Table 48

Evidence addressing key question 2 for statin plus omega-3 fatty acids versus statin monotherapy comparison

OutcomesEvidence availabilityKey points of evidence synthesis
Patients attainting ATP III LDL-c targetsNo
LDL-cYesIn one trial in a population requiring intensive lipid lowering therapy, no significant difference was noticeable (MD -4.60, 95% CI -16.32, 7.12). Compared with monotherapy, in mixed populations, significantly smaller reduction in LDL-c concentrations with omega-3 plus statin combination than statin monotherapy, (MD 5.26 %; 1.79 %, 8.74 %).
HDL-cYesIn one trial in a population requiring intensive lipid lowering therapy, no significant difference were noticeable (MD 1.80; 95% CI -5.61, 9.21). Compared with monotherapy, in mixed populations, significantly greater increase in HDL-c concentrations with omega-3 plus statin combination than statin monotherapy, (MD 5.31 %; 95% CI 3.16, 7.45).
TC:HDL ratioYesIn one trial in a population requiring intensive lipid lowering therapy, no significant difference were noticeable (MD -0.41; 95% CI -1.43, 0.61). Compared with monotherapy, in mixed populations, significantly smaller reduction in LDL-c concentrations with omega-3 plus statin combination than statin monotherapy, (MD -7.77 %; 95% CI -10.27, -5.27).
CIMTNo
Treatment AdherenceNo
Total adverse eventsYesCompared with monotherapy, no significant difference was observed for the outcome in mixed populations (OR 1.11; 95% CI 0.82, 1.51). Long-term trials favored monotherapy over combination (OR 1.22; 1.14, 1.31)
Withdrawal due to adverse eventsYesCompared with monotherapy, no significant difference was observed for the outcome (OR 1.09; 95% CI 0.22, 5.52).
Elevated serum AST and/or ALT > 3 times ULN and/or hepatitisYesNo significant difference in the incidence observed for the outcome as there was no reported incidence in either group
MyalgiaNo
CPK > 10 times ULNYesNo reported incidence in either group
RhabdomyolysisYesNo reported incidence in either group

Abbreviations: ALT = alanine transferase, AST = aspartate transferase, ATP III = Third Adult Treatment Panel of the National Cholesterol Education Program, HDL-c = high density lipoprotein cholesterol, LDL-c = low density lipoprotein cholesterol, TC = total cholesterol

From: 3, Results

Cover of Comparative Effectiveness of Lipid-Modifying Agents
Comparative Effectiveness of Lipid-Modifying Agents [Internet].
Comparative Effectiveness Reviews, No. 16.
Sharma M, Ansari MT, Soares-Weiser K, et al.

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