GI

<body topmargin=0 leftmargin=0 marginheight=0 marginwidth=0> <table cellpadding=0 cellspacing=0 border=0 height="100%"><tr> <td valign="top" width=210 BGCOLOR="#FFFFFF" TEXT="#080000" bgproperties="fixed" background="112f2f02egerdp.jpg"> <div> <A HREF="index.htm" TARGET="_top" TITLE="_"><U><B><U>HOME</U></B></U></A></div> <div> <TABLE BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="172" BORDERCOLORLIGHT="#C0C0C0" BORDERCOLORDARK="#808080" FRAME="BOX" RULES="ALL" HSPACE="0" VSPACE="0" > <tR> <tD VALIGN=TOP BGCOLOR=#66FFFF HEIGHT= 23 WIDTH="172"><div> <A HREF="id91.htm" TARGET="_top" TITLE="BRUCE ROSEMAN, M.D. 140 WEST 86th Stree"><U>CONTACT ME</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#FFCC99 HEIGHT= 23 WIDTH="172"><div> <A HREF="id17.htm" TARGET="_top" TITLE="office info"><U>OFFICE INFO</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#FFFF99 HEIGHT= 24 WIDTH="172"><div> <A HREF="id116.htm" TARGET="_top" TITLE="MEDICATION INFORMATION"><U>DRUG INFO</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#66FF99 HEIGHT= 23 WIDTH="172"><div> <A HREF="id77.htm" TARGET="_top" TITLE="kids"><U>KIDS</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#66FFCC HEIGHT= 23 WIDTH="172"><div> <A HREF="id24.htm" TARGET="_top" TITLE="SPECIALISTS"><U>SPECIALISTS</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#FFFF99 HEIGHT= 23 WIDTH="172"><div> <A HREF="id75.htm" TARGET="_top" TITLE="research"><U>LOOK IT UP</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#33CCFF HEIGHT= 44 WIDTH="172"><div>  <A HREF="id89.htm" TARGET="_top" TITLE="TEST YOURSELF"><U>TEST YOURSELF</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#FFFFCC HEIGHT= 23 WIDTH="172"><div> <A HREF="id23.htm" TARGET="_top" TITLE=" RADIOLOGY AND IMAGING"><U>RADIOLOGY</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#FF99FF HEIGHT= 23 WIDTH="172"><div> <A HREF="id47.htm" TARGET="_top" TITLE="HANDOUTS "><U>HANDOUTS </U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#FFCC99 HEIGHT= 23 ><NOBR><div>  I<A HREF="id53.htm" TARGET="_top" TITLE=" ANATOMY"><U>LLUSTRATIONS</U></A></div> </NOBR></tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#33FFFF HEIGHT= 23 WIDTH="172"><div> <A HREF="id22.htm" TARGET="_top" TITLE="PHARMACIES"><U>PHARMACIES</U></A></div> </tD> </tR> </TABLE></div> <bR> <bR> <bR> </td> <td valign="top" BGCOLOR="#FFFFFF" TEXT="#080000" bgproperties="fixed" background="115f0f03.jpg"> <div> <I>GI</I></div> <div> <A HREF="#natalizumab_effective_for_active" TITLE="GI"><U>Natalizumab Effective for Active Crohn's Disease</U></A></div> <div> <A HREF="#28_tips_for_nighttime_heartburn_relief" TITLE="GI"><U>28 Tips for Nighttime Heartburn Relief</U></A></div> <div> <A HREF="#gastroesophageal_reflux_disease__gerd_" TITLE="GI"><U>Gastroesophageal Reflux Disease (GERD) </U></A></div> <bR> <bR> <bR> <bR> <div> <TABLE BORDER="0" CELLPADDING="1" CELLSPACING="1" WIDTH="597" BORDERCOLORLIGHT="#C0C0C0" BORDERCOLORDARK="#808080" FRAME="VOID" RULES="NONE" HSPACE="0" VSPACE="0" > <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 25 ><NOBR><div>  <A NAME="gastroesophageal_reflux_disease__gerd_"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="1" ALIGN="bottom" WIDTH="1" HSPACE="0" VSPACE="0" ></A><FONT SIZE="4" COLOR="#660099" FACE="Arial" ><B>Gastroesophageal Reflux Disease (GERD)</B></FONT> </div> </NOBR></tD> <tD VALIGN=CENTER WIDTH="148"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="25" ALIGN="bottom" WIDTH="148" HSPACE="0" VSPACE="0"></tD> </tR> <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 19 WIDTH="434"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="19" ALIGN="bottom" WIDTH="434" HSPACE="0" VSPACE="0"></tD> <tD VALIGN=CENTER ROWSPAN=21 WIDTH="148"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="19" ALIGN="bottom" WIDTH="148" HSPACE="0" VSPACE="0"></tD> </tR> <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 414 WIDTH="434"><div> GERD is a common condition that affects from 5% to 7% of the population. The most common symptom of GERD is chronic heartburn, but it's not the only symptom.</div> <bR> <div> Other symptoms of GERD include: </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Belching </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Chronic sore throat </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Difficulty or pain when swallowing </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Waterbrash (sudden excess of saliva) </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Hoarseness </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Sour taste in the mouth </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Bad breath </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Inflammation of the gums </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Erosion of tooth enamel (the surface of the teeth)</div> <div> <I>NOTE: chest pain is also a symptom of heartburn. However, it is often difficult to differentiate chest pain due to heartburn/GERD and chest pain due to heart disease. Therefore, be sure to get all chest pain evaluated IMMEDIATELY by a health care professional.