Evaluating the Efficacy of Treatment with a GnRH Analogue in Patients with Central Precocious Puberty

Kendırcı, Havva Nur Peltek; Ağladıoğlu, Sebahat Yılmaz; Baş, Veysel Nijat; Önder, Aşan; Çeti̇nkaya, Semra; Aycan, Zehra

doi:10.1155/2015/247386

Cited by 11 publications

(9 citation statements)

References 23 publications

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“…In this study we showed that LA treatment at a dose of 3.75 mg/28 days was effective in suppresing the HPG axis in the majority (88.6%) of girls with iCPP, while suppression was achieved in the remaining 11.4% of cases with a dose of 7.5 mg/28 days. Studies from Europe and Brazil have shown that suppression of the HPG axis can be achieved in 85-96% of the cases using a dose of 3.75 mg/28 days LA (7,9,22,23) which is consistent with our findings. Studies carried out in the United States report higher LA doses of at least 7.5 mg/monthly for HPG suppression (24,25).…”

Section: Discussionsupporting

confidence: 92%

Treatment with Depot Leuprolide Acetate in Girls with Idiopathic Precocious Puberty: What Parameter should be Used in Deciding on the Initial Dose?

Vurallı¹,

Alikaşifoğlu²,

Iyigun³

et al. 2020

Jcrpe

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Doses of gonadotropin releasing hormone (GnRH) analogues used to treat idiopathic central precocious puberty (iCPP) vary among clinicians. Study aims were to evaluate the efficacy of a monthly 3.75 mg dose of leuprolide acetate (LA) to suppress the hypothalamo-pituitary-gonadal (HPG) axis in girls with iCPP and to determine factors that may have an impact on the supressing dose. Methods: Study subjects were 220 girls receiving LA for iCPP. LA was started at a dose of 3.75 mg/28 days. Suppression was assessed using the GnRH test at the third month. To assess clinical suppression signs and symptoms of puberty were also evaluated. The dose of LA was increased to 7.5 mg/28 days in those who had a peak luteinising hormone (LH) ≥2 IU/L and in whom adequate clinical suppression of puberty was absent. Receiver operating characteristic curves were used to determine thresholds for clinical and hormonal factors affecting the suppressing dose of LA. Logistic regression analyses were used to investigate thresholds which might differentiate between those requiring high dose for suppression and those in whom lower dose LA was adequate. Results: Peak stimulated LH <2 IU/L was achieved in 88.6% with a dose of LA of 3.75 mg (0.11±0.03 mg/kg). Significant variables for differentiating the two doses were body weight (Wt) of 36.2 kg and/or body mass index (BMI)-standard deviation scores (SDS) of 1.64 (p<0.001). Multiple logistic regressions showed that Wt and BMI-SDS values above thresholds indicated requirement of LA at a dose of 7.5 mg/28 days (p<0.001). Conclusion: Monthly injections of 3.75 mg LA is an effective treatment in the majority of girls with iCPP. However, a higher initial dose may be preferred in patients with a Wt ≥36 kg or BMI-SDS ≥1.6 for effective suppression of the HPG axis.

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Section: Discussionsupporting

confidence: 92%

Treatment with Depot Leuprolide Acetate in Girls with Idiopathic Precocious Puberty: What Parameter should be Used in Deciding on the Initial Dose?

Vurallı¹,

Alikaşifoğlu²,

Iyigun³

et al. 2020

Jcrpe

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“…As expected, leuprorelin decreased FSH and LH release, producing a delay in progression of puberty, consistent with the known effects of GnRH agonists ( 21 , 22 ). The effects on gonadotrophins and puberty were reversible when leuprorelin was stopped, and growth of the patients re-accelerated.…”

Section: Discussionsupporting

confidence: 86%

Growth hormone in combination with leuprorelin in pubertal children with idiopathic short stature

