The risks and benefits of long-term use of hydroxyurea in sickle cell anemia: a 17.5 year follow-up
Open accessAbstract
A randomized, controlled clinical trial established the efficacy and safety of short‐term use of hydroxyurea in adult sickle cell anemia. To examine the risks and benefits of long‐term hydroxyurea usage, patients in this trial were followed for 17.5 years during which they could start or stop hydroxyurea. The purpose of this follow‐up was to search for adverse outcomes and estimate mortality. For each outcome and for mortality, exact 95% confidence intervals were calculated, or tests were conducted at α = 0.05 level ( P ‐value <0.05 for statistical significance). Although the death rate in the overall study cohort was high (43.1%; 4.4 per 100 person‐years), mortality was reduced in individuals with long‐term exposure to hydroxyurea. Survival curves demonstrated a significant reduction in deaths with long‐term exposure. Twenty‐four percent of deaths were due to pulmonary complications; 87.1% occurred in patients who never took hydroxyurea or took it for <5 years. Stroke, organ dysfunction, infection, and malignancy were similar in all groups. Our results, while no longer the product of a randomized study because of the ethical concerns of withholding an efficacious treatment, suggest that long‐term use of hydroxyurea is safe and might decrease mortality. Am. J. Hematol. 2010. © 2010 Wiley‐Liss, Inc.
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By inducing increased levels of HbF through mechanisms that include suppressing erythropoiesis, hydroxyurea was first associated with reduction of morbidity and mortality in adults.
“By inducing increased levels of HbF through mechanisms that include suppressing erythropoiesis, hydroxyurea was first associated with reduction of morbidity and mortality in adults.81,82”
From Fetal hemoglobin in sickle cell anemia (2020) · cites this paper as [82]
The Introduction reports that hydroxyurea increased HbF and was associated with fewer painful episodes and acute chest syndrome events in an adult trial. The Discussion reports an association with improved survival in the adult follow-up. Neither section identifies suppression of erythropoiesis as a mechanism for increasing HbF. (LLM, conf=0.86)
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- Authors
- Steinberg, M. H., McCarthy, W. F., Castro, O., Ballas, S. K., Armstrong, F. D., Smith, W., Ataga, K., Swerdlow, P., Kutlar, A., DeCastro, L., & Waclawiw, M. A.
- Affiliations
- Boston University (US)
- Maryland Medical Research Institute (US)
- Howard University (US)
- Thomas Jefferson University (US)
- Virginia Commonwealth University (US)
- University of North Carolina at Chapel Hill (US)
- Wayne State University (US)
- Augusta University (US)
- Duke University (US)
- National Institutes of Health (US)
- Corresponding author
- Steinberg, Martin H.
- Venue
- American Journal of Hematology
- Publisher
- Wiley
- Published
- 2010-04-12
- Volume
- 85
- Issue
- 6
- Pages
- 403-408
- ISSN
- 0361-8609 (ISSN-L)
- 1096-8652
- PMC
- PMC2879711
- OpenAlex
- W1995325755
- Semantic Scholar
- 27c5d117a06e8b347b8b3676b42fcab173cd5936
- Cited by
- 486
- References
- 53
- Citations by year
- 2026: 14 · 2025: 35 · 2024: 26 · 2023: 26 · 2022: 32 · 2021: 33 · 2020: 35 · 2019: 25 · 2018: 28 · 2017: 35 · 2016: 38 · 2015: 45 · 2014: 35 · 2013: 26 · 2012: 17
- FWCI
- 11.24
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- American Journal of Hematology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- The Medicine Forum (submittedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- UNC Libraries
- Funders
- National Institutes of Health (n01hb067129-006)
- National Heart, Lung, and Blood Institute (N01 HB067129)
- Topics
- Health Sciences › Medicine › Genetics › Hemoglobinopathies and Related Disorders
- Health Sciences › Medicine › Hematology › Blood groups and transfusion
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
- Keywords
- hydroxyurea, sickle cell disease, long-term drug use, mortality, survival, pulmonary complications, stroke, organ dysfunction, infection, cancer, drug safety, long-term follow-up
- MeSH terms
- Adolescent, Adult, Anemia, Sickle Cell, DNA Damage, Drug Utilization, Female, Follow-Up Studies, Humans, Hydroxyurea, Kidney Diseases, Liver Diseases, Lung Diseases, Male, Middle Aged, Neoplasms, Practice Patterns, Physicians', Prospective Studies, Survival Analysis, Risk Assessment, Statistics, Nonparametric, Sepsis, Stroke, Young Adult, Early Termination of Clinical Trials
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