<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_448"
                     title="Inflammatory Bowel Disease Linked to Dangerous VT (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/Gastroenterology/InflammatoryBowelDisease/tb/18362?impressionId=1265777868843"
                     
      &lt;p&gt;Patients with active inflammatory bowel disease (IBD) could be at far greater risk for potentially deadly blood clots than doctors previously thought, a new British study found.&lt;/p&gt;
&lt;p&gt;Nonhospitalized patients with active IBD are 16 times more likely to suffer venous thromboembolism than the general population, with an occurrence rate of 6.4 per 1,000 person-years (HR 15.8, 95% CI 9.8 to 25.5, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001), according to an online report in the Feb. 9 issue of &lt;em&gt;The Lancet&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The authors concluded that such patients could benefit from preventative treatment to prevent blood clotting.&lt;/p&gt;
&lt;p&gt;&quot;Despite the low absolute risks during nonhospitalised periods, these results suggest that active inflammatory bowel disease in ambulatory patients might be a far greater risk factor for venous thromboembolism than previously recognised,&quot; Matthew J. Grainge, MD, of the University of Nottingham, and colleagues wrote.&lt;/p&gt;
&lt;p&gt;Patients with venous thromboembolism in the leg have a short term-mortality rate of about 6%, increasing as high as 20% when the clot has circulated to the lung.&lt;/p&gt;
&lt;p&gt;Researchers believe that infection and inflammation, such as occur in IBD, predispose patients to this life-threatening condition, and those with inflammatory bowel disease seem to be at particular risk.&lt;/p&gt;
&lt;p&gt;Grainge and colleagues used records from the U.K. General Practice Research Database from November 1987 through July 2001, to match 13,756 patients with IBD against 71,672 controls without the disease.&lt;/p&gt;
&lt;p&gt;Of the subjects, 139 patients and 165 controls developed a blood clot during the study period.&lt;/p&gt;
&lt;p&gt;Their results agreed with previous studies indicating that patients hospitalized for IBD are at high risk for venous thromboembolism. However, the new study also found the danger extends to nonhospitalized IBD patients, particularly during a flare-up.&lt;/p&gt;
&lt;p&gt;Overall, the researchers reported, patients with IBD had three times as much risk of an embolism as controls (HR 3.4, 95% CI 2.7 to 4.3; &lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001) with an occurrence rate of 2.6 per 1,000 per person-years.&lt;/p&gt;
&lt;p&gt;During a flare-up, IBD patients were at dramatically greater risk.&lt;/p&gt;
&lt;p&gt;The researchers cautioned that the study excluded patients likely to have received corticosteroids for chronic respiratory disease and rheumatoid arthritis, so the results may not reflect blood clotting rates in these populations.&lt;/p&gt;
&lt;p&gt;They also noted that they relied on anonymous patient records and were dependent on family doctors&apos; diagnoses of inflammatory bowel disease, flare-ups and venous thromboembolism.&lt;/p&gt;
&lt;p&gt;Despite the limitations of the study, they argued that research into ways to prevent embolism in IBD outpatients is warranted.&lt;/p&gt;
&lt;p&gt;&quot;We believe that the medical profession needs to recognise the increased risk in people with inflammatory bowel disease when assessing the likelihood of venous thromboembolism and to address the difficulty of reducing this risk in patients with a flare who are not admitted to hospital,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;They suggested that strategies used to prevent blood clots in hospitalized patients  --  courses of low molecular weight heparin or other newly available anticoagulants  --  might be also be used to prevent clots in nonhospitalized IBD patients experiencing a flare-up.&lt;/p&gt;
&lt;p&gt;In an accompanying editorial, Geoffrey C. Nguyen, MD, and Erik L. Yeo, MD, of the University of Toronto, noted that &quot;the use of steroid prescriptions as a surrogate indicator of acute disease flare restricts the applicability of Grainge and colleagues&apos; findings to flares that are moderate to severe. Whether patients with mild flares are also at increased risk is not clear.&quot;&lt;/p&gt;
&lt;p&gt;&quot;Recognition of venous thromboembolism might be increased during periods of frequent contact with doctors, such as during flares compared with during remission of inflammatory bowel disease, thus potentially introducing a bias in ascertainment of venous thromboembolism,&quot; they added.&lt;/p&gt;
