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Presenter Disclosure Information. Jochen Senges. The following relationships exist related to this presentation:. Speaker Compensation Trommsdorff Arzneimittel Modest Level Speaker Compensation Pronova Biopharma Modest Level Institutional Interests Trommsdorff Arzneimittel Significant Level.

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  1. Presenter Disclosure Information Jochen Senges The following relationships exist related to this presentation: Speaker Compensation Trommsdorff Arzneimittel Modest Level Speaker Compensation Pronova Biopharma Modest Level Institutional Interests Trommsdorff Arzneimittel Significant Level

  2. Randomized Trial ofOmega – 3 Fatty Acidson Top of Modern Therapy afterAcute Myocardial Infarction:The OMEGA-Trial Jochen Senges FACCfor the OMEGA Study Group Ludwigsburg 10/06 Annual Scientific Session of the American College of Cardiology 2009 IHF 10/06

  3. Inuit in GreenlandHigh consumption of fish oil

  4. Background • Inconclusive clinical evidence on Ω 3 • Leon BMJ 2008 • Benefit of Ω 3 in patients with: • acute myocardial infarction • on top of optimized guideline therapy ?

  5. Objectives • Effectofomega-3-acid ethylesters 90 (1g daily)(460mg EPA + 380mg DHA) for 1 year • Primary Endpoint • Suddencardiac death • Secondary Endpoints • Total mortality • Reinfarction • Stroke • Arrhythmic Events • Revascularization

  6. Methods (1)

  7. Methods (2) • Inclusioncriteria • Patients 3-14 days after acutemyocardialinfarction • STEMI or NSTEMI • Male andfemale • Age ≥ 18 years • From April 2005: rule 6 of 8 pt: ≥ 70y or EF < 40 % or Diabetes ornorevasc • Exclusioncriteria • Women pregnant, nursingorwithoutcontraception • Hypersensitivitytostudydrugs • Takingotherformulationsoffishoil • Expected Non-compliance

  8. Methods (3) • Assumption: • SCD Placebo: 3.5 % • SCD Ω 3: 1.9 % (↓ 45 % RR GISSI-P) •  Sample size 1,733 pt per group •  3,800 pt total (including 9 % expected Drop-outs) • Publication of study design:Rauch B et al.: „Highly Purified Omega-3 Fatty Acids for Secondary Prevention of Sudden Cardiac Death After Myocardial Infarction – Aims and Methods of the OMEGA-Study.“ Cardiovasc Drugs Ther (2006) 20:365-375. • ClinicalTrials.gov ID: NCT00251134

  9. Enrollment 3,851 patients, randomlyassigned Placebo 1g oliveoiln = 1,911 Receivedallocatedinterventionn = 1,909 Withdrawal IC beforeallocationn = 2 1g omega-3 acidethylesters 90per day n = 1,940 Receivedallocatedinterventionn = 1,937 Withdrawal IC beforeallocation n = 3 Allocation Lost tofollow-up(withregardtoprimary EP) n = 6 i.e. 0.31 % Lost tofollow-up(withregardtoprimary EP) n = 8 i.e. 0.42 % Follow-Up AnalyzedforprimaryEndpoint n = 1,919 (Excluded n=12) AnalyzedforprimaryEndpoint n = 1,885 (Excluded n=16) Analysis Withdrawal / nodata / lost to FU Total 1.1 % Withdrawal / nodata / lost to FU Total 1.4 %

  10. Patient characteristicsAdmission

  11. Acute treatment

  12. Treatment atHospital Discharge

  13. The Omega-Trial Results

  14. Primary EndpointSudden Cardiac Death Mortality Sudden Cardiac Death 10 % 8 % 6 % Primary EP SCD ≤ 365 days Ω 3 = 1.5 % Placebo = 1.5 % p=0.84 chi²-test 4 % 2 %

  15. Secondary Endpoints (1) ≤ 365 days

  16. Secondary Endpoints (2) ≤ 365 days

  17. Triglycerides 1y Follow UpGuideline indication for Ω 3 mg/dl Triglycerides > 150 mg/dl p < 0.01 p < 0.05

  18. SCD in predefinedhigh risk Subgroups favours Ω 3 <OR> favours Placebo

  19. Conclusions • In moderate/high risk AMI patients, strict guideline treatment is associated with a very low rate ofsudden cardiac death: 1.5 % / first year • 1g Ω 3 vs Placebo for 1 year • No significant difference in Primary Endpoint: • Sudden cardiac death: 1.5 % Ω / 1.5 % Placebo • No significant difference in Secondary Endpoints: • Total death, reinfarction, stroke • Progression CAD, arrhythmic events

  20. Limitation • Low rate of sudden cardiac death 1.5 % •  calculated sample size too small (power)! • A-posteriori power calculation •  calculated power 80 % •  realized power ~50 % • No trend favouring Ω 3

  21. The OMEGA – Trial The End

  22. Per Protocol Analysis 0,98 1.20 favours Ω 3 <OR> favours Placebo

  23. Lost to follow-up • Lost to Follow-Up (6 patients Ω3, 8 Placebo) • Worst-case-scenario: • Ω3: 6 patients SCD, Placebo: none  p=0.56 • Placebo: 8 patients SCD, Ω3: none  p=0.23

  24. Reasons for Exclusion from Analysis

  25. Not predefined Events≤ 365 days

  26. Follow Up 1 yearAdherence to Treatment

  27. Antiarrhythmic effectof Ω 3 in dogs Ischemia induced VTs Kang: Circulation 94, 1996

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