot; while taking the drug.&lt;/p&gt;
&lt;p&gt;The most troubling adverse event, however, was an uptick in investigator-reported, new onset diabetes mellitus in the treatment arm, 2.8% versus 2.5%, for a hazard ratio of 1.27 (95% CI 1.05 to 1.53, &lt;em&gt;P&lt;/em&gt;=0.015).&lt;/p&gt;
&lt;p&gt;Rosuvastatin in marketed by AstraZeneca, which also sponsored the JUPITER trial.&lt;/p&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_439"
                     title="Heart Often Affected in Churg-Strauss (CME/CE)"
                     score="0.014"
                     href="http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/tb/18353?impressionId=1265793895849"
                     
      &lt;p&gt;Cardiac involvement is common in patients with Churg-Strauss syndrome, even when their vasculitis is in clinical remission, a Dutch study found.&lt;/p&gt;
&lt;p&gt;Cardiac MRI detected abnormalities in 62% of patients with this rare, systemic disorder but in only 3% of matched controls (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001), according to Robert M. Dennert, MD, of Maastricht University in the Netherlands, and colleagues.&lt;/p&gt;
&lt;p&gt;Yet only 26% of the patients had clinical symptoms suggesting cardiac involvement, the researchers reported in February&apos;s &lt;em&gt;Arthritis &amp;amp; Rheumatism.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;Cardiac involvement is an important predictor of poor outcome in Churg-Strauss syndrome, with approximately half of the associated mortality being heart-related. Myocardial damage typically results from eosinophilic infiltration and granuloma formation.&lt;/p&gt;
&lt;p&gt;However, the cardiac manifestations are often subclinical. They remain undiagnosed, and the exact incidence is unclear.&lt;/p&gt;
&lt;p&gt;So Dennert and colleagues enrolled 32 patients with confirmed Churg-Strauss syndrome who were in complete clinical remission, performing detailed imaging assessments to determine the frequency and extent of heart involvement.&lt;/p&gt;
&lt;p&gt;About two-thirds were men. The mean age was 61 years, and disease duration was slightly over six years.&lt;/p&gt;
&lt;p&gt;A total of 41% had antineutrophil cytoplasmic antibodies (ANCA), and most were on maintenance steroids or immunosuppressants.&lt;/p&gt;
&lt;p&gt;On EKG, major abnormalities (atrial fibrillation and conduction disturbances) were detected in only 13% of patients. Minor abnormalities such as T wave abnormalities were seen in 50% of patients and in one control subject.&lt;/p&gt;
&lt;p&gt;Echocardiography identified abnormalities in 50% of patients and in 3% of controls (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001). These included wall motion and valvular abnormalities, pericardial effusion, and pulmonary hypertension.&lt;/p&gt;
&lt;p&gt;In the 62% of patients whose MRIs revealed abnormalities, findings included fibrosis, inflammation, wall motion and valvular abnormalities, pericardial effusion, and obliterated right ventricle.&lt;/p&gt;
&lt;p&gt;Previous reports had suggested that ANCA positivity in Churg-Strauss syndrome was more often associated with renal disease and peripheral neuropathy, while ANCA negativity was associated with fever and heart involvement.&lt;/p&gt;
&lt;p&gt;In this cohort, 74% of ANCA-negative patients had cardiac involvement, and in 64%, these were wall motion disturbances.&lt;/p&gt;
&lt;p&gt;In comparison, only 23% of ANCA-positive patients had heart involvement.&lt;/p&gt;
&lt;p&gt;Defects were identified with echocardiography or MRI in 88% of patients who had clinical symptoms, and in all who had major EKG abnormalities.&lt;/p&gt;
&lt;p&gt;But in the absence of symptoms and even with a normal EKG, abnormalities could still be detected on echocardiography or MRI in almost 40% of patients, according to the investigators.&lt;/p&gt;
&lt;p&gt;&quot;We therefore recommend that the evaluation for cardiac involvement in patients with [Churg-Strauss syndrome] should include not only detailed history of cardiac symptoms and EKG, but also imaging with echocardiography or cardiac MRI,&quot; they stated.&lt;/p&gt;
&lt;p&gt;The high prevalence of heart abnormalities could not be attributed to concomitant heart disease such as coronary artery disease or hypertension, because the prevalence of these diseases among patients was comparable to that in controls.&lt;/p&gt;
&lt;p&gt;Churg-Strauss syndrome typically develops in three phases, beginning with asthma, followed by peripheral and tissue eosinophilia accompanied by pulmonary infiltrates, and finally the systemic small-vessel vasculitis.&lt;/p&gt;
&lt;p&gt;During this late phase the vasculitic lesions in the coronary vessels and myocardium can lead to myocardial infarction, heart failure, and cardiac tamponade.&lt;/p&gt;
&lt;p&gt;Studies have shown that long-term treatment with immunosuppressive drugs can improve survival and resolve the cardiac abnormalities, so early diagnosis is needed.&lt;/p&gt;
