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Twelve months of daily doses of omega-3 fatty acids resulted in substantial improvements in chronic heart failure, according to a randomized, placebo-controlled study of 133 patients with mild to moderate chronic heart failure due to nonischemic dilated cardiomyopathy.
The study, published Jan. 5 in the Journal of the American College of Cardiology, demonstrated improvements in left ventricular ejection fraction, peak oxygen uptake (VO2), exercise duration, and New York Heart Association functional class among patients taking about 5 g of omega-3 polyunsaturated fatty acids (PUFAs) daily for 1 month followed by another 11 months of 2-g daily doses (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/ j.jacc.2010.11.017]).
"These beneficial effects suggest that omega-3 PUFAs may favorably affect cardiac remodeling and the decline of myocardial function in patients with [heart failure (HF)] and may account for the reduction in cardiovascular hospitalizations and hospitalizations for HF observed in our study," wrote Dr. Savina Nodari of the University of Brescia [Italy], and colleagues. "However, whether omega-3 PUFAs exert similar effects in patients with HF caused by other etiologies, at more advanced stages, or who are not receiving evidence-based therapy remains to be verified."
At the end of 12 months, patients taking omega-3 PUFAs experienced a 10.4% average increase in left ventricular ejection fraction, compared with a decrease of 5.0% among patients taking placebo. Peak VO2 increased 6.2% in patients taking omega-3 PUFAs, while decreasing 4.5% among patients taking placebo. Patients taking omega-3 PUFAs showed a 7.5% increase in exercise duration, while those taking placebo showed a 4.8% decrease. Finally, average New York Heart Association (NYHA) functional class decreased from 1.88 to 1.61 in patients taking the active supplement, while patients taking placebo showed an increase in NYHA functional class from 1.83 to 2.14. All these differences were statistically significant.
The difference between the groups in all-cause hospitalizations (27% of the patients in the PUFA group vs. 42% of placebo patients) did not reach statistical significance, but there were significant differences in cardiovascular-related hospitalizations (15% vs 39%) and in HF-related hospitalizations (6% vs. 30%).
The authors stated that there were no serious adverse events in either group, and there were no discontinuations due to noncompliance, as judged by pill counts.
The study was funded by the University of Brescia, Brescia, Italy. One of the study’s coauthors (Dr. Mihai Gheorghiade of Northwestern University, Chicago) acknowledged consulting for, and receiving travel funds from, a number of pharmaceutical and device manufacturers. The other coauthors stated that they had no conflicts.
In an accompanying editorial, Dr. W. H. Wilson Tang and Dr. Michael A. Samara pointed out that a number of other studies have suggested that omega-3 fatty acids may be beneficial in chronic heart failure (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/j.jacc.2010.11.014]). On the other hand, at least one large randomized study, called GISSI-HF, found only modest reductions in the relative risk of all-cause mortality associated with omega-3 fatty acids.
"Although not a prespecified end point with relatively small event rates, the marked reduction in cardiovascular and heart failure hospitalizations in the current study stand in stark contrast to the modest reduction present in GISSI-HF," wrote Dr. Tang and Dr. Samara, both of the Cleveland Clinic. "Although patients in both studies were generally on optimal medical therapy, several contrasts between this study and GISSI-HF are illustrative. First, this study was confined to patients with angiographically proven nonischemic cardiomyopathy as compared with patients in GISSI-HF who may have had heart failure from any etiology. Furthermore, in contrast to GISSI-HF, this study focused on a patient population with less advanced heart failure, having a mean left ventricular ejection fraction of 37% (vs. 33% in GISSI-HF), NYHA functional class I to II symptoms (vs. approximately 40% of patients with NYHA functional class III or IV symptoms in GISSI-HF), and no deaths during the 12 months of follow-up. Predefined subgroup analysis from GISSI-HF suggested a stronger trend favoring [omega-3 polyunsaturated fatty acids (PUFAs)] use in patients with NYHA functional class II symptoms as compared with those with NYHA functional class III to IV symptoms.
"Cumulatively, the previously demonstrated marked benefits observed in the primary prevention of heart failure and the contrasting results of these 2 trials suggest the possibility that omega-3 PUFAs are most effective when introduced early in the course of cardiomyopathy, when they may potentially exert their effects on viable myocardium. This type of divergent effect across the spectrum of heart failure has been proposed for other drugs such as statins, and should [omega-3] PUFA therapy be considered, they should be given prior to advanced stages of heart failure."
Dr. W. H. Wilson Tang and Dr. Michael A. Samara are in the department of cardiovascular medicine, Heart and Vascular Institute, Cleveland Clinic. Dr. Tang acknowledged serving as a consultant for Medtronic Inc. and St. Jude Medical, and receiving research support from Abbott Laboratories. Dr. Samara reported that he had no relationships to disclose.
In an accompanying editorial, Dr. W. H. Wilson Tang and Dr. Michael A. Samara pointed out that a number of other studies have suggested that omega-3 fatty acids may be beneficial in chronic heart failure (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/j.jacc.2010.11.014]). On the other hand, at least one large randomized study, called GISSI-HF, found only modest reductions in the relative risk of all-cause mortality associated with omega-3 fatty acids.
