1 / 101

The PREDIMED trial

The PREDIMED trial. JAMA 2008;299:2437. PREDIMED TRIAL. Rationale Funding sources Methods and intervention protocol Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) Cross-sectional assessments: Diet & inflammatory markers (Eur J Clin Nutr 2007)

winifred-buck
Télécharger la présentation

The PREDIMED trial

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. The PREDIMED trial

  2. JAMA 2008;299:2437

  3. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) • Cross-sectional assessments: • Diet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

  4. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) • Cross-sectional assessments: • Diet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

  5. Evolution of designs High High Randomized Trial Cohort Nested case - control Quality of evidence Quality of evidence Case - control Ecological ( cross - cultural, international comparisons ) Low Low

  6. Mediterranean Food pattern • Rapidly increasing evidence • Increased Longevity • Prevention of • CV mortality • Cancer mortality • CVD incidence • Metabolic syndrome • Diabetes • Dementia • Depression • Highly palatable! • Scarcity of large randomized trials

  7. Int J Epidemiol 2006;35:1417-22. BMJ 2008;336:1348 SUN BMJ 2008;337:a1344 Mediterranean Food pattern • Rapidly increasing evidence • Increased Longevity • Prevention of • CV mortality • Cancer mortality • CVD incidence • Metabolic syndrome • Diabetes • Dementia • Depression • Highly palatable! • Scarcity of large randomized trials

  8. de Lorgeril M, Salen P, Martin JL, et al. Final Report of the Lyon Diet Heart Study. Circulation 1999;99:779-785.

  9. Eur J Epidemiol 2004;19:9-13. • What is the MeDiet? • Olive oil as the main added lipid • Unrestricted Total Fat • MUFA-rich diet in the intervention group • Low consumption of meat / meat products • and what it is NOT the MeDiet • Margarine, soybean oil, mustard oil...

  10. de Lorgeril et al. Lyon trial. Circulation 1999;99:779-785. • Diet assessed in • ~30% of control • ~50% of experimental No biochemical confirmation of adherence. Trial stopped after 27 months. Low number of observed endpoints (14 vs. 44).

  11. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) • Cross-sectional assessments: • Diet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

  12. Funding agency Network RD 06/0045 www.isciii.es Consortium (CIBER-OBN)

  13. Funding History # centers Network RD 06/0045 Initial Network Consortium ciberobn

  14. Centers • 11 RECRUITMENT GROUPS • Navarra- MA Martinez-Gonzalez • Valencia- D Corella • Reus- J Salas-Salvado • Mallorca- M Fiol • Sevilla- J Lapetra • Málaga- E Gomez-Gracia • Barcelona-1- R Estruch • Vitoria- F Aros • Barcelona-2- MI Covas • Las Palmas- L Serra-Majem • Barcelona-3- X Pinto • 8 ONLY-LAB GROUPS • Barcelona-1- E Ros • Sevilla- V Ruiz-Gutierrez • Barcelona-2- RM Lamuela-Raventos • Navarra- JA Martinez • Valencia- G Saez • Barcelona-3- MT Mitjavila • Mallorca- JA Tur • Vitoria- MP Portillo

  15. Funded by network (RD 06/0045) • 6 RECRUITMENT GROUPS • Navarra- MA Martinez-Gonzalez • Valencia- D Corella • Reus- J Salas-Salvado • Mallorca- M Fiol • Sevilla- J Lapetra • Málaga- E Gomez-Gracia • Barcelona-1- R Estruch • Vitoria- F Aros • Barcelona-2- MI Covas • Las Palmas- L Serra-Majem • Barcelona-3- X Pinto • 7 LAB-ONLY GROUPS • Barcelona-1- E Ros • Sevilla- V Ruiz-Gutierrez • Barcelona-2- RM Lamuela-Raventos • Navarra- JA Martinez • Valencia- G Saez • Barcelona-3- MT Mitjavila • Mallorca- JA Tur • Vitoria- MP Portillo ~750,000 $/yr

  16. Funded by consortium (ciberobn) • 5 RECRUITMENT GROUPS • Navarra- MA Martinez-Gonzalez • Valencia- D Corella • Reus- J Salas-Salvado • Mallorca- M Fiol • Sevilla- J Lapetra • Málaga- E Gomez-Gracia • Barcelona-1- R Estruch • Vitoria- F Aros • Barcelona-2- MI Covas • Las Palmas- L Serra-Majem • Barcelona-3- X Pinto • 1 LAB-ONLY GROUP • Barcelona-1- E Ros • Sevilla- V Ruiz-Gutierrez • Barcelona-2- RM Lamuela-Raventos • Navarra- JA Martinez • Valencia- G Saez • Barcelona-3- MT Mitjavila • Mallorca- JA Tur • Vitoria- MP Portillo ~1 M $/yr

  17. Food industry: only food items Provision of Olive oil ~2 000 l/wk Provision of nuts 30 kg/wk walnuts 15 kg/wk almonds ~125,000 $/yr ~350,000 $/yr

  18. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) • Cross-sectional assessments: • Diet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

  19. All free of CVD at baseline Random PREDIMED TRIAL: DESIGN • Men: 55-80 yr • Women: 60-80 yr • High CV risk without CVD type 2 diabetics 3+ risk factors • Smoking • Hypertension •  LDL •  HDL • Overweight/obes • Family history

  20. PREDIMED Participants • 11 RECRUITMENT GROUPS • Navarra- MA Martinez-Gonzalez • Valencia- D Corella • Reus- J Salas-Salvado • Mallorca- M Fiol • Málaga- E Gomez-Gracia • Barcelona-1- R Estruch • Sevilla- J Lapetra • Vitoria- F Aros • Barcelona-2- MI Covas • Las Palmas- L Serra-Majem • Barcelona-3- X Pinto

