8. Results from renal sympathetic nerve ablation for hypertension presented at AHA (3/126)- The much awaiting 6-month results from the Australia based SYMPLICITY HTN2 trial were presented at AHA and published in the Lancet. This was a randomized trial of 106 patients with refractory hypertension assigned to either catheter-based renal sympathetic nerve ablation + medical management vs. medical management alone. BP dropped by 32mmHg systolic and 13mmHg diastolic in the treatment group compared to 1mmHg and 0mmHg in the control group and were sustained over the 6-month followup period. Minimal side effects were observed. This is similar to the proof of principle study that was discussed in detail on RFN . It will be interesting to see how these results hold up over time. Offering renal sympathetic nerve ablation to patients with refractory hypertension could prove to be nice therapeutic option if this procedure is shown to have good results over the long term. Right now all we have is the 6-month data which do, however, look encouraging.
8. Kidney transplantation in HIV+ patients published in NEJM (3/126)- Kidney transplantation for individuals with concomitant ESRD and HIV has been a controversial topic. This study , reviewed on RFN will likely put some of these issues to rest. This was a prospective multi-center trial following 150 HIV+ transplant recipients. The group was followed for up for a median of 1.7 years. They found patient survival rates were similar to the general population and graft survival rates were somewhere in between the general population and a high risk population of patients receiving kidney transplants. These are encouraging results and pave the way for opening up transplantation for this group of patients.
7. Propublica article on chronic hemodialysis (5/126)- On Nov. 7th Propublica reporter Robin Fields published "God Help You. You're on Dialysis" in The Atlantic. This story chronicles the ongoing saga of chronic hemodialysis in the United States from when congress granted comprehensive coverage for all patients with ESRD in 1972 to present. Robin interviewed several patients and investigated several dialysis centers in her multi-year investigation into this topic for which she highlighted several deficiencies. The Propublica piece is a timely article as it comes on the heals of the most ambitious change in funding for chronic dialysis care and our #1 story of the year- "medicare bundling for dialysis". The story has garnered reactions from several entities including CMS chief Barry Straube ( listen to his interview on NPR), dialysis giant DaVita and several others (click here for a comprehensive list from the Fix Dialysis blog).
6. Two Rituximab trials ( RITUXIVAS and RAVE ) for ANCA-vasculitis (7/126)- These two trials compared rituximab (anti-B cells antibody) vs. IV or oral cyclophosphamide respectively during the induction phase of ANCA-vasculitis and were published simultaneously in the NEJM in July of this year. Dr. Falk wrote an excellent editorial in regards to these trials here . Both trials although with significant differences in the study design showed that rituximab was efficacious in inducing remission. However, no significant differences were seen in toxicity parameters between the groups (a result that was surprising). Although these results are encouraging, only 12-month (in RITUXIVAS) and 6-month (RAVE) remission rates are presented. Long term data on remission will be important before rituximab will be considered first line.
5. The Frequent Hemodialysis Network Trial published in NEJM (10/126)- This was one of four positive trials presented at ASN Renal Week this year. Thrice-weekly dialysis has been the mantra of dialysis care in much of the world and the US. Several observational studies have been performed comparing thrice-weekly with longer dialysis duration (click here or here for reviews of these studies). These studies have shown that longer duration dialysis can improve a variety of parameters. As such, quotidian (or daily) dialysis has begun to gain increased popularity in the dialysis community. However, large randomized trials are lacking. This trial randomized 245 patients to either frequent (six-times per week, 1.5-2.75hrs/day) or standard (three-times per week, 2.5-4hrs/day) dialysis. The patients were followed for 1 year. Frequent dialysis was significantly superior on both co-primary outcomes: The composite of death or change in left ventricular mass as well as the composite of death or change in RAND Physical Health Composite from the SF-36. Secondary outcomes of hypertension and hyperphosphatemia were also improved. This is an important trial that will likely impact how dialysis will be offered to patients with ESRD. How these results will be incorporated into the new CMS model will be interesting.
4. APOL1 gene variants reported in Science are associated with increased risk of renal disease in African Americans (16/126)- The surprise story of 2010 was definitely the publication in Science that two APOL1 gene variants are associated with an increased risk of renal disease in African Americans. All of the attention had been focused squarely on MYH9 variants and now it looks as if the next door neighbor (at least genetically) might be even more important. This again was covered by RFN . To summarize the researchers found that the same two variants of the APOL1 gene that are associated with the increased risk of renal disease may also protect against African sleeping sickness (Trypanosoma brucei rhodesiense). I'm sure we will hear more on this story as well.
3. SHARP trial results released at ASN showing statin/zetia benefit in CKD (19/126)- Another big surprise at ASN renal week this year were the results from the long-awaited SHARP trial. With all of the negative or neutral studies looking at statin therapy in ESRD patients it was quite the surprise that this was a positive study. SHARP compared the combination of ezetimibe/simvastatin to placebo in 9,438 patients with CKD (1/3 of which were on dialysis). The investigators found that patients taking ezetimibe/simvastatin had a significant (p=0.0010) 16.1% reduction in the incidence of first major vascular event (nonfatal MI or cardiac death, stroke, or revascularization). Furthermore, they did not find a difference in adverse events including rhabdo, cancer, muscle cramps etc. No differences were seen in renal outcomes in patients not on dialysis at the beginning of the trial as well. Full results of the trial are not yet published. Read this summary of the results from CardioBrief.
2. The IDEAL trial comparing early versus late initiation of dialsyis published in NEJM (21/126)- Coming in at #2 is the IDEAL Trial comparing early versus late initiation of hemodialysis. This trial was discussed in detail on RFN . When to start a patient on dialysis is a frequent clinical conundrum in nephrology and this trial shed some light onto this topic. Researchers from Australia and New Zealand randomized 828 patient to either start dialysis early (eGFR of 10-14 regardless of uremic symptoms) or late (eGFR of 5-7 or uremic symptoms were present). No differences were seen in the primary or secondary outcomes after an average of 3.5 years of followup. Although, this trial doesn't definitively answer this question, it does allow for more comfort when following a patient with with advanced CKD.
1. Medicare bundling for dialysis (42/126)- The #1 nephrology-related story of the year and likely for the last 2 years is "medicare bundling of payments for chronic dialysis". This is scheduled to begin on January 1, 2011. Much apprehension and anxiety about these changes have been evident over the last 2 years. CMS released the final report on July 26th of this year. Reaction to these rules have been covered by DSEN and ASN . Medicare will provide a single payment that covers all renal dialysis services—including drugs and diagnostic laboratory tests—to dialysis facilities for each dialysis treatment. Furthermore, an algorithm adjusting for patient demographics and a quality incentive program (QIP) will be put into place. How these changes affect the care of patients on dialysis will be under intense scrutiny after the changes are put into place. CMS plan to undertake a monitoring campaign to see how these changes impact patient care. I'm sure this topic will be high on the Top Stories list of 2011 as well.
As you can see, quite a busy and exciting year in the world of nephrology in 2010. RFN will continue to provide coverage of all-things-renal in 2011. Thanks to all of our contributors and readers for keeping the site going strong in 2010. 2011 is promising to be an even better year for nephrology and RFN.
Thanks for supporting RFN in 2010. We'll be back in January.