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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: Frostman who wrote (9247)	6/5/1998 6:24:00 PM
From: DaiS	Read Replies (2) \| Respond to of 23519

Frostman, I am embarrassed to say that I made an error. I just realised that the numbers do not add up in step 1. Sorry, I have to look again - can anyone see the problem. DaiS

To: Frostman who wrote (9247)	6/5/1998 7:01:00 PM
From: DaiS	Read Replies (1) \| Respond to of 23519

Frostman or anyone, below is the abstract I still cannot see it. OK, There were 115 men and 27% got success Thus 115 x 0.27 = 31 successes Therefore 115-31 = 84 failures, these must have failed on 250ug Of these, 84 x 0.17 = 14 then succeeded on 500ug Then 4 of 10 failing on 500ug subsequently succeeded on 1000ug Thus the number succeeding overall is 4 + 14 + n = 31 n = 13, this must be the number succeeding on 250ug But then 13 + 84 not equal to 115 (credit to lpmost on the yahoo thread for pointing this out). So, can we get it by assuming that some men dropped out during the experiment and/or more than 115 started - I'll look? Weird abstract. Sorry the balls up after shooting my mouth off - that'll teach me. DaiS ***** 115 men aged 64.8ñ10.6 with regular sexual partner were treated in a manner patterned after the initial NEJM report. They were in general well educated with 50.9%. college and 28.9% postgraduate education. Self rating of genera health resulted in a mean of 8.1 (scare from 1-10), and of sexual function in a mean of 3.5 (1-10). Status post prostatectomy and diabetes were the most common etiologies. In-office treatment with increasing doses of MUSE were conducted with self-rating of penile rigidity (1-5, 4 and 5 being sufficient for intercourse) and level of comfort (1-5) as well as blood pressure checks in 15 min intervals. RESULTS: Peak rigidities were achieved at 30 min with means of 2.6 (250 mcg), 2.4 (500 mcg), and 2.9 (1000 mcg). Only 27% of pts achieved rigidity sufficient for intercourse despite being challenged to the highest dose. Of those pts who failed on 250 mcg, 17% achieved a level 4 or 5 with 500 mcg, and of those 10 failing on 500 mcg only 4 achieved such level with 1000 mcg. Discomfort was maximal at 15 min with means of 3.5 (250 mcg), 3.7 (500 mcg), and 4.2 (1000 mcg). Blood pressure decreased significantly at 15 and 30 min. and orthostatic hypotension (decrease by >20 mmHg at 30 min) occurred in 6.%. Penile pain and burning with 41% each were the most common adverse events, followed by dizziness (14%). There was no significant interaction between mean rigidity scores and age or etiologies. Most disappointing is the fact that at follow-up only 18.6% of pts continue the use of the MUSE system, while the majority have chosen alternative treatment forms, citing disappointment with the results and cost as the most important reasons for dicontinuation

To: Frostman who wrote (9247)	6/5/1998 8:23:00 PM
From: DaiS	Respond to of 23519

Frostman, Panic over I hope. It can work with 18 dropouts after step one, but it is not necessary to assume this. This is the revised analysis. I made mistake to assume that because 27% or 31 men were successful then 115-31 = 84 men failed at the lowest dose. In fact more could fail. Step 1: They took 115 men and tested with 250ug muse. They had 9 successes and 106 failures (8% success on 250ug muse) Step 2: They tested the 106 failures with 500ug muse. They had 17% or 18 successes and 88 failures (20% success with up to and including 500ug muse) Step 3: They then tested only 10 of these 88 failures with 1000ug muse. They had 4 successes and 6 failures (10/115 is 9% as in the Vivus press release) An adjusted overall success rate for up to and including 1000ug muse can be obtained, ((9 + 18 + (4/10 x 88))/115 x 100 = 54% Allowing dropouts there are a range of possibilitites including the one I posted earlier. This above solution is obtained by solving the 3 simultaneous equations 4+x+y=31 x=0.17N N+y=115 where, N becomes 106 above, x becomes 18 and y becomes 9. If I made a mistake this time I will look a real fool, but it's bedtime now I'll check tomorrow. DaiS