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Entries in Crestor (2)

Monday
Mar192012

Statins May Lower Pneumonia Risk

iStockphoto/Thinkstock(NEW YORK) -- Statins, the same drugs that help millions of Americans control their cholesterol may also help prevent pneumonia, a new study found.

Blocking cholesterol build-up inside arteries, statin reduces the risk of heart disease. But a clinical trial of Crestor, made by the London-based drug company AstraZeneca, suggests the benefits of statins extend beyond the heart.

“Participants randomly assigned to receive rosuvastatin [Crestor is the brand name] had a modest reduction in the incidence of pneumonia compared with participants assigned to the placebo group,” wrote lead author Dr. Victor Novack of the Soroka University Medical Center. The study was published Monday in the journal CMAJ.

Novack and colleagues analyzed data from more than 17,800 men and women aged 50 and older who had no history of heart disease or diabetes. During a follow-up period of almost two years, 214 people taking statins contracted pneumonia, compared with 257 people taking a placebo — a small, but significant difference that held even when the researchers controlled for pneumonia risk factors, such as age and smoking.

“Although a number of observational studies have suggested a protective effect  of statin use on the incidence of pneumonia and other infections, we are not aware of any evidence from prior randomized trials that specifically evaluated this question,” according to the study.

Previous studies have found that statins have positive effects on inflammation — the hallmark feature of pneumonia, which is triggered by infection. Pneumonia is often a complication of another condition, such as influenza. A study published last year in the Journal of Infectious Diseases linked statins with a decreased risk of death for patients hospitalized for flu.

“They reduce inflammation that may be triggered by the influenza virus,” Dr. Cam Patterson, distinguished professor of cardiovascular medicine at the  University of North Carolina at Chapel Hill, said of the 2011 study. “This may lead to less tissue damage from the virus, making it easier for patients to recover from severe bouts of the flu.”

The proportion of pneumonia cases stemming from flu included in Monday’s study is not known.

Infections other than pneumonia, such as urinary tract infections and sepsis, were diagnosed in 3,760 participants who were taking Crestor, and 3,828 taking a placebo. The infections were classified as serious in 412 patients taking Crestor, and 456 patients taking a placebo.

“These data provide support for ongoing studies such as the Statins for Acutely Injured Lungs from Sepsis, or Sails, trial, and emphasize the need for basic investigators to continue exploring novel mechanisms by which statin therapy appears to reduce the incidence of clinical events,” the authors wrote.

Copyright 2012 ABC News Radio

Wednesday
Feb292012

FDA Announces New Warning Labels for Cholesterol Drug

iStockphoto/Thinkstock(WASHINGTON) -- Federal regulators announced on Tuesday they would add additional safety warnings to the labels on statins, a class of drugs that lower cholesterol.

Statins -- more commonly known by the brand names Lipitor, Crestor and Zocor -- inhibit the enzyme that plays a big part in the liver's production of cholesterol.

The U.S. Food and Drug Administration now requires that statin labels include warnings about the rare, but serious risk of liver damage, memory loss and confusion along with type 2 diabetes.  Certain statins, known by the generic name lovastatin, can raise the risk of muscle weakness.

The decision came following an internal meeting between the FDA's Office of Surveillance and Epidemiology and Office of New Drugs, according to Dr. Amy Egan, the FDA's deputy director of safety in the division of metabolism drug products.

Egan said most of the information reviewed, especially the effect of statins on memory loss, came from a small number anecdotal reports compiled over one year.  She added that the warning for memory loss was more for serious cognitive problems than simple forgetfulness.

"We can't establish causality with statin therapy," said Egan, regarding the new warnings.

Most of the studies the division evaluated were short-term studies, suggesting that the long-term effects of statin therapy were unclear.  Egan also said it had yet to be determined which statins and at what dose could increase the risk of the listed side effects.

Many experts said the added labels should not deter patients from statins.  Instead, they should report any side effects they experience to their physician.

Consumers will be able to see the label changes on their medications within the next 30 days, Egan said. 

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