A 6-month depot formulation of leuprolide acetate is safe and effective in daily clinical practice: a non-interventional prospective study in 1273 patients

Abstract

BackgroundTestosterone stimulates growth in many prostate tumours. The established GnRH analogue leuprolide acetate is incorporated in a novel biodegradable polymer matrix (Atrigel® delivery system), that can be administered to reduce testosterone levels in men with advanced hormone-dependent prostate cancer. This novel formulation is available as a 1-, 3- and most recently 6-month depot (Eligard® 45 mg). The latter was shown to lower and maintain safe and effective serum testosterone suppression in a clinical study.MethodsA non-interventional study to confirm the efficacy and safety of 6-monthly leuprolide acetate (Eligard® 45 mg) in routine urological practice was performed in Germany. Data were obtained from 1273 patients under the care of 634 urologists, and were analysed descriptively. Concentrations of PSA and serum testosterone were documented at the baseline visit and at 6 and 12 months following 6-monthly leuprolide acetate. The participating physicians were also asked to assess the efficacy, tolerabilty and handling of 6-monthly leuprolide acetate.ResultsSerum concentrations of PSA and testosterone were decreased substantially within 6 months of initial 6-monthly leuprolide acetate administration. At 12 months, median reductions of 96% (to 0.5 ng/ml) in PSA, and 90% (to 8.9 ng/dl) in serum testosterone, were observed. Further PSA and serum testosterone decreases were also observed in a subpopulation of patients who switched to 6-monthly leuprolide acetate from other GnRH analogues. Physicians rated 6-monthly leuprolide acetate as easy to use, and patients reported good tolerability. Adverse events occurred in 9% of patients; the majority were not serious. In particular, low rates of hot flushes were reported.ConclusionsThis non-interventional study showed that the reliable reduction of PSA and testosterone levels demonstrated in previous clinical studies of twice-yearly leuprolide acetate can also be achieved in routine clinical practice. This study also confirmed good tolerability of 6-monthly leuprolide acetate in routine clinical use and received positive appraisal from physicians.

Design of Highly Dispersible PLGA Microparticles in Aqueous Fluid for the Development of Long-Acting Release Injectables

“…[3][4][5][6] Since it was marketed in the U.S.A. in 1989, Leuplin ® has been used worldwide, and a recently developed six-month formulation that lasts up to 24 weeks currently contributes to improving the QOL of many patients. 7,8) However, such formulations are manufactured through multiple processes, such as by dissolution of the active pharmaceutical ingredient and additives, filtration, primary and secondary emulsification, evaporation of the organic solvent, centrifugation, lyophilization, pulverization, and powder filling. Enormous effort and expense are required for quality control, as all processes must be completed in a sterile environment.…”

Final results of the prospective multicenter observational program RU-EGD-NI-001 for evaluation of efficacy and tolerability of the 6-month depot Eligard 45 mg in patients with advanced prostate carcinoma in routine clinical practice of uro-oncologists in the Russian Federation

“…По данным U. W. Tunn и соавт. (2011), средний уровень ПСА снизился на 94 % (с 11,6 до 0,7 нг / мл), а тестостерона -на 89 % (с 89 до 10 нг / дл) через 6 мес после введения Элигарда 45 мг [14].…”

Experience with a luteinizing hormone-releasing hormone agonist in patients with prostate cancer

“…Оценка резуль-татов лечения препаратом лейпрорелина ацетат в кли-нической практике уже проводилась в ряде европейских стран. Примером такого исследования является работа U. Tunn [23], в которой оценивалась эффективность и безопасность 6-месячной депо-формы лейпрорелина аце-тата (элигард 45 мг) в клинической практике в Германии. В исследовании участвовали 1273 пациента с распростра-ненным РПЖ.…”