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Metabolic changes with degarelix vs leuprolide plus bicalutamide in patients with prostate cancer: a randomized clinical study.

Abstract

PURPOSE

In a mouse model, degarelix generated the least metabolic consequences via low follicle-stimulating hormone (FSH) levels compared with orchiectomy and leuprolide after 4 months of androgen deprivation therapy (ADT). Here, we comparatively investigated the influence of ADT with degarelix or leuprolide on the development of metabolic syndrome in patients with prostate cancer (PCa).

METHODS

Patients with hormone-naive PCa were recruited. Eligible patients were randomized (1:1) to monthly degarelix or monthly leuprolide for 6 months. Key trial variables were monitored monthly. The primary endpoint was changes in fasting blood sugar (FBS). Secondary endpoints were changes in body weight, abdominal circumference, lipid profiles, and hemoglobin A1c (HbA1c) and FSH levels. Computed tomography was performed to measure subcutaneous and visceral fat areas before and after 6 months of ADT. Data were analyzed using the χ2 test, Student's t test, and analysis of variance.

RESULTS

From the 100 patients registered, 85 completed the trial (degarelix: 40 patients; leuprolide: 45 patients). Mean increases in FBS did not differ between the two arms. Similarly, there were no differences between the arms in mean increases in body weight, abdominal circumference, lipid profiles, HbA1c, or subcutaneous and visceral fat areas. Follicle-stimulating hormone levels were significantly lower in the degarelix arm than in the leuprolide arm (p < 0.05).

CONCLUSIONS

Lipid and glucose metabolism did not differ significantly between the arms, while FSH levels were significantly lower in the degarelix arm.

Authors+Show Affiliations

Department of Urology, Tama-hokubu Medical Center, 1-7-1 Aobacho, Higashimurayama, Tokyo, 189-8511, Japan. harutake_sawazaki@tokyo-hmt.jp.Department of Urology, Tama-hokubu Medical Center, 1-7-1 Aobacho, Higashimurayama, Tokyo, 189-8511, Japan.Department of Urology, National Defense Medical College, Tokorozawa, Japan.Department of Urology, National Defense Medical College, Tokorozawa, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31482294

Citation

Sawazaki, Harutake, et al. "Metabolic Changes With Degarelix Vs Leuprolide Plus Bicalutamide in Patients With Prostate Cancer: a Randomized Clinical Study." World Journal of Urology, 2019.
Sawazaki H, Araki D, Kitamura Y, et al. Metabolic changes with degarelix vs leuprolide plus bicalutamide in patients with prostate cancer: a randomized clinical study. World J Urol. 2019.
Sawazaki, H., Araki, D., Kitamura, Y., & Yagi, K. (2019). Metabolic changes with degarelix vs leuprolide plus bicalutamide in patients with prostate cancer: a randomized clinical study. World Journal of Urology, doi:10.1007/s00345-019-02937-x.
Sawazaki H, et al. Metabolic Changes With Degarelix Vs Leuprolide Plus Bicalutamide in Patients With Prostate Cancer: a Randomized Clinical Study. World J Urol. 2019 Sep 3; PubMed PMID: 31482294.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Metabolic changes with degarelix vs leuprolide plus bicalutamide in patients with prostate cancer: a randomized clinical study. AU - Sawazaki,Harutake, AU - Araki,Daiji, AU - Kitamura,Yosuke, AU - Yagi,Kota, Y1 - 2019/09/03/ PY - 2019/06/22/received PY - 2019/08/28/accepted PY - 2019/9/5/entrez KW - Androgen deprivation therapy KW - Degarelix KW - Leuprolide KW - Lipid and glucose metabolism KW - Prostate cancer JF - World journal of urology JO - World J Urol N2 - PURPOSE: In a mouse model, degarelix generated the least metabolic consequences via low follicle-stimulating hormone (FSH) levels compared with orchiectomy and leuprolide after 4 months of androgen deprivation therapy (ADT). Here, we comparatively investigated the influence of ADT with degarelix or leuprolide on the development of metabolic syndrome in patients with prostate cancer (PCa). METHODS: Patients with hormone-naive PCa were recruited. Eligible patients were randomized (1:1) to monthly degarelix or monthly leuprolide for 6 months. Key trial variables were monitored monthly. The primary endpoint was changes in fasting blood sugar (FBS). Secondary endpoints were changes in body weight, abdominal circumference, lipid profiles, and hemoglobin A1c (HbA1c) and FSH levels. Computed tomography was performed to measure subcutaneous and visceral fat areas before and after 6 months of ADT. Data were analyzed using the χ2 test, Student's t test, and analysis of variance. RESULTS: From the 100 patients registered, 85 completed the trial (degarelix: 40 patients; leuprolide: 45 patients). Mean increases in FBS did not differ between the two arms. Similarly, there were no differences between the arms in mean increases in body weight, abdominal circumference, lipid profiles, HbA1c, or subcutaneous and visceral fat areas. Follicle-stimulating hormone levels were significantly lower in the degarelix arm than in the leuprolide arm (p < 0.05). CONCLUSIONS: Lipid and glucose metabolism did not differ significantly between the arms, while FSH levels were significantly lower in the degarelix arm. SN - 1433-8726 UR - https://www.unboundmedicine.com/medline/citation/31482294/Metabolic_changes_with_degarelix_vs_leuprolide_plus_bicalutamide_in_patients_with_prostate_cancer:_a_randomized_clinical_study L2 - https://dx.doi.org/10.1007/s00345-019-02937-x DB - PRIME DP - Unbound Medicine ER -