Two Innovative Pharmaceutical Forms of Leuprorelin: Results from 818 Patients with Advanced Prostate Cancer

Gravel, Patricia; Samland, Dirk; Löffler, Martin; Maier, Susanne; Panozzo, Micol; Muenzberg, Michael

doi:10.1007/s12325-013-0010-y

Cited by 9 publications

(30 citation statements)

References 10 publications

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“…The recurrent injection site reactions experienced by all 10 Finnish patients who initially received degarelix could be attributed to the associated histamine release from mast cells, which has been associated with all LHRH antagonists [13]. The data reported here for men switching from degarelix to the leuprorelin acetate implant are consistent with other switching experiences between LHRH analogues in terms of efficacy and safety [6, 8, 10] as well as the potential for associated for cost savings [1]. …”

Section: Discussionsupporting

confidence: 71%

“…Previous studies have also reported LHRH agonists and LHRH antagonists to be generally well tolerated (with most adverse events being consistent with androgen suppression or the underlying condition), with the exception of reactions at the injection site with LHRH antagonists [4–8]. …”

Section: Introductionmentioning

confidence: 99%

“…Switching between hormonal therapies has been reported to have clinical benefits [6, 8–10]. There are currently no clinical guidelines for switching between LHRH analogues [2, 11, 12], but it has been reported that there could potentially be clinical benefits for patients if they switch between the different formulations of LHRH agonists [8] as well as from an LHRH agonist to LHRH antagonist [6, 10].…”

Section: Introductionmentioning

confidence: 99%

“…There are currently no clinical guidelines for switching between LHRH analogues [2, 11, 12], but it has been reported that there could potentially be clinical benefits for patients if they switch between the different formulations of LHRH agonists [8] as well as from an LHRH agonist to LHRH antagonist [6, 10]. There have, however, been no published data reported for switching from an LHRH antagonist to an LHRH agonist.…”

Section: Introductionmentioning

confidence: 99%

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Switching from an LHRH Antagonist to an LHRH Agonist: A Case Report of 10 Finnish Patients with Advanced Prostate Cancer

Visapää

2017

Oncol Ther

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IntroductionLuteinizing hormone-releasing hormone (LHRH) analogues are widely used for the treatment of advanced hormone-dependent prostate cancer. However, there are currently no clinical guidelines for switching between LHRH analogues. It has been reported that there may be clinical benefits for patients switching between different formulations of LHRH agonists, as well as from an LHRH agonist to LHRH antagonist, but there are no published data on switching from an LHRH antagonist to an LHRH agonist. In this paper, we summarize the clinical notes of 10 patients with hormone-sensitive advanced prostate cancer who switched from an LHRH antagonist to an LHRH agonist.MethodsPatients with T3N0M0–T4N1M1 prostate cancer experiencing injection site reactions, such as pain and swelling, with monthly degarelix (Firmagon®) subcutaneous injections were switched to the 3-monthly leuprorelin acetate implant (Leuprorelin Sandoz®) subcutaneous injections.ResultsMean patient age was 75 years (SD 8.3; range 59–85) and Gleason scores ranged from 7 to 9. The mean [±standard deviation (SD)] duration of degarelix treatment was 5 ± 3.7 months (range 2–13). After switching, prostate serum antigen levels were comparable or reduced from those measured prior to switching, showing that efficacy was not compromised. Throughout the course of treatment, no patients reported injection site reactions. Patients reported increased satisfaction with the leuprorelin acetate implant versus degarelix, mainly because of a lack of injection site reactions and reduced frequency of injection.ConclusionThis is the first report of the clinical experience and potential cost implications of switching from an LHRH antagonist to an LHRH agonist. These data are consistent with other experiences of switching between LHRH analogues in terms of efficacy, safety, and potential cost savings, and provide preliminary evidence that the switch from an LHRH antagonist to an agonist is safe and equally efficacious.

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Section: Discussionsupporting

confidence: 71%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Switching from an LHRH Antagonist to an LHRH Agonist: A Case Report of 10 Finnish Patients with Advanced Prostate Cancer

Visapää

2017

Oncol Ther

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“…Damit ist Leuprorelin seit über 30 Jahren das führende GnRH-Analogon und bildet die Grundlage für viele multimodale Therapiekonzepte [11]. Neben der langjährigen Erfahrung der Ärzte mit dem Wirkstoff unterstützen auch sehr umfassende Daten zur Wirksamkeit und Sicherheit von Leuprorelin dessen Einsatz [12,13,14].…”

Section: Diskussionunclassified

Einsparpotenziale für die medikamentöse Therapie des Prostatakrebs sind in der GKV regional unterschiedlich

