Dancing With The Stars Family Rallies On Twitter In Support Of Brooke Burke-Charvet Following Thyroid Cancer Diagnosis
















Members of the “Dancing with the Stars” family Tweeted their well-wishes for the show’s co-host, Brooke Burke-Charvet, who revealed on Thursday she has thyroid cancer.


Helio Castroneves, who was recently eliminated from the “All-Stars” season, said he is confident she will overcome the disease.













PLAY IT NOW: Brooke Burke-Charvet’s Sexy Lingerie Shoot!


“Hi @brookeburke, I have sure that you will win this battle. My affection for you,” the Indy driver wrote.


Brooke revealed on Thursday that she will be undergoing thyroid surgery and a thyroidectomy, and Erin Andrews, who competed in Season 10, noted she was praying for the host.


VIEW THE PHOTOS: The Lovely Brooke Burke-Charvet


“Thinking about @DancingABC friend @brookeburke..Prayers and all the best your way Brooke,” Erin wrote.


Also sending her kind words was Sabrina Bryan, who was eliminated last week on the show.


“@brookeburke hey girl!! You’re in my thoughts and prayers! Always here for you during this fight! Stay strong,” Sabrina wrote.


VIEW THE PHOTOS: Dancing With The Stars: All-Stars — Week 6


Season 13 vet Ricki Lake wrote, “@brookeburke sending huge healing love your way.”


Current contender Melissa Rycroft shared her support, Tweeting, “You’re such a strong woman, and I admire your courage. I hope you feel all the love and support behind you…We love you!”


VIEW THE PHOTOS: ‘Dancing’s’ Derek Hough


And some of the professional dancers chimed in too.


Pro Derek Hough (Brooke’s Season 7 partner) Tweeted, “Love you Brookie B. [You're] in my prayers.”


Cheryl Burke Tweeted, “I love u @brookeburke!! Stay strong. Will be praying for u and sending u lots of positive energy!”


– Jolie Lash


Copyright 2012 by NBC Universal, Inc. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


Social Media News Headlines – Yahoo! News



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Taylor Swift reigns over Billboard 200, Meek Mill debuts high
















LOS ANGELES (Reuters) – Country-pop star Taylor Swift held onto the top spot on the Billboard 200 album chart on Wednesday as her latest album “Red” kept rapper Meek Mill from the top spot.


“Red,” Swift’s fourth studio album safely took the No. 1 position after selling 344,000 copies according to figures from Nielsen SoundScan.













Last week, “Red” scored the highest first week U.S. sales in a decade after selling 1.2 million copies. The album has outsold One Direction’s “Up All Night” to become the second-biggest album of 2012, behind Adele’s juggernaut record “21,” which has sold more than 4 million copies this year.


Rapper Meek Mill entered the chart at No. 2 with his debut studio album “Dreams & Nightmares,” selling 164,000 copies. The rapper collaborated with fellow Maybach Music artists for his debut, including Trey Songz, Wale, Rick Ross and Mary J. Blige.


Ahead of the holiday season, two festive albums debuted on the chart, with veteran crooner Rod Stewart’s “Merry Christmas Baby” at No. 3 and Trans-Siberian Orchestra’s extended play record “Dreams of Fireflies (On a Christmas Night)” at No. 9.


Country singer Toby Keith landed at No. 6 with his latest album “Hope on the Rocks,” following his appearance and best music video win at the County Music Association (CMA) awards last week.


Country group Little Big Town also saw a boost from their CMA vocal group of the year win as their album “Tornado” climbed the chart to No. 10.


Canadian singer Neil Young and his band Crazy Horse scored their second top ten album this year with “Psychedelic Pill” at No. 8, following their “Americana” album in June.


Over on the Digital Songs chart, Korean rapper Psy held the top spot with his infectious dance-pop single “Gangnam Style,” while Bruno Mars’ “Locked Out of Heaven” remained at No. 2 and Ke$ ha’s “Die Young” was a non-mover at No. 3.


