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    <recommendedItem id="20100101_19_397"
                     title="AAPM: Nerve Growth Factor Antibody  May Reduce Pain (CME/CE)"
                     score="0.009"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18300?impressionId=1265768932090"
                     
      &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_336"
                     title="In Prostate CA, Sexual Decline After Radiation Has Limit (CME/CE)"
                     score="0.007"
                     href="http://www.medpagetoday.com/HematologyOncology/ProstateCancer/tb/18214?impressionId=1265768932090"
                     
      &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="20090101_3_742"
                     title="On-Demand SSRI Called Effective for Premature Ejaculation"
                     score="-0.005"
                     href="