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    <recommendedItem id="20100101_19_426"
                     title="AAPM: Spine Stimulation Leads to Durable Pain Relief (CME/CE)"
                     score="0.013"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18344?impressionId=1265779128458"
                     
      &lt;p&gt;SAN ANTONIO  --  Spinal cord stimulation provided durable pain relief for patients with complex regional pain syndrome (CRPS) but did not halt progression, a retrospective analysis of a small clinical series showed.&lt;/p&gt;
&lt;p&gt;During follow-up for as long as 20 years, patients continued to rate their pain as significantly below baseline levels. Improvements in depression, medication use, and quality of life also proved durable.&lt;/p&gt;
&lt;p&gt;However, the pain syndrome progressed to other areas in all patients.&lt;/p&gt;
&lt;p&gt;&quot;All patients in this series experienced a gradual enlargement in the area affected over time,&quot; Krishna Kumar, MB, BS, of Regina Qu&apos;appelle Health Region in Regina, Saskatchewan, said at the American Academy of Pain Medicine meeting. &quot;Stimulation does not appear to retard disease spread.&quot;&lt;/p&gt;
&lt;p&gt;Nonetheless, 22 of the 25 patients in the series said they were satisfied with their pain relief and would have the procedure again.&lt;/p&gt;
&lt;p&gt;In a separate presentation at the meeting, Kumar reported that spinal cord stimulation led to significantly better outcomes than medical management in patients with failed back surgery syndrome.&lt;/p&gt;
&lt;p&gt;CRPS has an undetermined etiology, and there&apos;s no cure. The condition responds poorly to conventional medical therapy and to interventions such as transcutaneous electrical nerve stimulation, chemical blocks, sympathectomy, and physical therapy, said Kumar.&lt;/p&gt;
&lt;p&gt;Several studies and meta-analyses have shown that spinal cord stimulation relieves pain and other symptoms of CRPS during short- and mid-term follow-up. Whether the benefits persisted over the long term was unclear, Kumar continued.&lt;/p&gt;
&lt;p&gt;To assess long-term outcomes after spinal cord stimulation, Kumar and colleagues examined records of 196 patients who underwent spinal cord stimulation procedures. They identified 25 patients who met International Association for the Study of Pain criteria for CRPS and who agreed to participate.&lt;/p&gt;
&lt;p&gt;The cohort had a median follow-up of 63 months, a mean of 88 months, and a range of 18 to 235 months. The group comprised 13 men and 12 women whose mean age was 51 and whose ages ranged from 32 to 91. Ten of the 25 had upper-extremity pain and 15 had lower-extremity pain. In all cases the pain had not responded to conventional medical therapy.&lt;/p&gt;
&lt;p&gt;Assessment of each patient included pain rating by a visual analog scale (VAS), an index of physical functioning, a depression scale, a general health status survey, and a quality-of-life survey. Patients were assessed at implantation, three months and one year after implantation, and at last follow-up.&lt;/p&gt;
&lt;p&gt;All categories of medication use remained below baseline levels at last follow-up, including antidepressants, anticonvulsants, anti-inflammatory drugs, and narcotic drugs.&lt;/p&gt;
&lt;p&gt;Average scores on all of the survey instruments improved significantly from implantation to three months (&lt;em&gt;P&lt;/em&gt;=0.002 to &lt;em&gt;P&lt;/em&gt;=0.000). One-year results showed some reversal of the improvement, but scores for all outcomes remained below baseline levels.&lt;/p&gt;
&lt;p&gt;At last follow-up, mean scores remained significantly improved over baseline values (&lt;em&gt;P&lt;/em&gt;=0.003 to &lt;em&gt;P&lt;/em&gt;=0.001).&lt;/p&gt;
&lt;p&gt;The greatest improvement in health status and pain scores occurred in patients who were 40 or younger, who had stage I CRPS, and who underwent spinal cord stimulation within a year of diagnosis, said Kumar.&lt;/p&gt;
&lt;p&gt;&quot;Spinal cord stimulation is equally effective for men and women and for upper- and lower-limb CRPS,&quot; he said. &quot;Early institution is necessary to secure optimal patient outcomes, as delay exceeding one year appears to limit the effectiveness of the intervention.&quot;&lt;/p&gt;
&lt;p&gt;&quot;On the basis of these results, we conclude that spinal cord stimulation is an effective long-term management modality for CRPS and should be considered earlier in the treatment continuum, preferably within the first year of symptom onset,&quot; Kumar added.&lt;/p&gt;
