<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_463"
                     title="AAPM: Online Program Helps Manage Pain (CME/CE)"
                     score="0.015"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18393?impressionId=1265797311955"
                     
      &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_439"
                     title="Heart Often Affected in Churg-Strauss (CME/CE)"
                     score="0.013"
                     href="http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/tb/18353?impressionId=1265797311955"
                     
      &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_438"
                     title="Rituximab Shows Promise in Scleroderma (CME/CE)"
                     score="0.013"
                     href="http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/tb/18352?impressionId=1265797311955"
                     
      &lt;p&gt;Rituximab (Rituxan) improved lung function in patients with scleroderma, a small proof-of-principle study found.&lt;/p&gt;
&lt;p&gt;At one year, patients randomized to receive rituximab had a median 10.25% increase in forced vital capacity (FVC) compared with baseline, while those who received standard treatment had a deterioration of 5.04% (&lt;em&gt;P&lt;/em&gt;=0.002), according to Dimitrios Daoussis, MD, and colleagues from the University of Patras in Greece.&lt;/p&gt;
&lt;p&gt;There also was a significant 19.46% increase in diffusing capacity of carbon monoxide (DL&lt;sub&gt;co&lt;/sub&gt;) in the rituximab-treated patients, while the controls showed deterioration of 7.5% (&lt;em&gt;P&lt;/em&gt;=0.023), the researchers reported in the February issue of &lt;em&gt;Rheumatology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Interstitial lung disease is a common manifestation of diffuse scleroderma and represents the disease component that dictates prognosis because it can be progressive and typically responds poorly to treatment. Animal and human studies have suggested a possible pathogenic role for B cells in the disease.&lt;/p&gt;
&lt;p&gt;There have been a few reports of clinical and histologic improvements in scleroderma and in graft-versus-host disease (which shares some features with scleroderma) after treatment with the B-cell depleting monoclonal antibody rituximab.&lt;/p&gt;
&lt;p&gt;These encouraging early findings led Daoussis and colleagues to undertake an open-label, controlled study that included 14 patients with diffuse disease.&lt;/p&gt;
&lt;p&gt;Median age was 55 and mean disease duration was seven years.&lt;/p&gt;
&lt;p&gt;All patients continued their standard medications, which included various agents such as prednisone, bosentan (Tracleer), mycophenolate mofetil (CellCept), and cyclophosphamide.&lt;/p&gt;
&lt;p&gt;Those randomized to rituximab treatment also underwent four weekly pulses of the drug (375 mg/m&lt;sup&gt;2&lt;/sup&gt;) at baseline and six months later.&lt;/p&gt;
&lt;p&gt;By one year, the mean FVC in the rituximab group had risen from 68.13% of normal predicted value based on age, sex, and height, to 75.63% (&lt;em&gt;P&lt;/em&gt;=0.0018), while FVC in the control group fell nonsignificantly from 86% of normal to 81.67%.&lt;/p&gt;
&lt;p&gt;In the rituximab group, DL&lt;sub&gt;co&lt;/sub&gt; increased from a mean of 52.25% of normal at baseline to 62% (&lt;em&gt;P&lt;/em&gt;=0.017) at one year, while the controls decreased nonsignificantly from 65.33% to 60.17%.&lt;/p&gt;
&lt;p&gt;None of the patients treated with rituximab experienced worsening of FVC or DL&lt;sub&gt;co&lt;/sub&gt;, whereas lung function deteriorated in five controls.&lt;/p&gt;
&lt;p&gt;&quot;We should note, however, that patients in the control group tended to have more early disease and better lung function parameters (although not statistically different from the [rituximab] group) making them more likely to deteriorate over the time of the study,&quot; the investigators commented.&lt;/p&gt;
&lt;p&gt;Skin manifestations of the disease also showed improvements in the rituximab group. Skin thickening, as measured by the Modified Rodnan Skin Score, improved by 39.25% in the rituximab group and by 20.80% in the control group, a difference that was not statistically significant.&lt;/p&gt;
&lt;p&gt;Skin fibrosis also improved by a median of 38.33%, while it worsened by 5.23% in controls.&lt;/p&gt;
&lt;p&gt;Histologic improvement was seen in four of the rituximab-treated patients, corresponding with clinical benefits. One patient in the active treatment group had a significant reduction of fibrosis in both the papillary and reticular dermis, accompanied by an almost complete resolution of skin lesions.&lt;/p&gt;
&lt;p&gt;Improvement in skin fibrosis was most common in patients who had evidence of B-cell depletion in the skin.&lt;/p&gt;
&lt;p&gt;Overall function, as evaluated by the Health Assessment Questionnaire, improved from a median baseline score of 0.687 to 0.312 at one year (&lt;em&gt;P&lt;/em&gt;=0.03), while no change was seen in controls.&lt;/p&gt;
&lt;p&gt;The pathogenesis of scleroderma is poorly understood, according to the authors, but this study adds support to a possible role for B cells.&lt;/p&gt;
&lt;p&gt;In addition, rituximab indirectly targets T cells, which also are thought to be implicated.&lt;/p&gt;
&lt;p&gt;The authors noted potential limitations, including the study&apos;s small size and the fact that most patients had longstanding disease, had been treated with multiple immunosuppressive agents in the past, and were receiving concurrent therapies during the study.&lt;/p&gt;
&lt;p&gt;&quot;This is a proof-of-principle study that was performed in order to obtain preliminary data regarding the effect of [rituximab] on a limited number of patients,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;&quot;Our data could serve as a good starting point for the design of larger scale, multicenter studies with longer evaluation periods and especially in earlier stages of the disease,&quot; they concluded.&lt;/p&gt;
&lt;p&gt;In an accompanying editorial, Robert W. Simms, MD, and Robert Lafyatis, MD, of Boston University, echoed concerns about the small number of patients and the lack of blinding in the study.&lt;/p&gt;
&lt;p&gt;&quot;One cannot...on the basis of this study, recommend rituximab in the routine clinical care of patients with scleroderma,&quot; the editorialists wrote.&lt;/p&gt;
&lt;p&gt;The findings will need to be replicated in a multicenter randomized trial, but &quot;do provide some hope that B-cell depletion might enhance the currently restricted therapeutic armamentarium of this 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 Hellenic Rheumatology Society.&lt;/p&gt;&lt;p&gt;Funding to pay Open Access publication charges was provided by Roche Hellas.&lt;/p&gt;&lt;p&gt;Authors and editorialists declared to 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_424"
                     title="AAPM: Facet Graft Quells Refractory Back Pain (CME/CE)"
                     score="0.013"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18343?impressionId=1265797311955"
                     
