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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20090101_19_3513"
                     title="ASN: ESA Use Rose Substantially in Dialysis Units Worldwide (CME/CE)"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/ASN/tb/16759?impressionId=1265782431189"
                     
      SAN DIEGO  --  From the mid-1990s to early 2007, the use of erythropoiesis-stimulating agents (ESAs) for anemia increased dramatically around the world, which resulted in a rise in hemoglobin levels, researchers found.&lt;br&gt;
&lt;br&gt;The trends appeared to be independent of policies regarding the way the drugs were reimbursed, Philip McFarlane, MD, of the University of Toronto, reported at the American Society of Nephrology meeting here.&lt;br&gt;
&lt;br&gt;&quot;There must be other drivers ... that are contributing to this in an important way,&quot; he said, although he didn&apos;t know what those were.&lt;br&gt;
&lt;br&gt;The study stopped collecting data in early 2007, just months after the results of two major trials  --  CHOIR and CREATE  --  showed that aggressively raising hemoglobin worsened cardiovascular outcomes in patients with anemia.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;Subsequently, the FDA added boxed warnings to the ESAs and the Kidney Diseases Outcomes Quality Initiative revised their recommended target hemoglobin value to between 11 and 12 g/dL.&lt;/p&gt;
&lt;p&gt;McFarlane said the effects of these actions would not have been captured in the current analysis.&lt;/p&gt;
&lt;p&gt;Nor would the effects of the recently reported TREAT trial, which found that, in patients with type 2 diabetes, chronic kidney disease, and anemia, treating to a high target hemoglobin had no impact on cardiovascular outcomes or death, but did result in a higher stroke rate. (See: &lt;a href=&quot;http://www.medpagetoday.com/MeetingCoverage/ASN/16724&quot; mce_href=&quot;http://www.medpagetoday.com/MeetingCoverage/ASN/16724&quot; target=&quot;_blank&quot;&gt;ASN: No Clinical Benefit for ESA in Anemic Patients with Diabetes, CKD&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;&quot;It may be that physician perception of what the target hemoglobin should be will start to drift back downwards again,&quot; he said.&lt;/p&gt;
&lt;p&gt;It had been known that the use of ESAs was increasing for U.S. patients on hemodialysis, prompting concerns that reimbursement policies were providing a financial incentive for clinicians to use these drugs. ESAs were reimbursed at mean cost plus 6%, McFarlane said.&lt;/p&gt;
&lt;p&gt;But he and his colleagues thought other factors were contributing to the rise, and they wanted to look at trends across countries to evaluate the contribution of reimbursement policies.&lt;/p&gt;
&lt;p&gt;So they examined data from the Dialysis Outcomes and Practice Patterns Study (DOPPS), which included information from 12 countries  --  Australia, Belgium, Canada, France, Germany, Italy, Japan, New Zealand, Spain, Sweden, the U.K., and the U.S.&lt;/p&gt;
&lt;p&gt;More than 7,500 patients on hemodialysis, hemofiltration, or hemodiafiltration from more than 300 dialysis units were evaluated.&lt;/p&gt;
&lt;p&gt;From 1996 through 2007, ESA dose increased significantly in all countries but Belgium. At the end of the study, the highest average dose was used in the U.S. (21,420 U/patient/week) and the lowest was in Japan (5,270 U/patient/week).&lt;/p&gt;
&lt;p&gt;This increase in the amount of ESA used was accompanied by an expected rise in hemoglobin levels in all countries but Sweden.&lt;/p&gt;
&lt;p&gt;In every country but Japan, more than 40% of patients had hemoglobin levels that exceeded 12 g/dL by the end of the study. In five countries  --  Australia, Belgium, New Zealand, Spain, and the U.S.  --  more than half of all patients exceeded that value.&lt;/p&gt;
&lt;p&gt;McFarlane and his colleagues reviewed publicly available policy statements and incentives in funding of ESAs in each country and surveyed governmental affairs sections of ESA manufacturers and some of the DOPPS investigators to evaluate the effect of reimbursement policy on the observed trends.&lt;/p&gt;
&lt;p&gt;They did not find a correlation between reimbursement and the rise in the use of ESAs or hemoglobin levels.&lt;/p&gt;
&lt;p&gt;Although McFarlane couldn&apos;t explain what contributed to the increases, he said clinicians likely became more convinced that a higher hemoglobin level was better over time, an attitude that likely would have changed after the CREATE and CHOIR results were announced in late 2006.&lt;/p&gt;
&lt;p&gt;However, further DOPPS data will be needed to evaluate that, McFarlane said.&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;DOPPS receives funding from Amgen and Kirin.&lt;/p&gt;&lt;p&gt;McFarlane reported receiving research/grant support from and serving as a consultant for Amgen Canada, Ortho Biotech of Canada, and Roche Canada, as well as serving as a scientific adviser for and receiving honoraria from Amgen Canada and Ortho Biotech of Canada.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_19_3544"
