Fatty Acids in Statin Users vs Non-Users With MI History
Fatty Acids in Statin Users vs Non-Users With MI History
Of the 4837 patients who were enrolled in the Alpha Omega Trial, 3740 (77%) patients were consistent statin users and 413 (9%) patients were consistent statin non-users. The remainder of the patients (n= 684, 14%) were starters, stoppers, or inconsistent users of statins and were for this reason excluded from the study. The mean age of all participants was 68.9 ± 5.6 years and 78% were males. The median time since last MI before study entry was 3.7 years (inter-quartile range: 1.7–6.3). For statin users as well as for statin non-users, the four study groups receiving placebo, EPA–DHA only, ALA only, or EPA–DHA plus ALA were similar for most characteristics (Table 1). Among statin users, significant differences between study groups were observed for the use of blood pressure-lowering drugs, triglyceride levels, and consumption of fish. Among statin non-users, significant differences between study groups were observed for the percentage of patients with diabetes mellitus, self-reported stroke, the use of antithrombotic drugs, physical activity, and plasma glucose and serum triglyceride levels.
Table 2 presents the average changes in lipid levels between baseline and 41-month follow-up among statin users and statin non-users, respectively. No significant effects were observed in the groups receiving EPA–DHA only and ALA only. Yet, the combination of EPA–DHA and ALA reduced triglycerides significantly by 0.17 mmol/L in statin users.
No patient was lost to follow-up and hence all patients' data were included in the Cox proportional hazard analysis. During 12 048 persons-years of follow-up, 495 (13%) statin users had a major cardiovascular event. For statin non-users, 1234 persons-years of follow-up were accumulated and 62 (15%) major cardiovascular events occurred. Among statin users, there was no significant difference in the rate of major cardiovascular events between the four groups (Table 3). Supplementation with EPA–DHA only or with ALA only did not reduce major cardiovascular events in statin non-users. However, 9% of the statin non-users who received EPA–DHA plus ALA had a major cardiovascular event during the 41-month follow-up period compared with 18% of the patients in the placebo group. Statin non-users receiving EPA–DHA plus ALA had a 54% lower incidence of major cardiovascular events compared with the placebo group, which was borderline statistically significant (HRadj 0.46; 95% confidence interval: 0.21, 1.01; P= 0.051). The effect of the combination of EPA–DHA plus ALA on major cardiovascular events was borderline statistically significantly different between statin users and non-users (P= 0.057).
Results
Demographic and Health Characteristics of the Patients
Of the 4837 patients who were enrolled in the Alpha Omega Trial, 3740 (77%) patients were consistent statin users and 413 (9%) patients were consistent statin non-users. The remainder of the patients (n= 684, 14%) were starters, stoppers, or inconsistent users of statins and were for this reason excluded from the study. The mean age of all participants was 68.9 ± 5.6 years and 78% were males. The median time since last MI before study entry was 3.7 years (inter-quartile range: 1.7–6.3). For statin users as well as for statin non-users, the four study groups receiving placebo, EPA–DHA only, ALA only, or EPA–DHA plus ALA were similar for most characteristics (Table 1). Among statin users, significant differences between study groups were observed for the use of blood pressure-lowering drugs, triglyceride levels, and consumption of fish. Among statin non-users, significant differences between study groups were observed for the percentage of patients with diabetes mellitus, self-reported stroke, the use of antithrombotic drugs, physical activity, and plasma glucose and serum triglyceride levels.
Effects of n-3 Fatty Acids on Lipid Levels
Table 2 presents the average changes in lipid levels between baseline and 41-month follow-up among statin users and statin non-users, respectively. No significant effects were observed in the groups receiving EPA–DHA only and ALA only. Yet, the combination of EPA–DHA and ALA reduced triglycerides significantly by 0.17 mmol/L in statin users.
Effects of n-3 Fatty Acids on Major Cardiovascular Events
No patient was lost to follow-up and hence all patients' data were included in the Cox proportional hazard analysis. During 12 048 persons-years of follow-up, 495 (13%) statin users had a major cardiovascular event. For statin non-users, 1234 persons-years of follow-up were accumulated and 62 (15%) major cardiovascular events occurred. Among statin users, there was no significant difference in the rate of major cardiovascular events between the four groups (Table 3). Supplementation with EPA–DHA only or with ALA only did not reduce major cardiovascular events in statin non-users. However, 9% of the statin non-users who received EPA–DHA plus ALA had a major cardiovascular event during the 41-month follow-up period compared with 18% of the patients in the placebo group. Statin non-users receiving EPA–DHA plus ALA had a 54% lower incidence of major cardiovascular events compared with the placebo group, which was borderline statistically significant (HRadj 0.46; 95% confidence interval: 0.21, 1.01; P= 0.051). The effect of the combination of EPA–DHA plus ALA on major cardiovascular events was borderline statistically significantly different between statin users and non-users (P= 0.057).
Source...