Cardiovascular Drug Development: Protocol Design and Methodology

edited by Jeffrey S. Borer
and John C. Somberg

These multidisciplinary presentations provide information essential to devising effective drug protocols in cardiovascular drug development, facilitating the approval process.

Guides researchers and developers through the government drug approval process, facilitating development, minimizing costs, and "harmonizing" international standards employed in the creation of vital new cardiovascular therapies!

Features:

• Explores the delicate balance of efficacy and safety that cardiovascular therapy must achieve to gain regulatory approval
• Discusses the search for surrogates and the need in some areas for natural history endpoints
• Reviews optimum strategies for protocol design in the development of drugs to treat hypertension, cardiac arrhythmias, heart failure, coronary artery disease, and hypercholesterolemia and other lipid disorders
• Compares and contrasts the varying standards of evidence for drug approval in the United States, Europe, and Asia
• And more!

Cardiovascular Drug Development is a valuable asset for cardiologists, pharmacologists and pharmacists, regulatory affairs specialists, and directors of research and development for pharmaceutical companies.

Contents

1. Introduction
   • Drug Discovery and Development

2. Development of Congestive Heart Failure Therapy
   • Background Therapy in Congestive Heart Failure Studies
   • Congestive Heart Failure Trial Design
   • Angiotensin-Converting Enzyme Inhibitors for Mortality Reduction in Congestive Heart Failure: Should Approval Be
   • Granted for a Class Effect?
   • Sudden Death in Congestive Heart Failure Trials
   • Panel Discussion

3. Development of Antihypertensive Therapy
   • Antihypertensive Clinical Trials
   • Calcium Channel Blockers: Safety Issues
   • Panel Discussion

4. Development of Antiarrhythmic Drug Therapy
   • Antiarrhythmics: Indications, Claims, and Trial Design
   • Supraventricular Tachycardia Drugs and Trial Design Issues
   • Antiarrhythmic Trials: Update
   • Inter-Ethnic Differences in the Susceptibility to Drug-Induced QT Interval Prolongation and Torsade de Pointes
   • Panel Discussion

5. Development of Antilipid and Anti-Ischemic Therapy
   • Antilipid Trial Endpoints
   • Natural History Endpoints and Angina Trials
   • Development of Antiplatelet Drugs
   • Panel Discussion

6. Conclusion
   • Future Directions of Cardiovascular Drug Development

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