<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_454"
                     title="Glaucoma Meds Linked to Lower Mortality Risk (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/Ophthalmology/Glaucoma/tb/18371?impressionId=1265742683803"
                     
      For patients diagnosed with glaucoma, taking medications for the condition appears to improve survival, researchers found.&lt;br&gt;
&lt;br&gt;Patients with suspected or confirmed glaucoma were 74% less likely to die during a five-year period if they were prescribed any glaucoma medication (HR 0.26, 95% CI 0.16 to 0.40), according to Joshua Stein, MD, of the University of Michigan Kellogg Eye Center in Ann Arbor, and colleagues.&lt;br&gt;
&lt;br&gt;However, in an analysis of patients with suspected glaucoma only, the association was no longer significant (HR 1.19, 95% CI 0.43 to 3.27), the researchers reported in the February issue of the &lt;em&gt;Archives of Ophthalmology&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;&quot;Additional studies need to be done to try to sort out exactly why the patients who have diagnosed glaucoma tend to have reduced mortality relative to the other patients who are not being treated,&quot; Stein told &lt;em&gt;MedPage Today&lt;/em&gt;, adding that changes in clinical management should not be made until this is sorted out.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;Previous studies of glaucoma and mortality have yielded conflicting results. Few have examined the effect of glaucoma medications, which can be absorbed systemically and affect the body in ways that may confound such analyses.&lt;/p&gt;
&lt;p&gt;So Stein and his colleagues looked at data from a large managed care network involving 21,506 patients 40 and older with suspected or confirmed glaucoma.&lt;/p&gt;
&lt;p&gt;About half (50.5%) had suspected glaucoma and the rest had received a definite diagnosis, most commonly open-angle glaucoma (21.5%).&lt;/p&gt;
&lt;p&gt;Comorbidities were common: 52.7% of the patients had hypertension and 41.3% had diabetes.&lt;/p&gt;
&lt;p&gt;From 2003 through 2007, 28.1% of the patients filled a prescription for a glaucoma medication. The most frequently prescribed drugs were prostaglandin analogues (20.8%) and beta-antagonists (12.8%).&lt;/p&gt;
&lt;p&gt;More than a quarter (28%) were also prescribed oral beta-blockers.&lt;/p&gt;
&lt;p&gt;During the study, 1.1% of the patients died.&lt;/p&gt;
&lt;p&gt;The overall reduction in risk of death during the study held for both single agents  --  topical beta-antagonists (HR 0.40, 95% CI 0.18 to 0.86) and prostaglandin analogues (HR 0.27, 95% CI 0.14 to 0.52),&lt;strong&gt; &lt;/strong&gt;as well as for combinations of glaucoma medications.&lt;/p&gt;
&lt;p&gt;The mortality risk declined as the number of prescribed medications increased (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001). The hazard ratios for one, two, and three or more medications were 0.29, 0.19, and 0.12, respectively.&lt;/p&gt;
&lt;p&gt;Among those with the most common diagnosis, open-angle glaucoma, the risk of dying during the study was reduced by a relative 77% for those prescribed at least one medication (HR 0.23, 95% CI 0.14 to 0.37).&lt;/p&gt;
&lt;p&gt;It is unclear why glaucoma medication use is associated with a lower mortality risk, but it is possible that topical medications absorbed systemically could affect blood pressure, heart rate, breathing, and kidney function, Stein said.&lt;/p&gt;
&lt;p&gt;&quot;But the fact that multiple different medication classes are showing this protective effect suggests to me that it may not necessarily be the medications themselves, but perhaps it&apos;s the types of patients who are receiving the medications,&quot; he said.&lt;/p&gt;
&lt;p&gt;The patients taking medication for glaucoma might be healthier than the untreated patients, he said.&lt;/p&gt;
&lt;p&gt;Those with more serious conditions might have to selectively choose which drugs they buy, and might purchase medications for more serious conditions than glaucoma.&lt;/p&gt;
&lt;p&gt;Also, physicians treating patients with more serious conditions might not focus on glaucoma, Stein said.&lt;/p&gt;
&lt;p&gt;A final possibility might be differences in the beneficiaries&apos; access to healthcare.&lt;/p&gt;
