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    <recommendedItem id="20100101_19_425"
                     title="AAN: Industrial Cleaner Again Tied to Parkinson Risk (CME/CE)"
                     score="0.014"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAN/tb/18338?impressionId=1265764088243"
                     
      TORONTO  --  The degreasing agent trichloroethylene (TCE) has been linked to increased rates of Parkinson&apos;s disease among industrial workers in yet another study, this time involving a large, well-studied group of World War II veterans.&lt;br&gt;
&lt;br&gt;Parkinson&apos;s disease developed in individuals with occupational exposure to TCE at more than five times the rate seen in those without such exposure (odds ratio 5.5, 95% CI 1.02 to 30), reported Samuel Goldman, MD, of the Parkinson&apos;s Institute in Sunnyvale, Calif.&lt;br&gt;
&lt;br&gt;Goldman described the research in a phone interview with &lt;em&gt;MedPage Today&lt;/em&gt;. It&apos;s scheduled for presentation here in April at the American Academy of Neurology&apos;s annual meeting.&lt;br&gt;
&lt;br&gt;A previous study in 2008 had fingered TCE as the most likely culprit behind a cluster of Parkinson&apos;s disease cases afflicting workers at a single industrial plant. (See &lt;a href=&quot;http://www.medpagetoday.com/Geriatrics/ParkinsonsDisease/7894&quot; mce_href=&quot;http://www.medpagetoday.com/Geriatrics/ParkinsonsDisease/7894&quot; target=&quot;_blank&quot;&gt;Trichloroethylene Implicated as Risk for Parkinsonism&lt;/a&gt;)&lt;p&gt;&lt;/p&gt;
&lt;p&gt;Also, Goldman said, animal studies have found that TCE is selectively toxic to nigral dopaminergic neurons, the same type of nerve cell that progressively dies off in Parkinson&apos;s disease. He said the chemical&apos;s activity in rodent brains is very similar to that of MPTP (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine), a dopaminergic neurotoxin commonly used to simulate Parkinson&apos;s disease in preclinical research.&lt;/p&gt;
&lt;p&gt;Goldman said the new study was the first population-based analysis to link TCE to the disease.&lt;/p&gt;
&lt;p&gt;It focused on 198 twin pairs in the National Academy of Sciences-National Research Council&apos;s World War II Twins Cohort, which comprises some 16,000 twin pairs overall.&lt;/p&gt;
&lt;p&gt;Members of the all-male cohort, who were born from 1917 to 1927 and served in the war, have been followed since the 1960s. Occupational histories for participants are available along with medical records from the VA healthcare system.&lt;/p&gt;
&lt;p&gt;In those pairs chosen for the current study, records showed that one twin had developed Parkinson&apos;s disease and the other had not. This design largely eliminates genetics as a confounding factor in the analysis.&lt;/p&gt;
&lt;p&gt;Goldman explained that occupational histories for each participant were reviewed by a blinded industrial hygienist and a preventive medicine physician to identify likely exposures to TCE and four other industrial chemicals: xylene, toluene, carbon tetrachloride, and tetrachloroethylene.&lt;/p&gt;
&lt;p&gt;As a single source of exposure, only TCE was significantly associated with development of Parkinson&apos;s disease, Goldman said.&lt;/p&gt;
&lt;p&gt;People working as aircraft mechanics, machinists, plumbers, and electricians likely had regular exposure to TCE, Goldman said. The chemical was commonly used as a &quot;spot&quot; cleaner to remove grease and oils from metal surfaces. It was also used for a time as a dry cleaning solvent, although tetrachloroethylene was more common for that purpose.&lt;/p&gt;
&lt;p&gt;Goldman said no increased risk was seen with xylene or toluene, but there were near-significant trends toward increased Parkinson&apos;s disease risk from carbon tetrachloride and tetrachloroethylene: &lt;ul&gt; &lt;li&gt;Carbon tetrachloride: OR 2.8 (95% CI 0.97 to 7.8)&lt;/li&gt; &lt;li&gt;Tetrachloroethylene: OR 9.0 (95% CI 0.78 to 103)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Twins exposed to either TCE or tetrachloroethylene were at significantly increased risk, with an odds ratio of 8.1 (95% CI 1.43 to 43) relative to individuals with no exposure to either chemical.&lt;/p&gt;
&lt;p&gt;Goldman said the analysis also examined whether duration of exposure was associated with increased risk. He said the results were in the same pattern as for the yes-no exposure analysis, but the findings were very uncertain because of the relatively small sample size.&lt;/p&gt;
&lt;p&gt;Occupational histories were available for only 99 of the 198 discordant twin pairs and some of the information was obtained by proxy rather than from the participant himself.&lt;/p&gt;
&lt;p&gt;Because of the wide confidence intervals even for the yes-no exposure analysis, the findings need confirmation in a larger study, he said, noting that the best approach would be a cohort study involving people with known, long-term exposure to TCE, compared with well-chosen controls.&lt;/p&gt;
&lt;p&gt;&quot;The study wouldn&apos;t have to be large,&quot; Goldman said. He estimated that 1,000 to 2,000 participants would be adequate to determine if the connection to Parkinson&apos;s disease is real.&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 National Institute of Neurological Disorders and Stroke, the Valley Foundation, and the James and Sharron Clark Family Fund.&lt;/p&gt;&lt;p&gt;No potential conflicts of interest were reported.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_296"
                     title="FDA Okays Morphine for Tolerant Patients"
                     score="0.005"
                     href="http://www.medpagetoday.com/PainManagement/PainManagement/tb/18157?impressionId=1265764088243"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has approved the first high-concentration, oral morphine sulfate solution as part of its unapproved drugs initiative.&lt;/p&gt;
&lt;p&gt;The drug is indicated for opioid-tolerant patients with moderate-to-severe acute and chronic pain, as well as end-of-life care.&lt;/p&gt;
&lt;p&gt;Opioid tolerance was defined as a patient using 60 mg of an opioid per day, Sharon Hertz, MD, deputy director of the Division of Anesthesia, Analgesics, and Rheumatoid Products at the Center for Drug Evaluation and Research, said in a conference call.&lt;/p&gt;
&lt;p&gt;The new solution is available in 100 mg per 5 mL and 20 mg per 1 mL concentrations.&lt;/p&gt;
&lt;p&gt;Although morphine use in pain management has been a common practice, this form and concentration of the drug was not previously FDA approved.&lt;/p&gt;
&lt;p&gt;Approval for the new drug was based on efficacy and safety data already available, which applicants can use when seeking approval for unapproved formulations of drugs with a known safety profile, Hertz said.&lt;/p&gt;
&lt;p&gt;The FDA initiated the unapproved drugs initiative in March, 2009, when it sent warning letters to nine companies requesting they pull a number of morphine sulfate, oxycodone, and hydromorphone products from the market. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13526&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13526&quot; target=&quot;_blank&quot;&gt;FDA Acts Against Unapproved Narcotic Drugs&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Seven of the warned companies produced unapproved concentrated morphine sulfate, but the FDA granted a reprieve from the initiative when it could not find a suitable approved replacement for the drug without disrupting patient care. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13682&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13682&quot; target=&quot;_blank&quot;&gt;FDA Gives Temporary Reprieve to Unapproved Morphine Elixir&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;The agency worked with manufacturer Roxane Laboratories to ensure that a sufficient supply of the drug was available and to develop a prescription and use guide for the medication.&lt;/p&gt;
&lt;p&gt;As part of the approval, the manufacturer needed to establish a safety profile prior to approval to address the risks of morphine misuse, abuse, and overdose.&lt;/p&gt;

