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The 30-day results were presented at ESC from the JUMBOTIMI-26 trial. Prasugrel, which Lilly licensed from Sankyo, is Concern over the liver elevations dominated a review of a novel thienopyridine P2Y12 antagonist. The data looked previously presented pooled SPORTIF data. An investigator good. made several interesting comments about Exanta: It is likely that monthly liver testing more frequently if However, several questions were raised that deserve continued ALT is elevated and discontinuation if ALT reaches watching: 5xULN will be required until and unless the five-year 1. Bleeding. At the highest dose of prasugrel, there was an Exanta data indicate the liver elevation problem subsides increase in minor bleeding, but it wasn't statistically with time. He implied but did not specifically say that significant. A speaker said, "Over time, we noted an monthly testing will be the recommendation of regulators, increase in this type of bleeding in the follow-up period." "Monthly testing has to be done. I can't see using it any other way." 30-Day Results of JUMBO-TIMI-26 Trial of Prasugrel The five-year data will not be ready to present to the Exanta FDA Plavix All Prasugrel Prasugrel Prasugrel Prasugrel 300 mg LD 40 mg LD 60 mg LD 60 mg LD Measurement advisory panel on September 10, 75 mg MD 7.5 mg MD 10 mg MD 15 mg MD 2004, and he wouldn't say when it n 600 n 250 n 200 n 200 n 250 will be available. Safety Results He estimated that about 6% of 2.0% * Primary endpoint: 1.2% 1.7% 1.5% * 1.6% * patients experience elevated ALT Significant non-CABG ; p .77` with Exanta, and 2.8% have bleeding through Day 30 elevations 5xULN. 0.8% 0.5% * 0.5% * 0.4% * Major bleeding p .62 Exanta can be neutralized by 3.6% 4.1% 3.5% * 3.5% * 5.1% * Major, minor, and minimal FEIVA. He said, "It is a p .54 bleeding possibility, but reversing coagulaEfficacy Results tion means increasing the risk of 9.4% 7.2% 7.5% * 7.5% * 6.8% * Secondary endpoint: coagulation, and FEIVA almost MACE at 30 days p .31 never is used in the clinic. It has 7.9% 5.7% 7.0% * 6.5% * 4.0% * MI at 30 days turned out to be unnecessary." p .23 In the pooled SPORTIF data, ALT 0.6% 1.0% * 0.5% * 0.4% * 2.4% Target vessel thrombosis elevation is higher in the elderly. p .03 However, he warned, "It is wise to 3.5% 1.7% 1.5% * 1.5% * 2.0% * Recurrent ischemia p .09 remember we did the subanalysis on different ages, and the efficacy 0 0.5 0 0 0.5 Death p .56 was more favorable in the elderly * No statistically significant difference from Plavix than in patients younger than 75 years old.
The present study was carried out in February March 2005 at AstraZeneca R&D, Mlndal, Sweden AZ ; , as a test of the QPatch 16 automated patch-clamp system. Human ether--go-go related gene hERG ; potassium channels, expressed in Chinese hamster ovary CHO ; cells were targeted with Reference compounds: 10 known hERG inhibitors Test compounds: 20 in-house compounds developed by AstraZeneca blind test ; IC50 values and Hill coefficients determined in the study were compared to corresponding values previously determined at AZ with conventional manual patch-clamp technique. MATERIALS AND METHODS Cells and culturing procedures CHO cells generation 10-25 ; expressing hERG channels were cultured in F12 HAM medium supplemented with 10% FBS and 1% Hygromycin B all from Gibco BRL ; in culture flasks. Prior to experiments the cells were detached by trypsinization Trypsin EDTA, 10X, Gibco ; , and subsequently kept in fresh culture medium CHO-S-SFM II serum-free, low protein-formulation, with L-glutamine Gibco , with 0.25% soy bean trypsin inhibitor Sigma ; , and 2.5% HEPES buffer solution, w: 238, 3 g L prepared in distilled water, Gibco. Prior to an experiment the cells in suspension were spun down and washed twice in extracellular Ringer's solution. Ringer's solutions Cells suspended in extracellular Ringer's solution were applied to the sixteen measurement units in the QPlate. The extracellular Ringer's solution consisted of in mM ; 145 NaCl, 4 KCl, 2 CaCl2, 1MgCl2, 10 HEPES pH 7.2 ; , osmolarity 295-305 mOsm. The intracellular Ringer's solution consisted of in mM ; 120 KCl, 5.37 CaCl2 free [Ca2 + ] 100 nM ; , 1.75 MgCl2, 10 HEPES, 10 KOH EGTA pH 7.4 ; , osmolarity 285-296 mOsm. 4 mM Na2-ATP was added shortly before use. Compounds The reference compounds were from Sigma except azimilide, d-sotalol, dofetilide, and MK-499, which were synthesized at AstraZeneca. 100 mM stock solutions DMSO ; were prepared. The twenty test compounds were synthesized at AZ. Ten mM stock solutions in DMSO or methanol in the case of flecainide ; were prepared. Reference and test compounds were diluted to final concentrations immediately prior to experiments. Compound solutions were kept in glass microtitre plates to avoid non-specific binding to polymer materials. Four compound concentrations were employed for characterization of each concentration-response relationship. Voltage protocol Whole-cell currents were measured in response to continuously executed voltage protocols. Initially, cells were maintained at a holding potential Vh ; of -90 mV see below ; . Upon onset of the voltage protocol cells were maintained at Vh for 80 ms, then clamped briefly to -50 mV 20 ms ; , subsequently depolarized to 20 mV for 1920 ms, and finally repolarized to -50 mV at which potential the peak outward tail current was measured within the interval 5-80 ms after the voltage shift. The complete protocol lasted 4000 ms. Upon completion of a voltage protocol, V was maintained at Vh for 6000 ms. Thus, voltage protocols were executed each 10 seconds.

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