New paper indicates a potential fifty-percent reduction in cardiac events for prostate cancer patients with pre-existing cardiovascular disease when treated with FIRMAGON® (degarelix) compared to LHRH agonists

TORONTO, Feb. 11, 2014 /CNW/ - A paper published in the March edition of European Urology, the official journal of the European Association of Urology, indicates that the gonadotropin releasing hormone (GnRH) antagonist degarelix (brand name: FIRMAGON^®), may halve the relative risk of cardiovascular (CV) events and death in men with pre-existing CV disease (CVD) compared to treatment with commonly prescribed luteinising hormone-releasing hormone (LHRH) agonists. The report is based on a pooled analysis of 2,328 men with prostate cancer from six prospective, randomised trials.¹

Study co-author Jan Nilsson MD, Department of Clinical Sciences, Lund University, Sweden, said, "One recent study suggests that cardiovascular disease is among the most common causes of early mortality in men with advanced prostate cancer, not the cancer itself.² As a cardiologist I want urologists to be aware of this and to consider CV risk when selecting treatment options for their patients and analyses such as this are a positive step towards helping them to do just that."

The paper entitled "Cardiovascular Morbidity Associated with Gonadotropin Releasing Hormone Agonists and an Antagonist," reported that for men with pre-existing CVD at baseline there were 'significantly fewer cardiac events or deaths' experienced by patients receiving degarelix (6.5%) compared with patients receiving LHRH agonists (14.7%). A Cox proportional hazard model showed a 56% lower risk of a cardiac event or death during the initial year of treatment for men receiving degarelix compared with men receiving LHRH agonists (CI 0.26-0.74, p=0.002). The absolute risk reduction during the first year was 8.2% which yields a number needed to treat of 12.

Among the men who had no pre-existing cardiovascular disease at baseline there was no difference in the incidence of either death from any cause or the incidence of cardiac events. Moderate alcohol consumption and a low baseline serum testosterone level were the only other predictors of a lower risk of a cardiac event or death.

In the six prospective trials included in the analysis, cancer patients were randomised to receive androgen deprivation therapy (ADT) in the form of GnRH antagonist degarelix (1,491) or an existing LHRH agonist (458 received goserelin and 379 received leuprolide). Most patients (72%) received treatment for one year, while the remaining patients were treated for three to seven months. Both treatment groups were well balanced for baseline characteristics e.g. statin medication, elevated blood pressure, diabetes, cholesterol and history of CV disease. The CV event analysis was based on death from any cause or a serious CV event defined as arterial, embolic / thrombotic; haemorrhagic / ischemic cerebrovascular; myocardial infarction or other ischemic heart disease.

Laurence Klotz MD, Division of Urology, University of Toronto, Ontario, Canada said, "Androgen deprivation therapies play an important role in the treatment of men with prostate cancer. As these therapies become more widely used and for longer periods of time, we are understanding more about what needs to be done to help patients beyond management of the cancer itself. I believe this analysis provides insights which have the potential to help physicians better manage the cardiovascular health of their androgen deprivation therapy patients - particularly those with pre-existing cardiovascular disease".

The paper authors note that this post-hoc analysis of prospective randomized trials should be interpreted as hypothesis generating and highlights the need for additional studies.

FIRMAGON^® (degarelix) was approved for the treatment of advanced hormone-dependent prostate cancer in Canada in 2009. Today it is available in approximately 40 countries around the world, including a growing number in Asia, Latin America and the Middle East.

About FIRMAGON^® (degarelix)
FIRMAGON^® has chemical characteristics and a novel mechanism of action, different from traditionally used hormonal therapies.  Administered as a deep subcutaneous injection, FIRMAGON^® rapidly reduces levels of testosterone by blocking the GnRH receptors in the pituitary gland. Blocking the receptors suppresses the release of the luteinising hormone and follicle-stimulating hormone, resulting in a decrease in production of testosterone by the testicles to castration levels within three days. Prostate cancer is dependent on testosterone for its growth, and reducing testosterone levels slows the growth of cancer cells.

In clinical trials, FIRMAGON^® decreased the production of testosterone in a rapid and sustained way.^3,4,5. FIRMAGON^® also maintains the PSA control over the long term and reduces the risk of PSA progression.⁶  In clinical trials FIRMAGON^® was generally well tolerated. Common side effects are hot flushes, injection site pain and erythema, increased weight, nasopharyngitis, fatigue and back pain.^5,7

About Prostate Cancer
Prostate cancer is the most common form of cancer in Canadian men⁸ and represents 10% of all cancer deaths in Canada.⁹ It is estimated that 23,600 men are diagnosed with prostate cancer in Canada and close to 4,000 Canadian men die of the disease every year.¹⁰

About Ferring
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology and endocrinology. Ferring has its own operating subsidiaries in 55 countries and markets its products in more than 100 countries. To learn more about Ferring or its products please visit www.ferring.ca

© 2013 Ferring B.V.
FIRMAGON^® is a trademark owned by Ferring B.V.

References:

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¹ Albertsen, PC, Klotz L, Tombal B, Grady J, Olesen TK, Nilsson J. Cardiovascular Morbidity Associated with Gonadotropin Releasing Hormone Agonists and an Antagonist. Eur Urol 2014 Volume 65, Issue 3, March 2014, Pages 565-573
² Conteduca V, DiLorenzo G, Tartaron A, Aita M. The cardiovascular risk of gonadotropin releasing hormone agonists in men with prostate cancer. An unresolved controversy. Critical Reviews in Oncology/Hematology 2013; 86:42-51
³ Klotz L et al. BJU Int 2008; 102:1531-1538
⁴ Firmagon (degarelix).  Product Monograph, March 2013
⁵ Tombal B et al. Eur Urol 2010; 57:836-42
⁶ Crawford ED et al.  J Urol 2011;186(3):889-897
⁷Van Poppel H et al. Abstract (23.) Euro Urol Suppl 2007;6(2):28
⁸ Canadian Cancer Society. Available at: http://www.cancer.ca/en/cancer-information/cancer-type/prostate/overview/?region=on [Accessed on 19 Nov 2013]
⁹ Canadian Cancer Society. Available at: http://www.cancer.ca/en/cancer-information/cancer-type/prostate/overview/?region=on [Accessed on 19 Nov 2013]
¹⁰ Prostate Cancer Canada. Available at: http://prostatecancer.ca/Prostate-Cancer/About-Prostate-Cancer [Accessed on 19 Nov 2013]

Image with caption: "New paper indicates a potential fifty-percent reduction in cardiac events for prostate cancer patients with pre-existing cardiovascular disease when treated with FIRMAGON® (degarelix) compared to LHRH agonists (CNW Group/Ferring Pharmaceuticals)". Image available at: http://photos.newswire.ca/images/download/20140211_C8931_PHOTO_EN_36546.jpg

PDF available at: http://stream1.newswire.ca/media/2014/02/11/20140211_C8931_DOC_EN_36520.pdf

SOURCE: Ferring Pharmaceuticals

Carolyn Santillan
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Patrick Gorman
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