&lt;p&gt;Nguyen and Yeo also argued that the clinical efficacy and cost-effectiveness of pharmacological prevention in patients with inflammatory bowel disease should be proven before it is routinely recommended during acute flares.&lt;/p&gt;
&lt;p&gt;However, they acknowledged that such evidence could be difficult to acquire, given the low numbers of nonhospitalized IBD patients who suffer venous thromboembolism.&lt;/p&gt;
&lt;p&gt;&quot;A pragmatic initial approach to reduction of the rates of morbidity and mortality resulting from venous thromboembolism in ambulatory patients with inflammatory bowel disease would be nonpharmacological thromboprophylaxis, including patients&apos; education and awareness of risk and signs and symptoms of venous thromboembolism, and use of support stockings,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;&quot;Physicians should clinically assess for signs and symptoms of this embolism during visits for acute flare of inflammatory bowel 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 study was funded by the National Association for Colitis and Crohn&apos;s Disease.&lt;/p&gt;&lt;p&gt;The authors reported no financial conflicts of interest.&lt;/p&gt;&lt;p&gt;Nguyen reported serving on advisory boards for Schering-Plough, Canada, and Abbott Pharmaceuticals.&lt;/p&gt;&lt;p&gt;Yeo reported receiving an honorarium from sanofi-aventis.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_406"
                     title="AAPM: Opioid Gains Long-Term Control of Neuropathic Cancer Pain (CME/CE)"
                     score="0.011"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18316?impressionId=1265777868843"
                     
      &lt;p&gt;SAN ANTONIO  --  Patients with neuropathic cancer pain obtained consistent, long-term pain control with extended-release oxymorphone (Opana), according to results of a one-year, open-label extension study.&lt;/p&gt;
&lt;p&gt;Patients reported pain in the mild range throughout most of the follow-up, and only 11% discontinued because of lack of efficacy, Errol Gould, PhD, of Endo Pharmaceuticals in Chadds Ford, Pa., reported here at the American Academy of Pain Medicine meeting. The company manufactures Opana.&lt;/p&gt;
&lt;p&gt;No unexpected adverse events occurred.&lt;/p&gt;
&lt;p&gt;&quot;Current clinical guidelines recommend opioids as second- or third-line treatment for chronic neuropathic pain,&quot; Gould said in an interview. &quot;These results suggest that oxymorphone extended release may be a viable long-term option for patients with neuropathic pain.&quot;&lt;/p&gt;
&lt;p&gt;The findings came from a one-year extension of a multicenter, open-label, noncontrolled short-term study of patients with cancer-related chronic pain.&lt;/p&gt;
&lt;p&gt;Of 44 patients who entered the extension phase, 27 had pain that was primarily neuropathic in origin. The diagnosis of neuropathic pain was based on clinician judgment, with no prespecified diagnostic criteria for guidance.&lt;/p&gt;
&lt;p&gt;Patients began treatment in the extension phase with their ending dose from the short-term study. Dose adjustments to improve pain control or tolerability were allowed throughout the 52-week extension phase.&lt;/p&gt;
&lt;p&gt;Ten of the 27 patients completed the extension study. Principal reasons for withdrawal were adverse events, patient request, loss of effectiveness, and nonadherence.&lt;/p&gt;
&lt;p&gt;The median duration from initiation of long-term maintenance to final visit was 22 weeks. Baseline pain intensity averaged 32.9 on a 100-point scale and 32.6 at final visit. Mean least pain intensity was 13.8 at baseline and 16.2 at final visit, and worst pain intensity averaged 76.3 at baseline and 66.5 at final visit.&lt;/p&gt;
&lt;p&gt;&quot;Regression analysis showed that pain intensity changed very little throughout follow-up,&quot; Gould said.&lt;/p&gt;
&lt;p&gt;The median oxymorphone dose increased from 80 mg at baseline to 160 mg at 52 weeks.&lt;/p&gt;
&lt;p&gt;Eleven (41%) patients reported at least one treatment-related adverse event. The most common events were dry mouth, constipation, and fatigue. The only serious adverse event was an episode of depressed consciousness.&lt;/p&gt;
&lt;p&gt;&quot;Patients required some gradual increases in dosage over time, but that&apos;s consistent with the nature of the disease,&quot; said Gould.&lt;/p&gt;
