Timothy Fagan, M.D. Professor of Medicine and Associate Professor of Pharmacology University of Arizona, Tucson, Arizona

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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.)

Author: Andrea_Poffenberger