Monitoring treatment of central precocious puberty using basal luteinizing hormone levels and practical considerations for dosing with a 3-month leuprolide acetate formulation

Peter A. Lee; Margaret Luce; Peter Bacher

doi:10.1515/jpem-2016-0026

Article

Monitoring treatment of central precocious puberty using basal luteinizing hormone levels and practical considerations for dosing with a 3-month leuprolide acetate formulation

Peter A. Lee , Margaret Luce and Peter Bacher

Published/Copyright: October 14, 2016

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From the journal Journal of Pediatric Endocrinology and Metabolism Volume 29 Issue 11

Abstract

Background:

Peak gonadotropin-releasing hormone or agonist (GnRHa) stimulated luteinizing hormone (LH) testing with leuprolide acetate (LA) is commonly used to document suppression during therapy for central precocious puberty (CPP). The objective of the study was to investigate suitability of using basal LH levels to monitor GnRHa treatment and to determine optimal transition from 1-month to 3-month LA formulations via a post hoc analysis of a randomized, open-label, 6-month study.

Methods:

A total of 42 children with CPP, pretreated with 7.5-, 11.25-, or 15-mg 1-month LA formulations were randomized to 11.25- or 30-mg 3-month LA. Basal LH/peak-stimulated LH levels were measured at weeks 0, 4, 8 and 12. Positive/negative predictive values and sensitivities/specificities were determined for basal LH vs. LH-stimulation results.

Results:

Pretreatment with any 1-month formulation for the most part did not affect continuation of suppression after transitioning to 3-month formulation (mean peak-stimulated LH levels remained < 4 IU/L). Basal LH predicted suppression escape (basal LH-level cutoff ≥ 0.6 IU/L predicted 70% of those failing suppression). Tolerability was similar, regardless of dose.

Conclusions:

Our data indicate that a basal level of <0.60 IU/L is adequate for monitoring suppression approximately two-thirds of the time. Furthermore, the effectiveness and safety of 3-month LA treatments are not influenced by previous CPP therapies.

Keywords: gonadotropin-releasing hormone; leuprolide acetate; luteinizing hormone; puberty, precocious

Corresponding author: Peter A. Lee, MD, PhD, Penn State School of Medicine, Milton S. Hershey Medical Center, P.O. Box 850, Hershey, PA 17033, USA, Fax: +717-531-6139

Acknowledgments

The authors would like to thank James W. Thomas of AbbVie for his assistance with this paper. Medical writing and editorial support were provided by Robin Smith, PhD, of The Curry Rockefeller Group, LLC, Tarrytown, NY. Funding for this support was provided by AbbVie.

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: This study was funded by AbbVie.
Employment or leadership: PB is an employee of AbbVie. At the time of the study, ML was an intern at AbbVie.
Honorarium: PL has received research support and honoraria as a member of a speaker’s bureau for AbbVie. He has also received honoraria from Novo Nordisk as a consultant and as a member of a medical advisory board.
Competing interests: AbbVie was involved in study design, research, analysis, data collection, interpretation of data, and writing, reviewing, and approval of the article.

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Received: 2016-1-18

Accepted: 2016-8-29

Published Online: 2016-10-14

Published in Print: 2016-11-1

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Articles in the same Issue

https://doi.org/10.1515/jpem-2016-0026

Keywords for this article

gonadotropin-releasing hormone; leuprolide acetate; luteinizing hormone; puberty, precocious