זומרה (Zomera, zoledronic acid) שיפרה BMD של חולי סרטן הערמונית המטופלים הורמונלית

בהודעה שהועברה אלינו מטעם חברת נוברטיס אונקולוגיה פרמצ’, ייצרנית ומשווקת ה- Zomera , מדווחת החברה על מחקר חדש שפורסם החודש ב- Journal of Urology לפיו טיפול בזומרה הביא לעלייה ב- BMD (צפיפות העצם) של חולי סרטן הערמונית המטופלים הורמונלית. 

טיפול הורמונלי בסרטן גורם, כתופעת לואי לאיבוד צפיפות העצם. במחקר זה נמצא כי הטיפול בזומרה, למשך שנה, לא רק שמנע ירידה של ה- BMD (של 2.2% כפי שהיה בקבוצת הפלצבו) , אלא אף גרם לגידול של 5.6% ב- BMD.

להלן הידיעה המלאה כפי שנמסרה על ידי נוברטיס:

Zometa® significantly increased bone mineral density in men receiving hormonal therapy for non-metastatic prostate cancer, study showed

Data in Journal of Urology show benefits of Zometa treatment in preventing cancer treatment-induced bone loss Basel, 23 May 2003 Treatment with Zometa® (zoledronic acid) significantly increased bone-mineral density (BMD) in the spines and hips of men receiving hormonal therapy for prostate cancer, according to a study published in this months Journal of Urology.

 Cancer treatment-induced bone loss is a side effect of androgen deprivation, a hormone-based treatment approach that is commonly used in prostate cancer.

The condition has been associated with hip and other serious skeletal fractures. The published results in Journal of Urology demonstrated that Zometa treatment not only prevented treatment-related bone loss, but in one year of treatment it led to a mean 5.6% increase in lumbar spine bone mineral density, compared with a 2.2% loss in men receiving placebo.

Androgen deprivation therapy, a standard treatment approach for metastatic prostate cancer, is being used with increasing frequency and success to treat non-metastatic prostate cancer as well.

More than 350,000 men worldwide are diagnosed with prostate cancer every year.

 “The data indicating that Zometa increases bone density in prostate cancer patients being treated with androgen deprivation therapy are very encouraging,” said lead author Matthew R. Smith, M.D., Ph.D., Massachusetts General Hospital, Boston, Massachusetts, USA, Assistant Professor of Medicine, Harvard Medical School.

“Many patients and physicians dont recognize the seriousness of cancer treatment-induced bone loss. This study demonstrates that Zometa not only prevents bone loss, but also increases bone density.”

Study Details

The multicenter, randomized, placebo-controlled trial enrolled 106 men who were beginning initial androgen deprivation therapy with a gonadotropin-releasing hormone agonist (GnRH) with or without an antiandrogen.

Patients had no evidence of distant metastases. After randomization to Zometa 4 mg or placebo, the men received a 15-minute infusion every three months for one year.

Participants were instructed to take a daily calcium supplement (500 mg) and a daily multivitamin containing 400 IU of vitamin D. The majority of men in the Zometa group (47, or 86%) and in the placebo group (42, or 82%) received all five injections.

 After a year, the lumbar spine BMD was increased by 5.6% from baseline for the Zometa group (p = <0.001) while the BMD in the placebo group decreased by 2.2% (p = 0.012).

The difference between the groups was 7.8% (95% CI 5.6%-10.0%, p = 0.001). For Zometa patients, BMD also increased significantly from baseline vs. placebo in the total hip, femoral neck, and trochanteric region (p = < 0.001).

 The rate of severe adverse events (grade 3 or 4) was 24% for those in the Zometa group and 39% for men receiving placebo. Two men receiving Zometa and three men receiving placebo withdrew from the study because of an adverse event.

 Prostate Cancer, Androgen Deprivation Therapy/Breast Cancer, Aromatase Inhibitor Therapy and Bone Loss Cancer treatment-induced bone loss is a condition that is prevalent in many types of cancer, particularly prostate cancer treated with androgen deprivation therapy and breast cancer treated with aromatase inhibitor therapy.

 This condition causes the bones to weaken, often leading to serious complications, which may include fractures. There has been an increasing and earlier use of androgen deprivation therapy in men with prostate cancer and of aromatase inhibitor therapy in women with breast cancer. As a result, there is also a need for an effective treatment to prevent bone loss and restore bone integrity in these populations, reducing the risk of serious complications.

About Zometa (Zomera)

Novartis has received marketing authorisation for Zometa in more than 60 countries, including the member states of the European Union and the United States, for the prevention of skeletal related events in patients with advanced malignancies metastatic to bone.

These malignancies include multiple myeloma, prostate cancer, breast cancer, lung cancer, renal cancer and other solid tumors. Novartis also has received marketing clearance for Zometa in the treatment of tumor-induced hypercalcemia (TIH), also known as hypercalcemia of malignancy (HCM), in more than 80 countries throughout the world.

 The proven safety and efficacy profile of this treatment has resulted in more than 300,000 patients worldwide receiving Zometa to date. Contraindications and Adverse Events In clinical trials in patients with bone metastases and hypercalcemia of malignancy (HCM), Zometa had a safety profile similar to other intravenous bisphosphonates.

 The most commonly reported adverse events included flu-like syndrome (fever, arthralgias, myalgias, skeletal pain), fatigue, gastrointestinal reactions, anemia, weakness, cough, dyspnea and edema. Zometa should not be used during pregnancy. Zometa is contraindicated in patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation of Zometa. In this study, the safety profile with Zometa was similar to that of other intravenous bisphosphonates.

 Zometa and other IV bisphosphonates, such as pamidronate, have been associated with reports of renal insufficiency. Patients should have serum creatinine assessed prior to receiving each dose of Zometa. Caution is advised when Zometa is used in aspirin-sensitive asthma patients, or with aminoglycosides, loop diuretics, and other potentially nephrotoxic drugs. Due to the risk of clinically significant deterioration in renal function, single doses of Zometa should not exceed 4 mg and the duration of infusion should be no less than 15 minutes.

The foregoing release contains forward-looking statements that can be identified by terminology such as “encouraging,” “may reduce,” or similar expressions, or by express or implied discussions regarding potential new indications for Zometa, or regarding potential future sales of Zometa.

Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Zometa to be materially different from any future results, performance or achievements expressed or implied by such statements.

 There can be no guarantee that Zometa will be approved for any additional indications in any market. Neither can there be any guarantee regarding potential future sales of Zometa.

In particular, management’s expectations regarding Zometa could be affected by, among other things, additional analysis of Zometa clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; and other risks and factors referred to in the Company’s current Form 20-F on file with the Securities and Exchange Commission of the United States.

 Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. About Novartis

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group’s businesses achieved sales of USD 20.9 billion and a net income of USD 4.7 billion.

 The Group invested approximately USD 2.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 77 200 people and operate in over 140 countries around the world.

For further information please consult http://www.novartis.com.

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