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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EIn a pooled analysis of 1,510 patients enrolled in seven randomized controlled trials, pregabalin (150\u2013600 mg\/day) provided significant improvements in pain, sleep interference due to pain, and global health. Improvements in pain were dose-related; a clinically meaningful (=30%) improvement in pain was noted by 43%\u201362%, though 37% of placebo patients also reported this level of improvement.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Ediabetes mellitus\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EIn a pooled analysis of 1,510 patients enrolled in seven randomized controlled trials, pregabalin (150\u2013600 mg\/day) provided significant improvements in pain, sleep interference due to pain, and global health, said Roy Freeman, MD, Harvard Medical School, Boston, Massachusetts, United States. Improvements in pain were dose-related; a clinically meaningful (\u226530%) improvement in pain was noted by 43- 62%, though 37% of placebo patients also reported this level of improvement.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003E\u201cThere was a dose-related rapid onset of durable pain relief,\u201d Dr. Freeman reported. While pregabalin was well tolerated overall, there was also a dose-related increase in weight gain of approximately 2 kg. For 4% of the 600 mg group, the weight gain was a clinically meaningful increase of at least 7% of body weight. Peripheral edema occurred in 10% (300 mg) to 16% (600 mg). \u201cClearly the 600 mg dose was more effective, though there were more side-effects,\u201d Dr. Freeman said.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EResults of another international study, the NATHAN 1 Study, showed that antioxidant treatment with \u03b1-lipoic acid improved some neuropathic deficits and symptoms in mild to moderate diabetic neuropathy, but did not affect nerve conduction, based on a composite neurological assessment. The randomized study included 454 subjects given \u03b1-lipoic acid 600 mg\/day. After 4 years of treatment, the difference between the treatments based on the changes of the composite score including clinical signs (neuropathic deficits) and nerve conduction was only 0.7 points, but the neuropathic deficits did improve in the \u03b1-lipoic acid-treated group compared to placebo administration. Dan Ziegler, MD, German Diabetes Center, Dusseldorf, Germany, noted that the \u201cmarginal progression\u201d of neuropathy in the placebo arm made it difficult to show a treatment effect. \u201cThe designs of future trials must assume a long-term stable neuropathic condition,\u201d he said.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EPerspective\u003C\/h2\u003E\n         \u003Cp id=\u0022p-5\u0022\u003E\n            \u003Cem\u003EMD Conference Express\u003C\/em\u003E asked Nicolaas C. Schaper, MD, PhD, Professor of Endocrinology and Diabetes at University Hospital, Maastricht, the Netherlands, and session moderator, to comment on the studies reported at the Novel Therapies for Peripheral Neuropathy session.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EHe first noted that there are problems with clinical trials of agents. \u201cYou see a huge placebo effect in many studies, as in this study with pregabalin, and many are too short to be clinically relevant,\u201d he pointed out. Another problem is the inconsistency between epidemiologic data and clinical trial data, he said. Epidemiologic data suggest there is a steady deterioration in nerve function over time however, a study reported at this EASD showed very little deterioration among trial subjects. \u201cClinical trials, therefore, may not reflect our clinical practice with this complication,\u201d he said.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EIn studies reported at the EASD \u03b1-lipoic acid and aldose reductase inhibitors were found to be either problematic or with relative small effects. \u201cWhile there may be short-term efficacy in reducing pain with pregablin, there were some relevant side-effects, including edema and weight gain. If these appear by 13 weeks, as shown in this study, then what happens after treatment for 10 years? We need to think carefully about this issue,\u201d he continued. \u201cAlthough we currently have treatments such as tricyclic antidepressants (eg, amitriptyline) and anticonvulsants (eg, pregabalin and gabapentin) that can result in pain relief, pharmacologic pain treatment is still ineffective in too many patients and we urgently need more effective therapies.\u201d\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2007 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/7\/6\/26.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzm8dp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}