Stroke Treatment Saves Lives -- In-Depth Doctor's Interview

Ivanhoe Broadcast News Transcript with
Joseph Broderick, M.D., Neurologist,
University of Cincinnati, Cincinnati, Ohio,
TOPIC: Stroke Treatment Saves Lives

How common and deadly is a hemorrhagic stroke?

Dr. Broderick: A hemorrhage stroke makes up for about 10 percent of all strokes, which means there are going to be about 70,000 or so persons in the United States every year who will have a hemorrhage. It's a terrible type of stroke though in that 40 percent to 45 percent of the patients who have a hemorrhage are dead at a month, and only about 20 percent of the patients have any kind of independent function in a year. This is by far the deadliest type of stroke.

What treatment options are there right now for these patients?

Dr. Broderick: Well, they're very sick, so we do a lot of things for them, but we do not have a scientifically proven treatment for hemorrhage. We often put tubes down their throat to help patients breathe, and we give medications for their blood pressure which is often very high. But the point is, none of the things we do have any evidence that they really make a difference in terms of how the patients do.

What happens to patients when they have this type of stroke? Are they bleeding into the brain?

Dr. Broderick: Right. When somebody has bleeding in the brain, they often look like somebody who has a blockage kind of, ischemic, stroke. They will often complain of one side of the body being weak or numb, and they may have a little bit of a headache, but what differentiates them from the blockage kind of stroke is that the patients go from being pretty bad to terrible within an hour or two. That quick progression means being able to talk and being able to have a little weakness in one side to going into a coma within an hour or two. That's pretty characteristic of a hemorrhage.

Do they bleed into their brain for only a short time?

Dr. Broderick: Back in the 1980s and 1990s when we were first studying hemorrhage here in Cincinnati, everyone thought the bleeding occurred over just a few minutes, three or four minutes, and it was all done. What happened was we began to study these patients within the very first hours when they had their hemorrhage, and we repeated the picture an hour later for examination and found many of them had ongoing growth in their bleeding in the first couple hours, and that was the reason they were getting worse. What this meant is that since the bleeding growth was the problem, if we had a therapy that could stop the bleeding, then that could make a difference for these patients.

What is NovoSeven, and who is it used for right now?

Dr. Broderick: NovoSeven is an activated factor seven which is one of the clotting factors of proteins in our blood that a body uses to help stop bleeding and to make clots. Right now it's used for people who have problems with bleeding because they have a deficiency in one of these factors, and these people are hemophiliacs.

Why is it thought that NovoSeven may work for stroke patients?

Dr. Broderick: We knew that it would stop bleeding in people who had hemophilia and who did not have enough of the factor. What we didn't know is whether or not people who presumably had enough factors and who had bleeding, either because a blood vessel broke or because somebody hit them on the head, whether or not this drug also helped stop the bleeding in those cases. We didn't know the answer to that, and that's why we have to do research to understand that.

How was that study done?

Dr. Broderick: The study was designed to treat people very soon after they had bleeding in their brain. So in the study, patients had to have the drug started within four hours of when the onset of symptoms began, and people had to have the brain image done within the first few hours after the onset of symptoms. This is the time period we knew, from our study in Cincinnati, when the bleeding is continuing, and we have an opportunity to stop the bleeding. But let's say you're at eight or 10 hours after the onset of symptoms, well it's most likely then that most of the bleeding is over, and so giving a drug that stops bleeding probably is not going to do you much good.

So, it is very important to get this drug to these patients early on?

Dr. Broderick: Yes. If this drug is approved, it will be something that will be used very much in some respects like tPA, in that we would use it very soon, within the first several hours after onset of their stroke symptoms.

What is the difference between tPA and NovoSeven?

Dr. Broderick: They really do opposite things. In a stroke, you have a blood clot that forms in the artery, and it's blocking the blood flow to the brain. What tPA does is it helps stimulate the blood to help break up the blood clot and reestablish the blood flow. Here, it's the opposite. You have an artery that has burst, and it's oozing blood. NovoSeven helps accelerate the clot to form around the hole and plug the leak.