                     title="ASN: Heavy Burden from CKD-Related Anemia in Patients with Diabetes (CME/CE)"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/ASN/tb/16803?impressionId=1265782431189"
                     
      &lt;p&gt;SAN DIEGO  --  Patients with type 2 diabetes and anemia related to nondialysis chronic kidney disease have a significantly impaired quality of life, two surveys showed.&lt;/p&gt;
&lt;p&gt;Of 60 such patients, the vast majority reported having low energy (88%) and feeling tired or worn out (86%), Shravanthi Gandra, PhD, MBA, manager of global health economics for Amgen, reported at the American Society of Nephrology meeting here.&lt;/p&gt;
&lt;p&gt;Many also reported being limited physically by the anemia, she said.&lt;/p&gt;
&lt;p&gt;A separate survey showed that these patients have worse health-related quality of life than patients with other conditions, including survivors of myocardial infarction and those with congestive heart failure and type 2 diabetes alone.&lt;/p&gt;
&lt;p&gt;They even had slightly worse scores in some quality-of-life measures than patients on hemodialysis  --  including bodily pain and impaired daily activities caused by emotional problems.&lt;/p&gt;
&lt;p&gt;&quot;Most of the time we forget to bring the patient&apos;s perspective into how they feel,&quot; Gandra said.&lt;/p&gt;
&lt;p&gt;These findings can &quot;help inform clinicians about what&apos;s the impact of quality of life in these patients and help them make choices about treatment.&quot;&lt;/p&gt;
&lt;p&gt;Patient perceptions of quality of life related to anemia have been well studied in patients on dialysis, but not in those with type 2 diabetes and chronic kidney disease that doesn&apos;t require dialysis, Gandra and her colleagues said.&lt;/p&gt;
&lt;p&gt;Nearly half (47%) of patients with nondialysis chronic kidney disease have anemia, they said.&lt;/p&gt;
&lt;p&gt;Data from the Dialysis Outcomes and Practice Patterns Study showed that reduced scores on the Short Form-36 quality-of-life questionnaire were associated with increased risks of death and hospitalization in patients on dialysis, they said.&lt;/p&gt;
&lt;p&gt;So it&apos;s important to assess the burden of quality-of-life problems in patients not yet on dialysis, Gandra said.&lt;/p&gt;
&lt;p&gt;In one survey, she and her colleagues interviewed 60 patients with type 2 diabetes, nondialysis chronic kidney disease, and anemia who had not yet started receiving erythropoiesis-stimulating agents.&lt;/p&gt;
&lt;p&gt;Their mean estimated glomerular filtration rate was 32.5 mL/min/1.73 m&lt;sup&gt;2&lt;/sup&gt; and their mean hemoglobin was 10.3 g/dL.&lt;/p&gt;
&lt;p&gt;The most frequent physical limitations occurred when climbing stairs (41%), bending (43%), walking (48%), and bathing or dressing (30%).&lt;/p&gt;
&lt;p&gt;Compared to patients with moderate chronic kidney disease, those with more severe disease were more likely to report being tired (60% versus 32.3%) or low in energy (50% versus 26.7%) most of the time (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05).&lt;/p&gt;
&lt;p&gt;Those with more severe anemia (hemoglobin &amp;lt;10 g/dL) were more likely to report being limited in activities most of the time (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05).&lt;/p&gt;
&lt;p&gt;In a second survey, 57 similar patients completed the SF-36 health-related quality-of-life questionnaire.&lt;/p&gt;
&lt;p&gt;Their scores on all eight domains of the questionnaire  --  physical function, physical health affecting daily living, bodily pain, general health, vitality, social function, emotional health affecting daily living, and mental health  --  were worse compared with the general population and those with a history of MI, type 2 diabetes alone, and congestive heart failure.&lt;/p&gt;
&lt;p&gt;Scores were generally similar to those of patients on hemodialysis, but were slightly lower on all but two domains  --  social function and vitality.&lt;/p&gt;
&lt;p&gt;Gandra said the findings indicate that improving health-related quality of life should be an important goal of treatment for these patients.&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;Gandra is employed by Amgen, which makes medications for treating anemia.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_19_973"
                     title="ACC: Potent Statin Fails to Improve CV Outcomes in Patients on Dialysis"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/ACC/tb/13497?impressionId=1265782431189"
                     
      ORLANDO, March 30 -- Treatment with rosuvastatin (Crestor) did not prevent cardiovascular events or death in patients with end-stage renal disease who are undergoing hemodialysis, a multicenter, randomized trial showed.