Benabbad¹,

Rosilio²,

Tauber³

et al. 2018

Endocrine Connections

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ObjectiveThere is a scarcity of data from randomised controlled trials on the association of growth hormone (GH) with gonadotrophin-releasing hormone agonists in idiopathic short stature (ISS), although this off-label use is common. We aimed to test whether delaying pubertal progression could increase near-adult height (NAH) in GH-treated patients with ISS.MethodsPatients with ISS at puberty onset were randomised to GH with leuprorelin (combination, n = 46) or GH alone (n = 45). NAH standard deviation score (SDS) was the primary outcome measure. The French regulatory authority requested premature discontinuation of study treatments after approximately 2.4 years; patients from France were followed for safety.ResultsMean (s.d.) baseline height SDS was −2.5 (0.5) in both groups, increasing at 2 years to −2.3 (0.6) with combination and −1.8 (0.7) with GH alone. NAH SDS was −1.8 (0.5) with combination (n = 19) and −1.9 (0.8) with GH alone (n = 16). Treatment-emergent adverse events and bone fractures occurred more frequently with combination than GH alone.ConclusionDue to premature discontinuation of treatments, statistical comparison of NAH SDS between the two cohorts was not possible. During the first 2–3 years of treatment, patients treated with the combination grew more slowly than those receiving GH alone. However, mean NAH SDS was similar in the two groups. No new GH-related safety concerns were revealed. A potentially deleterious effect of combined treatment on bone fracture incidence was identified.

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“…Therefore, treatment with a dose of 3.75 mg leuprorelin every 4 weeks was consistent with the previously reported conventional therapeutic effect. [ 5 , 20 – 22 ]…”

Section: Discussionmentioning

confidence: 99%

An open label, multicenter clinical trial that investigated the efficacy and safety of leuprorelin treatment of central precocious puberty in Chinese children

et al. 2021

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Background: Leuprorelin is an analog of gonadotropin-releasing hormone that is used for the therapy of central precocious puberty (CPP). The aims of this prospective, open label, multicenter clinical trial were to establish its efficacy and safety during long-term use. Methods: Patients, who were all children, were treated with 1.88 to 3.75 mg leuprorelin subcutaneously once every 4 weeks for a total of 96 weeks between 2015 and 2018. The primary endpoint was the rate of occurrence of adverse events (AEs) and the secondary endpoint was no progression in the Tanner stage or regression by week 96 compared to baseline. Results: A total of 307 CPP patients, 305 (99.3%) females and 2 males (0.7%), completed the 96-weeks of treatment. Due to limited data for male patients, they are not discussed in the efficacy results. Treatment-emergent AEs (TEAEs) were reported for 252 (82.1%) patients, mostly (79.5%) being mild or moderate and only 33 (10.7%) of patients experienced TEAEs related to leuprorelin therapy. The most frequent (>2%) drug-related TEAEs were injection site induration (4.6%, 14/307) and vaginal bleeding (2.3%, 7/305). After treatment, 83.5% of patients had regression or no progression in the Tanner stage (95% confidence interval: 78.68%, 87.62%) and the majority had decreased gonadotropin-releasing hormone-stimulated peak luteinizing hormone and follicle-stimulating hormone concentrations, as well as reduced sex hormone concentrations and a reduction in the bone age/chronological age ratio compared to baseline. Conclusions: The trial revealed that CPP was effectively treated in most patients who received leuprorelin for nearly 2 years. Any drug-related AEs were reported with low incidence (<5%) and were consistent with the known safety profile of leuprorelin. Trial registration: The trial was registered at ClinicalTrials.gov (registration number: NCT02427958).

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Evaluating the Efficacy of Treatment with a GnRH Analogue in Patients with Central Precocious Puberty

Cited by 11 publications

References 23 publications

Treatment with Depot Leuprolide Acetate in Girls with Idiopathic Precocious Puberty: What Parameter should be Used in Deciding on the Initial Dose?

Treatment with Depot Leuprolide Acetate in Girls with Idiopathic Precocious Puberty: What Parameter should be Used in Deciding on the Initial Dose?

Growth hormone in combination with leuprorelin in pubertal children with idiopathic short stature

An open label, multicenter clinical trial that investigated the efficacy and safety of leuprorelin treatment of central precocious puberty in Chinese children

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