(Reporting by Piya Sinha-Roy, editing by Jill Serjeant)


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Statins may be linked to cancer survival
















NEW YORK (Reuters Health) – Danish cancer patients taking cholesterol-lowering statin drugs were 15 percent less likely to die, of cancer or any other cause, than patients who were not on the popular medications, in a new study.


The pattern held regardless of a person’s age, cancer type, tumor size or whether it had spread. Only patients who had received chemotherapy showed no apparent benefit from taking statins – the most commonly-prescribed drugs in the world.













Eric Jacobs, a researcher at the American Cancer Society who was not involved in the new work, called the findings “intriguing and exciting” but said they “do not mean that people with cancer should start using statins in the hopes of improving their progress.”


The study, published Wednesday in the New England Journal of Medicine, did not look at whether the statins, with familiar brand names such as Lipitor and Mevacor, can prevent cancer – only at what happens once cancer is diagnosed.


Using multiple registries containing data on cancer, drug use, population characteristics and deaths for the nation of Denmark, the research team analyzed the cancer cases of 18,721 people over age 40 who were diagnosed between 1995 and 2007.


All were taking statins regularly before their cancer was discovered, and the study compared them to 277,204 people who had not regularly taken the drugs before getting cancer treatments.


Overall, the cancer death rate among statin users was 15 percent lower, and so was the rate of death from any cause.


The appearance of a benefit from taking statins was strongest for 13 cancer types in particular, ranging from an 11 percent lower death rate among pancreatic cancer patients to a 36 percent lower rate among cervical cancer patients. For 14 other tumor types, the results were less clear-cut.


The study’s senior author, Dr. Stig Bojesen of the University of Copenhagen compared the difference in mortality to that seen with chemotherapy. “The benefit of receiving chemotherapy versus not receiving chemotherapy is 15 percent to 20 percent, depending on cancer type,” he told Reuters Health. “What we see (in the new study) is comparable to that. That’s really something.”


The fact that a seeming benefit from statins was not seen in people taking chemotherapy, however, doesn’t mean that people should avoid chemotherapy treatment and turn to statins instead, Bojesen stressed.


Rather, he thinks therapeutic use of statins might be considered when no good chemotherapy option is available for a particular cancer type.


And, if his team’s finding is confirmed in a larger study, statins may offer an easy, inexpensive way to reduce cancer deaths in some patients, he added.


Because the drugs are available in generic form, “The daily cost is about 10 cents or something like that. It’s extremely cheap,” Bojesen said.


An estimated one in four Americans over age 45 takes statin drugs, which work in the liver to reduce the amount of “bad” cholesterol in the bloodstream.


Bojesen speculates that the drugs may be robbing cancer cells of an important building block of cell membranes, and thereby slowing tumor growth.


“Our hypothesis is that by reducing cholesterol, you steal cholesterol from the proliferating cancer cells … improving survival,” he said.


But there is cause for skepticism. The people who took less than the recommended dose of a statin had a higher rate of survival than cancer patients who took higher doses. A positive relationship between dose and response is usually seen as evidence, at least, of cause and effect.


“The absence of a dose trend might indicate that just some statin might be enough,” Bojesen said. “But this is just an observational study, so the exact dose and the exact mechanism is something we can’t clarify with this paper.”


In an editorial accompanying the new report, Dr. Neil Caporaso of the National Cancer Institute said the study is also limited because no information on factors such as smoking were available.


So, for instance, the higher likelihood that people taking statins had heart disease and might therefore have also been targeted for smoking cessation treatment, would muddy the connection between being on statins and having lower cancer mortality.


In addition, information on treatment with chemotherapy and radiation were missing for 72 percent of the people taking statins, he noted.


“Because this study was an observational study, the slightly lower cancer death rates among cancer patients who had used statins before their cancer diagnosis could have been caused by factors other than the statin itself,” Jacobs told Reuters Health. “People using statins may have been more likely to use aspirin, which has been linked with improved cancer survival in some recent studies.”


SOURCE: http://bit.ly/TuzoQN New England Journal of Medicine, online November 7, 2012.