&lt;p&gt;The authors noted a number of limitations of the study: &lt;ul&gt; &lt;li&gt;The use of claims data, and not patient records, resulted in missing information on some important clinical variables&lt;strong&gt;,&lt;/strong&gt; such as smoking, body weight, blood pressure.&lt;/li&gt; &lt;li&gt;The results are not necessarily generalizable beyond the insured patients in this single, managed care network.&lt;/li&gt; &lt;li&gt;Death status could not be verified and cause of death could not be determined because of the use of de-identified data.&lt;/li&gt; &lt;li&gt;It is unclear whether patients actually took the prescribed medications.&lt;/li&gt; &lt;li&gt;The relationship between certain drug classes and mortality risk could not be determined because of low patient numbers.&lt;/li&gt; &lt;/ul&gt;&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 authors did not make any financial disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_442"
                     title="Most Mountaineers Can Enjoy the View (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/Ophthalmology/GeneralOphthalmology/tb/18359?impressionId=1265742683803"
                     
      &lt;p&gt;Although the vistas from some of the world&apos;s highest peaks are literally &quot;eye-popping,&quot; most climbers don&apos;t have to worry about their high-altitude vision.&lt;/p&gt;
&lt;p&gt;Corneal thickness did swell significantly among mountaineers at elevations up to 6,300 meters (about 21,000 feet), but they had no loss in visual acuity, Martina Monika Bosch, MD, of University Hospital Zurich in Switzerland, and colleagues reported in the February &lt;em&gt;Archives of Ophthalmology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;&quot;It seems that visual acuity in healthy corneas is not adversely affected despite the presence of edema at altitudes up to 6,300 meters,&quot; the researchers wrote.&lt;/p&gt;
&lt;p&gt;Yet they warned that altitudes above 8,000 meters, or 26,000 feet, &quot;may result in profuse edema leading to dangerous visual loss.&quot;&lt;/p&gt;
&lt;p&gt;Mt. Everest is just over 29,000 feet high.&lt;/p&gt;
&lt;p&gt;Research has shown that hypobaric atmospheric conditions are linked to acute mountain sickness, as well as to the more unusual cerebral edema.&lt;/p&gt;
&lt;p&gt;High altitudes have also been associated with decreases in visual acuity, as was the case for Dr. Beck Weathers, a Mount Everest climber who had lasik surgery prior to his climb and experienced severe vision loss before reaching the summit.&lt;/p&gt;
&lt;p&gt;So, to investigate the effects of very high altitudes on corneal thickness, the researchers conducted a study of 28 healthy mountaineers ages 26 to 62, who were on a medical research expedition to Mount Muztagh Ata in China, an elevation of 24,757 feet.&lt;/p&gt;
&lt;p&gt;The climbers were randomly assigned to two groups: one had a shorter time to acclimate to altitude conditions prior to reaching a camp at 21,736 feet.&lt;/p&gt;
&lt;p&gt;The researchers measured corneal thickness via ultrasound pachymetry.&lt;/p&gt;
&lt;p&gt;They found that corneal thickness increased in both groups at higher altitudes, with shorter acclimatization times leading to greater differences (&lt;em&gt;P&lt;/em&gt;=0.048). For this group, mean corneal thickness increased from 537 mcm to 572 mcm.&lt;/p&gt;
&lt;p&gt;Corneal thickness in the group that had more time to acclimate rose from 534 mcm to 563 mcm.&lt;/p&gt;
&lt;p&gt;Visual acuity didn&apos;t significantly decrease during the course of the expedition. However, the researchers warned that higher altitudes induce more endothelial pump function failure and may result in profuse edema, leading to vision loss.&lt;/p&gt;
&lt;p&gt;While the cause of corneal swelling in hypoxic conditions is still controversial, the researchers suggested that a higher concentration of lactate may reduce activity of the eye&apos;s endothelial pump function, resulting in corneal swelling.&lt;/p&gt;
&lt;p&gt;There were no differences in mountain sickness between the groups, but oxygen saturation during the expedition was significantly lower than at baseline in both.&lt;/p&gt;
&lt;p&gt;Changes in oxygen saturation paralleled those of corneal thickness, the researchers said, indicating that slower acclimatization resulted in less corneal edema.&lt;/p&gt;