&lt;p&gt;Not long ago opioids were considered ineffective for neuropathic pain, he added. This study provided additional evidence in support of opioids&apos; effectiveness in controlling neuropathic pain.&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 Endo Pharmaceuticals, which manufactures Opana.&lt;/p&gt;&lt;p&gt;Gould and another co-author are employees of Endo Pharmaceuticals.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_371"
                     title="Single Ultrasound for DVT May Suffice (CME/CE)"
                     score="0.009"
                     href="http://www.medpagetoday.com/Cardiology/VenousThrombosis/tb/18257?impressionId=1265777868843"
                     
      &lt;p&gt;For patients with suspected deep vein thrombosis, the risk of symptomatic venous thromboembolism after a single, negative whole-leg compression ultrasound examination is low, a meta-analysis showed.&lt;/p&gt;
&lt;p&gt;Pooled results from seven studies showed the risk to be just 0.57% (95% CI 0.25% to 0.89%) through three months of follow-up in patients who were not given anticoagulants, Scott Stevens, MD, of Intermountain Medical Center in Murray, Utah, and colleagues reported in the Feb. 3 issue of the &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The researchers suggested that a repeated compression ultrasound evaluation to detect distal thrombi moving upward  --  recommended in clinical practice guidelines five to seven days after a negative finding  --  may not be necessary.&lt;/p&gt;
&lt;p&gt;&quot;The efficiency and convenience of whole-leg compression ultrasound as a single study is superior to that of repeated ... evaluations,&quot; the researchers concluded.&lt;/p&gt;
&lt;p&gt;However, an accompanying editorial by Robert McNutt, MD, PhD, of Rush University Medical Center in Chicago, and Edward Livingston, MD, of the University of Texas Southwestern Medical Center in Dallas, cautioned against basing clinical decisions on a meta-analysis.&lt;/p&gt;
&lt;p&gt;They pointed to the variation in event rates among the seven included studies, ranging from 0.24% to 1.95%. The highest rate was found in hospitalized patients, although most of the studies included ambulatory patients.&lt;/p&gt;
&lt;p&gt;&quot;So using this average probability [0.57%] for clinical decision making in some clinical contexts may do more harm than good,&quot; they wrote. &quot;Greater detail about individual patient scenarios is necessary to facilitate better application of the study results to individual patients.&quot;&lt;/p&gt;
&lt;p&gt;Although whole-leg compression ultrasound reliably identifies the presence or absence of deep vein thrombosis above the knee, its accuracy for thrombi below the knee is less certain, according to Stevens and colleagues.&lt;/p&gt;
&lt;p&gt;So guidelines have recommended repeating the examination after a negative finding to rule out the upward propagation of a distal thrombus.&lt;/p&gt;
&lt;p&gt;But only 1% to 2% of those repeat exams actually detect thrombus propagation.&lt;/p&gt;
&lt;p&gt;Thus, a single whole-leg compression ultrasound may reliably exclude both proximal and distal deep vein thrombosis, the authors said.&lt;/p&gt;
&lt;p&gt;They reviewed the literature to assess the risk of venous thromboembolism in patients with suspected lower extremity deep vein thrombosis who had a single, negative whole-leg compression ultrasound and who had not received anticoagulation treatments for 90 days.&lt;/p&gt;
&lt;p&gt;Seven studies were included  --  one randomized controlled trial and six prospective cohort studies  --  comprising 4,731 patients, mostly from the ambulatory setting.&lt;/p&gt;
&lt;p&gt;Through three months of follow-up, 0.7% of patients had either confirmed venous thromboembolism or suspected venous thromboembolism-related death. All nine who died were either acutely ill, hospitalized patients, or patients with advanced cancer.&lt;/p&gt;
&lt;p&gt;The risk of having an event during follow-up increased with greater pretest probability of having deep vein thrombosis  --  0.29% for low risk, 0.82% for moderate risk, and 2.49% for high risk.&lt;/p&gt;
&lt;p&gt;However, because of low patient numbers, the researchers wrote, &quot;using a single negative whole-leg compression ultrasound result as the sole diagnostic modality in patients with high pretest probability of deep vein thrombosis requires further study.&quot;&lt;/p&gt;
