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Genzyme Announces Positive Results From DCOR Trial Favoring Use of Renagel

Posted on: Thursday, 28 July 2005, 09:00 CDT

CAMBRIDGE, Mass., July 28 /PRNewswire-FirstCall/ -- Genzyme Corporation today announced positive results from the Dialysis Clinical Outcomes Revisited (DCOR) trial, the largest outcomes study ever conducted in the hemodialysis population. The three-year trial involving more than 2,100 patients compared the difference in mortality and morbidity outcomes for patients receiving Renagel(R) (sevelamer hydrochloride) with those using calcium-based phosphate binders. There are approximately 1.3 million people worldwide with chronic kidney disease on hemodialysis, and approximately 20-25 percent of U.S. patients are estimated to die each year.

The study found that Renagel use resulted in the strongest clinical benefit in two groups of patients: those who were treated for two years or more, and those who were 65 years of age or older. The results seen in these groups make DCOR the first large-scale, prospective, randomized clinical trial to demonstrate a mortality or morbidity benefit for patients on hemodialysis.

Analysis of the study's primary and secondary endpoints related to mortality demonstrated that:

* Patients who used Renagel experienced a 9 percent reduced risk of death from all causes relative to patients using calcium-based phosphate binders. Although this result was not statistically significant (p=0.30), the mortality outcome of the study was found to be influenced by the age of patients and duration of treatment. Accordingly, patients using Renagel for two years or more were 34 percent less likely to die from all causes than those using calcium-based phosphate binders for the same period (p=0.02). These patients made up 43 percent of the study population. * Patients 65 years of age or older were 22 percent less likely to die from all causes than those using calcium-based phosphate binders (p=0.03). Those 65 years or older who used Renagel for more than two years were 54 percent less likely to die from all causes than those who used calcium-based phosphate binders (p=0.0009). * Secondary endpoints related to mortality included death from cardiovascular disease and from other causes. These results were consistent with those seen in the primary endpoint, but were not statistically significant.

The DCOR study examined two endpoints related to morbidity -- the comparative number of hospitalizations for the Renagel and calcium groups, and the comparative number of days each group was hospitalized. These results showed that:

* Patients using Renagel experienced a 23 percent reduction in the number of times they were admitted to the hospital per year compared with patients using calcium-based binders (p=0.06). In patients 65 years or older, this benefit achieved statistical significance (p=0.03). * In addition, patients using Renagel experienced a 14 percent reduction in the number of days hospitalized per year compared to calcium-based binders (p=0.09).

The strong trends in favor of the Renagel group for morbidity are expected to contribute to a better understanding of the pharmacoeconomic benefits of Renagel use. These data will be supplemented by additional information outlining Medicare expenditures, and will be the subject of a full economic analysis in the coming year.

"This is an unprecedented moment for patients on dialysis," said lead investigator Wadi N. Suki, M.D., clinical professor at Baylor College of Medicine. "For the first time, a treatment has been shown to reduce the alarmingly high rate of death and illness seen in patients on dialysis. These results strongly suggest that Renagel treatment can have a dramatic impact on patients' lives, and will help to redefine how physicians manage phosphorus in patients on dialysis."

Dr. Suki and co-investigators plan to present results of the DCOR trial at the American Society of Nephrology meeting in Philadelphia in November. Full results will be submitted for publication in a peer reviewed medical journal.

"The positive results shown in the DCOR study add to the mounting body of evidence showing that Renagel therapy has a meaningful impact on the health and lives of patients," said Henri A. Termeer, chairman and chief executive officer, Genzyme. "It is now our responsibility to do everything that we can to extend these benefits to all who need them."

Safety Results

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(R) or calcium carbonate). Approximately 27 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.

About Renagel

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 reduce 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. Product Labeling Information

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. 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 http://www.renagel.com/.

About Genzyme

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. Founded in 1981, Genzyme has grown from a small start-up to a diversified enterprise with 2005 revenues expected to exceed $2.6 billion and more than 7,600 employees in locations spanning the globe. With many established products and services helping patients in more than 80 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopedics, cancer, transplant and immune diseases, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as heart disease and other areas of unmet medical need.

Genzyme's press releases and other company information are available at http://www.genzyme.com/ and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-703-797-1866 outside the United States.

This press release contains forward-looking statements, including without limitation statements about: the size of the chronic kidney disease population; the potential use and benefits of the DCOR data, including the effect on physicians' treatment of dialysis patients; the expected release of supplemental information; and the anticipated timing of the presentation and publication of the DCOR results. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others: the accuracy of Genzyme's information concerning the chronic kidney disease population; additional analysis of the DCOR data; the results of other studies and whether such results are consistent with the DCOR data; the availability and extent of third-party reimbursement for Renagel(R); and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Factors Affecting Future Operating Results" in Genzyme's Quarterly Report on Form 10-Q for the period ended March 31, 2005. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise these statements.

Conference Call Information

There will be a conference call today at 10:00 a.m. Eastern to discuss Genzyme Corporation's results from the DCOR study. If you would like to participate in the call, please dial (785) 830-1921 just prior to the start. This call will also be Webcast live on the investor section of http://www.genzyme.com/. A replay of this call will be available from 1:30 p.m. Eastern today through midnight on August 4, 2005 by dialing (719) 457-0820. Please refer to reservation number 7481965.

Media Contact: Investor Contact: Dan Quinn Sally Curley (617) 768-6849 (617) 768-6140

Genzyme Corporation

CONTACT: Dan Quinn, +1-617-768-6849, or Sally Curley, +1-617-768-6140,both of Genzyme Corporation

Web site: http://www.genzyme.com/

Company News On-Call: http://www.prnewswire.com/comp/113803.html

Source: PRNewswire-FirstCall

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