Rosuvastatin cuts risk of catching pneumonia, study finds

Patients taking AstraZeneca Plc’s cholesterol-lowering medicine Crestor (Rosuvastatin) in a study were less likely to develop pneumonia, a finding that potentially will broaden use of such drugs.

The result supports earlier research suggesting drugs in this class, called statins, prevent deaths from pneumonia. The latest study, an analysis of a 17,000-person clinical trial that ended in 2008, was presented today, in Boston, at the Interscience Conference on Antimicrobial Agents & Chemotherapy.

Cholesterol drugs, led by Pfizer Inc.’s Lipitor, were the world’s second-best-selling category of medicines last year, with $35.3 billion in sales, according to IMS Health Inc., a health research company in Norwalk, Connecticut. Only cancer drugs exceeded that tally. The latest Crestor finding justifies further research into giving statins to patients with lung disease, scientists said.

“These data are consistent with the hypotheses that statin therapy may reduce incident pneumonia,” supporting further study of the drugs to treat pulmonary disease, the researchers wrote.

Statins work by blocking an enzyme involved in cholesterol production in the liver. Results from a separate study in 2008 showed that people hospitalized with pneumonia were less likely to die if they took a statin. There is also evidence the drugs may help reduce inflammation, the formation of blood clots, and the immune system’s inappropriate attacks on healthy tissue.

Side-Effect Reports

The results released today come from an analysis of a study called Jupiter designed to show whether Crestor was more effective than a placebo at reducing cholesterol levels. Since the original study didn’t set out to measure the effect on pneumonia, researchers went back and examined reports collected during the trial to compare rates of pneumonia and other infections among those getting Crestor and those on a placebo.

The analysis found that 257 patients taking a placebo developed pneumonia compared with 214 patients taking Crestor, researchers said. Patients taking Crestor were also less likely to develop fungal, soft tissue or gynecological infections.

Crestor generated $4.5 billion in revenue last year for London-based AstraZeneca; Lipitor had sales of $11.4 billion.

Pneumonia kills about 52,000 people a year in the U.S., with the elderly and infants being most at risk, according to the Centers for Disease Control and Prevention, based in Atlanta.

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Avandia Continues to Face Scrutiny: Biotech's Latest Mishaps

GlaxoSmithKline’s (GSK) diabetes drug Avandia is once again under regulatory scrutiny—this time it’s in Europe where the European Medicines Agency met to discuss whether Avandia should continue to be marketed. The agency in a press statement said that no final decision has been made about the drug.

It said it has further questions for GSK before deciding whether and what action needs to be taken. A final decision is expected by September 23. The meeting took place as a controversy erupted in the United Kingdom over a recommendation made at the end of July by the UK Commission on Human Medicines, according to TheHeart.Org. The commission unanimously voted that Avandia should be withdrawn. Though it informed the Medicines and Healthcare Products Regulatory Agency, the agency responsible for licensing drugs in the United Kingdom, its decision was not made public. Instead the agency sent letters to doctors restating safety information about the drug and suggesting they consider alternatives. Because the drug was approved by the European Medicines Agency, only it can revoke the license for the drug.

Roche said it halted dosing of patients in a late-stage trial of its experimental diabetes drug taspoglutide because side effects including nausea and vomiting resulted in many participants in the study to drop out of it, Bloomberg reported. The company is trying to determine what caused the side effects and see if it can reformulate the medication to reduce the risk, a spokeswoman told Bloomberg. Because a large number of patients dropped out of the study, the company said it would be difficult to determine whether the drug is effective.

Genzyme is laying off an undisclosed number of staff as part of a restructuring first announced in May, Reuters reported. The company said the move was unrelated to Sanofi-Aventis’ efforts to acquire the company. Genzyme has 12,800 employees. It offered no estimates on how much it expects to save through the restructuring.

Shares of Idenix Pharmaceuticals (IDIX) plummeted after the U.S. Food and Drug Administration ordered the company to halt a mid-stage study of two experimental hepatitis C drugs. Three healthy volunteers testing a combination of the drugs IDX184 and IDX320 showed elevated liver enzyme levels in a routine post-study safety test, the Cambridge, Massachusetts company says. Although liver function returned to nearly normal levels in all three subjects, the FDA placed a clinical hold on the study until it can discuss the results and other relevant data with Idenix. Idenix shares fell to $3.18 from $5.99 on the day it was announced. On top of that punishment, the hold will also likely make Idenix's ongoing search for an outside partner to advance its hepatitis C program more difficult. [see story].

