La Nariz De Moritz

ADIS DRUG EVALUATION

Drugs 2010; 70 (16): 2073-2088 0012-6667/10/0016-2073/$55.55/0

ª 2010 Adis Data Information BV. All rights reserved.

Dienogest
A Review of its Use in the Treatment of Endometriosis
Paul L. McCormack
Adis, a Wolters Kluwer Business, Auckland, New Zealand
Various sections of the manuscript reviewed by: S. Ferrero, Department of Obstetrics and Gynaecology, SanMartino Hospital and University of Genoa, Genoa, ¨ Italy; G. Kohler, Department of Gynecology and Obstetrics, University of Greifswald, Greifswald, Germany; M.R. Laufer, Division of Gynecology, Brigham and Women’s Hospital, Harvard Medical School, Boston, ` Massachusetts, USA; E. Somigliana, Fondazione Ca Granda, Ospedale Maggiore Policlinico, Milan, Italy; C. Templeman, Department of Obstetrics andGynecology, Women’s and Children’s Hospital, Keck School of Medicine of the University of Southern California, Los Angeles, California, USA.
Data Selection Sources: Medical literature published in any language since 1980 on ‘dienogest’, identified using MEDLINE and EMBASE, supplemented by AdisBase (a proprietary database). Additional references were identified from the reference lists of publishedarticles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug. Search strategy: MEDLINE, EMBASE and AdisBase search terms were ‘dienogest’ and ‘endometriosis’. Searches were last updated 1 October 2010. Selection: Studies in patients with endometriosis who received oral dienogest. Inclusion of studies was based mainly on themethods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included. Index terms: Dienogest, endometriosis, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.

Contents
Abstract. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Pharmacodynamic Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3. Pharmacokinetic Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1 Absorption and Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2 Metabolism and Elimination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . 3.3 Use in Special Populations and Potential Drug Interactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Therapeutic Efficacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1 Dosage Comparisons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2 Comparison with Placebo. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3 Comparisons with Gonadotropin-Releasing Hormone Agonists . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3.1 Comparison with Leuprorelin . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3.2 Comparison with Buserelin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3.3 Comparison with Triptorelin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4 Long-Term Efficacy . . . . . . . . . . . . . . . . . . . . . . . . ....