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    <recommendedItem id="20100101_19_397"
                     title="AAPM: Nerve Growth Factor Antibody  May Reduce Pain (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18300?impressionId=1265745558765"
                     
      &lt;p&gt;SAN ANTONIO  --  A humanized monoclonal antibody against nerve growth factor provided relief in three chronic pain syndromes, according to a summary of small studies reported as an abstract here.&lt;/p&gt;
&lt;p&gt;Treatment with tanezumab led to statistically or clinically significant reductions in pain for patients with osteoarthritis, chronic lower back pain, and interstitial cystitis. The most common adverse events were transient abnormal peripheral sensations, which generally occurred only after the first infusion.&lt;/p&gt;
&lt;p&gt;&quot;Patients with these three different pain syndromes all had significant improvement when treated with tanezumab,&quot; Leslie Tive, PhD, of Pfizer, said in an interview at the American Academy of Pain Medicine meeting. &quot;The pain relief was sustained over time, and patient acceptance was good.&quot;&lt;/p&gt;
&lt;p&gt;&quot;Nerve growth factor is increased in many types of chronic pain and therefore represents an attractive target for therapy,&quot; she added. &quot;Tanezumab is being evaluated in some of these other conditions in ongoing studies.&quot;&lt;/p&gt;
&lt;p&gt;A small phase I study showed that the humanized monoclonal antibody resulted in significant pain improvement in patients with osteoarthritis (&lt;em&gt;Arthritis Rheum&lt;/em&gt; 2005; 52: S461). Tive presented data from a phase II trial involving 400 patients with osteoarthritis of the knee. They were randomized to placebo or to one of five tanezumab doses, administered on day one and day 56.&lt;/p&gt;
&lt;p&gt;All five doses of tanezumab resulted in significant reductions (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05) versus placebo after one week and were sustained through 16 weeks. As assessed by a visual analog scale, the mean change in pain on walking from baseline to week 16 ranged from 30 to 45 points (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001), a two- to threefold difference compared with placebo.&lt;/p&gt;
&lt;p&gt;The trial in chronic low back pain involved 217 adults with Quebec Task Force on Spinal Disorders category 1 or 2 pain for at least three months. The primary location of the pain was between the 12th thoracic vertebra and the lower gluteal folds.&lt;/p&gt;
&lt;p&gt;Eligibility criteria included a score of at least 4 on an 11-point pain scale on at least four occasions in the five days before randomization, as indicated by entries in an electronic pain diary.&lt;/p&gt;
&lt;p&gt;Patients were randomized 2:2:1 to a single infusion of tanezumab, to oral naproxen, or to placebo. The primary endpoint was the change in mean Lower Back Pain Index score from baseline to six weeks, averaged over the last seven days.&lt;/p&gt;
&lt;p&gt;Beginning at week one and continuing through week six, patients who were randomized to either dose of tanezumab had significantly greater improvement in pain than those who took the placebo (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001), and compared with the naproxen group beginning at week two (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01).&lt;/p&gt;
&lt;p&gt;The interstitial cystitis study included 64 men and women who had a score &amp;#8805;13 on Pelvic Pain Symptom/Frequency questionnaire, &amp;#8805;7 score on the O&apos;Leary-Sant Interstitial Cystitis index, and micturition frequency &amp;#8805;8 times a day, as recorded in an electronic diary for at least five consecutive days prior to randomization.&lt;/p&gt;
&lt;p&gt;Patients were randomized to intravenous tanezumab or matching placebo. The primary efficacy endpoint was change from baseline to six weeks in the 11-point pain scale. A difference of at least one point from placebo was considered clinically significant. Statistical significance was not evaluated.&lt;/p&gt;
&lt;p&gt;The mean difference between tanezumab and placebo was -0.7 at week two, increasing to -1.1 at week four and -1.4 at week six. The advantage versus placebo was maintained at week 10 (-0.9) and week 16 (-0.5).&lt;/p&gt;
&lt;p&gt;Adverse events were evaluated for all patients combined in the three studies. Adverse events were reported by 66.3% of tanezumab patients, 61.4% of naproxen patients, and 59.3% of placebo patients. Serious and severe adverse events occurred in 1.6% to 3.4% of patients and 4.8% to 5.7%, respectively.&lt;/p&gt;
