Bayer Ag · XETR:BAYN
Bayer — Technical Presentation (August 2017)
10 slides from Bayer's technical presentation, Aug 28, 2017
Slide 1: Investor Conference Call
Investor Conference Call Data from the Phase III COMPASS trial, A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease August 28, 2017
Slide 2: Cautionary Statements Regarding Forward-Looking Information
Cautionary Statements Regarding Forward-Looking Information This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual
Slide 3: Key Findings
- Key Findings The combination of rivaroxaban 2.5 mg bid + aspirin 100 mg od compared to aspirin 100 mg od alone showed a 24% relative risk reduction in major adverse cardiovascular events showed an unprecedented 42% relative risk reduction in stroke and an 22% relative risk reduction in cardiov
Slide 4: Objective and Study Design
- Objective and Study Design Objective: To determine the efficacy and safety of rivaroxaban, rivaroxaban plus ASA or ASA alone for reducing the risk of MI, stroke and cardiovascular death in CAD or PAD patients Rivaroxaban 2.5 mg bid + ASA 100 mg od ± pantoprazole‡ N=27,395 30-day Rivaroxaban 5 mg b
Slide 5: Key Inclusion and Exclusion Criteria
- Key Inclusion and Exclusion Criteria Key inclusion criteria# Key exclusion criteria‡ PAD Stroke ≤1 month or any haemorrhagic or lacunar CAD with ≥1 of: stroke Age ≥65 years Severe HF with known ejection fraction <30% or NYHA class III or IV symptoms Age <65 years plus atherosclerosis i
Slide 6: Main Study Outcomes
- Main Study Outcomes Primary efficacy outcome Primary safety outcome Composite of MI, stroke or cardiovascular death Modified ISTH major bleeding fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, Secondary efficacy outcomes intraocul
Slide 7: Primary Efficacy Outcome and Components
- Primary Efficacy Outcome and Components 2.5 mg rivaroxaban bid + 100 mg aspirin od vs. 100 mg aspirin od p-value* HR** (95% CI) MI, stroke, or CV death <0.001 0.76 (0.66-0.86) MI 0.14 0.86 (0.70-1.05) Stroke <0.001 0.58 (0.44-0.76) CV death 0.02 0.78 (0.64-0.96) MI myocardial infarction; CV cardio
Slide 8: Secondary Efficacy Outcomes and Components
- Secondary Efficacy Outcomes and Components 2.5 mg rivaroxaban bid + 100 mg aspirin od vs. 100 mg aspirin od p-value* HR** (95% CI) MI, ALI, ischemic stroke, CHD death <0.001 0.72 (0.63-0.83) MI, ALI, ischemic stroke, CV death <0.001 0.74 (0.65-0.85) MI myocardial infarction; CV cardiovascular; ALI
Slide 9: Primary Safety Outcome
- Primary Safety Outcome 2.5 mg rivaroxaban bid + 100 mg aspirin od vs. 100 mg aspirin od p-value* HR** (95% CI) Modified major ISTH bleeding <0.001 1.70 (1.40-2.05) Fatal 0.32 1.49 (0.67-3.33) Non-fatal symptomatic intracranial 0.77 1.10 (0.59-2.04) Non-fatal, non-intracranial, symptomatic bleeding
Slide 10: Overall Summary and Conclusion
- Overall Summary and Conclusion The combination of rivaroxaban 2.5 mg bid + aspirin 100 mg od compared to aspirin 100 mg od alone significantly reduced the relative risk for the primary composite of stroke, myocardial infarction and cardiovascular death increased the risk of ISTH modified major