Carvedilol

Carvedilol (Coreg/Kredex/Dilatrend) is commonly referred to as a ‘third generation beta blocker’ that has a complex pharmacological profile, including non-selective beta-adrenergic and alpha-1 adrenergic receptor blocking actions, anti-oxidant activity and other properties. Carvedilol is the first beta blocker approved for treatment of all forms of congestive heart failure (mild, moderate, severe). Since its introduction, carvedilol has rapidly become the standard of care for the management of heart failure. The registration of carvedilol for heart failure treatment has broken old medical dogmas through strong scientific evidence, both pre-clinical and clinical. Carvedilol was approved for heart failure indication following a long and difficult saga of scientific, medical, business and regulatory issues within and outside the sponsoring company. This review of the case history of carvedilol's development in heart failure highlights the complex interpersonal, emotional, legal and political struggles that often govern and impact drug discovery and development. It also demonstrates the importance of personal and team ethics and a commitment to follow the direction of firm scientific evidence in order to overcome deeply rooted beliefs, fears and prejudices. We hope that this account of carvedilol's development for the treatment of congestive heart failure will explain the struggles that pharmaceutical scientists encounter in the drug discovery and development environment. This story is about the scientific team that lead the discovery and development of carvedilol, followed the direction of high quality science, stood firm in their belief in the benefits of the drug and the scientific process, openly expressed their scientific opinions and most importantly, sought support from visionary leaders who were willing to take calculated risks to provide an innovate new therapy that changed the paradigm of medicine with respect to the treatment of congestive heart failure.