Table F-29

Longer-term outcomes (clinical outcomes, serious adverse events and cancer) using omega-3 fatty acid plus statin therapy compared with statin monotherapy

TrialPopulationCombination Statin Dose (mg/day)Combo NMonotherapy Statin Dose (mg/day)Mono NFollow-up (wk)Trial Baseline LDL-c (mg/dL)Combo/mono: number of participants with events Odds ratio (95% CI)AACJadad ScoreITTA
All-cause mortality
Yokoyama (2007)141
JELIS Asia Pharm. Fund Multicenter
Participants with hypercholesterolemia in JapanMixed 5–209326Mixed 5–209319240182286/265 1.08 (0.91, 1.28)yes2yes
Davidson (2007)180
COMBOS trial North America Pharm. Fund Multicenter
Participants with persisting hypertriglyceridemia despite receiving simvastatinSimvastatin 40122Simvastatin 401328910/0yes4no
Nordoy (1998)177
Europe Pharm. Fund Single centre
Participants with combined hyperlipidemia and statin naïveSimvastatin 2021Simvastatin 202051610/0unclear4no
All-cause mortality – 24 weeks or more
Yokoyama (2007)141
JELIS Asia Pharm. Fund Multicenter
Participants with hypercholesterolemia in JapanMixed 5–209326Mixed 5–209319240182286/265 1.08 (0.91, 1.28)yes2yes
All-cause mortality – adequate allocation concealment
Yokoyama (2007)141
JELIS Asia Pharm. Fund Multicenter
Participants with hypercholesterolemia in JapanMixed 5–209326Mixed 5–209319240182286/265 1.08 (0.91, 1.28)yes2yes
Davidson (2007)180
COMBOS trial North America Pharm. Fund Multicenter
Participants with persisting hypertriglyceridemia despite receiving simvastatinSimvastatin 40122Simvastatin 401328910/0yes4no
All-cause mortality – Asian
Yokoyama (2007)141
JELIS Asia Pharm. Fund Multicenter
Participants with hypercholesterolemia in JapanMixed 5–209326Mixed 5–209319240182286/265 1.08 (0.91, 1.28)yes2yes
Fatal Myocardial Infarction – Participants requiring intensive lipid lowering therapy
Durrington (2001)176
Europe Pharm. Fund Single centre
Participants with CHD and persisting hypertriglyceridemia, despite receiving simvastatin.Simvastatin 20–4029Simvastatin 20–4026241490/1 0.12 (0.00, 6.11)unclear3no
Fatal Myocardial Infarction
Yokoyama (2007)141
JELIS Asia Pharm. Fund Multicenter
Participants with hypercholesterolemia in JapanMixed 5–209326Mixed 5–20931924018211/14 0.79 (0.36, 1.72)yes2yes
Durrington (2001)176
Europe Pharm. Fund Single centre
Participants with CHD and persisting hypertriglyceridemia, despite receiving simvastatin.Simvastatin 20–4029Simvastatin 20–4026241490/1 0.12 (0.00, 6.11)unclear3no
Non-fatal myocardial infarction
Yokoyama (2007)141
JELIS Asia Pharm. Fund Multicenter
Participants with hypercholesterolemia in JapanMixed 5–209326Mixed 5–20931924018262/83 0.75 (0.54, 1.03)yes2yes
Any myocardial infarction
Yokoyama (2007)141
JELIS Asia Pharm. Fund Multicenter
Participants with hypercholesterolemia in JapanMixed 5–209326Mixed 5–20931924018271/93 0.76 (0.56, 1.04)yes2yes
Hemorrhagic stroke
Yokoyama (2007)141
JELIS Asia Pharm. Fund Multicenter
Participants with hypercholesterolemia in JapanMixed 5–209326Mixed 5–20931924018249/39 0.42 (0.10, 1.87)yes2yes
Ischemic stroke
Yokoyama (2007)141
JELIS Asia Pharm. Fund Multicenter
Participants with hypercholesterolemia in JapanMixed 5–209326Mixed 5–209319240182115/123 0.93 (0.72, 1.21)yes2yes
Any stroke
Yokoyama (2007)141
JELIS Asia Pharm. Fund Multicenter
Participants with hypercholesterolemia in JapanMixed 5–209326Mixed 5–209319240182166/162 1.02 (0.82, 1.27)yes2yes
Serious adverse events
Davidson (2007)180
COMBOS trial North America Pharm. Fund Multicenter
Participants with persisting hypertriglyceridemia despite receiving simvastatinSimvastatin 40122Simvastatin 401328914/1 4.44 (0.49, 40.29)yes4no
Cancer
Yokoyama (2007)141
JELIS Asia Pharm. Fund Multicenter
Participants with hypercholesterolemia in JapanMixed 5–209326Mixed 5–209319240182242/218 1.11 (0.92, 1.34)yes2yes

From: Appendix F, Included Evidence

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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