  21. Project Leader: Dr. Ramón Estruch E Ros Clinic, Barcelona R Estruch Clinic, Barcelona E Gomez-Gracia Univ Málaga

  22. PREDIMED Participants

  23. PREDIMED: primary end-point Either: • cardiovascular death • myocardial infarction • stroke

  24. PREDIMED: Secondary end-points • total mortality • heart failure • major cancers • diabetes • dementia • We will also ascertainintermediate outcomes: • blood pressure (BP) • fasting blood glucose • lipid profile • markers of inflammation • other markers of CVD

  25. Virgin olive oil PREDIMED: intervention Introduce changes in the overall food pattern • Mediterranean diet: 2 groups • Total Fat: ad libitum • High in • MUFA (virgin olive oil) • Fish • Fruits, vegetables, legumes • Low in meats & dairy • alcohol permitted: wine • Low-fat diet - Control • Reduce every fat • Increase CHO • No Energy limitation tocopherols polyphenols flavonoids phytosterols

  26. Ann Intern Med 2006;145:1-11 Appendix, table 1 (on-line) 14-point score • Olive oil main culinary fat 8. Wine >=3 glasses/wk • Olive oil >=4 tablespoons/d 9. Legumes >=3/wk • Vegs>=2 serv./d 10. Fish & seafood >=3/wk • Fruits>=3 serv./d11. Cakes, sweets <3/wk • Red meats<1/d 12. Nuts >=1/wk • Butter, marg, cream<1/d 13. Poultry> red meats • Soda drinks<1/d14. Sofrito

  27. Strategies for behavior change • Repeated personal contacts: every 3-mo • Group sessions: every 3-mo • Holistic approach • Written information • Self-monitoring • Individualized goal-setting • Quick feedback • Individual motivational interviews (every 3-mo) • adapted to the patient’s features • clinical condition • preferences • beliefs • expressed in servings/d to improve understanding

  28. 1 l/week 30 g/day Strategies for behavior change-2 • Additional strategies • Seasonal buying lists • Menus and recipes • Only in the 2 MeDiet groups • Provision of key food items for free

  29. Special emphasis • Negotiated goal setting • Contracted agreement • Understandable: units=servings • Options for the negotiation • Serving size • Frequency of consumption • Way of cooking

  30. Group sessions

  31. Projected follow-up = 6 years (median)

  32. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo(Ann Intern Med 2006) • Cross-sectional assessments: • Diet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

  33. 3-mo changes Ann Intern Med 2006;145:1-11

  34. 3-mo changes in RF • 772 participants (55-80 yr) • Randomization: • 257 to a MeDiet + (free provision of olive oil) • 258 to a MeDiet + (free provision of nuts) • 257 to a LFD (control group) • Follow-up: 3 months • Nutrient profile and food items consumption • Mediterranean score (14-point score) • Classical risk factors • Novel risk factors (CRP, IL6, VCAM, ICAM)

  35. 3-mo changes in RF

  36. 3-mo changes in diet

  37. 3-mo changes in Risk Factors p<0.001 p=0.048 p<0.001 p=0.001 p<0.001 p=0.006

  38. 3-mo changes in Risk Factors p<0.001 p=0.017 p<0.001 p=0.022 p=0.039

  39. 3-mo changes in Risk Factors p<0.001 p<0.001 p=0.37 p=0.002 p<0.001 p=0.84

  40. 3-mo changes in Risk Factors

  41. 3-mo changes in Risk Factors

  42. 3-mo changes in Risk Factors

  43. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) • Cross-sectional assessments: • Diet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

  44. Salas-Salvado et al, Eur J Clin Nutr 2008;62:651-9

  45. Salas-Salvado et al, Eur J Clin Nutr 2008;62:651-9 • 339 men and 433 women (55-80 yr) • Exposure: • Food groups (137-item FFQ) • MeDiet adherence (14-point score) • Outcomes: • hs-C Reactive protein • interleukin-6 (IL-6) • intracellular adhesion molecule-1 (ICAM-1) • vascular cell adhesion molecule-1 (VCAM-1)

  46. Salas-Salvado et al, Eur J Clin Nutr 2008;62:651-9 *Adjusted for age, gender, diabetes, smoking, BMI, educational level, use of statins, NSAID, and aspirin. **Test for linear trend (multivariate adjusted)

  47. 8 IL-6 (pg/ml) CRP (mg/l) 7 6 5 4 3.59 3.51 3 3.18 2 1 0 <7 7 to 10 >10 MeDiet score (0-14) Salas-Salvado et al, Eur J Clin Nutr 2008;62:651-9

  48. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) • Cross-sectional assessments: • MeDiet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

  49. All of them together Sánchez-Tainta, et al. Eur J Cardiovasc Prev Rehabil. 2008;15:589-93. • 3204 participants • Exposure: MeDiet (14-point score) • Adherence: Above Median (9) in the score • Ordered categories (5) in the score • Outcomes: • Diabetes • Hypertension • Obesity • Hypercholesterolemia

  50. MeDiet (>Median) and prevalence of Risk Factors Sánchez-Tainta, et al. Eur J Cardiovasc Prev Rehabil. 2008;15:589-93. Adjusted for age, gender, leisure-time physical activity (tertiles), smoking (5 categories), marital status (4 categories), educational level (4 categories), and BMI (3 categories, except when using obesity as outcome).

More Related