&lt;p&gt;Also, climbers with more acute mountain sickness had thicker corneas, possibly due to their higher overall susceptibility to hypoxia.&lt;/p&gt;
&lt;p&gt;&quot;These findings further support our hypothesis that blood oxygen saturation becomes more important for the endothelial pump function when environmental oxygen pressure and, thus, tear film oxygen saturation, is reduced to a critical level,&quot; they wrote. &quot;Our results thus highlight the importance of aqueous humor oxygen delivery.&quot;&lt;/p&gt;
&lt;p&gt;The study was limited by the inability to measure corneal thickness daily due to adverse weather conditions.&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 grants from the Swiss National Research Science Foundation, the Swiss Society of Mountain Medicine, and Pfizer.&lt;/p&gt;&lt;p&gt;The researchers reported no 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_463"
                     title="AAPM: Online Program Helps Manage Pain (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18393?impressionId=1265742683803"
                     
      &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_462"
                     title="BLOG: Good Conscience is Bad Business"
                     score="0.01"
                     href="http://www.medpagetoday.com/Blogs/18386?impressionId=1265742683803"
                     
      &lt;span style=&quot;font-family: Times; font-size: medium;&quot;&gt;&lt;div style=&quot;margin: 0px; padding: 0.6em; background-color: rgb(255, 255, 255); font-family: Georgia,&apos;Times New Roman&apos;,&apos;Bitstream Charter&apos;,Times,serif; font-style: normal; font-variant: normal; font-weight: normal; font-size: 13px; line-height: 19px; font-size-adjust: none; font-stretch: normal; -x-system-font: none;&quot;&gt;&lt;p&gt;I am going to state something that is completely obvious to most primary care physicians:  &lt;span style=&quot;font-style: italic;&quot; mce_style=&quot;font-style: italic;&quot; mce_name=&quot;em&quot;&gt;I do not accept Medicare and Medicaid patients because it is good business, I accept them despite the fact that it is bad business.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;In truth, I could make that statement about insurance as a whole; my life would be easier and my income would be less precarious if I did not accept any insurance.  If I did, I would charge a standard amount per visit based on time spent and require payment at the time of that visit.  This is totally obvious to me, and I suspect to most primary care physicians.  A huge part of our overhead comes from the fact that we are dealing with insurance.  A huge part of our headache and hassle comes from the fact that we are dealing with insurance.&lt;/p&gt;
&lt;p&gt;If I chose to post my charges up front and expected payment at the time of the visit, the impact to the business would be huge. As  it stands, the percentage of my collections that goes to overhead is between 50 and 60% (depending on the month).  A huge amount of that overhead is due to the need to hire a large billing staff to deal with the complexity of coding, billing, and documenting.  If I dropped insurance and charged a fixed amount, I could:&lt;/p&gt;
&lt;ol&gt;
&lt;li&gt;Cut my billing staff nearly to zero (someone would still have to do bookkeeping).&lt;/li&gt;
&lt;li&gt;Increase my payment per visit, which would allow me to see fewer patients per day.&lt;/li&gt;
&lt;li&gt;Document for the sake of patient care, and not for the sake of getting paid.&lt;/li&gt;
&lt;li&gt;Add extra services like email access and house calls without worrying about how I would get paid.&lt;/li&gt;
&lt;/ol&gt;
&lt;p&gt;In short, I could make my life better, my hassles less, and improve the quality of the care I offer.&lt;/p&gt;
&lt;p&gt;So why just single out Medicare and Medicaid?  Dropping insurance would force all of my M/M patients to find another doctor, while my patients with insurance could still choose to see me.  There are several reasons why this is possible for insured patients:&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Insured patients generally have the option of filing for their own insurance (there are some that still don&apos;t allow this, but that number is dwindling with the decrease of HMO&apos;s).&lt;/li&gt;
