Cholesterol-Lowering Drugs Safe for Long-Term Use, Study Finds
TUESDAY Nov. 22, 2011 -- British researchers have good news for anyone taking the cholesterol-lowering medications known as statins: These drugs are effective and safe, even when used for long periods of time, they say.
The 11-year study found that simvastatin (brand name Zocor) reduced the risk of cardiovascular disease by almost one-quarter. In addition, the researchers found no increase in illness or deaths from cancer or other non-vascular causes.
"All those at increased vascular risk should start taking statins early and continue taking them long term," said the study's lead author, Dr. Richard Bulbulia, a consultant vascular surgeon and research fellow in the clinical trial service unit at the University of Oxford in England.
"This will maximize the reductions in heart attacks, strokes and other vascular diseases, and is safe," said Bulbulia, who added that the study's findings should provide reassurance to physicians and their patients.
There are numerous other drugs in this class of medication, and Bulbulia said, "it seems reasonable to assume that [this study's findings] should hold true for other currently prescribed statins." Other commonly used statins include Lipitor, Crestor and Mevacor.
Results of the study are published in the Nov. 23 online issue of The Lancet. Funding for the study was provided by the U.K. Medical Research Council, the British Heart Foundation, Merck & Co. (manufacturer of Zocor) and Roche Vitamins.
The study looked at the long-term safety of simvastatin because some research suggested that the rates of some cancers and non-vascular health conditions were increased in people who had lower levels of LDL (bad) cholesterol.
Initially, the study recruited more than 20,500 people who had a high risk of heart disease and other cardiovascular problems for a trial of simvastatin versus a placebo. The study volunteers were between 40 and 80 years old.
Half the group was randomly assigned to take 40 milligrams of simvastatin daily, while the other half took a placebo. At the end of the treatment phase of the trial, which lasted about five years, study participants were encouraged to continue on their study treatment for as long as another six years. About 17,500 of the initial participants continued in the follow-up phase, according to the report.
People taking simvastatin reduced their "bad" cholesterol an average of 1 millimole per liter over five years. This reduction translated into a 23 percent drop in the risk of major cardiovascular events, such as heart attack and stroke, the researchers said. This benefit continued throughout the follow-up, reported the study.
When the researchers examined the data from the treatment and follow-up phases for evidence of any increases in non-vascular events, such as cancer, they found no significant differences between the two groups.
"Statin therapy appears safe, with no hazards, such as an excess risk of cancer or other major non-vascular morbidity or mortality emerging during the 11-year post-trial period," said Bulbulia.
Another expert praised statins' record.
"I think the statin drugs are an extraordinary class of medications, and a necessity in Western populations, where there is less physical exercise and more calorie consumption," said Dr. Howard Weintraub, clinical director of the Center for the Prevention of Cardiovascular Disease at NYU Langone Medical Center in New York City.
"These are very safe drugs, and this study demonstrates that safety, and that the vascular protection continues well beyond the termination of treatment," said Weintraub.
"I think the picture for cardiovascular disease would be very different if these drugs weren't a part of our armamentarium," he added.
Learn more about statins from the U.S. Food and Drug Administration.
Posted: November 2011
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