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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_463"
                     title="AAPM: Online Program Helps Manage Pain (CME/CE)"
                     score="0.011"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18393?impressionId=1265801651791"
                     
      &lt;p&gt;SAN ANTONIO  --  A personalized, online self-management program helped patients with pain syndromes improve coping skills and reduce stress and depression in two studies reported here.&lt;/p&gt;
&lt;p&gt;Patients randomized to the self-management program demonstrated significant improvement in multiple social, emotional, and behavioral outcomes after six months (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01). Improvement in some parameters occurred within one month. A control group that was not exposed to the program showed no significant improvement.&lt;/p&gt;
&lt;p&gt;&quot;Our goal is to help people communicate better with providers, understand better how they can use social support, understand the comorbid conditions, like anxiety and depression, and develop cognitive skills to help get them through their pain episodes,&quot; said Emil Chiauzzi, PhD, of Inflexxion, the Newton, Mass. company that developed the program.&lt;/p&gt;
&lt;p&gt;Although the studies involved patients with migraine or low-back pain, programs are being developed for other types of pain condition, including several forms of neuropathic pain.&lt;/p&gt;
&lt;p&gt;The online program, demonstrated at &lt;a href=&quot;http://www.painACTION.com&quot; mce_href=&quot;http://www.painACTION.com&quot; target=&quot;_blank&quot;&gt;www.painACTION.com&lt;/a&gt;, employs patient-specific information to generate individualized self-management strategies.&lt;/p&gt;
&lt;p&gt;Patient responses to assessments are analyzed by a &quot;recommendation engine,&quot; which produces content recommendations designed to address each patient&apos;s informational and self-management needs.&lt;/p&gt;
&lt;p&gt;Elements on the Web site include multimedia education units, a pain inventory, interactive tools that provide information based on patient-provider communication, and medication risk management.&lt;/p&gt;
&lt;p&gt;&quot;The content on the Web site is focused on teaching people practical skills to manage the behavioral side of pain,&quot; Jonas Bromberg, PsyD, also of Inflexxion, said in an interview.&lt;/p&gt;
&lt;p&gt;Bromberg presented results of a randomized study involving 210 patients, all of whom met International Headache Society diagnostic criteria for migraine, with or without aura.&lt;/p&gt;
&lt;p&gt;Patients assigned to the online program completed at least eight 30-minute session during the first month of the study and at least five more 30-minute sessions during the five-month follow-up period. Patients in the control group continued to receive usual care without exposure to the Web site.&lt;/p&gt;
&lt;p&gt;Participants assigned to the online program had a minimum set of requirements for each session, which were provided at log-in. Follow-up assessments occurred at one, three, and six months.&lt;/p&gt;
&lt;p&gt;The two groups were balanced with respect to sex and headache frequency and severity, the researchers said.&lt;/p&gt;
&lt;p&gt;Bromberg reported that patients assigned to the self-management program demonstrated significant improvement in: &lt;ul&gt; &lt;li&gt;Headache self-efficacy (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01 compared with baseline)&lt;/li&gt; &lt;li&gt;Use of relaxation (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Use of social support (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Pain catastrophizing (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Depression (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Stress (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Chiauzzi presented results from a randomized study of 209 patients with low-back pain. The design was similar to that of the migraine study, except results were analyzed for between-group differences.&lt;/p&gt;
&lt;p&gt;The results showed significant improvement in the study group versus control group with respect to: &lt;ul&gt; &lt;li&gt;Stress (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Coping (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Social supports (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The data showed significant effects of both treatment (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01) and time (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01) favoring the Web site versus control. Chiauzzi said patients assigned to the Web site had greater mean improvement at posttest, three months, and six months.&lt;/p&gt;
&lt;p&gt;Qualitative analysis suggested that Web site participants had clinically meaningful improvement in depression, anxiety, and stress.&lt;/p&gt;