&lt;li&gt;Insured patients could choose to just pay me cash if they choose.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Can&apos;t Medicare/Medicaid patients do this?  No, for several reasons:&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;If a doctor does not accept M/M, the government will not pay anything for the visit regardless of who files.&lt;/li&gt;
&lt;li&gt;If the doctor &lt;span style=&quot;font-style: italic;&quot; mce_style=&quot;font-style: italic;&quot; mce_name=&quot;em&quot;&gt;does&lt;/span&gt; accept M/M, they are required to accept that payment and cannot charge anything outside of that (aside from the 20% not covered).  So if I charge a M/M patient $50 cash for a visit and am signed up to accept M/M, I am committing fraud.&lt;/li&gt;
&lt;li&gt;If I drop M/M, I cannot sign up for it again for 3 years, so the impact of that move is too large to consider at this time.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;So why in the world do I accept M/M still?  Why would I continue to make my life so difficult?  Two words: duty and calling. I view my seeing M/M patients as a social responsibility (especially Medicare).  These people need to be seen and they deserve good care, and despite the hassle and drain on income they cause, I make a reasonable income.  So far.&lt;/p&gt;
&lt;p&gt;Plus, I just like to take care of the elderly and the poor.  My personal reasons for going into medicine included both a desire to have a good job and the calling to care for people in need.  If I dropped M/M I would reject the calling for personal gain, which is something I can&apos;t do in good conscience at this time.&lt;/p&gt;
&lt;p&gt;The fact that the only thing keeping me accepting M/M is my conscience (and tolerance of pain) gives a really clear explanation as to why M/M are failing in the realm of primary care.  The government is not paying enough to make a good business case to accept M/M; instead it is relying on the consciences of primary care physicians like me who are willing to put up with the &lt;span style=&quot;font-style: italic;&quot; mce_style=&quot;font-style: italic;&quot; mce_name=&quot;em&quot;&gt;huge&lt;/span&gt; hassle of the system.  I am personally willing to continue on this course as long as (it doesn&apos;t get too much worse) but I have complete sympathy for PCP&apos;s who drop insurance and no longer see M/M patients.&lt;/p&gt;
&lt;p&gt;One of the biggest costs to our system is the high proportion of specialists to PCP&apos;s.  PCP&apos;s keep down cost, as their success is measured by keeping people healthy, away from specialists, and out of the hospital.  The system is just holding on with the PCP&apos;s we have; decreasing that number would be devastating and perhaps fatal to the system.  It&apos;s a very bad sign when the best business model for PCP&apos;s is to do something that, if done by all PCP&apos;s, would wreck the system.  Yet even physicians like myself, who have a strong sense of duty and social responsibility, wonder how long we can afford to take M/M.&lt;/p&gt;
&lt;p&gt;I am sure some are thinking: &lt;span style=&quot;font-style: italic;&quot; mce_style=&quot;font-style: italic;&quot; mce_name=&quot;em&quot;&gt;Poor Doctors!  They have to earn less money!  They have to actually have a conscience!  What a horrible thing! &lt;/span&gt;To that I answer with the fact that I &lt;span style=&quot;font-style: italic;&quot; mce_style=&quot;font-style: italic;&quot; mce_name=&quot;em&quot;&gt;have&lt;/span&gt; chosen to earn less money, increase my hassle, and live by my conscience.  At this time, most PCP&apos;s accepting M/M are doing the same.  But setting up a system that requires the choice between conscience and sanity, between doing the right thing and self-care, is foolish.  Pushing down M/M payments for PCP&apos;s will make a bad situation worse.&lt;/p&gt;
&lt;p&gt;That&apos;s bad politics, bad medicine, and bad business.&lt;/p&gt;
&lt;p&gt;Consider yourself warned, Washington.&lt;/p&gt;
&lt;/div&gt;
&lt;/span&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_461"
                     title="Limited Benefit Seen in CML Drug, FDA Says"
                     score="0.01"
                     href="http://www.medpagetoday.com/HematologyOncology/Leukemia/tb/18390?impressionId=1265742683803"
                     