&lt;p&gt;The authors acknowledged that their study was cross-sectional, and that a longitudinal study could have provided more detailed data.&lt;/p&gt;
&lt;p&gt;Nonetheless, the study revealed a high incidence of cardiac involvement, which was often unrecognized, and they concluded that a multidisciplinary approach to management therefore should include a cardiologist.&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 the Netherlands Heart Foundation and the Dutch Organization for Scientific Research.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_364"
                     title="ADT for Prostate Cancer Raises Heart Risks"
                     score="0.011"
                     href="http://www.medpagetoday.com/Urology/ProstateCancer/tb/18250?impressionId=1265793895849"
                     
      &lt;p&gt;Androgen deprivation therapy (ADT) for prostate cancer can exacerbate cardiac risk factors and may increase the risk of heart attack and cardiac death, according to an advisory supported by four medical organizations.&lt;/p&gt;
&lt;p&gt;However, the groups did not offer specific guidelines for clinicians on when to employ ADT therapy or avoid it.&lt;/p&gt;
&lt;p&gt;Clinical trials have shown that ADT increases body weight, decreases lean mass and increases fat mass, reduces insulin sensitivity, and triggers or worsens dyslipidemia.&lt;/p&gt;
&lt;p&gt;Several studies have demonstrated a significant increase in cardiovascular death in prostate cancer patients treated with hormonal therapy or bilateral orchiectomy, although some studies have shown no association between ADT and increased cardiovascular risk, according to a report that will appear in the Feb. 16 issue of &lt;em&gt;Circulation: Journal of the American Heart Association&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Some evidence also suggests ADT may predispose men to metabolic syndrome.&lt;/p&gt;
&lt;p&gt;&quot;Based on current data, it was appropriate to conclude that there may be a relationship between ADT therapy in patients with prostate cancer and future cardiovascular risk,&quot; Glenn N. Levine, MD, of Baylor College of Medicine in Houston and chair of the advisory writing committee, said in a statement.&lt;/p&gt;
&lt;p&gt;The writing committee comprised representatives of the American Heart Association, American Urological Association, and American Cancer Society. Additionally, the American Society for Radiation Oncology endorsed the advisory.&lt;/p&gt;
&lt;p&gt;The authors&apos; review of literature showed that ADT increased cardiovascular risk in 1% to 6% of various studies&apos; patient populations. With that in mind, &quot;the decision about whether to initiate ADT should be based on weighing the benefits of therapy with this potential modest risk,&quot; Levine said.&lt;/p&gt;
&lt;p&gt;The decision to initiate ADT should remain with the physician who has responsibility for treating a patient with prostate cancer, the authors wrote. That includes patients with known cardiac disease.&lt;/p&gt;
&lt;p&gt;&quot;It is the consensus of the writing group that there is no clear indication for patients for whom ADT is believed to be beneficial to be referred to internists, endocrinologists, or cardiologists for evaluation before initiation of ADT,&quot; the authors said.&lt;/p&gt;
&lt;p&gt;&quot;The decision as to whether or not to initiate ADT in patients with cardiac disease, in whom the benefits of therapy would be weighed against any possible risks, is most appropriately made by the physician treating the patient for prostate cancer.&quot;&lt;/p&gt;
&lt;p&gt;However, the potential adverse metabolic effects warrant periodic evaluation by a patient&apos;s primary care physician, they added.&lt;/p&gt;
&lt;p&gt;Noting a lack of clinical guidance for follow-up of patients treated with ADT, the advisory authors concluded that at least an annual assessment of blood glucose and lipids seems reasonable. They also called for prospective assessment of cardiovascular risk factors before and after ADT is begun in future clinical trials.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_352"
                     title="ICAO: Future Chronic Disease Risk Goes Beyond BMI (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/Endocrinology/Diabetes/tb/18233?impressionId=1265793895849"
                     
      When it comes to predicting chronic disease, body mass index doesn&apos;t tell the whole story, according to a population-based study that found elevated risk with obesity and other metabolic risk factors independently.&lt;br&gt;
&lt;br&gt;Metabolically-healthy obese people tended toward being at least twice as likely to develop multiple metabolic risk factors and diabetes as healthy, normal weight individuals over the subsequent 3.5 years of a study led by Sarah Appleton, a postgraduate student at the University of Adelaide, Australia.&lt;br&gt;