</I></div> <bR> <div> Sometimes, there are no symptoms and GERD is only diagnosed when complications (see below) arise. </div> </tD> </tR> <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 19 WIDTH="434"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="19" ALIGN="bottom" WIDTH="434" HSPACE="0" VSPACE="0"></tD> </tR> <tR> <tD VALIGN=CENTER HEIGHT= 38 WIDTH="10"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="38" ALIGN="bottom" WIDTH="10" HSPACE="0" VSPACE="0"></tD> <tD VALIGN=CENTER COLSPAN=4 WIDTH="423"><bR> <div> How is GERD diagnosed?</div> </tD> </tR> <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 19 WIDTH="434"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="19" ALIGN="bottom" WIDTH="434" HSPACE="0" VSPACE="0"></tD> </tR> <tR> <tD VALIGN=CENTER HEIGHT= 208 WIDTH="10"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="208" ALIGN="bottom" WIDTH="10" HSPACE="0" VSPACE="0"></tD> <tD VALIGN=CENTER COLSPAN=4 WIDTH="423"><bR> <div> First your doctor will review your symptoms with you and do a complete physical examination.</div> <bR> <div> If he or she believes that you have GERD, usually you will be given a trial run of GERD medications (most often proton-pump inhibitors such as Nexium, Aciphex, Prilosec, Prevacid, and Protonix) for two weeks to see if you experience relief.</div> <bR> <div> In some instances, further testing, such as pH testing may be needed to aid in diagnosis.</div> </tD> </tR> <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 19 WIDTH="434"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="19" ALIGN="bottom" WIDTH="434" HSPACE="0" VSPACE="0"></tD> </tR> <tR> <tD VALIGN=CENTER HEIGHT= 38 WIDTH="10"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="38" ALIGN="bottom" WIDTH="10" HSPACE="0" VSPACE="0"></tD> <tD VALIGN=CENTER COLSPAN=4 WIDTH="423"><bR> <div> What causes GERD?</div> </tD> </tR> <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 19 WIDTH="434"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="19" ALIGN="bottom" WIDTH="434" HSPACE="0" VSPACE="0"></tD> </tR> <tR> <tD VALIGN=CENTER HEIGHT= 398 WIDTH="10"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="398" ALIGN="bottom" WIDTH="10" HSPACE="0" VSPACE="0"></tD> <tD VALIGN=CENTER COLSPAN=4 WIDTH="423"><bR> <div> There is no known single cause of GERD. What we know is that GERD occurs when the normal defenses of the esophagus are overwhelmed by acid refluxing into it from the stomach.</div> <bR> <div> Normally stomach acid is kept in the stomach by a muscular valve between it and the esophagus called the lower esophageal sphincter. If that valve is faulty for any reason, reflux occurs.</div> <bR> <div> Factors that may contribute to GERD include smoking, being overweight or pregnant, the use of certain medications and consumption of GERD-aggravating foods (which vary on an individual basis).</div> <bR> <div> The symptoms of GERD are a result of the damage caused by stomach acid that has entered the esophagus (heartburn, belching) or higher into the throat (hoarseness, sore throat) or even into the mouth (sour taste in the mouth, erosion of tooth enamel).</div> </tD> </tR> <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 19 WIDTH="434"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="19" ALIGN="bottom" WIDTH="434" HSPACE="0" VSPACE="0"></tD> </tR> <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 19 WIDTH="434"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="19" ALIGN="bottom" WIDTH="434" HSPACE="0" VSPACE="0"></tD> </tR> <tR> <tD VALIGN=CENTER HEIGHT= 38 WIDTH="10"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="38" ALIGN="bottom" WIDTH="10" HSPACE="0" VSPACE="0"></tD> <tD VALIGN=CENTER COLSPAN=4 WIDTH="423"><bR> <div> How is GERD treated?</div> </tD> </tR> <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 19 WIDTH="434"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="19" ALIGN="bottom" WIDTH="434" HSPACE="0" VSPACE="0"></tD> </tR> <tR> <tD VALIGN=CENTER HEIGHT= 57 WIDTH="10"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="57" ALIGN="bottom" WIDTH="10" HSPACE="0" VSPACE="0"></tD> <tD VALIGN=CENTER COLSPAN=4 WIDTH="423"><bR> <div> GERD is usually treated with a combination of prescription medications and lifestyle changes.