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    <recommendedItem id="20100101_19_252"
                     title="MS Walking Drug Gets FDA Nod"
                     score="0.001"
                     href="http://www.medpagetoday.com/Neurology/MultipleSclerosis/tb/18112?impressionId=1265764088243"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has approved the first drug that improves walking in patients with multiple sclerosis, the tablet dalfampridine (Ampyra).&lt;/p&gt;
&lt;p&gt;The approval was based on clinical trial data that found patients could walk better with the drug than those treated with placebo.&lt;/p&gt;
&lt;p&gt;Patients who exceed recommended dosage, 10 mg twice a day, or who have moderate to severe kidney disease, may experience seizures the FDA said.&lt;/p&gt;
&lt;p&gt;Adverse events reported during clinical trials include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, balance disorder, swelling of the nose or throat, constipation, diarrhea, indigestion, throat pain, and burning, tingling, or itching skin.&lt;/p&gt;
&lt;p&gt;The drug is manufactured by Elan of Dublin, Ireland and distributed by Acorda Therapeutics Inc. of Hawthone, NY.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_206"
                     title="Treadmill Training Improves Walking in Parkinson&apos;s (CME/CE)"
                     score="-0.001"
                     href="http://www.medpagetoday.com/Neurology/ParkinsonsDisease/tb/18049?impressionId=1265764088243"
                     