&lt;p&gt;Additionally, patients in the self-management program reported a 12.3% decrease in pain from baseline, versus 7% in the control group.&lt;/p&gt;
&lt;p&gt;Access to the Web site did not improve physical functioning.&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 were funded by the National Institutes of Health.&lt;/p&gt;&lt;p&gt;Chiauzzi and Bromberg are employees of Inflexxion, developer of the online program.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <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=1265801651791"
                     
      &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_268"
                     title="No Meds Needed for Two Effective OA Regimens (CME/CE)"
                     score="0"
                     href="http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/tb/18119?impressionId=1265801651791"
                     
      &lt;p&gt;Middle-aged patients with early knee osteoarthritis can benefit from either a self-managment program or strength training, but a combination of the two did not provide additional gains, a study found.&lt;/p&gt;
&lt;p&gt;During a two-year trial, roughly two-thirds of participants randomized to one of three groups achieved clinically meaningful improvements in functioning, defined as a 26% change from baseline, according to a new report in the Jan. 15 &lt;em&gt;Arthritis Care &amp;amp; Research&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Patients also achieved clinically meaningful improvements in pain -- defined as a 40% change from baseline -- regardless of treatment group, wrote Patrick E. McKnight, PhD, of George Mason University in Fairfax, Va., and colleagues.&lt;/p&gt;
&lt;p&gt;The functional improvements were 70% for patients in the strength training group, 64% for those in the self-management group, and a 66% improvement in the combined treatment group. For pain, the breakdown was as follows: &lt;ul&gt; &lt;li&gt;Strength training, 65%&lt;/li&gt; &lt;li&gt;Self-management, 56%&lt;/li&gt; &lt;li&gt;Combined treatment, 65%&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;McKnight and colleagues wrote that studies in older patients have reported positive changes for both strength training and self-management.&lt;/p&gt;
&lt;p&gt;To see if these modalities also could benefit younger patients with milder disease, and whether combining the two would lead to additional benefits, the investigators recruited 273 subjects ages 35 to 64 years.&lt;/p&gt;
&lt;p&gt;Participants all had pain on most days in at least one knee, had symptoms for less than five years, had radiographic evidence of osteoarthritis, and had self-reported disability.&lt;/p&gt;
&lt;p&gt;The strength training program consisted of two phases, the first being nine months focused on stretching and balance, range of motion and flexibility, and isotonic muscle strengthening in three sessions each week.&lt;/p&gt;
&lt;p&gt;Phase two involved the development of self-directed long-term exercising habits, following the guidance and advice of trainers.&lt;/p&gt;
&lt;p&gt;The self-management program also included two phases. During the first nine-month phase, participants attended 12 weekly 90-minute classroom sessions addressing coping and self-efficacy skills, promoting active adaptive strategies and increasing perception of control for physical function and pain management.&lt;/p&gt;
&lt;p&gt;Phase two consisted of telephone calls from instructors and problem-solving discussions.&lt;/p&gt;
&lt;p&gt;The combined treatment group concurrently participated in both strength training and self-management programs, adjusted to maintain equivalent contact time with the other two groups.&lt;/p&gt;
&lt;p&gt;Overall compliance was modest, with 55.8% of those in the strength training group completing the study, along with 69.1% and 59.6% of the self-management and combined groups, respectively.&lt;/p&gt;
&lt;p&gt;Objective measures of physical functioning consisted of five physical performance tests measured at baseline and at months nine and 24. Pain and disability were self-reported.&lt;/p&gt;
&lt;p&gt;All of these outcomes showed significant changes over time in all three treatment groups, with effect sizes computed using the standard Cohen&apos;s d units: &lt;ul&gt; &lt;li&gt;Leg press, d=0.85&lt;/li&gt; &lt;li&gt;Range of motion, d=1.00&lt;/li&gt; &lt;li&gt;Work capacity, d=0.60&lt;/li&gt; &lt;li&gt;Balance, d=0.59&lt;/li&gt; &lt;li&gt;Stair climbing, d=0.59&lt;/li&gt; &lt;li&gt;Pain, d= &amp;#8722;0.51&lt;/li&gt; &lt;li&gt;Disability, d= &amp;#8722;0.55&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Both men and women improved, although benefits were greater among men, who gained more large muscle mass strength. Study-related adverse effects included accident, injury, or increased pain with strength training.&lt;/p&gt;
