Desmopressin is an effective and well-tolerated treatment for nocturia due to NP in patients with LUTS/BPH in daily practice under routine conditions.
TPS392 Background: HDT with LHRH agonists (LHRH) or LHRH-antagonists (degarelix, D) is the standard of care in advanced mPCa. A correlation between leuprolide/goserelin and an increased risk of CV events as compared to D has been shown in a pooled analysis of 6 RCTs in 2013, therefore we aimed to evaluate potential changes in selection of HDTs in Germany. Methods: To evaluate changes in selection of HDT, we compared data from a retrospective (2013 - 2014) and prospective (FPFV in 09/2014) study on CV disease and selection of ADT that were collected from the same pool of study sites. In the ProComD, a two-arm, prospective non-interventional study (NIS), potential comorbidity dependent differences in the selection of D vs LHRH treatment were investigated. Preceding the ProComD we conducted the retrospective randomised analysis to determine baseline CV disease frequencies in ADT treated patients. Results: In the retrospective part, frequencies of CV-disease were skewed towards LHRH compared to D (59.8 vs. 49.0 %). In the prospective ProComD data on patients with a minimum follow-up period of one year (visit 5, n = 238, D = 149, LHRH = 89) up to two years (visit 7, n = 84, D = 51, LHRH = 33) were documented. Baseline criteria were generally similar except for disease T-stage (p = 0.0038). The average age of patients was 74.4 years. Stage distribution: D vs. LHRH, pT2 26.8/28.1 %, pT3 23.5/38.2 %, pT4 5.4/1.1 %, unkown. 44.3/32.6 %, cNX 51.0/44.9 %, cN0 32.2/42.7 %, cN+ 16.8/12.4 %, cMX 26.8/23.3 %, cM0 34.9/47.2 %, cM1 38.2/29.2 %. Comorbidities were reported in 184 patients (77.3 %). Most frequent comorb. were vascular and metabolic diseases (hypertension and diabetes mellitus; (n = 139/57; 75.5/31.0 %) followed by cardiac diseases (n = 74; 40.2 %). More patients with peripheral arterial disease (PAD) (17.9 vs 3.0 %) and cardiac diseases (41.9 vs 37.3 %) received D as compared to LHRH. Conclusions: Our results indicate that selection of ADT seems to have shifted following new data on CV-risk differences between leuprolide/goserelin and degarelix. Patients with cardiac and PAD comorbidities have received more often degarelix treatment as compared to LHRH treatment.
339 Background: Androgen deprivation therapy (ADT) with LHRH agonists leuprolide/goserelin compared to GnRH antagonists has been associated with higher risk for cardiovascular (CV) disease in patients with hormone-sensitive prostate carcinoma (hsPCa). Real life data from German PCa-patients with CV disease treated with ADT are lacking. Our study aimed to analyze occurrence of comorbidities with a focus on CV disease in hsPCa-patients treated with ADT. Methods: HsPCa-patients with initiation of ADT (1999–2014) and an ADT duration of a minimum of 12 months were included. Data were collected retrospectively from medical records and documented in a standardized electronic case report form by three German urological outpatient centers. Primary outcomes of interest were frequency of CV disease and hospitalization due to CV events. Descriptive statistics were performed. An ethics committee approval was obtained from Ärztekammer Nordrhein. Results: Data from 753 patients were evaluated. The mean and median age of patients was 75.4 years and 77 years. 556 patients were treated with a LHRH agonist, 59 with an antiandrogen, 132 with a LHRH agonist and an antiandrogen and 6 with a GnRH antagonist. CV disease was the most common comorbidity (241 patients), also when patients with hypertension as the sole CV comorbidity were disregarded (111 patients). 44 patients were hospitalized due to a CV event during or subsequently to an ADT. Of these, 27 patients initiated ADT with pre-existing CV disease. Overall, 21 patients were hospitalized due to myocardial infarction or stroke. Conclusions: Our results show CV disease as the most common comorbidity in German hsPCa-patients, yet our methods could be underestimating CV disease in this interdisciplinary field. Before initiating an ADT, the patient's CV risk profile should therefore be evaluated carefully. The literature suggests that different ADT types are associated with different CV risk, thus the choice of ADT should be considered to reduce the risk of additional CV events. Besides cost savings to health care systems, patients gain quality of life through prevented CV events.
240 Background: Degarelix, is a GnRH-antagonist, which is used in the treatment of prostate cancer since 2009. We performed a non-interventional study (NIS) with prostate cancer (PCA) patients treated routinely with degarelix. This NIS focused on pharmaco-economical data, quality of life as well as efficacy and safety in patients receiving degarelix as first or second line therapy. Methods: In the interims analysis of this ongoing NIS, data from 279 out of 670 PCA-patients treated with degarelix were included. The included cohort reflects advanced PCA patients (age: 72 years, PSA: 15.8 ng/ml (median values)).Testosterone and PSA values, quality of life and pharmaco-economical data were collected at baseline, 1, 3, 6, 9 and 12 months. Quality of life was assessed by EQ-5D. Pharmaco-economical data included direct costs for physicians, drugs, hospital, emergency treatment and others. Results: Treatment costs in hormon-naïve patients treated with degarelix were lower than in the hormonally pre-treated patients. Direct costs for six month were 498,- € for hormone naïve patients treated with degarelix in contrast to 1436,- € for hormonally pre-treated patients. As expected there was a marked difference in the PSA-decline between hormone-naïve patients and hormonally pre-treated patients. Hormone-naïve patients experienced a sharp median decrease in PSA by 80.7% (n=116) at month 1. This decline remained stable in 98.7% of the patients after one year. Median PSA reduction was significantly different (p=0.013) between hormone-naïve and pre-treated patients. Furthermore treatment of degarelix improved quality of life by 14% at one year compared to baseline. Testosterone was suppressed to a median of 0.2 ng/ml from month 1 to 12. Safety results mirrored the results of clinical trials. Conclusions: First-line treatment with degarelix was supported by a marked difference in health care costs between hormone naïve and pre-treated prostate cancer patients, who received degarelix. As expected a pronounced difference in the PSA-decrease in hormone naïve and pre-treated patients was seen. However a distinct quality of life improvement was noted in all patients.
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