Male reproductive hormones in patients treated with pretomanid.
Int J Tuberc Lung Dis
; 26(6): 558-565, 2022 06 01.
Article
in En
| MEDLINE
| ID: mdl-35650700
ABSTRACT
BACKGROUND:
Pretomanid (Pa) is a nitroimidazole-class drug recently approved by the US Food and Drug Administration and other regulatory authorities as part of a regimen for treating highly drug-resistant pulmonary Mycobacterium tuberculosis infections. Studies in rodents identified the testis as a target organ of concern, which led to monitoring of reproductive hormones in >800 male patients enrolled in four clinical trials of Pa-containing regimens and the HRZE (isoniazid+rifampin+pyrazinamide+ethambutol) control regimen.METHODS:
Serum hormone levels relevant to male reproductive health - follicle stimulating hormone (FSH), luteinizing hormone (LH), inhibin B (InhB) and total testosterone (T) - from the four clinical trials were summarized numerically and analyzed by repeated-measures modeling.RESULTS:
Hormone levels generally behaved similarly in Pa-containing and HRZE arms. Relative to baseline, serum T and InhB levels generally increased at the end of treatment and follow-up. FSH and LH levels were variable, but were generally at or below baseline levels by follow-up. Before treatment, many patients were borderline hypogonadal, with T levels near the lower limits of the normal range.CONCLUSION:
Changes in male hormones in four clinical trials studying patients with TB indicate that Pa-containing treatment was not associated with testicular toxicity but rather led to improvement in the underlying hypogonadism.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Tuberculosis, Multidrug-Resistant
/
Nitroimidazoles
Type of study:
Prognostic_studies
Limits:
Humans
/
Male
Language:
En
Journal:
Int J Tuberc Lung Dis
Year:
2022
Document type:
Article
Affiliation country: