Table of Contents
Timothy Fagan, M.D. Professor of Medicine and Associate Professor of Pharmacology University of Arizona, Tucson, Arizona
Hemodynamics
Syncope
Non-Cardiogenic Etiologies of Syncope
Evidence for Non-Cardiogenic Etiology
Evidence for Non-Cardiogenic Etiology
Distribution of Syncopal Events for all UprimaŽ Studies
Comparison of Syncope Patients vs. Non-Syncope Patients
Comparison of Prodrome* in Syncope vs. Non-Syncope Patients
Syncope: 2 and 4 mg
Uprima Development - Patient Safety
Summary of Syncope at 2 - 4 mg
Syncope Conclusion
Hemodynamics
Definition of Mean Maximum Decrease in Blood Pressure
Vital Signs and Hypotension in the Phase III Studies
Mean Maximum Decrease from Baseline in Blood Pressure
2 mg Arm Mean Change from Baseline in Systolic and Diastolic Blood Pressure
4 mg Arm Mean Change from Baseline in Systolic and Diastolic Blood Pressure
Mean Changes in Supine Systolic Blood Pressure Comparison of UprimaŽ to ViagraŽ
Adverse Event of Hypotension
Phase III Hypotension Summary
Diabetes Study M97-804
Mean Maximum Decrease from Baseline in Blood Pressure
Diabetes Safety Conclusion
Hemodynamics
Nitrate Interaction Study M98-930
Antihypertensives and Nitrates Study
UprimaŽ Antihypertensives and Nitrate Interaction Studies
Patients Taking Nitrates
Nitrates Plus UprimaŽ 5 mg Mean Maximum Decrease from Baseline in Blood Pressure
Short-Acting Nitrates Mean Change from Baseline in Systolic and Diastolic Blood Pressure
Long-Acting Nitrates Mean Change from Baseline in Systolic and Diastolic Blood Pressure
Short-Acting Nitrates Changes in Systolic Blood Pressure Comparison of UprimaŽ to ViagraŽ
Short-Acting Nitrates Changes in Diastolic Blood Pressure Comparison of UprimaŽ to ViagraŽ
Long-Acting Nitrates Changes in Standing Systolic Blood Pressure Comparison of UprimaŽ to ViagraŽ
Long-Acting Nitrates Changes in Standing Diastolic Blood Pressure Comparison of UprimaŽ to ViagraŽ
Nitrate Interaction Conclusion
Antihypertensive Interaction Study M98-930
Antihypertensives Plus UprimaŽ 5 mg Mean Maximum Decrease from Baseline in Blood Pressure
Antihypertensive Interaction Conclusion
Hemodynamics
History of Alcohol Interaction
Ethanol Interaction Studies M98-838 & M98-891
Ethanol Interaction Studies
Ethanol Interaction Studies
Ethanol Plus UprimaŽ 6 mg Mean Maximum Decrease from Baseline in Blood Pressure
Mean Change from Baseline in Systolic Blood Pressure
Mean Change from Baseline in Diastolic Blood Pressure
Mean Change from Baseline in Systolic Blood Pressure
Mean Change from Baseline in Diastolic Blood Pressure
Possibly Related Treatment-Emergent Adverse Events ɱ% in UprimaŽ (6 mg) Plus Ethanol (0.3 and 0.6 g/kg)
Patient Instructions in Phase III Trials
Related Treatment-Emergent Adverse Events ł10%
Ethanol Interaction Conclusion
Ethanol Interaction Conclusion (cont.)
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