Tuesday, May 6, 2014

Beerse, Belgium (ots / PRNewswire) - Results of a predefined interim analysis coughing of a randomi


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Beerse, Belgium (ots / PRNewswire) - Results of a predefined interim analysis coughing of a randomized, placebo-controlled Phase 3 study, COU-AA-301, demonstrated that patients, with the investigational WirkstoffAbirateron acetate plus a low dose of prednisone / Prednisolonbehandelt were a significant improvement in comparison with patients showed derGesamtüberlebenszeit coughing treated plus placebo coughing mitPrednison / prednisolone. This study included 1,195 patients with metastatic acquisitions, fortgeschrittenemProstatakrebs coughing (also known as castration-resistant prostate cancer oderCRPC coughing called). which had previously been with one or two cycles of chemotherapy treated, at least one of which Docetaxelbeinhaltete. The results of this randomized, placebo-controlled study were at a late-breaking presentation at the "Presidential Symposium" today at the 35th International Congress on "Annual European Society coughing for Medical Oncology" (ESMO) is presented. Treatment with abiraterone acetate resulted in a decrease um35 percent risk of death (HR = 0.65, 95 percent CI: 0.54, 0.77, p <0.0001) and derdurchschnittlichen to an increase of 36 percent survival (14 , 8 months vs. 10.9 months) compared with the placebo formulation. Patients who received abiraterone acetate coughing and an NiedrigdosisPrednison / prednisolone were given, even significant improvements demonstrated in secondary study endpoints compared with the group "prednisone / prednisolone plus placebo: a period of time until zurPSA coughing progression (TTPP) [average of 10.2 months beiAbirateron acetate vs. . 6.6 months in the placebo, HR = 0.58 (95 ProzentKI: 0.46, 0.73), p <0.0001] and an increase in the "radiographic progression-free survival" (rPFS) [average 5.6 months vs. 3.6 months beiAbirateron acetate during placebo, HR = 0.67 (95 ProzentKI: 0.58, 0.78);.. p <0.0001] The overall PSA response, defined alsgrösser than or equal to a 50 percent reduction in derBaseline, patients of group was achieved coughing in 38 percent of patients who mitAbirateron acetate were treated vs. 10 percent in the group "prednisone / prednisolone plus placebo" [p <0.0001]. "abiraterone Acetate "experienced mehrMineralokortikoid-related adverse events than the group" prednisone / prednisolone plus placebo. " The most common coughing undesirable events were present fluid retention (30.5 percent vs. 22.3 percent) and hypocalcemia (17.1 percent vs. 8.4 percent). Hypocalcemia and hypertension of grade 3/4 events coughing were more frequent in the arm "abiraterone acetate" on than in the placebo arm (3.8 percent vs. 0.8 percent and 1.3 percent vs. 0.3 percent). Abnormalities were observed in the derLeberfunktion 10.4 percent with abiraterone Azetatbehandelten patients, compared to 8.1 percent derGruppe "prednisone / prednisolone plus placebo." Cardiovascular disorders were detected in 12.5 percent of patients treated with abiraterone acetate vs.. 9.4 percent of patients receiving placebo Did. Mechanism-based coughing adverse events, pad Direction medical management and differed from the undesirable events that are usually associated with a cytotoxic Chemotherapiein connection. "Abiraterone has the potential to satisfy a significant, unmet need nochunzureichend. Nachrichtfür Therefore, these prostate cancer patients and their families wichtigsein incredible," said Johann S. de Bono, MD, FRCP, MSc, PhD from the Institute ofCancer Research, The Royal Marsden NHS Foundation Trust, a theleading COU-AA-301 investigators. "We are very pleased with the Endergebnissendieser rigorous study. These prove dassAbirateron acetate survival of men with metastatic, fortgeschri

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