From: Reuters
Published January 21, 2008 07:55 PM

Nexavar significantly boosts hypertension risk: study

LONDON (Reuters) - Bayer AG and Onyx Pharmaceutical Inc.'s key cancer drug Nexavar significantly raises the risk of high blood pressure, U.S. researchers said on Tuesday.

Writing in the journal Lancet Oncology, the researchers said people taking the drug generically known as sorafenib should be closely monitored and treated for high blood pressure to prevent cardiovascular complications.

Nexavar -- one of Bayer's top drug hopes -- is already approved in Europe and the United States for kidney cancer, and is Onyx's only drug on the market.

"Early detection and effective management of hypertension might allow for safer use of this drug," Shenhong Wu of State University of New York, Stoney Brook and colleagues wrote. "Future studies will be needed to identify the mechanism and appropriate treatment of sorafenib-induced hypertension."

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Representatives for the companies could not immediately be reached for comment.

In November, the U.S. Food and Drug Administration (FDA) approved Nexavar medicine to treat liver cancer in a move extending drug's reach.

Trial results last June also showed the drug 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 has said it expects Nexavar to reach 1 billion euros in annual sales if it gets approvals for treatment of various cancer indications. In 2006 Nexavar sales hit 130 million euros.

Wu and colleagues said the risk of hypertension with the drug taken as a pill has so far been unclear because of the limited number of patients in previous trials.

They 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 sorafenib 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.

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.

Nexavar is also being tested against several other types of cancer, including non-small cell lung cancer and breast cancer.

(Reporting by Michael Kahn; Editing by )

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