&lt;p&gt;In a separate poster presentation, Kumar reported findings from a study of 100 patients with failed back surgery syndrome who were treated at 12 centers worldwide. Half the patients received conventional medical management and half had medical management plus spinal cord stimulation. The primary outcome was pain at six and 24 months after treatment.&lt;/p&gt;
&lt;p&gt;At six months, 48% of patients with spinal cord stimulation had at least 50% improvement in leg pain, compared with 9% of patients who received only medical treatment. Additionally, 38% of the spinal stimulation-group reported at least 30% improvement in back pain at six months versus 14% of the medically managed patients.&lt;/p&gt;
&lt;p&gt;Patients who were dissatisfied with their assigned treatment after six months were allowed to switch to the opposite therapy. Kumar reported that 30 of 50 patients in the medical group opted for spinal cord stimulation, compared with four of 50 in the spinal stimulation group who opted for continued treatment with medication alone.&lt;/p&gt;
&lt;p&gt;At 24 months, 42 of the original 50 patients remained in the spinal stimulation group, compared with 11 of 50 in the medical group. Differences observed at six months were maintained, including leg pain (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001), physical functioning (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0002), and quality of life (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001).&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;Kumar disclosed relationships with Medtronic and Boston Scientific.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_386"
                     title="FDA Approves First Excess Finger Collagen Drug"
                     score="0.011"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18277?impressionId=1265779128458"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has approved the first drug for the progressive hand disease known as Dupuytren&apos;s contracture  --  the injectable collagenase clostridium histolyticum (Xiaflex).&lt;/p&gt;
&lt;p&gt;The biologic drug, manufactured by Auxilium Pharmaceuticals of Malvern, Pa., breaks down excess collagen that builds up in the hand, preventing preventing the fingers from relaxing and straightening normally.&lt;/p&gt;
&lt;p&gt;In announcing the approval, the FDA noted that until now the only effective treatment for the condition was surgery, which often entails a long recovery with physical therapy.&lt;/p&gt;
&lt;p&gt;Drug approval was based on data from two randomized, double-blind, placebo-controlled, multicenter trials of 374 adult patients who had not received surgical treatment on a selected primary joint within 90 days of the first injection, and who did not use anticoagulation medicine within seven days of the study.&lt;/p&gt;
&lt;p&gt;The primary endpoint in both studies was a reduction of joint contracture by five degrees after up to three injections. Patients in the collagenase group outperformed placebo, with 64% meeting endpoint in all joints versus 7% in placebo group in Study 1, and 44% versus 5% in Study 2.&lt;/p&gt;
&lt;p&gt;Serious side effects of the collagenase drug include tendon rupture and ligament damage that can prevent a finger from fully bending and may require surgery to correct.&lt;/p&gt;
&lt;p&gt;Other side effects include swelling, bruising, bleeding, and injection site pain.&lt;/p&gt;
&lt;p&gt;Patients using anticoagulants other than low-dose aspirin should avoid using collagenase clostridium histolyticum, according to the prescribing information.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_344"
                     title="FDA Revises HIV Drug Label for Liver Complication"
                     score="0.009"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18229?impressionId=1265779128458"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has updated labels of the HIV drug didanosine (Videx and Videx EC) to include warnings for potentially serious liver damage.&lt;/p&gt;
&lt;p&gt;Although these cases are rare, the drug may cause noncirrhotic hypertension in patients, a potentially fatal complication which the FDA discovered through 42 postmarket, adverse event reports.&lt;/p&gt;
&lt;p&gt;Of those patients, three required liver transplant and four died. Two deaths were caused by esophageal hemorrhage, while two more were caused by progressive liver failure.&lt;/p&gt;
&lt;p&gt;One patient suffered multiorgan failure, cerebral hemorrhage, sepsis, and lactic acidosis.&lt;/p&gt;
&lt;p&gt;The FDA said in a statement that it chose not to recall the drug because it believes its benefits outweigh potential risks, but advised that treatment decisions be made on an individual basis between healthcare professionals and patients.&lt;/p&gt;
