"New Data Support Bondronat's Superior Renal Safety Profile Against Zometa"
BASEL, SWITZERLAND -- March 24, 2006 -- New data announced today at the 8[th workshop on bisphosphonates in Davos shows Roche's Bondronat® (ibandronate) is associated with significantly less kidney damage than another commonly used bisphosphonate, zoledronic acid (Zometa), in multiple myeloma patients with bone lesions.1
Although Bondronat is not currently licensed for use in multiple myeloma, the audit results add to evidence from previous studies which indicate that Bondronat has renal safety similar to placebo, unlike other bisphosphonates.
Multiple myeloma is a cancer of the blood which develops in the bone marrow of patients. Bisphosphonates are used to treat the bone lesions that result from the cancer -- these lesions give rise to a high risk of fractures and considerable bone pain. Approximately 50% of multiple myeloma patients experience kidney problems, making renal safety a key consideration for physicians.2
In the audit, rates of renal impairment over a 4 year period were reviewed retrospectively in records of multiple myeloma patients treated with either Bondronat or zoledronic acid. The results showed:1
· Patients taking Bondronat were three times less likely to suffer renal impairment than those taking zoledronic acid: 10.8% for Bondronat vs. 39.1% with zoledronic acid (based on serum creatinine levels).
· The incidence rate of renal impairment was significantly higher in patients taking zoledronic acid: 0.87 events with Bondronat versus 2.65 events with zoledronic acid per person-year (indicated by the glomerular filtration rate, a recognized measure of renal function).
"These data confirm findings from previous studies and again highlight Bondronat's renal safety advantages over other bisphosphonates. They are especially promising given the particular risk of kidney complications faced by multiple myeloma patients," said Dr. Raoul Bergner from the Klinikum der Stadt Ludwigshafen in Ludwigshafen, Germany. "Patients with multiple myeloma experiencing bone pain may benefit from the loading dose currently under investigation in an international phase III study in cancer patients with bone metastases. The good renal safety profile means Bondronat can be given on 3 consecutive days without causing kidney damage."
In a further two studies also presented today, Bondronat was found to be suitable for use in patients with relapsed or refractory multiple myeloma and well-tolerated in multiple myeloma patients who had reached end stage renal disease, requiring haemodialysis.2,3 These promising results are being further evaluated in two multi-centre, multi-national phase III trials in multiple myeloma patients, investigating the efficacy and renal safety of Bondronat in these patients.
About Bone Disease in Cancer
Metastatic bone disease occurs when the cancerous cells from the original tumour spread to the bone via the blood stream resulting in pain, fractures and other clinical consequences like compression of the spine and hypercalcaemia (high concentrations of calcium in the blood stream). It is most commonly associated with breast, prostate, lung, kidney and thyroid cancer. The most common sites for metastatic bone disease are the ribs, skull, pelvis, hips, vertebrae and the ends of long bones.
Multiple myeloma is a progressive bone marrow disease. In multiple myeloma, bone is the primary site of tumour and in the great majority of patients causes extensive lesions, with a high risk of fractures and high levels of bone pain.
If left untreated, bone disease can have a tremendous impact on cancer patients' quality of life (e.g. limited mobility, disturbance in sleeping patterns, reduction in appetite).
REFERENCES:
1. Antrąs L, Smith M, Neary M et al. Comparison of renal impairment in multiple myeloma patients treated with zoledronic acid or ibandronate: a retrospective review. Poster presentation at the Eighth and Valedictory Workshop on Bisphosphonates – From the Laboratory to the Patient. Davos, Switzerland, 24 March 2006
2. Henrich D, Bergner R, Hoffman M et al. Dose escalation of ibandronate in patients with multiple myeloma and end-stage renal disease – an open label study. Poster presentation at the Eighth and Valedictory Workshop on Bisphosphonates – From the Laboratory to the Patient. Davos, Switzerland, 24 March 2006
3. Glasmacher A, Hoffman F, Orlopp K et al. Renal safety of ibandronate in patients with relapsed and refractory multiple myeloma. Poster presentation at the Eighth and Valedictory Workshop on Bisphosphonates – From the Laboratory to the Patient. Davos, Switzerland, 24 March 2006
4. Bondronat Summary of Product Characteristics 23 July 2003
SOURCE: Roche
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