UNASSIGNED: 68 Background: The use of ADT in @entity1 with @entity263 is well established. @entity1176 antagonists have a mode of action distinct to that of @entity4396 agonists and comparative trials have shown differences in efficacy and safety between these agents. Adverse events (AE) from the musculoskeletal and renal and urinary systems have now been analysed. METHODS: Results were pooled from 6 prospective, comparative randomised trials (n=2328). Most @entity1 (pts) received 1 year of degarelix or @entity4396 agonist treatment (n=1686); the remaining @entity1 had 3-7 months' treatment (n=642). AEs were analysed using Kaplan Meier plots and a log-rank test for homogeneity on relevant groups of MedDRA terms. RESULTS: Treatment groups (degarelix, n=1491; @entity4396 agonist, n=837) were balanced for baseline characteristics such as age, @entity251 , PSA and disease stage. In @entity1 with metastatic disease @entity623 ( @entity623 ) was reduced to a greater extent with degarelix (p=0.0373) throughout the year. Overall probability of @entity174 (<1% vs. 2%, p=0.0411) and incidence of joint related AEs (4% vs. 6%, p=0.0116) were significantly lower for degarelix-treated @entity1 . Incidence of @entity925 was lower for degarelix (9% vs. 12%, p=0.0822). Incidence of @entity293 ( @entity293 ) was reduced (5% vs. 8% with agonists) and time to first @entity293 was significantly increased (p=0.0010) with degarelix. Overall probability of any @entity13090 , including lower urinary tract symptoms (LUTS), was significantly lower in pts receiving degarelix (p<0.0001). Consistent with fewer skeletal and urinary tract AEs indicating better disease control, @entity1 with baseline PSA >50 ng/mL had significantly higher PSA PFS compared to agonist treated pts. @entity3012 during 1 year of treatment was significantly higher for degarelix pts (98.3% vs. 96.7%, p=0.0329). CONCLUSIONS: This analysis of 2,328 @entity1 shows degarelix-treated @entity1 had lower @entity623 , significantly fewer @entity174 , a lower incidence of urinary tract symptoms and higher overall survival than pts receiving an @entity4396 agonist over one year. Control of such disease symptoms is consistent with previous data on a significantly lower risk of PSA PFS during the first year of treatment.

Degarelix versus XXXX agonists: Differential skeletal and urinary tract outcomes from an analysis of six comparative randomized clinical trials.

@entity1 :: ('9606', 'Species') :: ['patients', 'men'] @entity4396 :: ('2796', 'Gene') :: ['LHRH'] @entity251 :: ('MESH:D013739', 'Chemical') :: ['testosterone'] @entity263 :: ('MESH:D011471', 'Disease') :: ['prostate cancer'] @entity174 :: ('MESH:D050723', 'Disease') :: ['fractures', 'fracture'] @entity3012 :: ('MESH:C567932', 'Disease') :: ['OS'] @entity13090 :: ('MESH:C566906', 'Disease') :: ['renal or urinary tract AEs'] @entity1176 :: ('MESH:D007987', 'Chemical') :: ['GnRH'] @entity925 :: ('MESH:D063806', 'Disease') :: ['muscle or bone pain'] @entity623 :: ('250', 'Gene') :: ['ALP', 'alkaline phosphatase'] @entity293 :: ('MESH:D014552', 'Disease') :: ['UI', 'urinary infections']
@entity4396 :: (2796,Gene) :: ['LHRH']