Diseases/Conditions News Headlines – Yahoo! News



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Statins may be linked to cancer survival
















NEW YORK (Reuters Health) – Danish cancer patients taking cholesterol-lowering statin drugs were 15 percent less likely to die, of cancer or any other cause, than patients who were not on the popular medications, in a new study.


The pattern held regardless of a person’s age, cancer type, tumor size or whether it had spread. Only patients who had received chemotherapy showed no apparent benefit from taking statins – the most commonly-prescribed drugs in the world.













Eric Jacobs, a researcher at the American Cancer Society who was not involved in the new work, called the findings “intriguing and exciting” but said they “do not mean that people with cancer should start using statins in the hopes of improving their progress.”


The study, published Wednesday in the New England Journal of Medicine, did not look at whether the statins, with familiar brand names such as Lipitor and Mevacor, can prevent cancer – only at what happens once cancer is diagnosed.


Using multiple registries containing data on cancer, drug use, population characteristics and deaths for the nation of Denmark, the research team analyzed the cancer cases of 18,721 people over age 40 who were diagnosed between 1995 and 2007.


All were taking statins regularly before their cancer was discovered, and the study compared them to 277,204 people who had not regularly taken the drugs before getting cancer treatments.


Overall, the cancer death rate among statin users was 15 percent lower, and so was the rate of death from any cause.


The appearance of a benefit from taking statins was strongest for 13 cancer types in particular, ranging from an 11 percent lower death rate among pancreatic cancer patients to a 36 percent lower rate among cervical cancer patients. For 14 other tumor types, the results were less clear-cut.


The study’s senior author, Dr. Stig Bojesen of the University of Copenhagen compared the difference in mortality to that seen with chemotherapy. “The benefit of receiving chemotherapy versus not receiving chemotherapy is 15 percent to 20 percent, depending on cancer type,” he told Reuters Health. “What we see (in the new study) is comparable to that. That’s really something.”


The fact that a seeming benefit from statins was not seen in people taking chemotherapy, however, doesn’t mean that people should avoid chemotherapy treatment and turn to statins instead, Bojesen stressed.


Rather, he thinks therapeutic use of statins might be considered when no good chemotherapy option is available for a particular cancer type.


And, if his team’s finding is confirmed in a larger study, statins may offer an easy, inexpensive way to reduce cancer deaths in some patients, he added.


Because the drugs are available in generic form, “The daily cost is about 10 cents or something like that. It’s extremely cheap,” Bojesen said.


An estimated one in four Americans over age 45 takes statin drugs, which work in the liver to reduce the amount of “bad” cholesterol in the bloodstream.


Bojesen speculates that the drugs may be robbing cancer cells of an important building block of cell membranes, and thereby slowing tumor growth.


“Our hypothesis is that by reducing cholesterol, you steal cholesterol from the proliferating cancer cells … improving survival,” he said.


But there is cause for skepticism. The people who took less than the recommended dose of a statin had a higher rate of survival than cancer patients who took higher doses. A positive relationship between dose and response is usually seen as evidence, at least, of cause and effect.


“The absence of a dose trend might indicate that just some statin might be enough,” Bojesen said. “But this is just an observational study, so the exact dose and the exact mechanism is something we can’t clarify with this paper.”


In an editorial accompanying the new report, Dr. Neil Caporaso of the National Cancer Institute said the study is also limited because no information on factors such as smoking were available.


So, for instance, the higher likelihood that people taking statins had heart disease and might therefore have also been targeted for smoking cessation treatment, would muddy the connection between being on statins and having lower cancer mortality.


In addition, information on treatment with chemotherapy and radiation were missing for 72 percent of the people taking statins, he noted.


“Because this study was an observational study, the slightly lower cancer death rates among cancer patients who had used statins before their cancer diagnosis could have been caused by factors other than the statin itself,” Jacobs told Reuters Health. “People using statins may have been more likely to use aspirin, which has been linked with improved cancer survival in some recent studies.”


SOURCE: http://bit.ly/TuzoQN New England Journal of Medicine, online November 7, 2012.