&lt;p&gt;Tive said 14.4% of tanezumab patients reported abnormal peripheral sensations, the most common being paresthesia (7.1%), hyperesthesia (4.1%), and hypoesthesia (3.9%).&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 studies included in the summary were funded by Pfizer.&lt;/p&gt;&lt;p&gt;Investigators included several Pfizer employees.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_352"
                     title="ICAO: Future Chronic Disease Risk Goes Beyond BMI (CME/CE)"
                     score="0.008"
                     href="http://www.medpagetoday.com/Endocrinology/Diabetes/tb/18233?impressionId=1265745558765"
                     
      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_336"
                     title="In Prostate CA, Sexual Decline After Radiation Has Limit (CME/CE)"
                     score="0.005"
                     href="http://www.medpagetoday.com/HematologyOncology/ProstateCancer/tb/18214?impressionId=1265745558765"
                     
      &lt;p&gt;Sexual function declines in the first two years after external beam radiation therapy for prostate cancer but stabilizes thereafter, according to data from a prospective cohort study.&lt;/p&gt;
&lt;p&gt;All parameters of sexual function declined significantly (&lt;em&gt;P&lt;/em&gt;&lt;0.05) in the first two years after external-beam radiation therapy (EBRT), Richard Valicenti, MD, of the University of California Davis, and colleagues found.&lt;/p&gt;
&lt;p&gt;But for years two through six of follow-up, none of the evaluated parameters of sexual function changed significantly.&lt;/p&gt;
&lt;p&gt;Pretreatment sexual function was the strongest predictor of sexual function at any time after EBRT, the investigators reported in the January issue of the &lt;em&gt;International Journal of Radiation Oncology*Biology*Physics&lt;/em&gt;&lt;em&gt;&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Their findings debunk the perception that sexual function declines continually after radiation therapy for prostate cancer.&lt;/p&gt;
&lt;p&gt;&quot;The results of this study allow patients and their partners to have a fuller understanding of the long-term sexual side effects of EBRT, and what they can expect after treatment should aid in deciding on a treatment course,&quot; Valicenti said in a statement.&lt;/p&gt;
&lt;p&gt;Reported rates of impotency after EBRT for prostate cancer have ranged from 8% to 85%, a variation the authors attributed to the different instruments used to assess sexual function. Moreover, many studies included men who received androgen deprivation therapy in addition to EBRT, possibly masking the contributions of radiation therapy to changes in sexual function.&lt;/p&gt;
&lt;p&gt;Several recent studies have suggested that rates of sexual dysfunction increase with follow-up. However, few studies included pretreatment assessment of sexual function or conducted serial assessments of sexual function after EBRT, the authors wrote.&lt;/p&gt;
&lt;p&gt;To shed more light on the question, the investigators prospectively followed 143 men who completed a sexual function questionnaire prior to EBRT for prostate cancer and at each follow-up visit. The questionnaire assessed four domains of sexual function: sexual drive, erectile function, ejaculatory function, and overall satisfaction.&lt;/p&gt;
&lt;p&gt;The mean age of the patients was 69, median Gleason score was 6, and median total radiation dose was 73.8 Gy (range of 66.6 to 79.2 Gy).&lt;/p&gt;
&lt;p&gt;During a median four-years of follow-up, the study participants completed a total of 1,187 questionnaires. Some patients were followed for as long as eight years after EBRT.&lt;/p&gt;
&lt;p&gt;Baseline scores for sexual drive and erectile function were significantly associated with patient age (&lt;em&gt;P&lt;/em&gt;=0.003 and &lt;em&gt;P&lt;/em&gt;=0.004, respectively). Ejaculatory function was significantly associated with age, race, and marital status (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05).&lt;/p&gt;
&lt;p&gt;Scores on all four domains of sexual function, as well as the total score, declined significantly in the first two years after EBRT (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05) compared with baseline values.&lt;/p&gt;
&lt;p&gt;Investigators grouped the patients according to baseline sexual function. Analysis of scores for patients above and below the median sexual function value showed that differences in sexual function persisted over time. Regression analysis showed that baseline score was the best predictor of later scores for all of the domains assessed (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;A separate analysis of scores from years two through six showed no significant changes in any of the domains: sexual drive, &lt;em&gt;P&lt;/em&gt;=0.067; erectile function, &lt;em&gt;P&lt;/em&gt;=0.5; ejaculatory function, &lt;em&gt;P&lt;/em&gt;=0.6; and overall satisfaction, &lt;em&gt;P&lt;/em&gt;=0.44.&lt;/p&gt;