Millas

Zimmermann

Höer

2018

Gesundh ökon Qual manag

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Zusammenfassung Zielsetzung Gonadotropin-Releasing-Hormon-Analoga (GnRH-Analoga) sind der Therapiestandard bei der Behandlung von fortgeschrittenem Prostatakrebs. Vier GnRH-Analoga (Buserelin, Goserelin, Leuprorelin und Triptorelin) waren 2015 und 2016 verfügbar. Nur Leuprorelin war generisch verfügbar. Es wurde modelliert, ob für die gesetzlichen Krankenkassen Einsparpotenziale im Bereich der GnRH-Analoga bestehen, wenn regionale Unterschiede im Verschreibungsverhalten aufgehoben werden. Methodik Datengrundlage waren monatliche ambulante Verordnungsdaten von IQVIA auf Ebene der Kassenärztlichen Vereinigungen (KVen) und gesetzlichen Krankenkassen (GKV). Auf Basis von zwei Benchmarks wurden regionale Einsparpotenziale berechnet. Der erste Benchmark ist die größte beobachtete Marktdurchdringung nach Verbrauch – gemessen in definierten Tagesdosen (DDD) – in einem Quartal 2015/2016 in einer KV-Region in Bezug auf den wirtschaftlichsten Wirkstoff. Der zweite Benchmark ist innerhalb des wirtschaftlichsten Wirkstoffs die größte beobachtete Marktdurchdringung des preisgünstigsten Produktes. Ergebnisse Die Umsätze des GnRH-Marktes in der GKV waren 2015 und 2016 mit 207,7 Mio. bzw. 212,3 Mio. relativ stabil. Leuprorelin war mit einem Marktanteil von 69,9 % (Q4 2016) das umsatzstärkste GnRH-Analogon. Innerhalb des Leuprorelin-Marktes ist der Erstanbieter mit 59,6 % Marktführer, während das einzige Generikum im Markt einen Anteil von 18,1 % erreichte (Q4 2016). Leuprorelin-Generika (4,51 Euro/DDD) stellen die wirtschaftlichste Alternative im Vergleich zu den übrigen Leuprorelin-Produkten (5,55 Euro/DDD) bzw. GnRH-Analoga (6,02 Euro/DDD) dar. Die Marktanteile nach Verbrauch (DDD) schwankten in den KVen für Leuprorelin im Q4 2016 zwischen 63,0 % und 79,7 %. Innerhalb des Leuprorelin-Marktes lagen die regionalen Generikaanteile zwischen 7,8 % und 39,5 %. Dabei wurde in KVen mit „Leitsubstanzquoten“ im Beobachtungszeitraum tendenziell höhere Einsparpotentiale erzielt. Regelungen zu Gunsten von Leuprorelin hatten im Betrachtungszeitraum vier von 17 KVen. In fünf KVen wurde eine entsprechende Regelung 2017 neu eingeführt. Die GKV hätte 2015 und 2016 insgesamt 20,6 Mio. Euro einsparen können, wenn in allen KV-Regionen die Benchmarks erreicht worden wären. Schlussfolgerung Die Ergebnisse zeigen einen niedrigen Marktanteil für das Leuprorelin-Generikum und starke regionale Unterschiede in der Marktverteilung. Klassische Instrumente der GKV zur Förderung von Generika greifen in diesem Fall nicht. Leitsubstanzregelungen können eine wirtschaftliche Verordnungsweise fördern, indem sie die Marktdurchdringung von Generika erhöhen. Sie werden daher verstärkt vereinbart. Es sind dadurch substantielle Einsparungen bei gleichbleibender Versorgungsqualität möglich.

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Efficacy of switching therapy of luteinizing hormone–releasing hormone analogue for advanced prostate cancer

Shen

Kang

Chiang

2016

The Kaohsiung J of Med Scie

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This study was conducted to determine the efficacy of switching therapy with a second-line luteinizing hormone-releasing hormone (LHRH) analogue after prostate-specific antigen (PSA) progression for advanced prostate cancer. We enrolled 200 patients, from December 2005 to September 2013, with nodal positive, metastatic prostate cancer or disease progression after definite treatment receiving continuous LHRH analogue therapy with monthly depot leuprorelin(sc) acetate 3.75 mg/vial (LA) or goserelin acetate(sc) 3.6 mg/vial (GA). If the patients had castration-resistant prostate cancer, the treatment choice of switching therapy (from LA to GA or from GA to LA) prior to starting chemotherapy was given. The LH, testosterone level, and PSA change were recorded. The records showed that there were 127 patients receiving LA as initial ADT therapy, whereas the other 73 patients were in GA therapy. A total of 92 patients received LHRH analogue switching therapy (54 patients switched from LA to GA and 38 switched from GA to LA). The effect of LH and testosterone reduction prior to and after switching therapy was comparable between the two groups, and increased PSA level after 3 months of treatment was seen in both groups (median PSA: 15.7-67.7 ng/mL in the LA to GA group; 15.2-71.4 ng/mL in the GA to LA group). This study concluded that switching therapy for patients with PSA progression after ADT has no efficacy of further PSA response.

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Two Innovative Pharmaceutical Forms of Leuprorelin: Results from 818 Patients with Advanced Prostate Cancer

Abstract: These results confirm the efficacy, tolerability, and ease of use of the leuprorelin implants among a large population of men with advanced, hormone-dependent prostate cancer treated in a clinical practice setting.

Cited by 9 publications

References 10 publications

Switching from an LHRH Antagonist to an LHRH Agonist: A Case Report of 10 Finnish Patients with Advanced Prostate Cancer

Switching from an LHRH Antagonist to an LHRH Agonist: A Case Report of 10 Finnish Patients with Advanced Prostate Cancer

Einsparpotenziale für die medikamentöse Therapie des Prostatakrebs sind in der GKV regional unterschiedlich

Efficacy of switching therapy of luteinizing hormone–releasing hormone analogue for advanced prostate cancer

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