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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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“The use of danazol was found to increase telomere length in patients with telomere diseases with a significant gain in telomere length at 24 months.(9) In our patient, danazol was introduced in the pretransplant period and maintained until this date without evidence of elevation in liver function tests, muscle cramps,…”
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“In a Phase I/II study which enrolled 27 patients with a rare aplastic anaemia associated with short LTL, treatment with the androgenic anabolic steroid danazol slowed attrition of LTL over a period of 24 months in the first 12 patients, leading to the study being halted early [38].”
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“Liver toxicity (41%) and muscle cramps (33%) were the most frequently reported side effects (37).”
BackgroundExercise as a Therapy to Maintain Telomere Function and Prevent Cellular Senescence
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“In a prospective study, daily administration of 800 mg of danazol for 24 months increased TL [181].”
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Practical considerations for diagnosis and management of patients and carriers
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Telomere and Its Role in Diseases
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“There are pilot data suggesting that danazol may be associated with stabilization of lung function for up to two years in patients with haematological disease related to telomere shortening [3].”
BackgroundTelomere length: biological marker of cellular vitality, aging, and health-disease process
Teixeira, M. Z. (2021) · Revista da Associação Médica Brasileira · doi:10.1590/1806-9282.67.02.20200655 · Cited by 16
Pneumocystosis revealing immunodeficiency secondary toTERCmutation
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Telomerase Variants in Patients with Cirrhosis Awaiting Liver Transplantation
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“Similarly, treatment with danazol, a non-aromatisable androgen, used as treatment resulted in LTL elongation of patients with telomeric diseases (Townsley et al., 2016).”
Next‐generation sequencing in hypoplastic bone marrow failure: What difference does it make?
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“Cytotoxic drugs (including cisplatin, alkylating agents, and anthracyclines) and radiotherapy have been shown to cause cellular senescence in both in vitro and in vivomodels (59–61), with induction of DNA damage, epigenetic alterations and telomere attrition (13, 50, 62).”
BackgroundEstrogen Signaling and MicroRNAs in Lung Fibrosis. Sex, Hormones, and Rock Scars
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Telomere biology disorders may manifest as common variable immunodeficiency (CVID)
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Liver disease and transplantation in telomere biology disorders: An international multicenter cohort
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No effect of danazol treatment in patients with advanced idiopathic pulmonary fibrosis
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Inducible CXCL12/CXCR4–dependent extramedullary hematopoietic niches in the adrenal gland
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“Furthermore, several studies have reported telomere elongation by androgens such as danazol [7,21] and by herbal products [22–27].”
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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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