When you did this study, what did you find with the patients? What improvement did they see?

Dr. Broderick: First of all, the study was designed to see what the right dose should be, and so they actually tested three different doses compared against a placebo. They found it actually did slow the bleeding down, and the patients did better. They were less likely to have a bad outcome and more likely to have a good outcome.

Is NovoSeven being used in the United States right now for this?

Dr. Broderick: It's not being used. If NovoSeven is being used in this country, it's being used off-label. In other words, it is used for a non-FDA approved indication. I think some people have used it in the setting where people have had extensive bleeding in the brain or elsewhere, and they want to turn off that bleeding. They have used it in people who have been on anti-coagulants, warfarin (Coumadin) or things like that, but that's been an off-label use, not something that is an FDA-approved use.

Do you think this could change the way these types of strokes are treated?

Dr. Broderick: I think this has a good opportunity to become the treatment that changes the paradigm for intracerebral hemorrhage, to become the first treatment for intracerebral hemorrhage. TPA was really the first treatment for a stroke that made an enormous difference, and it's changed the way we look at and treat stroke patients. This is the drug that changes things for intracerebral hemorrhage. Once you have one treatment, then you also start looking for other treatments that you can add and improve upon, but it has been a very frustrating type of stroke in that we've had no treatment to this point that we know makes a difference.

Where does it stand when it comes to FDA approval?

Dr. Broderick: It's just going through the initial processes. The company will be presenting the data to the FDA, the FDA has to look carefully at it. They may say they want more research and study with it, or they may decide to give some conditional approval, but that's really up to the FDA and their review of the data.

From your point of view and your knowledge of the research, why would you consider this a medical breakthrough for patients, if it becomes available for patients?

Dr. Broderick: The data is convincing enough for me, as an experienced stroke researcher, that it is a true step forward. It really does make a difference for patients who otherwise have miserable and terrible outcomes. However, even if you use this drug, clearly these patients are still going to have very rough roads to go. A lot of them are still going to die, but if you can give something that you know changes the odds in their favor, that's something that's exciting.

Does it come down to the idea that if we could've stopped the bleeding, the patient would not have to go through as challenging a situation?

Dr. Broderick: Yes. That's what it comes down to. It's not just about saving lives, it's that you can have a stroke and survive. Your life can be so devastating and the lives of people around you who have to take care of you can be so changed, that if you can move one of those people from being completely dependent to somebody who can take care of themselves and have a pretty good quality of life, that's every bit as important as saving life.

Is there anything else you want to add?

Dr. Broderick: I really think the National Rehabilitation Hospital (NRH) study that was done and funded in Cincinnati made a huge difference. It made it possible for this type of treatment to be considered. If you thought the bleeding was all done in a couple minutes, you're not even thinking about a treatment like this, but the fact that the bleeding was continuing over several hours, that's when we knew we could look for therapies that could maybe halt the bleeding.

The media has been big in emphasizing the message about the symptoms of stroke and the importance of getting help early, getting to a hospital right away. Are there different symptoms for this type of stroke?

Dr. Broderick: No. They're pretty much the same symptoms. In fact, no matter how good a neurologist or stroke doctor you are, you really don't know if it's the bleeding kind or the blockage kind of stroke without first getting a picture. That's why the picture of the brain is important. Now, patients who have bleeding in the brain are more likely to have headache, but this can also be true for ischemic strokes. They're more likely to vomit, throw up, but so do some patients with ischemic strokes. They're more likely to have very high elevations of the blood pressure, but so do ischemic strokes. While these things help shade you in one direction or the other, none of them are definitive.

This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.

END OF INTERVIEW

This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc., or any medical professional interviewed. Ivanhoe Broadcast News, Inc., assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors in different ways; always consult your physician on medical matters.

If you would like more information, please contact:

Sheryl Hilton
University of Cincinnati Medical Center
3223 Eden Ave., Room 165
Cincinnati, OH 45267-0550
(513) 558-4561
http://www.medcenter.uc.edu