&lt;p&gt;Within-group and between-group effect sizes were also computed. All within-group effect sizes differed significantly from zero, with the exception of the pain outcome in the strength training group, but none of the between-group effects were significant.&lt;/p&gt;
&lt;p&gt;&quot;The logic behind the combined treatment was that the different factors addressed in physical and psychological treatments might produce an additive effect if administered together. These results suggest otherwise,&quot; the investigators conceded.&lt;/p&gt;
&lt;p&gt;As to why there were no differences between the three treatment arms, the length of the study and the relative youth of the participants may have contributed.&lt;/p&gt;
&lt;p&gt;The sample was younger than are included in typical osteoarthritis studies and were higher functioning at baseline, which could mean that there was less opportunity to produce a significant effect, the investigators suggested.&lt;/p&gt;
&lt;p&gt;Also, the increased burden of the combined treatment may have diluted the effects of the two programs.&lt;/p&gt;
&lt;p&gt;Despite the fact that combined treatment in this study had negligible benefits beyond that seen with strength training and self-management, other long-term outcomes such as physical activity level might show a greater response. This remains speculative, but deserves further study, according to the investigators.&lt;/p&gt;
&lt;p&gt;Limitations of the study include the fact that the researchers did not assess effects of the treatment on articular cartilage or inflammation, and they did not include a no-treatment arm.&lt;/p&gt;
&lt;p&gt;Also, there may have been differences in self-medication practices between the groups.&lt;/p&gt;
&lt;p&gt;Nonetheless, the study findings suggest that the two nonpharmacologic approaches can produce gains in middle-age patients with osteoarthritis, and both can be recommended.&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 Institute of Arthritis and Musculoskeletal and Skin Diseases.&lt;/p&gt;&lt;p&gt;One co-author is an employee of Bristol-Myers Squibb and holds stock and/or stock options in the company.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_231"
                     title="FDA Adds Cardio Warnings to Weight-Loss Drug"
                     score="-0.003"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18088?impressionId=1265801651791"
                     
      &lt;p&gt;WASHINGTON  --  The FDA said the weight-loss drug sibutramine (Meridia) should not be taken by patients with history of cardiovascular disease following a review of additional data showing an increased risk of heart attack and stroke among that population.&lt;/p&gt;
&lt;p&gt;The agency said the manufacturer, Abbott, has agreed to add the contraindication to its labeling, which will be expanded to include patients with a history of the following: &lt;ul&gt; &lt;li&gt;Coronary artery disease (i.e., heart attack, angina)&lt;/li&gt; &lt;li&gt;Stroke or transient ischemic attack&lt;/li&gt; &lt;li&gt;Heart arrhythmia&lt;/li&gt; &lt;li&gt;Congestive heart failure&lt;/li&gt; &lt;li&gt;Peripheral arterial disease&lt;/li&gt; &lt;li&gt;Uncontrolled hypertension (&amp;gt;145/90 mmHg)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The initial review of sibutramine began in November 2009 when the FDA received preliminary data from the SCOUT study suggesting patients using the drug had a higher risk for cardiovascular events. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/17147&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/17147&quot; target=&quot;_blank&quot;&gt;Early Data Link Diet Drug to MI, Stroke, and Cardiac Death&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Prior to review, the product label included a warning for patients with cardiovascular disease.&lt;/p&gt;
&lt;p&gt;Healthcare professionals should monitor patients for increase in blood pressure and heart rate and should discontinue therapy if either increase is observed, an FDA statement said.&lt;/p&gt;
&lt;p&gt;Patients should also discontinue use of sibutramine if they do not lose 5% of their baseline body weight within the first three to six months of treatment, as the drug may not be effective and puts the patient at unnecessary risk, the release said.&lt;/p&gt;
&lt;p&gt;The FDA said its review of SCOUT study data, as well as other information related to the drug&apos;s risks and benefits, is ongoing and will be followed by an open public advisory committee meeting to determine if it requires additional regulatory action.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20090101_10_890"
                     title="New Data Confirms Cardiac Risk for Bextra (valdecoxib)"
                     score="-0.005"
                     href="