AstraZeneca's Epanova (omega-3-carboxylic acids) was approved by the FDA for the treatment of adults with severe hypertriglyceridemia; two new studies support the concept that there can be too much of a good thing when it comes to exercise; and the FDA has issued a new statement recommending against the use of aspirin to prevent a first heart attack or stroke in people with no history of cardiovascular disease.
FDA Approves New Medication for Severe Hypertriglyceridemia
straZeneca’s Epanova (omega-3-carboxylic acids) was approved by the FDA for the treatment of adults with severe hypertriglyceridemia. It is indicated as an adjunct to diet to reduce triglyceride levels in adults with triglyceride levels greater than or equal to 500 mg/dL.
Epanova is the first prescription omega-3 to be approved in the form of a free fatty acid, and to have a dosing option as small as 2 capsules once daily. (Epanova is dosed either 2 grams [2 capsules] or 4 grams [4 capsules] once daily.) It is taken with or without food.
Epanova is going to be further studied in combination with statin therapy in patients with mixed dyslipidemia who are at increased risk of cardiovascular disease.
In some patients Epanova increases low-density lipoprotein (LDL) cholesterol levels; LDL should thus be monitored periodically during Epanova therapy. In patients with hepatic impairment, ALT and AST levels should be monitored periodically. The drug should be used with caution in patients with known hypersensitivity to fish and/or shellfish. For further prescribing information, consult product labeling.
Exercise: Is Too Much of a Good Thing Possible?
wo new studies support the concept that there can be too much of a good thing when it comes to exercise.
In a study in the May 14, 2014, online issue of Ute Mons, MD, and colleagues at the German Cancer Research Center in Heidelberg found that those who participated in daily strenuous physical activity had an increased risk of dying from cardiovascular causes.1 In their study of over 1000 subjects with stable coronary heart disease they also confirmed previous findings of an increased risk of adverse events among inactive patients. Dr Mons and colleagues found a reverse J-shaped association of physical activity, especially with cardiovascular mortality. “Both inactive and daily-active patients had increased hazards of mortality compared with the reference group of patients who were active 2 to 4 times per week, but with the hazards being highest in the inactive-patient group,” they wrote.
A second study in the same issue of , by Nikola Drca, MD, of Karolinska University Hospital, Stockholm, Sweden, and fellow investigators found that men who exercised more than 5 hours per week when they were aged 30 years had a significantly higher risk of developing atrial fibrillation (AF) later in life compared with men who exercised less.2 The study followed over 44,000 men aged 45 to 79 years, and used a questionnaire that assessed the time spent on physical activity at 15, 40, and 50 years of age. After 12 years, the men who exercised more than 5 hours per week at age 30 years had a relative 19% higher risk of developing AF than 30-year-olds who exercised less than an hour per week. This risk persisted regardless of whether exercise was continued. Men who exercised more than 5 hours per week at age 30 but later stopped exercising had a relative 49% higher risk of developing AF compared with those who exercised less at age 30 and also quit exercising.
The study also found that older adults who walked or rode bicycles for approximately 1 hour per day had a significantly lower risk of AF compared with older adults who almost never participated in recreational physical activity.
Though both studies are limited by the use of self-reported measurements of physical activity, they raise important clinical questions, according to an editorial accompanying the studies.3 The results in the Mons et al study of patients with ischemic heart disease runs opposite to what is known, write Drs. Eduard Guasch and Liuis Mont of the University of Barcelona, Spain. “An increase in all-cause mortality in the most active groups is the most challenging outcome of the study,” they note. It remains unknown why some people develop ill effects when engaged in regular training whereas others remain unaffected, the editorial continues. “Exercise intensity, as well as the type of exercise, is clearly a major determinant.”
1. Mons Y, Hahmann H, Brenner H. A reverse J-shaped association of leisure time physical activity with prognosis in patients with stable coronary heart disease: evidence from a large cohort with repeated measurements. 2014; doi:10.1136/heartjnl-2013-305242.
2. Drca N, Wolk A, Jensen-Urstad M, Larsson SC. Atrial fibrillation is associated with different levels of physical activity levels at different ages in men. 2014; doi:10.1136/heartjnl-2013-305304.
3. Guasch E, Mont L. Exercise and the heart: Unmasking Mr Hyde. 2014. doi:10.1136/heartjnl-2014-305780.
FDA Recommends Against Aspirin for Primary Prevention of Heart Attack and Stroke
he FDA has issued a new statement recommending against the use of aspirin to prevent a first heart attack or stroke in people with no history of cardiovascular disease.
The agency said its review of available data does not support the use of aspirin for primary prevention of a heart attack or stroke, and noted that aspirin use is associated with serious risks, including an increased risk of bleeding in the brain and stomach.
However, the FDA continues to support the use of aspirin for secondary prevention for those with cardiovascular disease or those who have had a previous heart attack or stroke. The available evidence still supports the use of aspirin for secondary prevention, the FDA statement notes, and the known benefits of aspirin outweigh bleeding risk.
The FDA said it issued the recommendation at this time because the agency recently denied a request submitted by Bayer HealthCare, LLC, requesting a change in the professional labeling for aspirin to allow its marketing for prevention of heart attacks in patients with no prior history of cardiovascular disease. The FDA waited for results of studies over the past several years to see if studies supported the use of aspirin for primary prevention, and studies did not demonstrate a benefit.
For more information, visit www.fda.gov/drugs/resourcesforyou/consumers/ucm390574.htm.