              &lt;p&gt;
              &lt;p&gt;Although there were expected improvements in the lipid profiles of statin-treated patients, there was no difference compared with patients taking placebo in the primary endpoint of cardiovascular death, myocardial infarction, or stroke ( &lt;em&gt;P&lt;/em&gt;=0.59), according to Bengt Fellstrom, M.D., Ph.D., of University Hospital in Uppsala, Sweden.
              &lt;p&gt; 
               
              &lt;p&gt;Dr. Fellstrom reported the results at the American College of Cardiology meeting here. The study was published simultaneously online in the &lt;em&gt;New England Journal of Medicine&lt;/em&gt;. 
              &lt;p&gt; 
              &lt;p&gt;In an accompanying editorial Giovanni Strippoli, Ph.D., and Jonathan Craig, Ph.D., of the University of Sydney, wrote, &quot;It appears that statins have now joined this group of &apos;promising but ineffective&apos; interventions&quot; for patients undergoing hemodialysis.
              &lt;p&gt; 
              &lt;p&gt;Although the cardiovascular benefits of statins have been well established in high-risk patients, whether the drugs also helped patients on hemodialysis, who often have low or normal LDL cholesterol levels, had been unclear.
              &lt;p&gt; 
              &lt;p&gt;So Dr. Fellstrom and his colleagues enrolled 2,776 patients with end-stage renal disease into AURORA (A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis: An Assessment of Survival and Cardiovascular Events), which was conducted at 280 centers in 25 countries.
              &lt;p&gt; 
              &lt;p&gt;Patients ranged in age from 50 to 80 (mean 64). The mean baseline LDL cholesterol level was 100 mg/dL.
              &lt;p&gt; 
              &lt;p&gt;The patients were randomized to 10 mg of rosuvastatin a day or placebo.
              &lt;p&gt; 
              &lt;p&gt;As expected, after three months, there was a significantly greater reduction in LDL cholesterol concentration in the statin group (42.9% versus 1.9% from baseline, &lt;em&gt;P&lt;/em&gt;&lt;0.001).
              &lt;p&gt; 
              &lt;p&gt;Compared with placebo, total cholesterol and triglycerides were significantly reduced (&lt;em&gt;P&lt;/em&gt;&lt;0.001 for both) and HDL cholesterol was significantly increased (&lt;em&gt;P&lt;/em&gt;=0.045) in the statin-treated group.
              &lt;p&gt; 
              &lt;p&gt;The drug also decreased high-sensitivity C-reactive protein. The concentration of hsCRP dropped by 0.65 mg/L in the rosuvastatin group and increased by 0.21 mg/L in the placebo group (&lt;em&gt;P&lt;/em&gt;&lt;0.001 for the between-group comparison).
              &lt;p&gt; 
              &lt;p&gt;Despite these beneficial effects, statin therapy did not reduce the occurrence of the composite primary endpoint through a median follow-up of 3.8 years.