&lt;br&gt;However, normal weight individuals with metabolic risk factors  --  a group the researchers called &quot;metabolically obese&quot;  --  were at greater risk, she told attendees at the International Congress on Abdominal Obesity in Hong Kong, a conference sponsored by the International Chair on Cardiometabolic Risk.&lt;br&gt;
&lt;br&gt;Overall, just 4.1% of the 3,743 adults in the population-based, North West Adelaide Health Study were in the normal body mass index range at baseline but had at least two of the following metabolic risk factors:&lt;ul&gt; &lt;li&gt;Triglyceride levels of 1.7 mmol/L or greater&lt;/li&gt; &lt;li&gt;HDL cholesterol under 1.0mmol/L for men or 1.3 mmol/L for women&lt;/li&gt; &lt;li&gt;Blood pressure of 130/85 mm Hg or higher&lt;/li&gt; &lt;li&gt;A fasting plasma glucose of at least 5.6mmol/L or self-reported diabetes&lt;/li&gt; &lt;li&gt;Treatment for any of these disorders &lt;/li&gt; &lt;/ul&gt;
&lt;p&gt;Although free of cardiovascular disease when they entered the study through a random population sample of the northwest region of Adelaide, after a mean of 3.5 years of follow-up, this group was 2.48 times at risk of incident cardiovascular disease or stroke events (95% CI 1.1 to 5.4).&lt;/p&gt;
&lt;p&gt;Compared with metabolically-healthy, normal weight individuals, those with metabolic risk factors tended to be&lt;strong&gt; &lt;/strong&gt;3.27 times as likely to develop diabetes (&lt;em&gt;P&lt;/em&gt;=0.07).&lt;/p&gt;
&lt;p&gt;Identifying these individuals for prevention efforts may require less emphasis on BMI and increased surveillance of central obesity in primary care, the researchers told the congress.&lt;/p&gt;
&lt;p&gt;&quot;The problem with BMI is it doesn&apos;t tell you where the fat is,&quot; Appleton added in an interview. &quot;Visceral fat is really bad for you.&quot;&lt;/p&gt;
&lt;p&gt;Obese individuals without multiple metabolic risk factors at baseline comprised a larger group (12.1%).&lt;/p&gt;
&lt;p&gt;They were more likely to be middle age, live in a disadvantaged neighborhood, have smoked at some point, and get less exercise than their metabolically similar, but slimmer peers.&lt;/p&gt;
&lt;p&gt;Over the subsequent 3.5 years, they were 2.82 times more likely to develop more than one metabolic risk factor than metabolically-healthy, normal weight individuals (95% CI 2.0 to 4.0).&lt;/p&gt;
&lt;p&gt;The metabolically-normal obese also tended to be 2.36 times more likely to develop diabetes (95% CI 0.8 to 7.1). On the other hand, their risk of cardiovascular disease wasn&apos;t elevated, &quot;which likely related to the younger age of that group,&quot; Appleton told &lt;em&gt;MedPage Today&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Notably, abdominal obesity as determined by a waist circumference of 80 cm and over for men or 95 cm and greater for women was 6.1 times more likely among metabolically healthy individuals if their BMI was in the obese versus normal range.&lt;/p&gt;
&lt;p&gt;But those who were in the normal BMI range were 2.2-fold more likely to be overweight or obese according to waist circumference if they had metabolic risk factors, which was statistically significant as well and likely contributed to the health risks they faced over the short-term future, Appleton said.&lt;/p&gt;
&lt;p&gt;Maintenance of metabolic health in the obese population was more likely for younger individuals (OR 2.83 for age 40 or younger, 95% CI 1.1 to 7.6) and those who were at least moderately physically active (OR 2.04, 95% CI 1.01 to 4.1).&lt;/p&gt;
&lt;p&gt;Appleton noted that these findings generally fit with data from the U.S. National Health Assessment Survey and Examination.&lt;/p&gt;
&lt;p&gt;Regardless of whether patients have abdominal obesity, BMI obesity, or other metabolic risk factors, the solution is likely similar  --  improved diet and exercise, she 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 University of Adelaide and the South Australian Department of Health.&lt;/p&gt;&lt;p&gt;Appleton 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_348"
                     title="No Rebound Seen After Antiplatelet Withdrawal (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/Cardiology/PCI/tb/18226?impressionId=1265793895849"
                     
      &lt;p&gt;No evidence of a platelet aggregation rebound occurs with abrupt discontinuation of clopidogrel (Plavix) in patients undergoing percutaneous coronary intervention (PCI), investigators in a randomized clinical trial concluded.&lt;/p&gt;
&lt;p&gt;Values for adenosine diphosphate (ADP)-induced platelet aggregation did not differ significantly between patients whose clopidogrel therapy was withdrawn abruptly and those in whom clopidogrel was tapered before discontinuation, they wrote in an article in the Feb. 9 issue of the &lt;em&gt;Journal of the American College of Cardiology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The findings also showed that tapering of clopidogrel does not lead to lower platelet aggregation values after clopidogrel withdrawal, according to Dirk Sibbing, MD, of Technical University Munich in Germany, and colleagues&lt;em&gt;&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;&quot;The time course of platelet aggregation values  --  regardless of the device, the agonist, or the agonist concentration used  --  after clopidogrel cessation provides no evidence for the existence of a rebound phenomenon of platelets after discontinuing clopidogrel,&quot; they wrote in conclusion.&lt;/p&gt;