&lt;p&gt;The authors listed several limitations of the analysis: &lt;ul&gt; &lt;li&gt;The variability in ultrasound techniques between the included studies may limit the validity and generalizability of the findings.&lt;/li&gt; &lt;li&gt;The pretest probability of deep vein thrombosis was not assessed using a standardized clinical prediction rule by most studies.&lt;/li&gt; &lt;li&gt;The findings might have limited generalizability to pregnant women, patients with cancer, and inpatients, who were underrepresented in the studies.&lt;/li&gt; &lt;li&gt;Longer-term outcomes were not assessed.&lt;/li&gt; &lt;li&gt;The findings might have been affected by verification bias, because only patients with symptoms were evaluated for venous thromboembolism during follow-up.&lt;/li&gt; &lt;/ul&gt;&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;Steven did not report any conflicts of interest. One of his co-authors reported receiving consulting fees from AGEN Biomedical, Janssen-Ortho, Boehringer-Ingelheim, sanofi-aventis, and AstraZeneca, and receiving speaker&apos;s fees from Pfizer, Leo Pharma, and sanofi-aventis.&lt;/p&gt;&lt;p&gt;The editorialists did not make any financial disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_19_3961"
                     title="ASH: Study Suggests Maintenance Role for Novel Factor Xa Inhibitor (CME/CE)"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/ASHHematology/tb/17353?impressionId=1265777868843"
                     
      &lt;p&gt;NEW ORLEANS - Results from a randomized, placebo-controlled trial in patients with a history of venous thromboembolic events suggest a benefit for maintenance therapy with rivaroxaban, an investigational oral selective Factor Xa inhibitor.&lt;/p&gt;
&lt;p&gt;&quot;Rivaroxaban decreased the risk of a thrombotic event by 82% compared with placebo,&quot; said Harry Buller, MD, professor of medicine at the Academic Medical Center in Amsterdam. &quot;We would need to treat 15 patients for a year with rivaroxaban to prevent one event in this population.&quot;&lt;/p&gt;
&lt;p&gt;Buller reported the results at a late-breaking clinical trials session at the American Society of Hematology meeting.&lt;/p&gt;
&lt;p&gt;In the study, 42 patients assigned to placebo experienced a venous thromboembolism compared with 8 patients assigned to rivaroxaban (hazard ratio 0.18, 95% CI 0.09-0.39, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001).&lt;/p&gt;
&lt;p&gt;And although bleeding risk remains a concern with anticoagulation therapy, Buller said the number needed to treat to cause a rivaroxaban-related major bleeding episode was 139.&lt;/p&gt;
&lt;p&gt;Four major bleeds occurred with rivaroxaban use compared with none in the placebo patients. &quot;None of the major bleeds were fatal or occurred in a critical organ,&quot; Buller said at a press briefing.&lt;/p&gt;
&lt;p&gt;&quot;Oral rivaroxaban, 20 mg once-daily, provides clinicians and patients with a simple option if continued anticoagulant treatment is indicated,&quot; Buller said.&lt;/p&gt;
&lt;p&gt;Patients in the study were recruited from treatment arms of the EINSTEIN Extension study.&lt;/p&gt;
&lt;p&gt;The patients had been treated for either six-months or 12-months with either rivaroxaban or a vitamin K antagonist such as warfarin and their doctors had reached a point &lt;strong&gt;w&lt;/strong&gt;here they were unsure if they should stop therapy or continue to anticoagulate these individuals who had previously experienced deep vein thrombosis or pulmonary embolism.&lt;/p&gt;
&lt;p&gt;&quot;This is a daily clinical question,&quot; Buller said. &quot;You are in your clinic and you have to decide if the patient can stop taking medication or he should continue to be treated, and have to continue getting his clotting times checked, making trips to anticoagulation clinics, etc. That was our question.&quot;&lt;/p&gt;
&lt;p&gt;Buller and colleagues randomized 594 people to receive placebo while 602 were assigned to receive rivaroxaban, a drug that is under review with the U.S. Food and Drug Administration. The mean time on the extension study was about 6 months.&lt;/p&gt;
&lt;p&gt;The average age of the patients in the study was 58 years and about 58% were men.&lt;/p&gt;
&lt;p&gt;Buller said that the fixed dose of rivaroxaban did not require adjustment for body mass index or renal status.&lt;/p&gt;
&lt;p&gt;He said that the issue of how long to treat the patients was critical in combating a condition what often manifests as fatal pulmonary embolism.&lt;/p&gt;
&lt;p&gt;&quot;Worldwide, pulmonary embolism kills more people than AIDS, breast cancer, prostate cancer and traffic accidents combined,&quot; Buller said.&lt;/p&gt;