</div> </tD> </tR> <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 19 WIDTH="434"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="19" ALIGN="bottom" WIDTH="434" HSPACE="0" VSPACE="0"></tD> </tR> <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 19 WIDTH="434"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="19" ALIGN="bottom" WIDTH="434" HSPACE="0" VSPACE="0"></tD> </tR> <tR> <tD VALIGN=CENTER HEIGHT= 38 WIDTH="10"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="38" ALIGN="bottom" WIDTH="10" HSPACE="0" VSPACE="0"></tD> <tD VALIGN=CENTER COLSPAN=4 WIDTH="423"><bR> <div> What happens if GERD goes untreated?</div> </tD> </tR> <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 19 WIDTH="434"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="19" ALIGN="bottom" WIDTH="434" HSPACE="0" VSPACE="0"></tD> </tR> <tR> <tD VALIGN=CENTER HEIGHT= 227 WIDTH="10"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="227" ALIGN="bottom" WIDTH="10" HSPACE="0" VSPACE="0"></tD> <tD VALIGN=CENTER COLSPAN=4 WIDTH="423"><bR> <div> Besides the obvious affect on quality of life, untreated GERD can lead to some serious complications. They include: </div> <div> <B><IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Esophagitis.</B> This is an irritation and inflammation of the lining of the esophagus caused by stomach acid. </div> <div> <B><IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Dysphagia.</B> Over time, untreated GERD causes difficulty swallowing or dysphagia. </div> <div> <B><IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Barrett's esophagus.</B> The chronic exposure to stomach acid can cause changes in the cells of the esophagus that may be precancerous. </div> <div> <B><IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Esophageal cancer.</B> Years of exposure to stomach acid may cause cancer of the esophagus.</div> </tD> </tR> <tR> <tD VALIGN=CENTER COLSPAN=5 HEIGHT= 19 WIDTH="434"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="19" ALIGN="bottom" WIDTH="434" HSPACE="0" VSPACE="0"></tD> </tR> </TABLE></div> <div> For a complete guide to heartburn for your patient visit <FONT SIZE="3" COLOR="#0000FF" FACE="Arial" ><U>WebMD Health</U></FONT> </div> <div> Reviewed by the doctors at the Cleveland Clinic Department of Gastroenterology & Hepatology. </div> <div> Edited by Cynthia Haines, MD, WebMD, January 2006.</div> <bR> <div> SOURCES: American Gastroenterology Association. International Foundation for Functional Gastrointestinal Disorders, Inc. The National Institute of Diabetes and Digestive and Kidney Diseases. </div> <div> Copyright © 2006, <FONT SIZE="3" COLOR="#0000FF" FACE="Arial" ><U>The Cleveland Clinic</U></FONT>.</div> <bR> <bR> <div> <B> <A NAME="28_tips_for_nighttime_heartburn_relief"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="1" ALIGN="bottom" WIDTH="1" HSPACE="0" VSPACE="0" ></A></B><B>28 Tips for Nighttime Heartburn Relief</B></div> <div> Stop suffering heartburn symptoms at night. Get relief with these food, drink, and lifestyle tips. </div> <div> By <FONT SIZE="3" COLOR="#0000FF" FACE="Arial" ><U>Wendy C. Fries</U></FONT> </div> <div> WebMD Feature </div> <div> Reviewed by <FONT SIZE="3" COLOR="#0000FF" FACE="Arial" ><U>Brunilda Nazario, MD</U></FONT> </div> <div> A bitter taste in the mouth, a chronic cough, sore throat, fatigue ... if you're waking every morning with these symptoms of nighttime heartburn, you want relief.</div> <div> Millions experience heartburn and the more serious condition gastroesophageal reflux disease (GERD) daily. And research shows that nighttime heartburn affects nearly four out of five of heartburn sufferers -- disturbing sleep and impairing their ability to function the next day.</div> <div> If you're one of these people, find nighttime heartburn relief with these simple lifestyle, exercise, and food tips.