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GLG News by Physicians who Treat End Stage Renal Disease (ESRD)

Analysis of: Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) (www.fda.gov)
DDAVP reduces urine output and is useful in the treatment of bedwetting (enuresis). However the reduction in excretion of water can be associated with water intoxication (hyponatremia). FDA advises that DDAVP is no longer considered indicated for the treatment of enuresis.
Analysis of: Early Results Of The CellCept(R) Spare The Nephron Study Examine Kidney Function (www.medicalnewstoday.com)
Interim results from "Spare the Nephron Trial" demosntrate improved outcomes with Rapamycin based immunosupression compared with Calcinuerin based therapy.   If the results hold up the trial may precipitate a shift away from the use of cyclospoin and tacrolimus based therapy in favor...
Analysis of: US FDA staff cautious on anemia drugs' risks (www.therapeuticsdaily.com)
Results of recent studies have suggested that using erythropoetin to fully correct anemia in patients with chronic kidney disease or the use of Epo products in patients with cancer associated anemia is not associated with substantial clinical benefits and may actually increase the risk of...
Analysis of: FDA Panel Favors First-Line Use of Irbesartan/HCTZ Combo (www.medscape.com)
It is unusual for a combination tablet (of the angiotensin receptor blocker irbesartan with the thiazide diuretic hydroclorothiazide) to be recommended as a first line agent. Combination tablets were often reserved for patients who had been titrated to appropriate effective doses and...
Jeffrey Gosin, M.D., Attending Surgeon and Chief of Vascular Surgery
Jeffrey Gosin, M.D., Attending Surgeon and Chief of Vascular Surgery
Shore Memorial Hospital
Analysis of: Breakthrough Clinical Results Reveal Extended Retrieval Times for Cook Medical's Gunther Tulip(TM) Vena Cava Filter (salesandmarketingnetwork.com)
New data from Cook shows 94% success rate in retrieving a temporary vena caval filter at 12 weeks post implant. This new data confirms what many of us have believed; that retrievable filters can successfully and safely be removed months after implantation.
Analysis of: Fresenius Medical Care Announces Positive Results from PhosLo CARE-2 Study (www.pipelinereview.com)
The hypothesis that calcium administered as a phosphate binder is an important cause of calcification of blood vessels (particularly coronary arteries) is not supported by this study. The study, however, is too short to be definitive, the same problem the DCOR study had for Genzyme to prove the superiority...
Analysis of: Phase 3 Trial of Ferumoxytol Demonstrates Statistically Significant Achievement of All Primary and Secondary Endpoints (www.ptcommunity.com)
Ferumoxytol may have the advantage over its competitors Venofer and Ferrlecit that it can be administered more quickly and in a larger dose. This study showed that it led to better iron supplementation than oral iron which is not an important route of iron supplementation in patients taking Epo, Procrit,...
December 1, 2006
Epo use will decline
Analysis of: Heart Risk Seen in Drug for Anemia (www.nytimes.com)
Higher hemoglobin values were again associated with higher cardiovascular endpoints. The NKF will put together a group to consider revising the target for treatment of anemia to a lower value, perhaps 10-12 or 11-12 g/dl.
Analysis of: Roche, Amgen Prepare For Battle (biz.yahoo.com)
CERA may be longer acting than Epogen or Procrit but its superiority to Aranesp, the long-acting Amgen product, has not yet been demonstrated.
November 21, 2006
Fast, but not yet better
Analysis of: Phase 3 Trial of Ferumoxytol Demonstrates Statistically Significant Achievement of All Primary and Secondary Endpoints (www.ptcommunity.com)
Ferumoxytol is a parenteral iron preparation with the key advantage of being administered quickly and in a relatively higher dose than other parenteral agents. However, its superiority in this study to oral iron is not surprising; the question will be how it compares to the other popular agents, Ferrlecit...

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