Diseases/Conditions News Headlines – Yahoo! News



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China submarines soon to carry nukes, draft US report says
















WASHINGTON (Reuters) – China appears to be within two years of deploying submarine-launched nuclear weapons, adding a new leg to its nuclear arsenal that should lead to arms-reduction talks, a draft report by a congressionally mandated U.S. commission says.


China in the meantime remains “the most threatening” power in cyberspace and presents the largest challenge to U.S. supply chain integrity, the U.S.-China Economic and Security Review Commission said in a draft of its 2012 report to the U.S. Congress.













China is alone among the original nuclear weapons states to be expanding its nuclear forces, the report said. The others are the United States, Russia, Britain and France.


Beijing is “on the cusp of attaining a credible nuclear triad of land-based intercontinental ballistic missiles, submarine-launched ballistic missiles, and air-dropped nuclear bombs,” the report says.


China has had a largely symbolic ballistic missile submarine capability for decades but is only now set to establish a “near-continuous at-sea strategic deterrent,” the draft said.


The deployment of such a hard-to-track, submarine-launched leg of China’s nuclear arsenal could have significant consequences in East Asia and beyond. It also could add to tensions between the United States and China, the world’s two biggest economies.


Any Chinese effort to ensure a retaliatory capability against a notional U.S. nuclear strike “would necessarily affect Indian and Russian perceptions about the potency of their own deterrent capabilities vis-à-vis China,” the report said, for instance.


ARMS CONTROL TALKS URGED


China is party to many major international pacts and regimes regarding nuclear weapons and materials. But it remains outside of key arms limitation and control conventions, such as the New Strategic Arms Reduction Treaty signed in April 2010 and the 1987 Intermediate-Range Nuclear Forces Treaty. The United States historically has approached these bilaterally with Russia.


Congress should require the U.S. State Department to spell out current and planned efforts to integrate China into existing and future nuclear arms reduction, limitation, and control discussions and agreements, the draft said.


In addition, Congress should “treat with caution” any proposal to unilaterally, or in the context of a bilateral deal with Russia, reduce operational U.S. nuclear forces without clearer information being made available to the public about China’s nuclear stockpile and force posture, it said.


A spokesman for the Chinese embassy in Washington, Geng Shuang, did not immediately respond to a request for comment.


China is estimated by the Arms Control Association, a private nonpartisan group in Washington, to have a total of 240 nuclear warheads. The United States, by contrast, has some 5,113, including tactical, strategic and nondeployed weapons.


CHINA DEPLOYING NEW CLASS OF SUBS


Beijing already has deployed two of as many as five of a new class of nuclear-powered ballistic missile submarine. The JIN-class boat is due to carry the JL-2 submarine-launched ballistic missile with an estimated range of about 7,400 km (4,600 miles).


The new submarines and the JL-2 missile will give Chinese forces its “first credible sea-based nuclear capability,” the U.S. Defense Department said in its own 2012 annual report to Congress on military and security developments involving China.


The JL-2 program has faced repeated delays but may reach an initial operating capability within the next two years, according to the Pentagon report, released in May.


The Pentagon declined to comment directly on China’s march toward creating a credible nuclear “triad” involving strategic bombers, intercontinental ballistic missiles and submarine-launched ballistic missiles.


“We monitor carefully China’s military developments and urge China to exhibit greater transparency regarding its capabilities and intentions,” Lieutenant Colonel Monica Matoush, a Defense Department spokeswoman, said by email.


Any assessment of China’s ability to have a nuclear triad would be an intelligence matter and likely be classified in nature, she added.


The final version of the report is to be released next Wednesday by the U.S.-China commission, a 12-member bipartisan group set up in 2000 to report to U.S. lawmakers on security implications of U.S.-China trade.


The draft, in its section on cyber-related issues, called on the Congress to develop a sanctions regime to penalize specific companies found to engage in, or otherwise benefit from, industrial espionage.


Congress should define industrial espionage as an illegal subsidy subject to countervailing duties, it added.


Lawmakers also should craft legislation to boost the security of critical supply chains, “particularly in the context of U.S. government and military procurement,” the draft said.


