05.11.2007 – 07:08
Mircera(R) Shown to be Effective Anaemia Treatment for Renal Patients With Low Haemoglobin Levels
Basel, Switzerland, November 5 (ots/PRNewswire)
-Low Haemoglobin Levels Associated With Increased Risk of Cardiovascular Disease and Death
Data from the analysis of six major trials for the innovative new renal anaemia treatment MIRCERA, have shown that it effectively corrects and maintains haemoglobin levels in chronic kidney disease patients whose haemoglobin levels were among the lowest 20% upon entering the studies.
Correcting low haemoglobin Hb levels is important as a number of studies have observed that low Hb levels expose patients to an increased risk of death, cardiovascular events, hospitalisation and transfusions. (1) In fact, a U.S. study previously found that dialysis patients with Hb<9 g/dl were more than twice as likely to die compared with those with Hb levels of greater than or equal to 11 and less than 12 g/dl.(2)
"MIRCERA achieved a response rate of nearly 90% in patients with low haemoglobin and 97% in patients with higher haemoglobin levels in the two correction studies," said investigator Dr Robert Provenzano of the St. John Hospital and Medical Center, Detroit, Michigan. "This clearly shows efficacy in a broad patient population," he added. He noted that the investigators found that MIRCERA provided comparable anemia correction across the spectrum of initial Hb levels to ESAs dosed more frequently.
One pooled analysis presented at the 40th Annual Meeting of the American Society of Nephrology (ASN) in San Francisco assessed the impact of baseline low and high Hb levels on anaemia correction in patients treated with MIRCERA every two weeks or epoetin three times a week or darbepoetin alfa once a week.(3) A second pooled analysis investigated the impact of baseline Hb in dialysis patients converted directly from epoetin or darbepoetin alfa to once monthly MIRCERA in four maintenance studies.(4)
Similarly the second analysis found that once monthly MIRCERA maintained Hb levels as effectively as more frequently-dosed ESAs, in patients with the lowest baseline Hb who are difficult to treat.
- Data from two Phase III anaemia correction studies (AMICUS, ARCTOS) were pooled as were data from four 52-week, Phase III maintenance studies (MAXIMA, PROTOS, RUBRA and STRIATA). MIRCERA was given once every two weeks to correct anaemia in patients not previously treated. In the maintenance studies, patients previously treated with an ESA were directly converted to MIRCERA at two dosing intervals.
- In the correction studies, the mean baseline low Hb in the MIRCERA group was 8.58 g/dL and 8.62 in the comparator group. Mean baseline high Hb in the MIRCERA group was 10.22g/dL and 10.25 g/dL in the comparator group.
- Response rates in patients with low Hb were 89.7% for MIRCERA and 88.2% for the comparator. Patients with a high Hb upon entry achieved a 97.4% response rate with MIRCERA and a 96.6% response rate with the comparator.
- In the maintenance studies the impact of baseline Hb on Hb maintenance in dialysis patients converted directly from epoetin or darbepoetin alfa to once monthly MIRCERA was evaluated. The mean baseline low Hb level was 10.8 g/dL for MIRCERA and 10.9 g/dL for the comparator. The mean baseline high Hb level was 12.0 and 12.1 respectively.
- Mean Hb levels remained stable between baseline and the evaluation period in both treatment groups and within the low and high subgroups.
"It is very valuable for us as clinicians to be able to assess the efficacy of new and existing ESAs across a host of patient factors which can provide us with greater insights into how best to treat our patients and guide us in our use of ESAs," said Dr. Provenzano.
MIRCERA, a continuous erythropoietin receptor activator, has a different activity at the receptor level involved in stimulating red blood cell production which more closely mimics the body's physiologic processes. This is believed to be instrumental in delivering predictable and stable haemoglobin levels with once-monthly maintenance dosing.
MIRCERA was approved in July in the EU in and in September in Switzerland and Norway. MIRCERA is the first ESA in the EU approved to directly convert all CKD patients types previously treated with any ESA to once-monthly maintenance dosing. It is also the first ESA in the EU that offers a convenient dosing schedule of once every two weeks to correct anaemia in all CKD patient types not previously treated. The safety and efficacy of MIRCERA in other indications has not been established. MIRCERA has now been launched in Austria, Sweden, Germany and the UK and an FDA decision on MIRCERA is expected by November 14.
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Additional information about the Roche Group is available on the Internet at http://www.roche.com.
- AMICUS compared intravenous (IV) MIRCERA versus epoetin in patients on dialysis (CKD stage 5); ARCTOS compared subcutaneous (SC) MIRCERA versus darbepoetin alfa in patients with CKD stage 3-4 not on dialysis.
(1) Ebben JP et al. Hemoglobin level variability: associations with comorbidity, intercurrent events, and hospitalizations. Clin J Am Soc Nephrol 2006. 1205-1210.
(2) Ofsthun N, Labrecque J, Lacson E, Keen M, Lazarus JM. The effects of higher hemoglobin levels on mortality and hospitalization in hemodialysis patients. Kidney Int 2003; 63:1908-1914.
(3) Anemia correction with C.E.R.A. in patients (pts) with chronic kidney disease (CKD) is unaffected by baseline hemoglobin (Hb) level. R. Provenzano et al. (SU-PO796)
(4) Effect of baseline hemoglobin (Hb) on Hb stability in patients (pts) with chronic kidney disease (CKD) receiving once-monthly C.E.R.A. N.W. Levin et al. (SU-PO817)
ots Originaltext: Roche Pharmaceuticals
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