MONDAY, June 28 (HealthDay News) -- Despite being used widely to lower cholesterol levels, statins don't appear to reduce the chances of death in people at risk of developing cardiovascular disease, British scientists have found.
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Statins are used widely to treat and prevent cardiovascular disease. They are given both to people with heart disease and -- in more recent years -- to those who are at risk for heart disease but who have no history of it.
In people with a history of heart disease, statin therapy is known to reduce the risk of complications from the illness and premature death, the British researchers noted. But they said their new meta-analysis of previously published studies -- along with the known risks that statins pose to certain people -- calls into question the benefits of statins to prevent the development of heart disease.
One U.S. expert said the findings need to be taken in context.
"Statin therapy has been demonstrated in individual randomized clinical trials and in pooled analysis to prevent fatal and nonfatal cardiovascular events in individuals without established cardiovascular disease," said Dr. Gregg C. Fonarow, director of the Ahmanson-UCLA Cardiomyopathy Center at the University of California, Los Angeles.
"In eligible men and women without contraindications, statin therapy -- along with lifestyle modifications-- represents one of the most effective means to prevent myocardial infarction [heart attack] and stroke," he said.
This new analysis examined a number of primary prevention trials to determine, during the first few years after statin therapy is initiated, whether there is a reduction in deaths from all causes, Fonarow noted.
"As expected, with primary prevention studies having only a mean duration of follow-up of 3.7 years, a reduction in all-cause mortality was not observed," he said. "To detect a reduction in all-cause mortality in a primary prevention population, studies of longer duration or confined to only the most potent statins would be required."
This study also shows the safety of statin therapy, even in apparently healthy people, as "there was no evidence for an increase in non-cardiovascular mortality," Fonarow said.
The report is published in the June 28 issue of the Archives of Internal Medicine.
For the study, Dr. Sreenivasa Rao Kondapally Seshasai, from the cardiovascular epidemiology unit at the University of Cambridge and Addenbrooke's Hospital, Cambridge, and colleagues pooled data from 11 studies, which included 65,229 participants. In all, 32,623 of these individuals took statins and 32,606 were taking a placebo.
During almost four years of follow-up, 2,793 people died. Among those who died, 1,447 were taking a placebo and 1,346 were taking statins, the researchers found. This difference was not statistically significant, they noted.
Even though the statins were doing their job and the levels of LDL, or "bad," cholesterol were higher among people taking the placebo than those taking statins, there was no association between risk of dying and LDL levels, Seshasai's group found.
Currently, some 33.5 million older Americans, according to the American Heart Association, are taking a statin or have risk factors that suggest a need for statin therapy. However, another 11 million older Americans at risk for heart disease may be eligible for statin therapy, according to the association.
Previous data suggests that people who have cardiovascular disease benefit from statin therapy. Various studies have found that these drugs prevent complications from cardiovascular disease and lower the risk of dying in this population.
However, there is much less evidence that statins lower the risk of dying prematurely in people without heart disease.
"Current prevention guidelines endorse statin therapy for subjects at high global risk of incident cardiovascular disease as a means to reduce fatal and nonfatal vascular events," the researchers write. "Due consideration is needed in applying statin therapy in lower-risk primary prevention populations," they conclude.
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SOURCES: Gregg C. Fonarow, M.D., professor, medicine, and director, Ahmanson-UCLA Cardiomyopathy Center, University of California, Los Angeles; June 28, 2010, Archives of Internal Medicine