"Although not a prespecified end point with relatively small event rates, the marked reduction in cardiovascular and heart failure hospitalizations in the current study stand in stark contrast to the modest reduction present in GISSI-HF," wrote Dr. Tang and Dr. Samara, both of the Cleveland Clinic. "Although patients in both studies were generally on optimal medical therapy, several contrasts between this study and GISSI-HF are illustrative. First, this study was confined to patients with angiographically proven nonischemic cardiomyopathy as compared with patients in GISSI-HF who may have had heart failure from any etiology. Furthermore, in contrast to GISSI-HF, this study focused on a patient population with less advanced heart failure, having a mean left ventricular ejection fraction of 37% (vs. 33% in GISSI-HF), NYHA functional class I to II symptoms (vs. approximately 40% of patients with NYHA functional class III or IV symptoms in GISSI-HF), and no deaths during the 12 months of follow-up. Predefined subgroup analysis from GISSI-HF suggested a stronger trend favoring [omega-3 polyunsaturated fatty acids (PUFAs)] use in patients with NYHA functional class II symptoms as compared with those with NYHA functional class III to IV symptoms.
"Cumulatively, the previously demonstrated marked benefits observed in the primary prevention of heart failure and the contrasting results of these 2 trials suggest the possibility that omega-3 PUFAs are most effective when introduced early in the course of cardiomyopathy, when they may potentially exert their effects on viable myocardium. This type of divergent effect across the spectrum of heart failure has been proposed for other drugs such as statins, and should [omega-3] PUFA therapy be considered, they should be given prior to advanced stages of heart failure."
Dr. W. H. Wilson Tang and Dr. Michael A. Samara are in the department of cardiovascular medicine, Heart and Vascular Institute, Cleveland Clinic. Dr. Tang acknowledged serving as a consultant for Medtronic Inc. and St. Jude Medical, and receiving research support from Abbott Laboratories. Dr. Samara reported that he had no relationships to disclose.
In an accompanying editorial, Dr. W. H. Wilson Tang and Dr. Michael A. Samara pointed out that a number of other studies have suggested that omega-3 fatty acids may be beneficial in chronic heart failure (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/j.jacc.2010.11.014]). On the other hand, at least one large randomized study, called GISSI-HF, found only modest reductions in the relative risk of all-cause mortality associated with omega-3 fatty acids.
"Although not a prespecified end point with relatively small event rates, the marked reduction in cardiovascular and heart failure hospitalizations in the current study stand in stark contrast to the modest reduction present in GISSI-HF," wrote Dr. Tang and Dr. Samara, both of the Cleveland Clinic. "Although patients in both studies were generally on optimal medical therapy, several contrasts between this study and GISSI-HF are illustrative. First, this study was confined to patients with angiographically proven nonischemic cardiomyopathy as compared with patients in GISSI-HF who may have had heart failure from any etiology. Furthermore, in contrast to GISSI-HF, this study focused on a patient population with less advanced heart failure, having a mean left ventricular ejection fraction of 37% (vs. 33% in GISSI-HF), NYHA functional class I to II symptoms (vs. approximately 40% of patients with NYHA functional class III or IV symptoms in GISSI-HF), and no deaths during the 12 months of follow-up. Predefined subgroup analysis from GISSI-HF suggested a stronger trend favoring [omega-3 polyunsaturated fatty acids (PUFAs)] use in patients with NYHA functional class II symptoms as compared with those with NYHA functional class III to IV symptoms.
"Cumulatively, the previously demonstrated marked benefits observed in the primary prevention of heart failure and the contrasting results of these 2 trials suggest the possibility that omega-3 PUFAs are most effective when introduced early in the course of cardiomyopathy, when they may potentially exert their effects on viable myocardium. This type of divergent effect across the spectrum of heart failure has been proposed for other drugs such as statins, and should [omega-3] PUFA therapy be considered, they should be given prior to advanced stages of heart failure."
Dr. W. H. Wilson Tang and Dr. Michael A. Samara are in the department of cardiovascular medicine, Heart and Vascular Institute, Cleveland Clinic. Dr. Tang acknowledged serving as a consultant for Medtronic Inc. and St. Jude Medical, and receiving research support from Abbott Laboratories. Dr. Samara reported that he had no relationships to disclose.
Twelve months of daily doses of omega-3 fatty acids resulted in substantial improvements in chronic heart failure, according to a randomized, placebo-controlled study of 133 patients with mild to moderate chronic heart failure due to nonischemic dilated cardiomyopathy.
The study, published Jan. 5 in the Journal of the American College of Cardiology, demonstrated improvements in left ventricular ejection fraction, peak oxygen uptake (VO2), exercise duration, and New York Heart Association functional class among patients taking about 5 g of omega-3 polyunsaturated fatty acids (PUFAs) daily for 1 month followed by another 11 months of 2-g daily doses (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/ j.jacc.2010.11.017]).