&lt;p&gt;Bradford Schwartz, MD, professor of medicine and biochemistry at the University of Illinois College of Medicine at Urbana-Champaign, said the approval of rivaroxaban and other promising anticoagulation agents will be helpful to clinicians.&lt;/p&gt;
&lt;p&gt;&quot;Physicians are going to have to learn about each drug and decide which drug is optimum for their patients,&quot; said Schwartz who moderated the press briefing.&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 Healthcare and Johnson &amp;amp; Johnson Pharmaceutical Research &amp;amp; Development.&lt;/p&gt;&lt;p&gt;Buller disclosed financial relationships with Bayer Healthcare and GlaxoSmithKline.&lt;/p&gt;&lt;p&gt;Schwartz had no relevant disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_19_4002"
                     title="ASH: Once-a-Day Enoxaparin Okay for Kids at Risk of VTE (CME/CE)"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/ASHHematology/tb/17407?impressionId=1265777868843"
                     
      &lt;p&gt;NEW ORLEANS -- Researchers said it is feasible to provide once daily dosing of the low molecular weight heparin enoxaparin (Lovenox) to children at high risk of venous thromboembolism.&lt;/p&gt;
&lt;p&gt;Using pharmacokinetic modeling and data from 126 children -- including neonates, infants and children -- who were administered enoxaparin off-label, researchers performed pharmacokinetic analyses, said Mirjam Trame, a PHD candidate at Westf&amp;#228;lische-Wilhelms-Universit&amp;#228;t M&amp;#252;nster, Germany.&lt;/p&gt;
&lt;p&gt;&quot;According to these results,&quot; she reported in a poster at the American Society of Hematology meeting here, &quot;a once-daily enoxaparin dosing regimen seems to be feasible for at least 50% of this population.&quot;&lt;/p&gt;
&lt;p&gt;In her poster presentation, Trame noted, &quot;Enoxaparin has been extensively studied in adults on its safety and efficacy during the prevention of symptomatic thromboembolism when acute anticoagulation is required due to venous thrombosis or stroke.&quot;&lt;/p&gt;
&lt;p&gt;And, although used in children off-label when they are at risk of thromboembolism due to a variety of conditions including cancers and some hematological malignancies, the optimal dosing in children is not well studied.&lt;/p&gt;
&lt;p&gt;Roy Silverstein, MD, professor of molecular medicine at the Cleveland Clinic, was cautious about the findings, noting that the while the research team is &quot;a respected group&quot;, the data were slim.&lt;/p&gt;
&lt;p&gt;&quot;Ultimately, before this work will need to be assessed by peer review, we will need some sort of clinical trial to validate this approach,&quot; preferably a randomized, controlled trial, he told &lt;em&gt;MedPage Today&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Silverstein was not involved in the study.&lt;/p&gt;
&lt;p&gt;Trame said the goal of her study was to determine if once-daily or twice-daily dosing was feasible in this pediatric population.&lt;/p&gt;
&lt;p&gt;While once daily dosing was found to be feasible, Trame noted, &quot;the high inter-individual variety in clearance and central volume of distribution in our population underlined the need for monitoring the anti-Factor Xa activity and individualizing the dose.&quot;&lt;/p&gt;
&lt;p&gt;By pharmacokinetic modeling, the median enoxaparin trough levels of the population were predicted to be 0.095 IU/ml anti Factor Xa activity for the once-daily dosing regimen and 0.27 IU/ml anti-Factor Xa activity for the twice daily dosing,&quot; she explained in the poster.&lt;/p&gt;
&lt;p&gt;But in clinical practice, she found that the 12-hour enoxaparin levels for the once-daily dosing regimen resulted with 0.27 IU/ml anti-Factor Xa activity -- in the same anti-Factor Xa activity as the trough levels of the twice daily dosing, leading the researchers to conclude that once daily dosing of was feasible.&lt;/p&gt;
&lt;p&gt;In her study population, children less than a year old received a starting dose of 1.5 mg/kg enoxaparin and those older than 12 months were started on 1.0 mg/kg.&lt;/p&gt;
&lt;p&gt;The maintenance dose for children less than a year of age was reduced to 1.3 mg/kg; it remained the same for children over a year of age. Patients were dosed at 12 or 24-hour intervals.&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;No funding source was reported for the study.&lt;/p&gt;&lt;p&gt;Trame made no financial disclosures.&lt;/p&gt;&lt;p&gt;Silverstein had no financial disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
</recommendedContent>