Dan, I called 0.5% "iffy". When I mentioned the 1% in the ERGO press release, I indicated that it was an invalid number. It was obtained by comparing a subset of patients who received the drug (the top 60%), with the entire group receiving the placebo. That is not a vaild comparision. The top 60% of those receiving the drug can be compared to the top 60% receiving the placebo, but not to the entire group. The "responders" can also be compared to their own baseline, and such a comparision produces 0.6% to 0.7% drop in Hb1Ac. Similar numbers are obtained when the whole group receiving the drug is compared to the whole group receiving the placebo. In one study, such a comparision was very borderline in the "statistically significant" category, which was another reason I called it "iffy" (it was below 0.05, but not below 0.01, which is what the FDA likes to see).
Of course these iffy numbers were better that the type II numbers generated by Pramlintide, so I agree that AMLN might be happy to see such an improvement. From an investor and patient standpoint, the ability to synergize with existing oral compounds such as sulfonylureas is a decided plus. In such a combination, Rezulin acheived a 2.7% reduction. Ergoset, when combined with sulfonylureas, failed to improve on the weak numbers generated in the monotherapy study. I don't think that AMLN has started such a combination approach.
Of course I also indicated that in the TZD class, Rezulin may be the weakest. The poster to the diabetes board indicated that Pioglitizone worked very well for her and it was taken at a much lower dose (15 to 30 mg instead of 200 to 600 mg). She also thought that it would be on the market next year, so the type II market may be pretty stiff by then. Targretin, in animal and in vitro studies, is on a par with the 2nd generation TZDs such as Pioglitizone. Moreover, the rexinoids have been shown to synergize with the two most clinically advanced 2nd generation TZDs, Pioglitazone and BRL49653.
P.S. Your linker worked just fine. As long as you include http:// before the link and leave a space on either side of the URL, the link will be created automatically. The data in the press release you linked indicates:
"The average HbA1c reduction for the combination Rezulin-sulfonylurea patients was 2.7 percentage
points compared to micronized glyburide alone and the average reduction for the Rezulin-insulin
combination patients was 1.3 percentage points compared to insulin alone"
(which is markedly better than 0.35% to 0.7% for dugs used alone or in combination with sulfonylureas). |