      &lt;p&gt;WASHINGTON  --  Chronic myeloid leukemia (CML) patients who are resistant to imatinib (Gleevec) had a low response rate to treatment with omacetaxine (Omapro), according to Food and Drug Administration (FDA) reviewers.&lt;/p&gt;

&lt;p&gt;The FDA released its assessment of omacetaxine, made by ChemGenex Pharmaceuticals, in preparation for a meeting of an outside panel of oncology experts who will recommend whether the agency should approve the drug for imanitib-resistant CML patients with a Bcr-Abl T3151 mutation.&lt;/p&gt;
    &lt;p&gt;That meeting, original scheduled for Wednesday, was postponed when the federal government closed most Washington area offices because of snow. An FDA spokesman said no new date has been set.&lt;/p&gt;


&lt;p&gt;The agency does not have to follow the advice of its advisory panels, but it usually does.&lt;/p&gt;
&lt;p&gt;The Oncologic Drugs Advisory Committee will look at data from manufacturer ChemGenex&apos;s lone trial, which tested the safety and efficacy of subcutaneously administered omacetaxine in the target population.&lt;/p&gt;
&lt;p&gt;The trial divided 66 patients into disease stage cohorts of &quot;chronic phase,&quot; &quot;accelerated phase,&quot; or &quot;blast phase,&quot; and gave them 1.25 mg/m&lt;sup&gt;2&lt;/sup&gt; subcutaneous omacetaxine twice daily for 14 days every 28 days until hematologic response for induction therapy.&lt;/p&gt;
&lt;p&gt;If a patient achieved a complete hematologic response, hematologic improvement, or any cytogenetic response, the patient was transitioned to a maintenance does twice daily for seven days every 28 days.&lt;/p&gt;
&lt;p&gt;Researchers found: &lt;ul&gt; &lt;li&gt;For the chronic phase cohort of 40 patients, the major cytogenetic response rate was 15%, and the median duration of response was 7.7 months. &lt;/li&gt; &lt;li&gt;After a mean of nine months, 86% of the 49 chronic patients who were no longer controlling their diseases with imatinib had achieved a complete hematological response. &lt;/li&gt; &lt;li&gt;For the &quot;accelerated phase&quot; cohort of 16 patients, the major cytogenetic response rate was 6%, and the complete hematological response rate was 31%, with a median of duration of response of 22 weeks. &lt;/li&gt; &lt;li&gt;No patients responded in the more severe &quot;blast&quot; group, indicating omacetaxine works best among patients who are not as sick.&lt;/li&gt; &lt;li&gt;Overall, about 27% of patients achieved a major cytogenetic response, defined as absence of Bcr-Abl mutation in at least 35% of cells. About 18% of the patients had achieved a complete cytogenetic response, defined as all cells appearing to have lost the Bcr-Abl mutation.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;&quot;The response rate observed in the efficacy study was low,&quot; FDA reviewers concluded in documents released in advance of Wednesday&apos;s meeting.&lt;/p&gt;
&lt;p&gt;However, ChemGenex researchers said, &quot;These results demonstrate that omacetaxine is an effective and durable therapy with rapid onset of action for CML patients with the Bcr-Abl T315I mutation.&quot;&lt;/p&gt;
&lt;p&gt;The most common adverse events in the trial were thrombocytopenia, anemia, diarrhea, and neutropenia.&lt;/p&gt;
&lt;p&gt;The FDA reviewers cited a number of concerns with the ChemGenex study, noting that the company planned to enroll 100 patients but submitted efficacy data from only 66, and then continued to enroll additional patients after the prespecified data cutoff.&lt;/p&gt;
&lt;p&gt;Also, the reviewers said there is no commercially available test to detect the T3151 mutation. And, although it was a requirement of the study that the patients have a confirmed T3151 mutation, the mutation status of 35% of the patients in the trial was not confirmed.&lt;/p&gt;
&lt;p&gt;There are currently no approved drugs that have been found to be effective at treating CML patients with the T315I mutation.&lt;/p&gt;
&lt;p&gt;&quot;Omacetaxine offers an important therapeutic option for the treatment of CML patients who have the T315I mutation, a population that has a clear unmet medical need and no proven treatment options,&quot; ChemGenex researchers wrote in the company&apos;s briefing document.&lt;/p&gt;

    </recommendedItem>
</recommendedContent>