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Danazol Treatment for Telomere Diseases
Open accessAbstract
BACKGROUND: Genetic defects in telomere maintenance and repair cause bone marrow failure, liver cirrhosis, and pulmonary fibrosis, and they increase susceptibility to cancer. Historically, androgens have been useful as treatment for marrow failure syndromes. In tissue culture and animal models, sex hormones regulate expression of the telomerase gene. METHODS: In a phase 1-2 prospective study involving patients with telomere diseases, we administered the synthetic sex hormone danazol orally at a dose of 800 mg per day for a total of 24 months. The goal of treatment was the attenuation of accelerated telomere attrition, and the primary efficacy end point was a 20% reduction in the annual rate of telomere attrition measured at 24 months. The occurrence of toxic effects of treatment was the primary safety end point. Hematologic response to treatment at various time points was the secondary efficacy end point. RESULTS: After 27 patients were enrolled, the study was halted early, because telomere attrition was reduced in all 12 patients who could be evaluated for the primary end point; in the intention-to-treat analysis, 12 of 27 patients (44%; 95% confidence interval [CI], 26 to 64) met the primary efficacy end point. Unexpectedly, almost all the patients (11 of 12, 92%) had a gain in telomere length at 24 months as compared with baseline (mean increase, 386 bp [95% CI, 178 to 593]); in exploratory analyses, similar increases were observed at 6 months (16 of 21 patients; mean increase, 175 bp [95% CI, 79 to 271]) and 12 months (16 of 18 patients; mean increase, 360 bp [95% CI, 209 to 512]). Hematologic responses occurred in 19 of 24 patients (79%) who could be evaluated at 3 months and in 10 of 12 patients (83%) who could be evaluated at 24 months. Known adverse effects of danazol--elevated liver-enzyme levels and muscle cramps--of grade 2 or less occurred in 41% and 33% of the patients, respectively. CONCLUSIONS: In our study, treatment with danazol led to telomere elongation in patients with telomere diseases. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01441037.).
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“The use of the androgen receptor agonist danazol in patients with aplastic anaemia with critically short telomeres improved their condition by increasing telomerase expression and lengthening telomeres. This provides support for a causative role of telomere length in this disease83.”
From Telomere dysfunction in ageing and age-related diseases (2022) · cites this paper as [83]
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“androgen therapy, based on the clinical use of danazol, a synthetic testosterone, has been part of clinical practice for many years in the treatment of aplastic anaemia with some efficacy83”
From Telomere dysfunction in ageing and age-related diseases (2022) · cites this paper as [83]
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Ferreira, M. S. V., Kirschner, M., Halfmeyer, I., Estrada, N., Xicoy, B., Isfort, S., Vieri, M., Zamora, L., Abels, A., Bouillon, A., et al. (2019) · Annals of the New York Academy of Sciences · doi:10.1111/nyas.14248 · Cited by 44
Telomere Shortening and Its Association with Cell Dysfunction in Lung Diseases
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Implications of telomeres and telomerase in endometrial pathology
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Telomeres, Aging and Exercise: Guilty by Association?
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Clinical manifestations of telomere biology disorders in adults
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Chromosomal Instability in Hodgkin Lymphoma: An In-Depth Review and Perspectives
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Telomeres in Interstitial Lung Disease
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Genome-Protecting Compounds as Potential Geroprotectors
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“Particularly, in mice with aplastic anemia and danazol administration [742] and in patients with telomeropathies [743], testosterone therapy led to elongation of leukocyte telomeres and improved health parameters.”
Backgroundp53 Mediates Failure of Human Definitive Hematopoiesis in Dyskeratosis Congenita
Fok, W. C., Niero, E. L. D. O., Dege, C., Brenner, K. A., Sturgeon, C. M., & Batista, L. F. Z. (2017) · Stem Cell Reports · doi:10.1016/j.stemcr.2017.06.015 · Cited by 40
Ovarian rescue in women with premature ovarian insufficiency: facts and fiction
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Safety and efficacy of pirfenidone in patients carrying telomerase complex mutation
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Hereditary Predisposition to Hematopoietic Neoplasms
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Ribosomopathies: New Therapeutic Perspectives
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The Emerging Role of Senotherapy in Cancer: A Comprehensive Review
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“The accumulation of senescent cells (SNCs) over time can worsen the toxic side effects of treatments, increase treatment resistance, and lead to a poor prognosis [11].”
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“Authors also observed that the increase in telomere length seen in patients treated with hormones was consistent with hormone-mediated up-regulation of TERT and of telomerase enzymatic activity [75].”
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Self-citationDrug-induced endocrine blood pressure elevation
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Pilot experience of multidisciplinary team discussion dedicated to inherited pulmonary fibrosis
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“Danazol has been tested in patients with a TRG mutation and hematological abnormalities, but the data concerning the lung in that study are very limited [8].”
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Metadata
- Authors
- Townsley, D. M., Dumitriu, B., Liu, D., Biancotto, A., Weinstein, B., Chen, C., Hardy, N., Mihalek, A. D., Lingala, S., Kim, Y. J., Yao, J., Jones, E., Gochuico, B. R., Heller, T., Wu, C. O., Calado, R. T., Scheinberg, P., & Young, N. S.
- Affiliations
- National Institutes of Health (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-05-19
- Volume
- 374
- Issue
- 20
- Pages
- 1922-1931
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4968696
- OpenAlex
- W2394724717
- Cited by
- 415
- References
- 40
- Citations by year
- 2026: 23 · 2025: 32 · 2024: 36 · 2023: 46 · 2022: 32 · 2021: 45 · 2020: 46 · 2019: 41 · 2018: 49 · 2017: 46 · 2016: 19
- FWCI
- 41.60
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- HAL (submittedVersion)
- Funders
- National Institutes of Health (Z99 HL999999)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cell Biology › Telomeres, Telomerase, and Senescence
- Health Sciences › Medicine › Hematology › Blood disorders and treatments
- Life Sciences › Immunology and Microbiology › Immunology › Immunodeficiency and Autoimmune Disorders
- Keywords
- danazol, telomere shortening, telomere length, telomerase, sex hormones, androgens, bone marrow failure syndromes, telomere maintenance, telomere elongation, hematologic response, liver cirrhosis, pulmonary fibrosis, drug safety, elevated liver enzymes, muscle cramps, treatment discontinuation
- MeSH terms
- Administration, Oral, Adolescent, Adult, Aged, Bone Marrow Diseases, Danazol, Estrogen Antagonists, Female, Hair Color, Humans, Liver Cirrhosis, Male, Middle Aged, Mutation, Prospective Studies, Pulmonary Fibrosis, Up-Regulation, Telomere, Telomerase, Young Adult
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