Retrospective Analysis of Patients With Prostate Cancer Initiating GnRH Agonists/Antagonists Therapy Using a German Claims Database: Epidemiological and Patient Outcomes

Abstract

Objective: The objective of this study was to obtain real-world information on gonadotropin-releasing hormone agonist/antagonist (GnRHa) therapy in patients with advanced prostate cancer (PCa).Materials and methods: Anonymized, routine healthcare claims data from approx. 75 German statutory health insurance funds from 2010–2015 (n = 4,205,227) were analyzed. Patients had an enrolment of 1 year before GnRHa, 1 index quarter of initial GnRHa prescription and ≥2 years of follow-up.Results: In total, 2,382 patients with PCa were eligible. The most frequent index therapy was leuprolide in 56.6%. The rank order of PCa comorbidity prevalence was consistent over time (% at index and 3-years of follow-up): hypertension (71.5; 85.0), hyperlipidemia (45.2; 60.8), cardiovascular disease (CVD) (35.7; 54.1), and diabetes (28.3; 36.2). Comparing pooled therapy classes (agonists, hybrids, and antagonist), no significant differences in the incidence of CVD or diabetes were observed. For hypertension, there was a significant increase for agonists (16.4%) compared to antagonists (6.9%, p = 0.022) and leuprolide hybrid group (11.6%, p = 0.006). During the follow-up period 23.9% of all PCa patients died. There were no significant differences concerning mortality rate and discontinuation rates between the cohorts. In total, 11.2% of all patients discontinued GnRHa after first prescription; the mean time to first switch to another GnRHa therapy was 100 days earlier for hybrids than for agonists (p = 0.016).Conclusion: This comparative retrospective analysis provides real-world information about healthcare characteristics and treatment patterns, highlighting the impact of different GnRHa on clinical outcomes for patients with advanced PCa in Germany.

Cardiovascular risk profiles of GnRH agonists and antagonists: real-world analysis from UK general practice

“…Most but not all real-world observational data suggest that treatment with GnRH antagonists is associated with fewer cardiovascular event rates than treatment with GnRH agonists [ 35 ]. Real-world observational data from 2382 patients with advanced prostate cancer from a German claims database showed no significant differences in the incidence of CVD or diabetes between GnRH agonists or antagonists overall, although there was a significant increase in hypertension in patients receiving a GnRH agonist (16.4%) compared with those receiving a GnRH antagonist (6.9%, p = 0.022) [ 42 ]. Similarly, data from 35,118 ADT users identified from a French population-based claims reimbursement database demonstrated no significant association between GnRH antagonists and CV risk [ 43 ].…”

“…A major limitation was the small sample size of degarelix-treated patients, which prevented subgroup analysis of individual risk factors. The small sample size is common to other retrospective analyses of degarelix, with the low number of patients taking degarelix possibly due to clinicians favouring GnRH agonists as first-line treatments [42,47]. Further, events of hypertension, stroke, and CV death were not included in the analysis.…”

Efficacy of Leuprorelide acetate (Eligard®) in daily practice in Brazil: a retrospective study with depot formulations in patients with prostate cancer

“…Similar to the present study, toxicity was reported in the German study in 9% of patients, and the majority were not considered serious. Of note, this LHRH agonist was found to be the most frequently used form of medical castration in another study from Germany, in this case based on a claims database (15).…”

Retrospektive GKV-Versorgungsforschungsstudie über GnRH-Antagonisten/-Agonisten zur initialen Therapie des fortgeschrittenen Prostatakarzinoms – Verordnungsmuster und Krankenhauskosten in Deutschland

“…Die Ergebnisse werden im Folgenden in 4 Abschnitten dargestellt: 1) Patientencharakteristika, 2) Komorbidität und Mortalität, 3) Therapiemuster sowie 4) Hospitalisierung. Die ersten Ergebnisse mit Fokus auf den Krankheitsverlauf sind in einer kürzlich erschienenen Studie unserer Arbeitsgruppe ausführlicher beschrieben [18]. Bei der vorliegenden Studie mit Schwerpunkt Gesundheitsökonomie liegt der Fokus hingegen auf den Therapie-und Verschreibungsmodalitäten sowie den Krankenhaustagen und -kosten.…”