</div> <div> <B>12 Food and Drink Tips for Nighttime Heartburn Relief</B></div> <div> Prevent heartburn by limiting acidic foods, such as grapefruit, oranges, tomatoes, or vinegar </div> <div> Spicy foods giving you heartburn? Cut back on pepper or chilies. </div> <div> Don't lie down for two to three hours after you eat. When you are sitting up, gravity helps drain food and stomach acid into your stomach. </div> <div> Enjoy lean meats and nonfatty foods. Greasy foods (like French fries and cheeseburgers) can trigger heartburn. </div> <div> Want to avoid GERD symptom triggers? You may want to cut back on chocolate, mint, citrus, tomatoes, pepper, vinegar, catsup, and mustard. </div> <div> Avoid drinks that can trigger reflux, such as alcohol, drinks with caffeine, and carbonated drinks. </div> <div> Size matters: Eat smaller meals and you may avoid triggering GERD symptoms. </div> <div> Enjoy an after-work drink? You may want to turn to teetotaling: Alcohol can relax the esophageal sphincter, worsening GERD. </div> <div> Crazy about colas? It may be time to cut back. Colas can be related to reflux and to GERD symptoms. </div> <div> Keep heartburn at bay: Don't eat too quickly! Try putting your fork down between bites. </div> <div> Avoid snacking at bedtime. Eating close to bedtime can trigger heartburn symptoms. </div> <div> Reduce your nighttime heartburn risk: Eat meals two to three hours before sleep. </div> <div> <B>16 Lifestyle Tips for Nighttime Heartburn Relief</B></div> <div> Steer clear of tight clothes. Tight belts, waistbands, and pantyhose can press on your stomach, triggering heartburn. </div> <div> Strive for a less stressful life. Stress may increase stomach acids, boosting heartburn symptoms. </div> <div> Heavy? Try losing weight. The pressure of excess weight increases the chance stomach acid will backup into the esophagus. </div> <div> Popping antacids more than once a week? You may have GERD, not heartburn, and need more aggressive treatment. </div> <div> Try chewing gum at night. This can boost the production of saliva, which neutralizes stomach acid. </div> <div> Not all "trigger" foods cause GERD symptoms in everyone. Keep track of your symptoms to find <I>your</I> personal triggers. </div> <div> Pregnant? You may experience heartburn or GERD. Talk to your doctor about finding relief. </div> <div> Heartburn worse after exercise? Drink plenty of water. It helps with hydration and digestion. </div> <div> Untreated GERD can radically increase your risk of esophageal cancer. But reflux <I>can</I> be managed. Talk with your doctor. </div> <div> Try keeping a diary or heartburn log to keep track of activities that might trigger incidents. </div> <div> A full tummy can mean a night full of heartburn pain. Wait at least 2-3 hours after you eat before going to bed. </div> <div> Wait for your workout. Don't want to trigger heartburn? Wait at least two hours after a meal before exercising. </div> <div> Nicotine can cause your esophageal sphincter to relax. If you smoke, kick the habit. </div> <div> Some medicines can worsen reflux. Talk with your doctor about alternatives. </div> <div> Use blocks or bricks under the bedpost to raise the head of your bed 6 inches so you can sleep with head and chest elevated. You can also try a wedge pillow. </div> <div> Bend with your knees. Bending over at the waist tends to increase reflux symptoms. </div> <bR> <bR> <div>  <A NAME="natalizumab_effective_for_active"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="1" ALIGN="bottom" WIDTH="1" HSPACE="0" VSPACE="0" ></A>Natalizumab Effective for Active Crohn's Disease CME </div> <div> <B>News Author: David Douglas</B></div> <div> <B>CME Author: Laurie Barclay, MD</B> </div> <div> Complete author <FONT SIZE="3" COLOR="#0000FF" FACE="Arial" ><U>affiliations and disclosures, and other CME information</U></FONT>, are available at the end of this activity.</div> <div> <B>Release Date: June 8, 2007</B>; Valid for credit through June 8, 2008 </div> <div> <B>Credits Available</B></div> <div> <B>Physicians</B> - maximum of 0.25 <I>AMA PRA Category 1 Credit(s)™</I> for physicians;</div> <div> <B>Family Physicians</B> - up to 0.25 AAFP Prescribed credit(s) for physicians </div> <div> All other healthcare professionals completing continuing education credit for this activity will be issued a certificate of participation.</div> <div> Physicians should only claim credit commensurate with the extent of their participation in the activity.</div> <bR> <div> June 8, 2007 — Natalizumab, a humanized immunoglobulin G4 monoclonal antibody targeting a-4 integrins, is more effective than placebo in treatment of certain patients with Crohn's disease and active inflammation.</div> <div> "These studies confirm that natalizumab can treat active Crohn's disease patients," lead author Dr. Stephan R. Targan told Reuters Health. "If approved by the FDA, it will offer patients an alternative therapy with a different mechanism of action from therapies targeted to tumor necrosis factor."</div> <div> In the May issue of <I>Gastroenterology</I>, Dr. Targan of Cedars Sinai Medical Center, Los Angeles and colleagues report the results of their study of 509 patients with moderately to severely active Crohn's disease and elevated C-reactive protein levels.