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Nexavar Raises Blood Pressure, Study Says

Jan 22, 2008 | Parker Waichman LLP

Nexavar, a drug used to treat kidney and liver cancer, can raise blood pressure substantially, a new study has found.  The authors of the Nexavar study wrote in the medical journal “Lancet Oncology” that patents being treated with drug – known generically as sorafenib – should be closely monitored and treated for high blood pressure to prevent cardiovascular side effects.

Nexavar was approved to treat kidney cancer in  2005, and in 2006 the Food & Drug Administration extended its use to liver cancer.  Nexavar is one of a new class of therapies often called targeted therapy,   Nexavar is an anti-angiogenesis drug, meaning it fights cancer by cutting off a tumor's blood supply. The growth of new blood vessels and the growth of new cells are 2 processes which do not function normally in tumors. Nexavar is designed to interfere with these 2 processes. By reducing the blood supply of the tumor,  Nexavar may prevent the growth and spread of cancer.

However, like all chemotherapy drugs, Nexavar can affect other body systems, and the Lancet study shows that this may extend to the cardiovascular system.  Researchers at the State University New York, Stony Brook,  conducted a review called a meta-analysis of nine studies that included 4,599 patients and were published between January 2006 and July 2007. They found patients treated with Nexavar have a 23 percent higher chance of having an increase in blood pressure than those not given the drug. The risk of developing a more severe form of high-blood pressure rose 6 percent.

Because it is one of the limited options available to the sufferers of liver and kidney cancer, the authors of the Lancet study wrote that “Early detection and effective management of hypertension might allow for safer use of this drug.  Future studies will be needed to identify the mechanism and appropriate treatment of sorafenib-induced hypertension.”

According to US News & World Report, this is not the first time hypertension has been associated with an angiogenesis inhibitor. Several other drugs in this category, including Avastin (bevacizumab) and Sutent (sunitinib), have also raised blood pressure in patients.

According to Reuters.com, liver cancer kills more than 600,000 people globally each year and is currently treated with limited success using a mix of surgery, radiation and chemotherapy. Trial results last June also showed the Nexavar was the first medicine to extend the life of patients with advanced liver cancer in a large study -- adding about three months to survival compared with a placebo.

Bayer AG, which is developing Nexavar with US partner Onyx Pharmaceuticals Inc, responded to the Lancet article by maintaining that hypertension is a known risk of any anti-angiogenesis drug, and that this side effect is reflected on the Nexavar label.  


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