      Treadmill training can improve the impaired walking associated with Parkinson&apos;s disease, researchers said.&lt;br&gt;
&lt;br&gt;The technique leads to improvements in gait speed, stride length, and walking distance, but not gait cadence, according to Jan Mehrholz, PhD, of the Klinik Bavaria in Kreischa, Germany, and colleagues.&lt;br&gt;
&lt;br&gt;However, it remains unclear how long such improvements last, the researchers noted in a &lt;em&gt;Cochrane Systematic Review&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;Treadmill training has emerged recently as a &quot;promising investigational therapy&quot; aimed at patients with weakness on one side of the body and impaired gait, Mehrholz and colleagues wrote in their review.&lt;br&gt;
&lt;br&gt;To evaluate what&apos;s known about the subject, the researchers searched the literature and found eight randomized, controlled studies with a total of 203 participants.&lt;/p&gt;
&lt;p&gt;On average, patients were 61, with an average duration of disease in the studies ranging from one to eight years.&lt;/p&gt;
&lt;p&gt;When the studies were analyzed, the researchers found: 


&lt;table style=&quot;color: #151515; line-height: 16px; font: normal 14px Arial;&quot;&gt;
                &lt;tr&gt;&lt;td valign=&quot;top&quot;&gt;&lt;li&gt;&lt;/li&gt;&lt;/td&gt; &lt;td&gt;Seven studies  --  with153 participants all told  --  found that treadmill training improved gait speed. The pooled standardized mean difference was 0.50, which was significant at &lt;em&gt;P&lt;/em&gt;=0.003.&lt;/td&gt;&lt;/tr&gt;
                &lt;tr&gt;&lt;td valign=&quot;top&quot;&gt;&lt;li&gt;&lt;/li&gt;&lt;/td&gt; &lt;td&gt;Five studies, with a total of 95 participants, looked at stride length and found that treadmill training was beneficial. The pooled standardized mean difference was 0.50, which was significant at &lt;em&gt;P&lt;/em&gt;=0.05.&lt;/td&gt;&lt;/tr&gt;
                &lt;tr&gt;&lt;td valign=&quot;top&quot;&gt;&lt;li&gt;&lt;/li&gt;&lt;/td&gt; &lt;td&gt;Two studies, with 41 participants, found that treadmill training improved walking distance. The mean difference was 358 meters, which was significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001.&lt;/td&gt;&lt;/tr&gt;
&lt;tr&gt;&lt;td valign=&quot;top&quot;&gt;&lt;li&gt;&lt;/li&gt;&lt;/td&gt; &lt;td&gt;Finally, four studies (with 78 participants) found no significant mean difference in cadence.&lt;/td&gt;&lt;/tr&gt;
              &lt;/table&gt;

&lt;p&gt;The treadmill training was acceptable to patients, the researchers said, in that it did not increase the risk of patients dropping out of studies. Adverse events were not reported.&lt;/p&gt;
&lt;p&gt;The researchers noted that the study protocols varied markedly.&lt;/p&gt;
&lt;p&gt;The treadmill training lasted from one 30-minute session to eight weeks, although most studies used a four-, six- or eight-week period. Frequency varied from a single session to four times a week, the researchers said.&lt;/p&gt;
&lt;p&gt;The type of treadmill training also varied, with some investigators using body-weight supported treadmill training and others a speed-dependent approach.&lt;/p&gt;
&lt;p&gt;Primary outcomes also differed, Mehrholz and colleagues said.&lt;/p&gt;
&lt;p&gt;Because of those variations, they said, there is &quot;still a need for well-designed large-scale studies&quot; to look at the risk and benefits of treadmill training for Parkinson&apos;s patients.&lt;/p&gt;
&lt;p&gt;Specifically, they said, those studies should address open questions about how long the effect lasts and what should be the frequency and duration of training.&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 Klinik Bavaria Kreischa, the Technical University Dresden, SRH Fachhochschule Gera, and the California State University Long Beach.&lt;/p&gt;&lt;p&gt;Mehrholz and another author were co-authors of one included trial but did not participate in its quality assessment and data extraction.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
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