</div> <div> They were randomized to receive natalizumab 300 mg or placebo intravenously at the start of the study and 4 and 8 weeks later.</div> <div> In all, 48% of natalizumab patients and 32% of placebo patients showed a decrease of 70 points or more in the Crohn's Disease Activity Index (CDAI) score at 8 through 12 weeks (p < 0.001). Active treatment patients also showed higher response rates at 4 and 8 weeks.</div> <div> Sustained remission, defined as a CDAI score less than 150 points, was seen in 26% of natalizumab patients and 16% of placebo patients (p = 0.002), the investigators report.</div> <div> Adverse event frequencies were similar in both groups, and in fact, "patients receiving placebo experienced more serious adverse events than those treated with natalizumab," the team found.</div> <div> They note in their discussion of the results that elevated CRP identifies patients whose symptoms are likely driven by inflammation. Patients with other causes such as bile salt diarrhea or bacterial overgrowth are unlikely to benefit from agents targeting inflammatory pathways.</div> <div> Nonetheless, the researchers advise that CRP "should not be the sole or the most important factor upon which treatment decisions are made." Factors such as endoscopic findings, the ESR, and response to prior treatments "should all be considered when attempting to determine appropriate patient treatment."</div> <div> Summing up, Dr. Targan and colleagues conclude that taken together with data from previous induction trials, the findings "indicate that natalizumab is effective for induction of sustained response and remission in patients with Crohn's disease and active inflammation as evidenced by elevated CRP concentration and may represent an alternative treatment option ... in appropriately selected patients."</div> <div> <I>Gastroenterology.</I> 2007;132:1672-1683.</div> <div> Reuters Health Information 2007. © 2007 Reuters Ltd.</div> <div> <B>Learning Objectives for This Educational Activity</B></div> <div> Upon completion of this activity, participants will be able to: </div> <div> Describe the efficacy of natalizumab in inducing response and remission in patients with moderately to severely active Crohn's disease. </div> <div> Describe the tolerability of natalizumab used in this setting. </div> <div> <B>Clinical Context</B></div> <div> The mechanism of Crohn's disease involves recruitment of leukocytes into gut tissue and dysregulated activation of immune cell function, mediated via the a4 integrins. Natalizumab is a humanized immunoglobulin G4 monoclonal antibody against a4 integrins. In previous studies, natalizumab was effective as induction therapy for patients with moderately to severely active Crohn's disease.</div> <div> Although the Efficacy of Natalizumab as Active Crohn's Therapy (ENACT-1) trial did not meet the primary endpoint of response at week 10, the Evaluation of Natalizumab as Continuous Therapy (ENACT-2) trial clearly showed the efficacy of natalizumab as a maintenance therapy in patients who responded to induction therapy. This report describes the Efficacy of Natalizumab in Crohn's Disease Response and Remission (ENCORE) trial, which was designed to confirm that natalizumab is effective as an induction therapy in patients with moderately to severely active Crohn's disease and active inflammation characterized by elevated C-reactive protein concentrations.</div> <div> <B>Study Highlights</B></div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">ENCORE was done at 114 centers between March 2004 and March 2005. Inclusion criteria were moderately to severely active Crohn's disease confirmed by radiologic or endoscopic studies within previous 36 months or following prior surgical resection, C-reactive protein concentration greater than 2.87 mg/L, 18 years of age or older, Crohn's disease Activity Index (CDAI) scores of 220 to no more than 450, and Crohn's disease duration of 6 months or longer. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Concurrent Crohn's disease therapies were allowed. Exclusion criteria were short-bowel syndrome, ostomy, total colectomy, stricture with obstructive symptoms, draining fistulas, abdominal abscess, anti–tumor necrosis factor therapy within previous 12 weeks, or previous natalizumab treatment. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Of 832 patients screened, 509 were eligible and randomized 1:1 to receive natalizumab (300 mg) or placebo intravenously at weeks 0, 4, and 8; they were followed up until week 12 for safety and efficacy assessments. Baseline characteristics were similar in both groups. Patients, site staff, and investigators were all blinded to treatment assignment. