Review update of Trilipix (fenofibric acid) and the ACCORD Lipid trial

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  • 1. Review update of Trilipix(fenofibric acid) and the ACCORD Lipid trialNicolas BERNARDFlorent ZOONEKYNDDecember 2nd,2011

2. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM258120.pdf 3. Action via PPAR : Increase lipoprotein liposis Stimulation of -oxydation Increase removal of LDLparticules Increase HDL productionPharmacological consequences : Reduce TG Increase HDL-C Variable effects on LDL-C 4. ACCORD = Action to Control Cardiovascular Risk inDiabetes Study began in 2001 and took place in 77 clinical sitesacross United States and Canada. Three clinical trials, which tested different treatmentapproaches to determine the best ways to decrease thehigh rate of major CVD events in patients with type 2diabetes :ACCORD blood sugar trialsACCORD blood pressure trialsACCORD lipids trialshttp://www.nhlbi.nih.gov/health/prof/heart/other/accord/q_a.htm#questions 5. Fenofibrate + simvastatin VS simvastatin + placebo 5518 patients with modest degree of dyslipidemia(2765randomized to fenofibrate) Primary Outcome: First occurrence of a majorcardiovascular event (nonfatal MI, nonfatalstroke, cardiovascular death) Mean duration of follow up was 4.7 years 6. http://www.nejm.org/doi/full/10.1056/NEJMoa1001282#t=articleResults 7. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM258121.pdf 8. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM258120.pdf 9. FDA is requiring the manufacturer of Trilipix toconduct a clinical trial to test the hypothesis thatTrilipix in combination with a statin versus statin alonesignificantly reduces the incidence of major adversecardiovascular events in high-risk men and women whoare at their LDL cholesterol goal on statin therapy, buthave residually high triglycerides and low HDLcholesterol. 10. Additional Information for Patients Trilipix has not been shown to lower patients risk of having a heartattack or a stroke. Patients should not stop taking their Trilipix medicine without firstconsulting with their healthcare professional. Patients should discuss the benefits and risks of taking Trilipix with theirhealthcare professional. Patients should read the Medication Guide that they get along with theirTrilipix prescription. Patients should talk to their healthcare professional if they have anyquestions or concerns about Trilipix. Patients should report serious side effects from the use of Trilipix to theFDA MedWatch program, using the information in the "Contact Us" boxat the bottom of this page. 11. Additional Information for Healthcare Professionals Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shownto reduce coronary heart disease morbidity and mortality in patientsin two large randomized controlled trials of patients with type 2diabetes mellitus. Healthcare professionals should consider the benefits and risks ofTrilipix when deciding to prescribe the drug to patients, and counselpatients about those benefits and risks. Healthcare professionals should encourage patients to read theMedication Guide they receive along with their Trilipix prescription. Healthcare professionals should report adverse events involvingTrilipix to the FDA MedWatch program using the information in the"Contact Us" box at the bottom of this page. 12. http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089806.pdf