Your Vioxx Lawyer - Vioxx, Celebrex & Bextra FDA Transcript

Your Vioxx lawyer provides you the complete transcript of the February 16^th, 2005 joint meeting of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. We have formatted the complete transcript of the three day conference for easy of navigation to provide you with the best possible vioxx information. To contact a Vioxx Lawyer, click here for a FREE case evaluation.

AFTERNOON PROCEEDINGS

DR. WOOD: Merck has a couple of slides they wanted to show to address the blood pressure issue that came up in the previous discussions. So, let's go ahead and do that first quickly.

DR. REICIN: The first was in relation to the issue about congestive heart failure, which is a known side effect of all NSAIDs and COX-2 inhibitors and is reflected in their labeling. Since the only data we showed was from APPROVe, we had an expected difference from placebo but if you look at this slide you see that in our OA database the incidence of congestive heart failure was low, and it was generally similar to ibuprofen. You can see that it ranged from 0.1 to 0.4 percent on rofecoxib; 0.4 percent on ibuprofen; and 0.8 percent on diclofenac--so, generally similar to the NSAID comparators. I will acknowledge that there was one epidemiologic study that suggested that the rate was higher on rofecoxib.

DR. WOOD: But the data in the APPROVe study are up to 1.5 in the rofecoxib group, and this is for serious heart failure--congestive heart failure, pulmonary edema. Right?

DR. REICIN: It was versus placebo. The rate was higher in that study than we have seen in other studies.

DR. WOOD: Right. But it is not a question of whether it is against placebo or not. The underlying rate is much higher.

DR. REICIN: The rate was higher in that study. We didn't see it as high in our other studies.

The other slide, 232--it was a question about whether rofecoxib had effects on blood pressure that were very different than the other NSAIDs. This was a study done in elderly patients. It was not an ambulatory blood pressure study but blood pressure was measured in these patients 4 times a day. If you look, rofecoxib 25 mg was compared to celecoxib 200 mg BID. That is the highest recommended chronic dose for both of these medications. The medications at that dose had similar inhibition of COX-2. We compared it also with naproxen 500 BID and placebo, and I think you can see that the changes in systolic blood pressure and diastolic blood pressure are similar among the active treatments and greater than placebo.

DR. WOOD: Okay. Thanks very much. These are helpful comments. Are there any questions specifically and only on these two things? Steve?

DR. NISSEN: Could you show us the use of antihypertensive agents in the two arms of APPROVe? I would be interested in seeing if there was a difference in use of antihypertensive drugs. I am also interested--you know, these mean changes are useful but it is also useful to know the fraction of patients that had sustained increases of, say, 15 mm or more because that is the kind of level of increase that would constitute a substantial risk. So, I am interested in use of antihypertensive drugs and I am interested in the number of people who had greater than a 15 mm sustained increase in each arm.

DR. NORGAN: Kevin Norgan, Merck. The use of antihypertensive drugs in the APPROVe study, at baseline it was approximately 30 percent. It was 30 percent in one treatment group and 29 percent in the other treatment group. Then, during the course of the study the numbers increased to approximately 40 percent in the rofecoxib group and approximately 35 percent in the placebo group. The actual numbers are in the publication that is on the Internet. DR. NISSEN: And was that difference statistically significant?

DR. NORGAN: I don't recall. I think it was but we would have to check.

DR. WOOD: Then 25 patients dropped out because of hypertension versus 7 in the placebo group. Right? So, that should be added to the number that actually ended up on antihypertensives in the APPROVe study.

DR. NISSEN: What about the issue of the 15 mm or greater? Do you have any data on that? Bob Temple, isn't that something you guys like to look at in the FDA, the sort of 15 mm outlier group?

DR. TEMPLE: I don't know. I think we look at mean just as often. DR. NISSEN: All right, but I would like to know because I didn't see that.

DR. REICIN: We will get back to you later with that data, Dr. Nissen. DR. WOOD: That being the case, let's move on to the next presentation which is from the FDA.

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