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Research Letter |

ω-3 Fatty Acid Supplements for Secondary Prevention of Cardiovascular Disease: From “No Proof of Effectiveness” to “Proof of No Effectiveness”

Andrea Messori, PharmD1; Valeria Fadda, PharmD1; Dario Maratea, PharmD1; Sabrina Trippoli, PharmD1
[+] Author Affiliations
1Health Technology Assessment (HTA) Unit, Ente dei Servizi Tecnici di Area Vasta (ESTAV) Toscana Centro, Regional Health Service, Florence, Italy
JAMA Intern Med. 2013;173(15):1466-1468. doi:10.1001/jamainternmed.2013.6638.
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In patients who have experienced cardiovascular events, ω-3 fatty acid supplements do not seem to be beneficial.1 However, there is not universal agreement on this conclusion.13 On the one hand, after examining the data of 14 randomized placebo-controlled studies, the meta-analysis by Kwak et al1 found no reduction in cardiovascular events (risk ratio, 0.99; 95% CI, 0.89-1.09) as well as no improvement in other relevant end points. On the other hand, the aforementioned meta-analysis has been criticized because 2 positive randomized studies4,5 were excluded owing to their open-label design and no administration of placebo; furthermore, a query of clinicaltrials.gov (run on March 5, 2013) indicates that 8 trials, registered on this website, are presently under way, thus confirming that the effectiveness of ω-3 fatty acid supplements is still thought to be an open question.

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Trial Sequential Analysis: Analysis of 14 Randomized Placebo-Controlled Trials

In the z curve (represented by grey dashed line), individual trials correspond to individual segments; trials are plotted in chronological order (from left to right). The x-axis indicates the cumulative number of patients; the starting point of the z curve is always at x = 0, ie, inclusion of no trials. At the cumulative number of 9343 included patients, the curve has already crossed the green boundaries and is in the futility area. The analysis estimates that at least 9775 patients would be the optimal information size to reach a conclusion in terms of superiority or inferiority or futility. The blue lines indicate the boundaries for superiority or inferiority; and green lines, the boundaries for futility. T indicates treatment group (receiving ω-3 fatty acid supplements); C, controls.

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