U.S.-based Valeant Pharmaceuticals International and Canada’s Biovail plan to eliminate about 25 percent of their combined workforce once a merger is completed between the two companies, Reuters reported. The company’s said they expect to save more than $300 million through cost synergies with more than $200 million being realized in 2011. The companies have a combined workforce of about 4,400.

Marc Tessier-Lavigne, Genentech’s (DNA) executive vice president of research and chief scientific officer, is leaving the biotech to become president of Rockefeller University in New York, Reuters reported. The departure of Tessier-Lavigne, the second highest executive in research at Genentech, is one of the most significant executive changes since Roche acquired Genentech last year. He takes on his new post in early 2011.

U.S. Food and Drug Administration is requiring that certain contrast agents used in magnetic resonance imaging carry new warnings on their labels about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis, if the drug is administered to certain patients with kidney disease.

Nephrogenic systemic fibrosis or NSF is a condition involving the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs. Symptoms of NSF can include scaling, hardening and tightening of the skin, red or dark patches on the skin, and stiffness. NSF may lead to death, especially if it involves body organs. The order pertains to gadolinium-based contrast agents or GBCAs.

The agency said three of the GBCAs—Magnevist, Omniscan, and Optimark— will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. All GBCA labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration.

GBCAs are intravenous drugs used to help detect abnormalities of body organs, blood vessels, and other tissues through MRI. Magnevist is marketed by Bayer Healthcare, Omniscan by GE Healthcare, and Optimark by Covidien (COV).

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Novartis's Experimental Meningitis Vaccine Meets Goals in Late-Stage Study

Novartis AG said an experimental meningitis B vaccine met the goals of a late-stage clinical study.

The vaccine, called 4CMenB, achieved a “robust immune response” in the study of more than 3,600 infants, the Basel, Switzerland-based company said today in an e-mailed statement. The drug also had “an acceptable” side-effect profile, the company said.

Novartis expects the results of additional clinical trials over the next few months and plans to seek European regulatory approval for the vaccine by the end of 2010. The compound may be used in different age groups and alongside other vaccines, the Swiss drugmaker said. Infants are particularly vulnerable to the meningitis B virus which can kill within 48 hours of the first symptoms appearing, according to Novartis.

“Meningitis B can be devastating for affected families and is a major concern for pediatricians who care for children with this serious illness,” said Andrew Pollard, Professor of Pediatric Infection and Immunity at the University of Oxford. “Many cases of meningitis are prevented today by the vaccines we give to our children, but the more complex meningitis B remains as a major threat.”

Novartis pioneered the technology known as “reverse vaccinology’’ to develop the shot after decoding the genetic makeup of a pathogenic meningitis strain.

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Some patients with severe heart disease receiving wrong treatment, study finds

Tens or even hundreds of thousands of Americans are having coronary artery angioplasty and stenting every year when they should be having bypass grafts, and the result is an extra 5,000 or more deaths annually, researchers said Sunday.

Patients and cardiologists frequently prefer angioplasty and the insertion of a stent to keep arteries open because it is quicker and easier; patients go home sooner and return to work more quickly.

But new data from a major European-American study on more than 1,800 patients show that three years after the procedure, those who got stents were 28% more likely to suffer a major event, such as a heart attack or stroke, and 46% more likely to require a repeat procedure to reopen arteries. They were 22% more likely to die.

"This is one of the strongest studies yet demonstrating that, in advanced coronary disease, bypass has a real patient advantage," said Dr. Robert Guyton, chief of cardiothoracic surgery at the Emory University School of Medicine, who was not involved in the study.

"This will change practice," he said. "It may not reverse some of the use of stenting, but it is certainly going to slow it down and make people think. Stenting is a little bit easier on you and the return to work is quicker. But the benefits of surgery are more enduring and tend to emerge as time goes by."

