Two JAMA studies justify increased use of statins
BOSTON - The argument for an OTC statin like Pfizer's Lipitor just got a significant boost Tuesday with the release of two studies supporting the latest cholesteroal treatment guidelines.
A new study from Harvard T.H. Chan School of Public Health found it would be cost-effective to treat 48%-67% of all adults aged 40-75 in the U.S. with cholesterol-lowering statins. By expanding the current recommended treatment guidelines and boosting the percentage of adults taking statins, an additional 161,560 cardiovascular-related events could be averted, according to the researchers.
"The new cholesterol treatment guidelines have been controversial, so our goal for this study was to use the best available evidence to quantify the tradeoffs in health benefits, risks and costs of expanding statin treatment," stated Ankur Pandya, assistant professor of health decision science at Harvard Chan School and lead author of the study. "We found that the new guidelines represent good value for money spent on healthcare, and that more lenient treatment thresholds might be justifiable on cost-effectiveness grounds even accounting for side-effects such as diabetes and myalgia."
The study was published online July 14 in the Journal of the American Medical Association.
The percentage of Americans taking statins has jumped in recent years - as of 2012, 26% of all adults over age 40 were taking them, according to the U.S. Centers for Disease Control and Prevention. In November 2013, the American Heart Association and the American College of Cardiology recommended that statins be prescribed for people with a 7.5% or greater risk of heart attack or stroke over a 10-year period, including many with no existing cardiovascular issues. Previous guidelines had advised statin use only if the risk was 10%-20% or higher.
After the 2013 recommendations were issued, proponents of expanding statin use said there was strong evidence that they reduce risk of heart attack and stroke; critics said the risks were overestimated, that healthy adults would be overtreated, and that more people would be at increased risk for negative side effects, such as memory loss, type 2 diabetes and muscle damage.
A separate study published Wednesday in JAMA found that the new guidelines for statin use are more accurate and more efficient. A team led by Massachusetts General Hospital investigators reported that the new guidelines improve identification of adults at higher risk for future cardiovascular events who were not captured by previous guidelines. "Extrapolating our results to the approximately 10 million U.S. adults who would be newly eligible for statin therapy under the new guidelines, we estimate that between 41,000 and 63,000 cardiovascular events - heart attacks, strokes or deaths from cardiovascular disease - would be prevented over a 10-year period," said Udo Hoffmann, director of the Cardiac MR PET CT Program in the MGH Department of Radiology and the Division of Cardiology.
The new guidelines have been expected to increase the number of statin-eligible adults by almost 13 million, raising some concerns that many individuals would be exposed to the risks of statin therapy without justification. However, Hoffmann and his team showed that the 598 study group participants who would be designated statin-eligible by ACC/AHA but not ATP III criteria had the same risk of cardiovascular events over 10 years as those who were statin-eligible under the older criteria.
"Our study shows that the ACC/AHA guidelines for statin eligibility aligned with risk levels indicated by CAC scores much better than the ATP III guidelines, providing a potential explanation for the improved prediction of cardiovascular risk." Hoffmann said. "However, 93% of those designated statin-eligible by ACC/AHA criteria would not be expected to have a cardiovascular event during the next 10 years, while nearly 30% of those with coronary calcification would not be captured by the new guidelines as statin eligible. That indicates that calcium scoring could be used to further improve our ability to identify people at truly high or low risk for cardiovascular events."