(RxWiki News) The way in which a medication is used can undergo a big shift — a shift that has the potential to affect many Americans. A new study hinted at such a shift in a common cholesterol medication.
Guidelines for use of statins, a type of medication used to lower cholesterol, have recently changed. The authors of a new study looked at how these new recommendations might change statin use in the US.
The researchers found that, based on the new guidelines, an estimated 12.8 million additional adults over the age of 40 may now fall into the group recommended to use statin medications.
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In 2013, the American College of Cardiology and the American Heart Association issued new guidelines for treating cholesterol, which the authors of this new study said potentially expanded how many people are considered eligible to use statin medications to prevent heart disease.
According to the authors of this study, which was led by Michael J. Pencina, PhD, of the Duke Clinical Research Institute at Duke University in Durham, North Carolina, the old guidelines recommended statins for established heart disease, diabetes, certain cholesterol levels and a certain risk level for heart disease.
The new guidelines lowered the cholesterol levels that would call for statin use and suggested that the medications be used in patients with a lower risk level for developing heart disease.
Using data from the National Health and Nutrition Examination Surveys for the years 2005 to 2010, Dr. Pencina and team looked at the surveys of 3,773 participants and used the data to estimate how many of the 115.4 million adults in the US between the ages of 40 and 75 the new guidelines could affect.
After analyzing the data, these researchers estimated that the number of adults in the US who could receive or be recommended for statin use would increase from 43.2 million (37.5 percent of US adults in the age group) under the old guidelines to 56 million (48.6 percent) under the new guidelines — an increase of 12.8 million users.
The majority of this increase (10.4 million adults) would include people without heart disease.
Dr. Pencina and team found big differences based on age. The new guidelines are not expected to drastically change rates of statin use among adults between the ages of 40 and 59, as 27 percent of adults in this age group were eligible under the old guidelines and 29.7 percent would be eligible under the new guidelines.
However, adults between the ages of 60 and 75 saw a much bigger change. Among this age group, the eligibility for statin use would increase from 47.8 percent to an estimated 77.3 percent.
Among US adults between age 60 and age 75 who are not currently using statins and do not have heart disease, the percentage who would be considered eligible for statins under the new guidelines would increase from 30.4 percent to 87.4 percent of men and from 21.2 percent to 53.6 percent of women.
It is important to note that Dr. Pencina and team's estimate of 12.8 million increased potential statin users is a "net" finding. The researchers first found that an estimated 14.4 million new users would now be eligible, but that 1.6 million adults who were previously eligible under the old guidelines would no longer fit in with the recommended requirements.
It is also important to remember that the study's findings were based on results from a fairly small sample size being estimated for a large population.
"Recommendations are just that — recommendations," said Dr. Pencina in a Duke University Medical Center press release. "These guidelines correctly call for a thorough discussion between the doctor and patient about the risks and benefits of statins. It's not like everybody who meets the guidelines should all of a sudden go on statins."
"The new ACC-ACH statin guidelines could see clinicians prescribing these medications to a much larger percentage of the population," said E. Lee Carter, RPh, Clinical Pharmacy Specialist at the Department of Veterans Affairs in Prestonsburg, Kentucky. "The researchers from Duke estimate that as many as 12.8 million more patients could be eligible for statin therapy under the new guidelines."
According to Carter, "Most new statin use would be prescribed for patients without current cardiovascular disease. Patients (mainly older adults) who present with a higher 10-year risk for developing cardiovascular problems would be now considered for possible statin therapy under the new guidelines. Although normally well tolerated by most patients, statins are not benign medications. Some risks and potential side-effects of statins include myopathies (muscle pain and/or weakness ranging from mild to severe) up to more serious side-effects such as rhabomyolysis and kidney failure."
Carter added, "If patients are concerned about their cardiovascular health, they should discuss whether statins are appropriate for them with their healthcare provider or pharmacist."
The analysis was published online March 19 in The New England Journal of Medicine. No conflicts of interest were reported.