Dr. Richard Shemin, chief of cardiac and thoracic surgery at UCLA's Ronald Reagan Medical Center, echoed that view. "Surgeons have had a strong feeling that, over time, surgery would be better for the most complex forms of heart disease," said Shemin, who also was not involved in the study.

The findings are "very strong, independent data that the public, payers and practitioners need to factor into how we make decisions in taking care of patients," he said.

"Any time that you compare angioplasty and surgery, the longer you go, the better surgery looks," said Dr. Michael J. Mack, first vice president of the Society of Thoracic Surgeons and a co-author of the study.

Coronary artery bypass grafts, commonly called CABG (pronounced cabbage), were the first treatment for blocked arteries. In the procedure, a blood vessel removed from elsewhere in the body, most often the chest or the leg, is used to bypass the blocked area, providing a new channel for blood to flow to the heart.

Hospital stays generally last five or six days, and the patient can return to work after a few weeks.

In recent years, however, cardiologists have turned more and more to balloon angioplasty, in which a catheter is threaded through a blood vessel in the groin to reach the blockage and a balloon is inflated at the site to compress the plaque. Originally, that was all that was done. Then physicians began inserting bare-metal stents, spring-like devices that hold the artery open.

More recently, doctors have begun using drug-eluting stents, which release a drug that helps prevent clot formation. Hospital stays are typically overnight, and the patient can return to work after a couple of days.

More than 1.3 million Americans now undergo angioplasty every year, compared with 448,000 who undergo bypass, according to the National Center for Health Statistics.

The new study, reported Sunday at a Geneva meeting of the European Assn. for Cardio-Thoracic Surgery, is the first large trial to compare stenting and CABG directly. Called SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery), the trial enrolled 1,800 patients at 85 centers in Europe and the United States.

Patients were randomized to receive either angioplasty with stenting or bypass.

Patients were considered to have mild disease if they had a single blocked artery. Their disease was considered moderate or severe if they had a blockage in the left main artery — the primary artery supplying blood to the heart — plus blockage in one of the other three arteries, or if they had blockages in all three other arteries. They were also considered severe if they had very long blockages, arteries that were totally blocked, or "very tortuous, curvy arteries" that make angioplasty difficult, Mack said.

For patients with mild disease, the two procedures produced equivalent results, so angioplasty might be preferred because it is easier on the patient. Previous studies have also shown that such patients can be successfully treated with medical therapy alone. But the differences were much more dramatic for those with more severe disease, which is present in about half of all patients undergoing angioplasty in the U.S.

Dr. John Conte, associate director of cardiac surgery at Johns Hopkins Hospital in Baltimore, noted that it is now incumbent on physicians to make sure patients have all the facts before they undergo any procedure. "It's absolutely amazing that the federal government and private insurers don't insist on it," he said. "Wouldn't it make sense to do the right procedure the first time, rather than do it over and over and drive up the cost of healthcare? To me, it's a no-brainer."

By Thomas H. Maugh II, Los Angeles Times

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New drug hope for pancreatic cancer

A commonly used chemotherapy drug may offer a new lifeline to sufferers of one of the most deadly cancers, research has shown.

Trial results suggest that the drug 5-fluorouracil (5-FU) is an effective alternative for pancreatic cancer patients who fail to respond to standard treatment.

They also raise hopes of providing better therapy by combining the two drugs.

A study now under way is looking at the effect of prescribing a pill version of 5-FU with the more expensive standard chemotherapy drug, gemcitabine.

5-FU is currently used to treat a wide range of cancers including those affecting the bowel, breast and ovaries.

Almost 8,000 people are diagnosed with pancreatic cancer each year in the UK.

The disease is one of the hardest cancers to treat, and only around 3% of patients survive more than five years.

The new findings are published in the Journal of the American Medical Association (Jama).

Study leader Professor John Neoptolemos, director of the Liverpool Cancer Research UK Centre based at the University of Liverpool, said: "Until now the best way to treat pancreatic cancer has been unclear. But these results are the first to directly compare these two chemotherapies and show undoubtedly that they are both as effective as each other.

"Importantly this means patients now have a backup in case their cancer fails to respond to the first line of treatment. A new trial investigating whether combining these two treatments could be even more effective and prolong life is already under way and we look forward to seeing the result."

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