To: Edderd who wrote (8077 ) 5/15/1998 10:03:00 AM From: MissLil Read Replies (1) | Respond to of 23519
The New England J of Medicine article does not look too bad for Vivus. There's a fair amount of hand waving in this article. First, in all fairness, there are some positives for Viagra. The pill does seem to work for many men in the study. There is a dose-response relationship. 68% of the men continued into the open label phase of the study. Of these, 92% completed the 32 week extension study (63% of the original group.) Minimal side-effects were reported. The good news for Vivus (if they take advantage of it) is that 32% did not continue into the long term study. Some probably did not need the drug once they either got their confidence back or, perhaps, their function improved. However, the fairly large number of subjects who did not continue using a FREE drug for sex suggests that it just didn't work for them. This population is the market for Vivus, assuming Vivus can actually market, of course. In addition, Muse + Viagra is a likely combination, so the other 2/3s of the market is not necessarily lost. The unsuccessful subjects probably have underlying physiology that is not likely to be treated by Vasomax either. Here's the hand-waving part: Who are the patients? We all know that men with vascular disease and diabetes are the most likely to have difficulty. However, out of 532 men in the dose-response study, only 28 had diabetes (5%) and only 16 (3%) had a history of "ischemic heart disease." Despite this, the authors said that "70%" had organic dysfunction. They never describe how organic dysfunction was measured but reference another article. The referenced article is a consensus statement which (I have not looked at it) is likely to have reasonably vague statements about what organic dysfunction is. So we still don't know what the patient population is, but this is not a population of men likely to have serious ED problems. Men were excluded only for "poorly controlled diabetes" or for heart attacks within the previous six months or using nitrates. The dose response increases with higher doses with no leveling off at the highest dose. This suggests that the response may be better with even higher doses and increases the likelihood that patients will use higher doses themselves. Viagra will of course sell more but the side effects of higher doses have not been tested. Incidentally, the FDA approval said that there was not much cross-reactivity between this drug and other related compounds that are known to cause life-threatening heart problems. I read between the lines and think that this is based on biochemistry, not on people, but it does imply that the risk of serious arrhythmias is low. We'll see soon as many men are apparently testing the drug. Vivus should now market to physicians: "If Viagra doesn't work"