ABSTRACT
Dr. Borer (Moderator): Dr. Lipicky, in discussing the approval of an intravenous drug for use in heart failure you said that if the drug is being developed only as an intravenous preparation, you need to show mortality and/or morbidity benefit for approval. I’d like to ask you to discuss this a bit because it seems to me that the benefit you really need to show is that you can get to the next step of the management plan, that is, the patient can survive long enough to have a transplant or long enough to have another surgical procedure or long enough to take another drug. What kind of mortality or morbidity benefit were you specifically thinking of?
Dr. Lipicky: Those things that you said. If one could demonstrate that the intravenous drug served as an effective bridge to the next stage in management, this would clearly be a morbidity or mortality benefit. I’d be satisfied with even less than that. For example, consider the circumstance of open heart surgery and coming off the pump. Just coming off the pump isn’t enough, but something significant happening during the in-hospital stay would be enough, for example, surviving to be intubated or to be off intravenous balloon counterpulsation. We have contemplated and, I believe, agreed with one sponsor, that a shorter time in the postop ICU might be regarded as a clinical benefit, provided that the patient left the hospital. These type of endpoints are viable.
