Genzyme Announces Publication of DCOR Study in Kidney International
CAMBRIDGE, MA, August 29, 2007--Genzyme Corporation today announced that results from the Dialysis Clinical Outcomes Revisited (DCOR) trial, the largest outcomes study ever conducted in the hemodialysis population, have been published in Kidney International. The three-year trial involving more than 2,100 patients compared the difference in outcomes for patients receiving Renagel® (sevelamer hydrochloride) with those using calcium-based phosphate binders.
The study did not meet its primary endpoint of demonstrating a statistically significant mortality benefit for patients treated with Renagel compared with those treated with calcium-based phosphate binders (seven percent reduction in favor of Renagel, p=0.40). However, a clinically meaningful benefit was associated with Renagel use for older patients.
In a pre-specified secondary analysis, those 65 years or older achieved a 23 percent reduction in all-cause mortality compared with those 65 or older using calcium-based phosphate binders, a result that was statistically significant in favor of the Renagel-treated patients (p=0.02). This finding is especially important given the high mortality rate seen among older patients on dialysis, and the high percentage of patients on dialysis who are 65 or older. In those younger than 65 years, where the overall mortality rate is substantially lower, Renagel-treated patients had a slightly higher level of mortality that was not statistically significant (p=0.21).
The mean number of hospitalizations per patient year was lower in the Renagel-treated arm (p=0.07), with the biggest difference seen in patients 65 years or older. Additionally, for patients remaining on study for at least two years (43 percent of the study population) a difference in mortality emerged favoring the Renagel patients (p=0.02).
“Genzyme is proud of the contribution that the DCOR study has made to the understanding of how phosphate binder choice can affect the outcomes of patients with chronic kidney disease on dialysis,” said John P. Butler, president, Genzyme Renal. “These findings, together with previously published results from the Renagel in New Dialysis (RIND) study and other trials, provide strong support for Renagel as a first-line treatment option.”
Only serious adverse events deemed by the study investigator as related to treatment were collected in the study. In the Renagel group there were three events reported involving three patients (one event each of constipation, vomiting, and osteoporosis). In the calcium group there were eight events reported in five patients (three events of calciphylaxis [deposition of calcium into arteries resulting in tissue death], and one each of hypercalcemia, acute pancreatitis, cholecystitis, nausea, and vomiting).
About the DCOR Study
The DCOR study enrolled 2,103 adult hemodialysis patients at 75 sites in the United States. Patients were randomly assigned to either Renagel or calcium-based binders (PhosLo® [calcium acetate] or TUMS® calcium carbonate). Approximately 30 percent of patients in the calcium group opted to use calcium carbonate rather than PhosLo. Patients were treated according to the usual treatment guidelines in their dialysis center in order to capture the real world experience of those on dialysis. Patients were followed for up to 45 months. The study population for both treatment groups was similar for demographics and baseline clinical characteristics, and similar to the overall U.S. dialysis population. The median age of patients in the study was 62 years old. Dropout rates throughout the study were similar for each group.
Renagel controls serum phosphorus in patients with chronic kidney disease on hemodialysis. Controlling serum phosphorus is an important element in the care of hemodialysis patients. Elevated serum phosphorus levels are common in dialysis patients and associated with increased risk of cardiovascular mortality. Renagel provides the added benefit of significant LDL cholesterol reduction (32 percent).
The National Kidney Foundation’s 2003 K/DOQI guidelines for Bone Metabolism and Disease in Chronic Kidney Disease recommend sevelamer hydrochloride as a first-line treatment option to control phosphorus. Renagel is the only phosphate binder available that does not contain either calcium or a metal. It has an established safety profile, is not systemically absorbed and provides phosphorus control without the concerns of calcium or metal accumulation. Renagel is used by more than 350,000 people worldwide.
Renagel is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on hemodialysis. Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction. Caution should be exercised in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery. In a 52-week study, the most common side effects included vomiting, nausea, diarrhea, and dyspepsia. Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renagel.
For more information about Renagel, including complete prescribing information, please visit www.renagel.com.
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,500 employees in locations spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. In 2006 and 2007, Genzyme was selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.
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Posted: August 2007