"These beneficial effects suggest that omega-3 PUFAs may favorably affect cardiac remodeling and the decline of myocardial function in patients with [heart failure (HF)] and may account for the reduction in cardiovascular hospitalizations and hospitalizations for HF observed in our study," wrote Dr. Savina Nodari of the University of Brescia [Italy], and colleagues. "However, whether omega-3 PUFAs exert similar effects in patients with HF caused by other etiologies, at more advanced stages, or who are not receiving evidence-based therapy remains to be verified."
At the end of 12 months, patients taking omega-3 PUFAs experienced a 10.4% average increase in left ventricular ejection fraction, compared with a decrease of 5.0% among patients taking placebo. Peak VO2 increased 6.2% in patients taking omega-3 PUFAs, while decreasing 4.5% among patients taking placebo. Patients taking omega-3 PUFAs showed a 7.5% increase in exercise duration, while those taking placebo showed a 4.8% decrease. Finally, average New York Heart Association (NYHA) functional class decreased from 1.88 to 1.61 in patients taking the active supplement, while patients taking placebo showed an increase in NYHA functional class from 1.83 to 2.14. All these differences were statistically significant.
The difference between the groups in all-cause hospitalizations (27% of the patients in the PUFA group vs. 42% of placebo patients) did not reach statistical significance, but there were significant differences in cardiovascular-related hospitalizations (15% vs 39%) and in HF-related hospitalizations (6% vs. 30%).
The authors stated that there were no serious adverse events in either group, and there were no discontinuations due to noncompliance, as judged by pill counts.
The study was funded by the University of Brescia, Brescia, Italy. One of the study’s coauthors (Dr. Mihai Gheorghiade of Northwestern University, Chicago) acknowledged consulting for, and receiving travel funds from, a number of pharmaceutical and device manufacturers. The other coauthors stated that they had no conflicts.
Twelve months of daily doses of omega-3 fatty acids resulted in substantial improvements in chronic heart failure, according to a randomized, placebo-controlled study of 133 patients with mild to moderate chronic heart failure due to nonischemic dilated cardiomyopathy.
The study, published Jan. 5 in the Journal of the American College of Cardiology, demonstrated improvements in left ventricular ejection fraction, peak oxygen uptake (VO2), exercise duration, and New York Heart Association functional class among patients taking about 5 g of omega-3 polyunsaturated fatty acids (PUFAs) daily for 1 month followed by another 11 months of 2-g daily doses (J. Am. Coll. Cardiol. 2011;57 [doi:10.1016/ j.jacc.2010.11.017]).
"These beneficial effects suggest that omega-3 PUFAs may favorably affect cardiac remodeling and the decline of myocardial function in patients with [heart failure (HF)] and may account for the reduction in cardiovascular hospitalizations and hospitalizations for HF observed in our study," wrote Dr. Savina Nodari of the University of Brescia [Italy], and colleagues. "However, whether omega-3 PUFAs exert similar effects in patients with HF caused by other etiologies, at more advanced stages, or who are not receiving evidence-based therapy remains to be verified."
At the end of 12 months, patients taking omega-3 PUFAs experienced a 10.4% average increase in left ventricular ejection fraction, compared with a decrease of 5.0% among patients taking placebo. Peak VO2 increased 6.2% in patients taking omega-3 PUFAs, while decreasing 4.5% among patients taking placebo. Patients taking omega-3 PUFAs showed a 7.5% increase in exercise duration, while those taking placebo showed a 4.8% decrease. Finally, average New York Heart Association (NYHA) functional class decreased from 1.88 to 1.61 in patients taking the active supplement, while patients taking placebo showed an increase in NYHA functional class from 1.83 to 2.14. All these differences were statistically significant.
The difference between the groups in all-cause hospitalizations (27% of the patients in the PUFA group vs. 42% of placebo patients) did not reach statistical significance, but there were significant differences in cardiovascular-related hospitalizations (15% vs 39%) and in HF-related hospitalizations (6% vs. 30%).
The authors stated that there were no serious adverse events in either group, and there were no discontinuations due to noncompliance, as judged by pill counts.
The study was funded by the University of Brescia, Brescia, Italy. One of the study’s coauthors (Dr. Mihai Gheorghiade of Northwestern University, Chicago) acknowledged consulting for, and receiving travel funds from, a number of pharmaceutical and device manufacturers. The other coauthors stated that they had no conflicts.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Major Finding: Twelve months of daily omega-3 fatty acid supplementation resulted in a 10% improvement in left ventricle ejection fraction, a 6% increase in peak VO2, a 7.5% increase in exercise duration, and significant improvements in New York Heart Association functional class.
Data Source: Randomized, double-blind, placebo-controlled study of 133 patients with mild to moderate chronic heart failure due to nonischemic dilated cardiomyopathy.
Disclosures: The study was funded by the University of Brescia. One study coauthors acknowledged consulting for, and receiving travel funds from, a number of pharmaceutical and device manufacturers. The other coauthors stated that they had no conflicts.