AHA comment on statin side effects as reported in Time magazine and FDA advisory
DALLAS, March 22, 2010 – A March 19 article in Time Magazine about the use of statins in women and a recent statement from the U.S. Food and Drug Administration (FDA) about the use of simvastatin in men and women have addressed both the benefits and side effects of statin therapy for elevated cholesterol values administered in an effort to reduce the risk of heart disease and stroke. Over the last several decades, deaths due to coronary heart disease and stroke have declined substantially, in part due to the use of important new medical treatments, among which includes statin therapy.
However, an area of appropriate concern is muscle pain or weakness, known as myopathy, a side effect that can be experienced by people taking statins. While uncommon and reversible, myopathy can be a reason to discontinue or reduce the dose of medication, and should be discussed with your healthcare provider.
The American Heart Association reminds patients that controlling cholesterol is critical for preventing coronary heart disease and reducing heart attack and stroke risk. American Heart Association guidelines for reducing the risk of cardiovascular disease and stroke have long recommended a healthy lifestyle and, when indicated, medications for lowering cholesterol, usually including a statin (ACCF/AHA 2009 Performance Measures for Primary Prevention of Cardiovascular Disease in Adults; AHA/ACC Guidelines for Secondary Prevention for Patients With Coronary and Other Atherosclerotic Vascular Disease: 2006 Update). These recommendations are based on the joint guidelines of the National Heart Lung and Blood Institute’s Cholesterol Education Program, in which the association participates. The 2007 Update of the American Heart Association’s Evidence-Based Guidelines for Prevention of Cardiovascular Disease in Women, written with the participation and co-sponsorship of multiple health organizations*, continues to support cholesterol-lowering as an important part of reducing risk of both heart disease and stroke. The scientific publication referred to in the Time article demonstrated that the specific categories of women studied benefited from taking a statin for primary prevention, with a reduction in risk for hospitalizations for unstable chest pain and for important blood vessel operations (surgical or catheterization-based).
Because of the well-documented benefit of cholesterol-lowering with statins, the association advises that patients respect the benefit of statin therapy and only consider discontinuation after a discussion with the appropriate healthcare provider. For the person who experiences myopathy with a statin, other alternatives should be discussed with their physician. Patients who are taking statins and not experiencing any side effects should continue to take their medication unless advised for other reasons to stop by their healthcare provider. Only the very rare side effect of rhabdomyolysis (muscle injury), signaled by dark urine, should lead a patient to stop their statin immediately but then talk promptly with their healthcare provider.
As with all therapies, the decision to use statins for primary or secondary prevention must include careful consideration of the risks and benefits, side-effects and cost. Side effects can vary by dose, by individual, and by the presence of other medical conditions or other medications. Awareness of possible side effects and open communication between patient and provider will allow optimal treatment benefit for each patient.
The FDA alert addresses an increased likelihood of side effects at higher doses (80mg) of the statin Zocor, also known as the generic simvastatin, as well as at lower doses when taken with specific other medications. The FDA recommends that patients be given the minimum effective dosage of that statin to reduce the likelihood of myopathy and rhabdomyolysis, and that healthcare providers be aware of drug-drug interactions when prescribing.
It’s important to note that the benefit of lowering cholesterol is most evident in people who have already had a cardiovascular event, such as a heart attack or stroke. The data for statins as preventive treatment for women who have not had a first event, as described in Time, is still building, but results so far tell us that certain women can benefit from more aggressive therapy to avoid a first heart attack or stroke. Your healthcare provider can tell you if you would benefit.
For more information on preventing heart disease and stroke, visit: www.heart.org/mylifecheck
* Including the American College of Cardiology Foundation, the American Academy of Family Practitioners, the American College of Obstetricians and Gynecologists, American Medical Women’s Association, the American College of Nurse Practitioners, the American College of Physicians, the Association of Black Cardiologists, the Society of Thoracic Surgeons, the Centers for Disease Control and Prevention, the Office of Research on Women’s Health, the World Heart Federation, and the National Heart, Lung, and Blood Institute.
The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.americanheart.org/corporatefunding.