&lt;p&gt;The agency added that causal association is difficult to determine in postmarket reports, but that alternative causes of the hypertension were ruled out in well-documented cases.&lt;/p&gt;
&lt;p&gt;Healthcare professionals who determine didanosine is effective in treating a patient should monitor that patient for the development of portal hypertension and esophageal varices, the agency said.&lt;/p&gt;
&lt;p&gt;Didanosine is used in combination with other HIV medications to help maintain CD4 cells in patients.&lt;/p&gt;
&lt;p&gt;The drug already has a black box warning for lactic acidosis and hepatomegaly with steatosis.&lt;/p&gt;
&lt;p&gt;Like the antiretroviral agents hydroxyurea and ribavirin, didanosine has been associated with the development of liver toxicity.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_343"
                     title="U.S. Marshals Seize Unapproved Ozone Generators"
                     score="0.009"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265779128458"
                     
      &lt;p&gt;WASHINGTON  --  U.S. Marshals have seized 77 unapproved ozone generators, valued at almost $76,000 from a California device manufacturer, the FDA announced.&lt;/p&gt;
&lt;p&gt;The devices were advertised as treatments for various conditions, including cancer, AIDS, hepatitis, herpes, and other diseases, but lacked approval or efficacy data to support the claims made on their behalf, an FDA release said.&lt;/p&gt;
&lt;p&gt;The raid came after the company, Applied Ozone Systems (AOS) of Auburn, Calif., failed to respond to a voluntary recall request last December, the agency said.&lt;/p&gt;
&lt;p&gt;The FDA raised concerns that patients using AOS-IM and AOS-IMD devices will consider it an appropriate treatment for an affliction and delay or stop FDA-approved and proven medical treatments. Patients using the devices may risk infection from contamination of the applicator or catheter, the release said.&lt;/p&gt;
&lt;p&gt;The FDA recommended that healthcare professionals and consumers cease use of the devices.&lt;/p&gt;
&lt;p&gt;The agency said it obtained an inspection warrant for the company&apos;s manufacturing facilities after the owner refused to admit FDA inspectors. It said the inspection revealed several breaches of the FDA&apos;s good manufacturing practice requirements for medical devices, which had never been approved in the first place.&lt;/p&gt;
&lt;p&gt;Ozone is an unstable allotrope of oxygen with three atoms, instead of the normal two. Ozone generators produce ozone from oxygen and have consumer and industrial applications, but ozone itself is harmful to the respiratory system, even at relatively low concentrations.&lt;/p&gt;
&lt;p&gt;Instructions with the Applied Ozone Systems devices suggest blowing ozoned air into the rectal and vaginal areas.&lt;/p&gt;
&lt;p&gt;Friday&apos;s seizure was part of a joint effort of the FDA and the California Department of Public Health to remove or prevent unapproved or unsafe medical devices from entering the market.&lt;/p&gt;
&lt;p&gt;A statement on the company&apos;s Web site said the two ozone generator models, which sold for $750 and $1,200 respectively, were no longer available by order of the FDA and California authorities.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_298"
                     title="FDA Updates Myeloma Drug Label for New Risks"
                     score="0.004"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18158?impressionId=1265779128458"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has revised dosage and safety information for bortezomib (Velcade), the myeloma and mantle cell lymphoma drug, to reflect an increased toxicity risk.&lt;/p&gt;
&lt;p&gt;The new labeling includes a warning for patients with moderate-to-severe hepatic impairment and now recommends at-risk patients start at a lower dosage of 0.7 mg for the first cycle of treatment and escalate to 1.0 mg, or reduce further to 0.5 mg, in subsequent cycles.&lt;/p&gt;
&lt;p&gt;The label has also been updated to include clinical study data showing a higher median survival rate in patients using a combination of bortezomib, melphalan, and prednisone versus a regiment of just melphalan and prednisone (&lt;em&gt;P&lt;/em&gt;=0.00084).&lt;/p&gt;
&lt;p&gt;The drug is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. The FDA also warns that women should avoid becoming pregnant while undergoing treatment with bortezomib.&lt;/p&gt;
&lt;p&gt;The drug is manufactured by Millennium: The Takeda Oncology Company of Cambridge, Mass.&lt;/p&gt;

    </recommendedItem>
</recommendedContent>