      &lt;p&gt;SAN ANTONIO  --  Minimally invasive facet arthrodesis significantly reduced pain and improved physical function for one&lt;strong&gt; &lt;/strong&gt;year in patients with medically refractory facet arthropathy, according to data from a prospective clinical series.&lt;/p&gt;
&lt;p&gt;Most patients discontinued narcotic pain relievers, researchers reported here, and only one of 28 patients in the series had no appreciable change in pain after the noninstrumented spinal surgery.&lt;/p&gt;
&lt;p&gt;&quot;The procedure does not disrupt stabilizing ligaments or muscular structures of the posterior spine, allowing unimpeded physiotherapy for low back muscular strengthening after 16 weeks,&quot; Daniel Bennett, MD, of Integrative Treatment Centers in Denver, told attendees at the American Academy of Pain Medicine meeting.&lt;/p&gt;
&lt;p&gt;&quot;If fusion occurs, symptoms should not return, as with traditional treatment modalities, such as thermal radiofrequency neurolysis.&quot;&lt;/p&gt;
&lt;p&gt;The results have provided the foundation for a prospective, multicenter, randomized clinical trial to compare radiofrequency neurolysis and minimally invasive spine facet arthrodesis, he added.&lt;/p&gt;
&lt;p&gt;Medical management of low back pain related to facet degeneration often provides minimal pain relief and can interfere with functioning. Direct injection of anesthesia into an affected joint also leads to negligible long-term benefits, said Bennett. Radiofrequency neurolysis provides only temporary pain relief and must be repeated because of nerve regeneration.&lt;/p&gt;
&lt;p&gt;All the patients had a return of pain after previous radiofrequency neurolysis and were eligible for repeat neurolytic procedures. Affected areas were confirmed by anesthetic injection, followed by a provocatory examination.&lt;/p&gt;
&lt;p&gt;The patients underwent a standardized procedure that included a small incision at the affected area, insertion of surgical pins to stabilize the joint, use of a surgical drill to achieve joint separation, and insertion of 5-mm or 7-mm Morse tapered cortical allografts.&lt;/p&gt;
&lt;p&gt;After surgery, patients wore a rigid brace for 16 weeks, at which point they began physical therapy to strengthen back muscles.&lt;/p&gt;
&lt;p&gt;The patients received a total of 102 grafts at 51 levels, and four dislodgements (3.9%) occurred. None of the patients had a return of pain after dislodgement.&lt;/p&gt;
&lt;p&gt;&quot;Among patients who retained grafts, all showed callus formation of the posterior joint and incorporation of the cortical allograft,&quot; said Bennett.&lt;/p&gt;
&lt;p&gt;At the 52-week follow-up, the average score on a 100-point visual analog pain scale was 23, down from an average of 79 prior to the intervention. Patients&apos; scores on the Oswestry Disability Index averaged 8.32, compared with 33.46 at baseline.&lt;/p&gt;
&lt;p&gt;All but four patients discontinued narcotic medication, and the morphine dose required by those four decreased from a baseline range of 150 to 360 mg to a range of 10 to 30 mg at one year.&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 Prism Healthcare Foundation.&lt;/p&gt;&lt;p&gt;Bennett disclosed relationships with Alphatec Spine, miniSURG, Boston Scientific, Cephalon, Nevro, and Paylon.&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="0.013"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18300?impressionId=1265797311955"
                     
      &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>
</recommendedContent>