&lt;p&gt;Baseline scores indicated that 74.1% of the study participants were sexually potent before EBRT. Among those who were potent before treatment, 74.4% remained potent at one year and 70.4% at two years after EBRT. The one- and two-year potency rates differed significantly from baseline, but the investigators found no statistically significant change in potency from years two through six.&lt;/p&gt;
&lt;p&gt;&quot;Our data have indicated that the widely held opinion that sexual function has a slow, progressive decline after EBRT might be incorrect,&quot; the authors wrote in conclusion. &quot;Most sexual function decline in men undergoing EBRT for prostate cancer occurred in the first two years after treatment and all domains of sexual function, including erectile dysfunction, then appeared to stabilize.&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 authors reported no relevant disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_207"
                     title="ISET: Women Fare Better in Small Leg Vessel Procedures (CME/CE)"
                     score="-0.004"
                     href="http://www.medpagetoday.com/Cardiology/PeripheralArteryDisease/tb/18051?impressionId=1265745558765"
                     
      &lt;p&gt;HOLLYWOOD, Fla.  --  Contrary to expectations, women who undergo last-ditch, minimally-invasive procedures to open small blood vessels in the leg  --  and forestall amputation  --  generally have better outcomes than men, researchers reported here.&lt;/p&gt;
&lt;p&gt;Overall, 87.5% of women who underwent the infragenicular endoscopic angioplasty avoided amputation for at least two years, compared with 82.9% of the men who were similarly treated (&lt;em&gt;P&lt;/em&gt;=0.041), according to Tejas Shah, MD, of Mount Sinai Medical Center in New York City.&lt;/p&gt;
&lt;p&gt;&quot;This study is the first to compare the outcomes of men and women being treated for blocked lower-leg arteries with endovascular therapy,&quot; Shah said at the International Symposium on Endovascular Therapy (ISET). &quot;The results suggest endovascular therapy should be strongly considered in women with blocked arteries below the knee.&quot;&lt;/p&gt;
&lt;p&gt;In many endovascular procedures, women tend to do worse then men, generally because they tend to have smaller blood vessels. But in this study, involving the smallest leg blood vessels, the opposite occurred. &quot;We really don&apos;t have any good reason why there should be this gender difference,&quot; Shah said.&lt;/p&gt;
&lt;p&gt;&quot;What made this difference significant,&quot; Shah told &lt;em&gt;MedPage Today&lt;/em&gt;, &quot;was that the women in the study, overall, were at significantly greater risk of amputation than the male patients.&quot; He said that about 22.3% of men underwent treatment for claudication, compared with 12.3% of the women, but 77.7% of men were being treated for limb-threatening conditions compared with 87.7% of women.&lt;/p&gt;
&lt;p&gt;The retrospective study involved review of angioplasties, stenting, and atherectomies performed on 152 men and 125 women at Mount Sinai between July 1999 and November 2009.&lt;/p&gt;
&lt;p&gt;When adjusted for comorbidities, women treated for tibial lesions with concurrent proximal disease had higher 24-month primary patency rates compared with men.&lt;/p&gt;
&lt;p&gt;Some 46% of treated leg arteries in women remained open, compared with 30% (&lt;em&gt;P&lt;/em&gt;=0.016) in men. Shah said that a subanalysis of isolated tibial lesions indicated that 50% of women achieved 24-month primary patency rates, compared with 28.8% of men (&lt;em&gt;P&lt;/em&gt; =0.002).&lt;/p&gt;
&lt;p&gt;On the downside, women experienced higher rates of blood clots forming at the access site of the treatment (9% versus 0.6%, &lt;em&gt;P&lt;/em&gt;&amp;lt;.0001). Clotting, typically treated with blood thinners, may require a longer stay in the hospital (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001).&lt;/p&gt;
&lt;p&gt;&quot;In both men and women it is hard to keep these smaller leg blood vessels open,&quot; said Constantino Pe&amp;#241;a, MD, medical director of vascular imaging at Baptist Cardiac &amp;amp; Vascular Institute, Miami.&lt;/p&gt;
&lt;p&gt;&quot;It might be possible that women do better because of their hormone status. But we need to do prospective clinical trials to see if we can determine what factor is involved in making the procedure work better for women.&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;Shah listed no relevant disclosures.  Pe&amp;#241;a reported financial relationships with Bard and Medtronic.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_1_189"
                     title="TRI: Erectile Dysfunction Drug Linked to Throat Problem"
                     score="-0.006"
                     href="