1 / 14

AGGRENOX TM Safety

AGGRENOX TM Safety. Kenneth Rakowski, MD. Head, Drug Surveillance and Information Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, Connecticut. Are there any particular safety concerns with the use of AGGRENOX TM ?. Safety Profile of AGGRENOX TM Summary. No unexpected adverse effects

newman
Download Presentation

AGGRENOX TM Safety

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. AGGRENOXTM Safety Kenneth Rakowski, MD Head, Drug Surveillance and Information Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, Connecticut

  2. Are there any particular safety concerns with the use of AGGRENOXTM?

  3. Safety Profile of AGGRENOXTMSummary • No unexpected adverse effects • Expected adverse effects are establishedfor the two components • Benefit/risk is favorable

  4. On-Treatment Adverse Events With an Incidence in the AGGRENOXTM Group Exceeding That in the Placebo Group by 1% or More Individual Treatment Group Placebo DP Alone ASA Alone AGGRENOX™ Body System/Preferred Term (%) (%) (%) (%) Total No. of Patients 1649 1654 1649 1650 Total No. of Patients With ³1 AE 1304 (79.1) 1305 (78.9) 1323 (80.2) 1319 (79.9) • Central & Peripheral Nervous 49.8 53.9 50.6 55.1 System Disorders • Headache 32.9 38.3 33.8 39.2 • Gastro-Intestinal System Disorders 36.4 41.8 37.7 43.7 • Dyspepsia 16.7 17.4 18.1 18.4 • Abdominal pain 14.5 15.4 15.9 17.5 • Nausea 14.1 15.4 12.7 16.0 • Diarrhea 9.8 15.5 6.8 12.7 • Vomiting 7.2 7.8 6.1 8.4 • Melena 0.8 0.6 1.2 1.9 • Platelet, Bleeding & Clotting Disorders 5.3 4.4 7.7 7.9 • Hemorrhage NOS 1.5 1.5 2.8 3.2 • Purpura 0.4 0.5 0.5 1.4 • Red Blood Cell Disorders 0.7 1.0 1.3 1.8 • Anemia 0.5 1.0 1.2 1.6

  5. Incidence of Most Common Adverse Events Associated With Treatment Cessation Treatment Groups Placebo DP ASA AGGRENOX™ % % % % • Total Number of Patients 1649 1650 1649 1654 • Patients With at Least One AEAssociated With Treatment 21 25 19 25 • Cessation • Headache 4 10 3 10Dizziness 4 6 4 5Nausea 3 6 3 6Abdominal pain 3 4 3 4Dyspepsia 3 4 3 4Vomiting 1 3 2 3 • Diarrhea <1 2 <1 2Stroke 4 3 3 2Transient ischemic attack 3 2 2 2Angina pectoris 2 1 <1 1Myocardial infarction 1 <1 <1 <1

  6. Potential Interactions • Drug-Disease • No clinically significant differences • Drug-Demographics • No clinically significant differences

  7. Laboratory Analyses • No clinically significant effects in any group • Hematology, indices of kidney function, presenceof abnormal or normal liver function, fasting glucose, total cholesterol, LDL cholesterol assessed

  8. Common Adverse Events of DP and ASA Confirmed by Factorial Analysis Factorial AnalysisSignificantP-Values Body System/ DP Main ASA Preferred Term Effect Effect • Headaches <0.001 • Gastro-Intestinal Events <0.001 • Nausea 0.009 • Diarrhea <0.001 <0.001 • Vomiting 0.027 • Bleeding Events <0.001 • Ulcers 0.059

  9. Incidence of On-Treatment Adverse Events (³1%)Bleeding Events and Ulcers Treatment Group Placebo DP ASA AGGRENOXTM (%) (%) Alone (%) (%) • Total No. of Patients 1649 1654 1649 1650 • Total No. of Patients 1304 (79.1) 1305 (78.9)1323 (80.2) 1319 (79.9)With ³1 Adverse Event • Bleeding Events 92 (6) 94 (6) 160 (10) 171 (10) • Epistaxis 25 (1.5) 16 (1.0) 45 (2.7) 39 (2.4) • Purpura 7 (0.4) 8 (0.5) 9 (0.5) 23 (1.4) • Melena 13 (0.8) 10 (0.6) 20 (1.2) 31 (1.9) • GI hemorrhage 7 (0.4) 5 (0.3) 15 (0.9) 20 (1.2) • Rectal hemorrhage 13 (0.8) 22 (1.3) 16 (1.0) 26 (1.6) • Hemorrhage NOS 24 (1.5) 24 (1.5) 46 (2.8) 52 (3.2) • Hematuria 8 (0.5) 13 (0.8) 26 (1.6) 11 (0.7) • Ulcers 14 (0.8) 10 (0.6) 20 (1.2) 19 (1)

  10. Incidence of On-Treatment Serious Adverse EventsBleeding Events and Ulcers Treatment Group Placebo DP ASA AGGRENOXTM (%) (%) Alone (%) Alone (%) Total No. of Patients 1649 1654 1649 1650 Total No. of Patients 560 (34) 467 (28) 529 (32) 454 (28)With ³1 SAE • Intracranial Hemorrhage 5 4 4 4 • Bleeding Events 11 6 17 25 • Melena 4 1 5 11 • Gastrointestinal hemorrhage 1 1 2 7 • Rectal hemorrhage 1 1 1 3 • Hemorrhage NOS 0 1 2 3 • Hematuria 0 2 3 3 • Hematemesis 5 2 4 3 • Gastro-Intestinal Ulcer 2 3 5 7

  11. On-Treatment DeathsBleeding Events and Ulcers Treatment Group Placebo DP ASA AGGRENOX™ (%) (%) (%) (%) Total No. of Patients1649 1654 1649 1650 Total Deaths135 (8) 124 (7) 125 (8) 107 (6) Ulcers or Bleeds2 1 0 5

  12. Safety Conclusions • ESPS-2 clinical data supports the safetyof AGGRENOX™ • No unexpected adverse events observedwith combined use of DP and ASA

  13. Safety Conclusions • DP-related adverse events are primarily headache and gastrointestinal complaints, as expected • ASA-related adverse events are primarily bleeding events, as expected

  14. Safety Conclusions • Serious adverse events of potential clinical significance other than stroke were uncommon • No demographic or disease-related factors identified • Data demonstrate the safety of AGGRENOX™when taken as directed • Benefit-risk of AGGRENOX™ is favorable

More Related