(Editing by Lisa Shumaker)


Economy News Headlines – Yahoo! News



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Merkel says Germany, Britain must work together on EU
















LONDON (Reuters) – Germany and Britain must cooperate to work round their differences on the European Union‘s long-term spending plans, German Chancellor Angela Merkel said on Wednesday.


“Despite differences that we have it is very important for me that the UK and Germany work together,” Merkel said through a translator before a meeting in London with Prime Minister David Cameron to discuss the EU‘s 2014-2020 budget.













“We always have to do something that will stand up to public opinion back home. Not all of the expenditure that has been earmarked has been used with great efficiency … We need to address that,” she said.


EU leaders meet in Brussels on November 22-23 to try to secure a seven-year budget for the 27-nation bloc amid signs of differences of opinion over what action should be taken.


(Reporting by Peter Griffiths; Editing by Andrew Osborn)


Europe News Headlines – Yahoo! News



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Video game maker Activision scores big gains in 3Q
















SANTA MONICA, Calif. (AP) — Video game maker Activision Blizzard Inc. scored points in the third quarter with a performance that topped analysts’ forecasts.


The results announced Wednesday encouraged management to predict more good times in the crucial holiday shopping season when the company is counting on video game aficionados to snap up the latest edition in its popular “Call of Duty” franchise.













Activision credited “Diablo III,” a role-playing game designed for personal computers, and its latest version of “World of Warcraft” for moving its latest quarter to a higher level.


The company earned $ 226 million, or 20 cents per share, for the three months ending in September. That represented a 53 percent increase from net income of $ 148 million, or 13 cents per share a year ago.


Excluding items unrelated to its ongoing business, Activision made 15 cents per share. The company beat the average estimate of 8 cents per share among analysts surveyed by FactSet. Adjusted earnings included a gain of 4 cents per share from the resolution of a U.S. tax audit.


Revenue for the period increased 12 percent from last year to $ 841 million. That figure, though, includes sales of games with online components, a revenue stream that the company and analysts prefer to spread out over time.


With that adjustment, Activision’s third-quarter revenue would have risen by 20 percent to $ 751 million — about $ 41 million above analysts’ projections.


The third quarter ended with a flourish as Activision sold 2.7 million copies of “World of Warcraft: Mists of Pandaria” in the first week after its Sept. 25 release.


CEO Bobby Kotick believes Activision has another hit on its hand with “Call of Duty: Black Ops II,” scheduled to go on sale Tuesday.


“We feel good about our product line-up, in spite of a difficult and challenging macroeconomic environment that could worsen,” Kotick said in an interview Wednesday.


Activision, based in Santa Monica, Calif., doesn’t expect the weak economy to keep people from buying its games as gifts during the upcoming holidays.


In the fourth quarter the company expects adjusted earnings of 70 cents per share on adjusted revenue of $ 2.41 billion. Analysts, on average, expect adjusted earnings of 67 cents per share on adjusted revenue of $ 2.34 billion.


Activision shares rose 23 cents, or 2 percent, to $ 11.36 in after-hours trading following the release of its earnings report.


Gaming News Headlines – Yahoo! News



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Rihanna unveils Chris Brown duet “Nobodies Business”
















LOS ANGELES (Reuters) – R&B star Rihanna unveiled a duet entitled “Nobodies Business” with ex-boyfriend Chris Brown on Tuesday, three years after Brown was charged with assaulting her.


The song was part of an official track list that Barbadian singer Rihanna tweeted to her followers for her upcoming album “Unapologetic,” and comes after weeks of speculation in the media that the couple have rekindled their romance being spotted together at numerous events.













While Rihanna, 24, has stayed mum on her relationship status with Brown, the “Turn Up The Music” singer attended Rihanna‘s Halloween party last week and tweeted a photograph of himself dressed in Arab robes and a rifle.


Brown, 23, is currently halfway through his five-year probation after pleading guilty to assaulting Rihanna on the eve of the Grammy awards in 2009. He was ordered to complete community service and a domestic violence program.


Brown was given permission by a Los Angeles judge to embark on his European tour at a recent hearing overseeing his progress on his probation.


