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      Pharmacodynamic Equivalence of a Decapeptyl 3-Month SR Formulation with the 28-Day SR Formulation in Patients with Advanced Prostate Cancer

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          Abstract

          Aims: The objective of the study was to assess the pharmacodynamic equivalence of LHRH analogue triptorelin 3-month and 28-day SR formulations. Methods: Patients with documented locally advanced or metastatic prostate cancer were randomized to receive one injection of the 3-month formulation (n = 63) or three injections at 28-day intervals of the 28-day formulation (n = 68). Group-chemical castration rates defined as the percentage of patients reaching a testosterone plasma level ≤0.5 ng/ml were compared at D84 (i.e., 3 × 28 days). Testosterone, LH and triptorelin plasma profiles, and change from baseline in plasma PSA were assessed over 3 months (from baseline to D91). Results: Chemical castration rates were 98 and 96% in the 3-month and 28-day formulation groups, respectively, with confidence interval (two-sided 94.2% CI) of [–8.1%; 9.6%]. Median times to reach chemical castration were 18.8 and 18.5 days (p = 0.86, log rank), respectively. Ratios for mean peak plasma levels and AUC<sub>91</sub> of the two formulations for both testosterone and LH fell within the [0.80; 1.25] equivalence interval. Mean PSA decreases from baseline at D91 were 91.0 and 91.7%, respectively (p = 0.73). Conclusion: Treatments with the two triptorelin formulations over 3 months are pharmacologically equivalent.

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          Most cited references 5

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          Gonadotropin-releasing hormone: one polypeptide regulates secretion of luteinizing and follicle-stimulating hormones.

           R Nair,  L Debeljuk,  Y Baba (1971)
          A polypeptide isolated from porcine hypothalami stimulates the release of both luteinizing hormone and follicle-stimulating hormone from the pituitaries of several species. This polypeptide has been structurally identified as (pyro)Glu-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH(2) and synthesized. The natural and synthetic materials share biological properties. It appears that this peptide represents the hypothalamic hormone regulating the secretion of both luteinizing hormone and follicle-stimulating hormone.
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            Chapter 21. Luteinizing Hormone Releasing Hormone (LHRH) Analogues

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              Bilateral orchiectomy for carcinoma of prostate Response of serum testosterone and clinical Response to subsequent estrogen therapy

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                Author and article information

                Journal
                HRE
                Horm Res Paediatr
                10.1159/issn.1663-2818
                Hormone Research in Paediatrics
                S. Karger AG
                1663-2818
                1663-2826
                2004
                November 2004
                22 November 2004
                : 62
                : 5
                : 252-258
                Affiliations
                aCentre Hospitalier Universitaire Saint Louis, Paris, France; bTygerberg Hospital, University of Stellenbosch, Department of Urology, Tygerberg, South Africa; cRoyal Free Hospital, Department of Urology, London, UK; dCHRU Hôtel-Dieu, Nantes, and eBeaufour Ipsen Pharma, Paris, France
                Article
                81629 Horm Res 2004;62:252–258
                10.1159/000081629
                15499224
                © 2004 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                Page count
                Figures: 4, Tables: 2, References: 26, Pages: 7
                Categories
                Original Paper

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