&lt;p&gt;For patients undergoing PCI, dual antiplatelet therapy with aspirin and clopidogrel has become the mainstay for prevention of thrombotic events. Lifelong aspirin therapy is recommended for patients after PCI, but clinical guidelines recommend discontinuation of clopidogrel after six or 12 months. The standard practice is to withdraw clopidogrel abruptly, the authors noted.&lt;/p&gt;
&lt;p&gt;Recent studies have shown a clustering of thrombotic events in the first few weeks after discontinuation of long-term clopidogrel therapy. The observations have led to the hypothesis of a rebound phenomenon of platelet aggregation. However, the hypothesis had not been examined specifically within the context of clopidogrel withdrawal.&lt;/p&gt;
&lt;p&gt;&quot;Because different studies have demonstrated that insufficient suppression of platelet reactivity to ADP is associated with an increased risk of thrombotic events after coronary stent placement, the observed clustering of adverse events reported in clinical studies might be related to an intermittent status of platelet hyperreactivity or so-called platelet rebound with very high ADP-induced platelet aggregation levels,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;&quot;A tapering of clopidogrel treatment over a certain period of time before stopping the intake of the drug completely might provide a beneficial treatment strategy to attenuate this supposed rebound phenomenon of platelets.&quot;&lt;/p&gt;
&lt;p&gt;Sibbing and colleagues designed a randomized clinical trial to determine whether a rebound phenomenon exists after discontinuation of clopidogrel and whether the rebound can be attenuated by a clopidogrel-tapering regimen.&lt;/p&gt;
&lt;p&gt;The investigators enrolled 69 patients receiving clopidogrel in association with PCI procedures. In all cases, discontinuation of clopidogrel was planned.&lt;/p&gt;
&lt;p&gt;The patients were randomized to two strategies of discontinuation: tapering of the clopidogrel dose over four weeks, followed by discontinuation; or treatment for four weeks, as planned, followed by abrupt discontinuation.&lt;/p&gt;
&lt;p&gt;Investigators assessed platelet aggregation at enrollment and during weeks two through eight after randomization. Aggregation was assessed simultaneously by light transmission aggregometry (LTA) and multiple electrode aggregometry (MEA).&lt;/p&gt;
&lt;p&gt;The primary endpoint was the highest rate of ADP-induced platelet aggregation by LTA in weeks five through eight after clopidogrel withdrawal.&lt;/p&gt;
&lt;p&gt;Platelet aggregation by LTA peaked at 73% in the group that had clopidogrel abruptly withdrawn and at 69.3% in the tapering group, resulting in a nonsignificant difference (&lt;em&gt;P&lt;/em&gt;=0.21). The between-group values did not differ across the range of ADP concentrations used (1.25 to 20 &amp;#181;mol/L).&lt;/p&gt;
&lt;p&gt;Results by MEA were similar: The peak aggregation value associated with abrupt withdrawal was 925 AU x min compared with 890 AU x min with clopidogrel tapering (&lt;em&gt;P&lt;/em&gt;=0.55).&lt;/p&gt;
&lt;p&gt;Studies with different agonists of platelet aggregation also yielded similar results in the two patient groups.&lt;/p&gt;
&lt;p&gt;Despite finding no difference between the two strategies for clopidogrel withdrawal, the authors did not rule out the possibility of a beneficial effect of tapering clopidogrel.&lt;/p&gt;
&lt;p&gt;&quot;It could be hypothesized that, apart from the maximal values of platelet aggregation observed, a more gradual increase of platelet aggregation values achieved by a clopidogrel-tapering regimen is beneficial for the reduction of thrombotic events,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;&quot;In fact, we observed a relatively rapid increase of platelet aggregation values in the [abrupt withdrawal] group of patients in our study. Whether this rapid increase might be disadvantageous in case of stopping clopidogrel treatment remains uncertain.&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 supported by Cordis, Medtronic, and Dynabyte.&lt;/p&gt;&lt;p&gt;Sibbing disclosed relationships with Dynabyte and Eli Lilly.&lt;/p&gt;&lt;p&gt;Co-author Adnan Kastrati disclosed relationships with Eli Lilly, sanofi-aventis, and Bristol-Myers Squibb.&lt;/p&gt;&lt;p&gt;Co-author Nicolas von Beckerath disclosed relationships with Eli Lilly and sanofi-aventis.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
</recommendedContent>