              &lt;p&gt; 
              &lt;p&gt;Nor was there a significant effect on the individual components or on all-cause mortality (&lt;em&gt;P&lt;/em&gt;=0.51).
              &lt;p&gt; 
              &lt;p&gt;Subgroup analyses did not yield any significant differences either.
              &lt;p&gt; 
              &lt;p&gt;As is typical of patients with end-stage renal disease, there were high rates of adverse events, but they did not differ between the two groups (96.3% with rosuvastatin versus 96.7% with placebo).
              &lt;p&gt; 
              &lt;p&gt;&quot;The lack of a benefit of statin therapy . . . suggests that cardiovascular disease in patients undergoing hemodialysis differs from that in other patients,&quot; Dr. Fellstrom and colleagues wrote.
              &lt;p&gt; 
              &lt;p&gt;&quot;Increasingly,&quot; they said, &quot;the benefits of statin therapy are attributed to pleiotropic effects that are independent of a lowering of the LDL cholesterol level, and they include improvements with respect to endothelial function and inflammation and a reduction of the high-sensitivity C-reactive protein level.&quot;
              &lt;p&gt; 
              &lt;p&gt;The researchers noted that patients who were already taking statins and those younger than 50 were excluded, which may have introduced selection bias. Younger patients have a higher cardiovascular risk, and thus might be affected differently by statin therapy, they said.
              &lt;p&gt; 
              &lt;p&gt;The authors also noted a high dropout rate for those taking rosuvastatin, which highlights the difficulties of performing studies in patients on hemodialysis.
              &lt;p&gt; 
              &lt;p&gt;The editorialists, Drs. Strippoli and Craig, suggested that treatment with rosuvastatin might not have been beneficial because the study may have been underpowered, there was a high dropout rate (about 50%), and those patients most likely to benefit -- those already on statins -- were excluded.
              &lt;p&gt; 
              &lt;p&gt;Or it might simply be that statins are actually not effective in this population, they said. 
              &lt;p&gt; 
              &lt;p&gt;However, they said, &quot;the most likely explanation is that, as compared with other populations, differences may exist in the causal pathway for early cardiovascular events and death in patients undergoing dialysis.&quot;
              &lt;p&gt; 
              &lt;p&gt;Although in the general population cardiac disease is mostly caused by atherosclerotic plaques, they said, about 75% of patients on dialysis have left ventricular hypertrophy and aortic calcification. Only a quarter of deaths among those on dialysis are caused by conditions for which statins are indicated, they said.
              &lt;p&gt; 
              &lt;p&gt;&quot;The search is on for more promising interventions for a desperately needy group of people with very poor outcomes,&quot; they said.
              &lt;p&gt; 
              &lt;p&gt; 
              &lt;p&gt;&lt;table cellspacing=&quot;0&quot; hspace=&quot;1&quot; style=&quot;border-style:solid; border-width:1px; border-color:#8dabbc; font-family:arial; font-size:12px; background-color:#DBE9F2; padding:5px 5px 5px 5px;&quot;&gt;
&lt;tr&gt;&lt;td&gt;The study was sponsored by AstraZeneca, which markets rosuvastatin.
              &lt;p&gt; 
              &lt;p&gt;Dr. Fellstrom reported receiving consulting fees from AstraZeneca, Novartis, Roche, and Wyeth; lecture fees from Astellas, Novartis, and Roche; and grant support from Novartis, Roche, Merck-Schering-Plough, and Wyeth, and serving as national coordinator for the Study of Heart and Renal Protection (SHARP) study at Oxford University&apos;s Clinical Trial Service Unit. The other study authors reported potential conflicts with numerous pharmaceutical companies. One of the study authors is an employee of AstraZeneca.
