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November 21, 2006 Dr. Bernd Ebeling Corporate Communications Tel.: +49-6172-6082378 Fax: +49-6172-6082294 e-mail: [email protected] www.fmc-ag.com
Fresenius Medical Care Announces Positive Results from PhosLo CARE-2 Study Bad Homburg, Germany – Fresenius Medical Care AG & Co. KGaA today
announced positive results from the PhosLo (calcium acetate) CARE-2 (Calcium
Acetate Renagel Evaluation) study. The study demonstrated that when lipid levels
are kept constant in both treatment groups, there is no difference in cardiovascular
calcification between patients treated with PhosLo and those treated with Renagel
(sevelamer hydrochloride). The data refute the hypothesis that the calcium in PhosLo
contributes to cardiovascular calcification. The findings were presented by Dr. Wajeh
Qunibi, of the University of Texas Health Science Center, San Antonio at the
American Society of Nephrology’s Renal Week 2006 Conference in San Diego,
The CARE-2 study was a randomized, controlled head-to-head comparison between
PhosLo and Renagel with the addition of Lipitor (atorvastatin calcium), as
appropriate, in both treatment groups to control LDL (Low Density Cholesterol) levels.
The study found no statistically significant difference in the progression in
cardiovascular calcification (CAC) between the two treatment groups after 12 months
of treatment. Patients treated with PhosLo and Renagel achieved comparable
reductions in Serum-Phosphorus and Calcium-Phosphorus product and even more
importantly K/DOQI target levels were reached significantly faster with PhosLo.
Fresenius Medical Care AG & Co. KGaA, Corporate Communications, D-61346 Bad Homburg
PhosLo, Renagel and Lipitor are registered trademarks. About PhosLo PhosLo is administered orally, and when given with food, combines with dietary phosphate to form insoluble calcium phosphate complexes that are eliminated from the body, thereby reducing phosphorus absorption, helping to prevent excess blood phosphorus levels. Patients should have serum calcium levels closely monitored and their dose of PhosLo adjusted or terminated to bring levels to normal. PhosLo is contraindicated in patients with hypercalcemia. No other calcium supplements should be given concurrently with PhosLo. PhosLo is well tolerated and has an excellent safety profile. Nausea, hypercalcemia, and pruritus (itching) have occasionally been reported during PhosLo therapy.
Fresenius Medical Care is the world's largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 1,400,000 individuals worldwide. Through its network of 2,085 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 161,433 patients around the globe. Fresenius Medical Care is also the world's leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products). Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME, FME3) and the New York Stock Exchange (FMS, FMS-p). For more information about Fresenius Medical Care visit the Company’s website at . For more information about the CARE-2 study visit the website www.advancedrenaleducation.com. This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius Medical Care AG & Co. KGaA, Corporate Communications, D-61346 Bad Homburg
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