The former couple have had a tumultuous relationship in the last three years, including a restraining order against Brown following the assault.


But recently the two singers have made peace, coming together on a remix of Rihanna‘s raunchy song “Birthday Cake” earlier this year.


The Barbadian singer told Oprah Winfrey in an emotional interview in August that she and Brown now had a “very close friendship,” and that she still loved him.


Other collaborations on Rihanna‘s upcoming “Unapologetic” album include rapper Eminem, newcomer singer-songwriter Mikky Ekko and rapper Future.


(Reporting By Piya Sinha-Roy, editing by Jill Serjeant)


Celebrity News Headlines – Yahoo! News



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Novartis heart failure drug cuts death by 37 percent: study
















LOS ANGELES (Reuters) – An experimental Novartis AG drug to treat hospitalized acute heart failure patients reduced deaths by 37 percent compared with a placebo and appeared to be safe, according to data from a late stage clinical trial presented on Tuesday.


The drug, serelaxin, which is a form of a human hormone that relaxes blood vessels and eases stress on the heart and other organs, is considered one of the most important medicines in the Swiss drugmaker’s developmental pipeline.













“With a meaningful mortality benefit, we believe Serelaxin could represent a $ 2.5 billion (annual) sales opportunity,” Deutsche Bank analysts said in a research note prior to release of the final data at the American Heart Association scientific meeting in Los Angeles.


Novartis said it now planned to seek approval for serelaxin. In the study of 1,161 patients, the drug cut deaths from any cause at six months by 37 percent and led to a marked reduction in worsening of heart failure during hospitalization, researchers said.


Patients who received 48 hours of continuously infused serelaxin experienced more than 45 percent fewer episodes of worsening heart failure symptoms than those who got a placebo.


Novartis had previously disclosed that serelaxin met one of the study’s two primary goals measuring relief of dyspnea, or extreme shortness of breath – a common symptom of acute heart failure – and that it reduced deaths. But the company did not say by how much. By one measure, serelaxin led to a 19 percent improvement in dyspnea, researchers said.


The drug failed to hit a secondary goal of the study that combined cardiovascular death with need for reshospitalizations, but researchers felt the life saving benefit was more important.


“We did have a startling death benefit. One of the reasons there may have been an inability to show a decrease in hospitalizations is more patients were alive to be rehospitalized,” said Dr John Teerlink, one of the trial’s co-lead researchers.


The data showed that only 29 acute heart failure patients would have to be treated with serelaxin to prevent one cardiovascular death, said Teerlink, a cardiologist and heart failure specialist at the San Francisco VA Medical Center.


Doctors say there is an enormous need for a treatment for acute heart failure, with few available options for the condition in which the heart is unable to pump enough blood.


“If it was approved we would not only use it, there would be a mandate to use it because we don’t have anything for acute decompensated heart failure,” said Dr. Milton Packer, a prominent cardiologist from the University of Texas Southwest Medical Center in Dallas, who was not involved in the study.


“If that mortality finding is real, boy are we going to get excited,” said Packer, who has been a member of FDA advisory panels for heart drugs.


There are more than one million hospitalizations in the United States each year for acute heart failure and another million in Europe. About half of all patients die within five years of diagnosis, often as a result of acute episodes that require urgent hospital care.


TREATMENT BENEFITS


The study showed the Novartis drug also reduced the duration of time spent in intensive care units by almost half a day and cut the length of hospital stay by almost a full day.


There was no difference in serious side effects between the two groups, but there was a significant increase in kidney impairment in the placebo group, as the Novartis drug appears to prevent worsening of kidney function, researchers said.


Despite missing some of the pre-set end points, or goals, of the study, Novartis said it is likely to seek approval of the drug based on the trial results.


“We believe this is a strong set of data and have started discussions with the main regulatory agencies. Our filing strategy will be determined by the outcome of these discussions,” said Ameet Nathwani, Novartis’ global business franchise head for critical care.