              &lt;p&gt; 
              &lt;p&gt;One of the editorialists, Dr. Craig, reported being a member of the international steering committee of the SHARP study.&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;
         
    </recommendedItem>
    <recommendedItem id="20090101_19_3475"
                     title="ASN: HCV Changes Dialysis Treatment Needs (CME/CE)"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/ASN/tb/16712?impressionId=1265782431189"
                     
      &lt;p&gt;SAN DIEGO  --  Patients on dialysis need less epoetin to treat their anemia if they are infected with hepatitis C (HCV), a researcher reported here.&lt;/p&gt;
&lt;p&gt;HCV-positive patients also needed a lower dose of IV iron than their noninfected counterparts, even though they had similar hemoglobin levels, according to David Goodkin, MD, of the Arbor Research Collaborative for Health in Ann Arbor, Mich.&lt;/p&gt;
&lt;p&gt;This is a &quot;surprising, unusual finding,&quot; Goodkin said at the American Society of Nephrology meeting, because most inflammatory diseases, which interfere with the signal the bone marrow sends to make more red blood cells, would result in the need for a higher dose of epoetin.&lt;/p&gt;
&lt;p&gt;&quot;We speculate that it may be that this viral infection is actually stimulating the liver to make this hormone erythropoietin,&quot; Goodkin said, although he admitted that he doesn&apos;t know why the virus would activate the erythropoietin-producing cells.&lt;/p&gt;
&lt;p&gt;He said the finding would probably not affect clinical practice because patients on dialysis have their epoetin doses adjusted regularly anyway.&lt;/p&gt;
&lt;p&gt;&quot;The doctors are still going to follow the hemoglobin level and adjust the EPO dose,&quot; Goodkin said. &quot;This is just a clue that if it&apos;s hepatitis C-positive, they&apos;ll need less EPO, on average, than people who are hepatitis C-negative.&quot;&lt;/p&gt;
&lt;p&gt;Goodkin said he decided to investigate after he saw the results of a small case-control study from 2008, involving 66 patients, showing that those on dialysis who were infected with HCV needed significantly lower doses of erythropoietin (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01). There was also a trend toward lower IV iron requirements (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.07).&lt;/p&gt;
&lt;p&gt;To explore the issue on a larger scale, he turned to the prospective Dialysis Outcomes and Practice Patterns Study (DOPPS).&lt;/p&gt;
&lt;p&gt;The current analysis included 36,245 patients in 12 countries who were on hemodialysis, 7.8% of whom were positive for HCV.&lt;/p&gt;
&lt;p&gt;After adjusting for age, sex, race, years of hemodialysis, country, and 14 comorbidities, he and his colleagues found that the weekly epoetin dose was significantly lower in the HCV-positive patients (7,737 versus 8,210 Units, &lt;em&gt;P&lt;/em&gt;=0.02).&lt;/p&gt;
&lt;p&gt;IV iron dose was also significantly lower in the infected patients (89.2 versus 96.4 mg/month, &lt;em&gt;P&lt;/em&gt;=0.02).&lt;/p&gt;
&lt;p&gt;Hemoglobin concentration was not significantly different in the two groups (&lt;em&gt;P&lt;/em&gt;=0.46).&lt;/p&gt;
&lt;p&gt;The odds ratios for not receiving epoetin or IV iron therapy among HCV-positive patients were 1.15 (&lt;em&gt;P&lt;/em&gt;=0.002) and 1.19 (&lt;em&gt;P&lt;/em&gt;=0.0002), respectively.&lt;/p&gt;
&lt;p&gt;Hepatitis B infection, on the other hand, offered no advantage.&lt;/p&gt;
&lt;p&gt;In addition to the unexpected effect of HCV infection on the epoetin dose, another surprising finding was that only seven infected patients in the study received antiviral treatment, including interferon.&lt;/p&gt;
&lt;p&gt;Goodkin speculated that clinicians might have been sparing the patients the adverse effects of antiviral therapy because most HCV-positive patients do not develop cirrhosis and liver failure, and patients on dialysis, many of whom are older, have a limited lifespan.&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;DOPPS is funded by Amgen, Kyowa Hakko Kirin, and Genzyme.&lt;/p&gt;&lt;p&gt;Goodkin reported relationships with Affymax, AMAG Pharmaceuticals, Amgen, FibroGen, Keryx, Seattle Life Sciences, Xenon Pharmaceuticals, and Urodynamix Technologies.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_2_957"
                     title="Case Monitoring Cuts First-Year Hemodialysis Death Risk by 41%"
                     score="-0.006"
                     href="