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Main outcome was induction of response (> 70-point decrease from baseline in CDAI score at week 8 sustained through week 12). Other outcomes were proportion of patients with sustained remission (CDAI < 150 points) and response or remission over time. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Response at week 8 sustained through week 12 occurred in 48% of natalizumab group vs 32% of placebo group (<I>P</I> < .001), and sustained remission occurred in 26% vs 16%, respectively (<I>P</I> = .002). At week 4, response rates were 51% for natalizumab and 37% for placebo (<I>P</I> = .001), and responses remained higher at later assessments in natalizumab group (<I>P</I> < .001). Remission rates at weeks 4, 8, and 12 were also higher with natalizumab vs placebo (<I>P</I> < .009). </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Both groups had similar frequency and types of adverse events, which were recorded at each visit. Safety assessments included vital signs, physical examinations, hematology, serum biochemistry, urinalysis, and testing for antinatalizumab antibodies (positive, = 0.5 µg/mL in validated enzyme-linked immunosorbent assay at any time point). Natalizumab was well tolerated. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Overall, 39 patients (15%) receiving natalizumab and 42 patients (17%) receiving placebo withdrew prematurely from study. Treatment was discontinued because of an adverse event in 9% vs 13%, respectively. Most common adverse events (reported by = 10% of patients in both groups) were headache, nausea, abdominal pain, nasopharyngitis, dizziness, fatigue, and Crohn's disease exacerbation. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Serious adverse events occurred in 5% of the natalizumab group vs 10% of the placebo group. The most common serious adverse event, Crohn's disease exacerbation, occurred in 3% vs 6%, respectively. There was 1 case of basal cell carcinoma in a patient receiving natalizumab. Infections occurred in 35% of the natalizumab group vs 30% of the placebo group, primarily because of more frequent nasopharyngitis in the natalizumab group (11% vs 6%). Serious infections occurred in 1 patient in the natalizumab group (perianal abscess not considered related to study drug) and in 4 in the placebo group. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Acute infusion reactions occurred in 9% of the natalizumab group vs 7% of the placebo group. Hypersensitivity-like reactions occurred in 4% of the natalizumab group vs less than 1% of the placebo group; all were medically nonserious and responded quickly to appropriate medical therapy. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">During weeks 0 to 12, 9.5% of the natalizumab group tested positive for antinatalizumab antibodies on at least 1 occasion; 22% of these had acute infusion reactions vs 8% of those who tested negative. Incidence of hypersensitivity-like reactions was 17% vs 3%, respectively. </div> <div> <B>Pearls for Practice</B></div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">In patients with moderately to severely active Crohn's disease, natalizumab induced response and remission at week 8 that was sustained through week 12. Response and remission rates for natalizumab were superior to those for placebo at weeks 4, 8, and 12. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Natalizumab was well tolerated in this study, with frequency and types of adverse events in the natalizumab group being similar to those in the placebo group. </div> <div> <B>Instructions for Participation and Credit</B></div> <div> There are no fees for participating in or receiving credit for this online educational activity. 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Credits will be tallied in your CME/CE Tracker and archived for 5 years; at any point within this time period you can print out the tally as well as the certificates by accessing "Edit Your Profile" at the top of your Medscape homepage.</div> <bR> <div> *The credit that you receive is based on your user profile.  <A NAME="target"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="1" ALIGN="bottom" WIDTH="1" HSPACE="0" VSPACE="0" ></A></div> <div> <B>Target Audience</B></div> <div> This article is intended for primary care clinicians, gastroenterologists, and other specialists who care for patients with Crohn's disease.</div> <div> <B>Goal</B></div> <div> The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.</div> <bR> </td> </tr></table></body>