Dr John McMurry of the University of Glasgow, who was on a panel to critique the study, said that if there were a second serelaxin trial that also showed a mortality benefit it would be hard for health regulators to ignore.


“I think the agent was beneficial. This drug is doing something good in terms of relief,” he said.


(Reporting by Bill Berkrot and Deena Beasley. Editing by Andre Grenon and Richard Pullin)


Medications/Drugs News Headlines – Yahoo! News



Read More..

Novartis heart failure drug cuts death by 37 percent: study
















LOS ANGELES (Reuters) – An experimental Novartis AG drug to treat hospitalized acute heart failure patients reduced deaths by 37 percent compared with a placebo and appeared to be safe, according to data from a late stage clinical trial presented on Tuesday.


The drug, serelaxin, which is a form of a human hormone that relaxes blood vessels and eases stress on the heart and other organs, is considered one of the most important medicines in the Swiss drugmaker’s developmental pipeline.













“With a meaningful mortality benefit, we believe Serelaxin could represent a $ 2.5 billion (annual) sales opportunity,” Deutsche Bank analysts said in a research note prior to release of the final data at the American Heart Association scientific meeting in Los Angeles.


Novartis said it now planned to seek approval for serelaxin. In the study of 1,161 patients, the drug cut deaths from any cause at six months by 37 percent and led to a marked reduction in worsening of heart failure during hospitalization, researchers said.


Patients who received 48 hours of continuously infused serelaxin experienced more than 45 percent fewer episodes of worsening heart failure symptoms than those who got a placebo.


Novartis had previously disclosed that serelaxin met one of the study’s two primary goals measuring relief of dyspnea, or extreme shortness of breath – a common symptom of acute heart failure – and that it reduced deaths. But the company did not say by how much. By one measure, serelaxin led to a 19 percent improvement in dyspnea, researchers said.


The drug failed to hit a secondary goal of the study that combined cardiovascular death with need for reshospitalizations, but researchers felt the life saving benefit was more important.


“We did have a startling death benefit. One of the reasons there may have been an inability to show a decrease in hospitalizations is more patients were alive to be rehospitalized,” said Dr John Teerlink, one of the trial’s co-lead researchers.


The data showed that only 29 acute heart failure patients would have to be treated with serelaxin to prevent one cardiovascular death, said Teerlink, a cardiologist and heart failure specialist at the San Francisco VA Medical Center.


Doctors say there is an enormous need for a treatment for acute heart failure, with few available options for the condition in which the heart is unable to pump enough blood.


“If it was approved we would not only use it, there would be a mandate to use it because we don’t have anything for acute decompensated heart failure,” said Dr. Milton Packer, a prominent cardiologist from the University of Texas Southwest Medical Center in Dallas, who was not involved in the study.


“If that mortality finding is real, boy are we going to get excited,” said Packer, who has been a member of FDA advisory panels for heart drugs.


There are more than one million hospitalizations in the United States each year for acute heart failure and another million in Europe. About half of all patients die within five years of diagnosis, often as a result of acute episodes that require urgent hospital care.


TREATMENT BENEFITS


The study showed the Novartis drug also reduced the duration of time spent in intensive care units by almost half a day and cut the length of hospital stay by almost a full day.


There was no difference in serious side effects between the two groups, but there was a significant increase in kidney impairment in the placebo group, as the Novartis drug appears to prevent worsening of kidney function, researchers said.


Despite missing some of the pre-set end points, or goals, of the study, Novartis said it is likely to seek approval of the drug based on the trial results.


“We believe this is a strong set of data and have started discussions with the main regulatory agencies. Our filing strategy will be determined by the outcome of these discussions,” said Ameet Nathwani, Novartis’ global business franchise head for critical care.


Dr John McMurry of the University of Glasgow, who was on a panel to critique the study, said that if there were a second serelaxin trial that also showed a mortality benefit it would be hard for health regulators to ignore.


“I think the agent was beneficial. This drug is doing something good in terms of relief,” he said.


(Reporting by Bill Berkrot and Deena Beasley. Editing by Andre Grenon and Richard Pullin)


Medications/Drugs News Headlines – Yahoo! News



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