As just seen in Safeway: the front cover of the July Oprah magazine trumpets the line "New Diet Drugs" - Rimonabant is mentioned as such and is characterized as the most highly anticipated new generation diet drug. We would concur - very highly anticipated - the sanofi PR machine is impressive. We pause, however, over side effect profile, particularly related to CNS, and we'll be eager to see more data on this front. At one of the posters at ADA, we asked about side effects related to depression - it struck us that depression was high compared to placebo (especially since depression was an exclusion criteria in these trials). One of the authors said depression wasn't as high as 5% "or anything like that" - so if 1% of overweight or obese patients with diabetes took the drug - call it, 110,000 (assuming a denominator of 11 mm overweight or obese PWD, basically 90% of type 2s and 10% of type 1s) people - so if there were more than zero but fewer than 110,000 more clinically depressed people around, would that be okay? Rhetorical, yes, mmm.
We digress. We won't know more 'til we see more data and certainly it is wonderful to hear about effective new drugs - but this is the Vioxx era so of course, even more these days, we look at side effect profile first and last and all the way through the middle.
The Oprah piece also mentioned a "safer" fen/phen that Arena Pharmaceuticals is developing - we know this as APD356, which is said to stimulate the 5-HT2C serotonin receptor more selectively (less noise) than fenfluramine and dexfenfluramine. Speaking of side effects, Fen-phen, aka appetite suppresents previously marketed by Wyeth, were withdrawn from the market in 1997, due to cardiovascular side effect profile (heart valve disease and pulmonary hypertension). At their height, sales apparently reached ~$400 million, according to the WSJ, and the slope of the curve was still pretty steep at that stage. Back on Arena. They announced Phase 2 results around the time of the AACE meeting in May - basically the 15mg dose (the highest dose) prompted a 3 pound weight loss over 28 days, compared to a 0.7 - 0.9 pound weight loss in placebo and the lower two doses. In the highest dose, 20% had headaches and 7% had nausea, compared to 14% and 4%, respectively, in the placebo arm. Next, the company will do a three-month Phase 2b trial - we'll look for results late this year.
Nice and informative post.
Where can I find more information about depression,especially about atypical depression?
Posted by: steven davies | 10/26/2007 at 09:03 AM