Jill P. Buyon, MD; Michelle A. Petri, MD, MPH; Mimi Y. Kim, ScD; Kenneth C. Kalunian, MD; Jennifer Grossman, MD; Bevra H. Hahn, MD; Joan T. Merrill, MD; Lisa Sammaritano, MD; Michael Lockshin, MD; Graciela S. Alarcón, MD, MPH; Susan Manzi, MD, MPH; H. Michael Belmont, MD; Anca D. Askanase, MD, MPH; Lisa Sigler, MA; Mary Anne Dooley, MD, MPH; Joan Von Feldt, MD; W. Joseph McCune, MD; Alan Friedman, MD; Jane Wachs, MD; Mary Cronin, MD; Michelene Hearth-Holmes, MD; Mark Tan, MD; Frederick Licciardi, MD
This trial is registered as NCT00000419 on http://clinicaltrials.gov.
Note: Drs. Buyon and Petri contributed equally as first authors and principal investigators.
Acknowledgments: The authors thank Dr. Mary Louise Skovron for biostatistical expertise and intellectual contribution to the initial design of the study, Marcus Vogel and Jeanie Kantrowitz (Hospital for Joint Diseases pharmacists) for assistance in establishing and maintaining the system for blinded allocation and distribution of study medications, Michael Fillius for technical and administrative support in the collection and assembly of data, and Ann Rupel for administrative support and assistance in the preparation of the manuscript.
Grant Support: By National Institutes of Health (NIH)/National Institute of Arthritis and Musculoskeletal and Skin Diseases grant U01 AR42540. Wyeth-Ayerst Pharmaceuticals (St. David's, Pennsylvania) provided the study drug (Premarin/cyclic Provera) and matching placebo for free (Wyeth-Ayerst study 0713X1-962). The Hopkins Lupus Cohort is supported by NIH grant AR 43727. This study used the resources of the General Clinical Research Centers of Johns Hopkins University (NIH grant M01 RR00052) and the Hospital for Joint Diseases of New York University School of Medicine (NIH grant M01 RR00096).
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Jill P. Buyon, MD, Department of Rheumatology, Room 1608, Hospital for Joint Diseases, 301 East 17th Street, New York, NY 10003; e-mail, email@example.com.
Current Author Addresses: Drs. Buyon, Belmont, and Askanase: Hospital for Joint Diseases, 301 East 17th Street, New York, NY 10003.
Dr. Petri and Ms. Sigler: Johns Hopkins University School of Medicine, 1830 East Monument Street, Baltimore, MD 21205.
Dr. Kim: Albert Einstein College of Medicine, 1300 Morris Park Avenue, Bronx, NY 10461.
Dr. Kalunian: Division of Rheumatology, Allergy and Immunology, University of California, San Diego, School of Medicine, 9350 Campus Point Drive, La Jolla, CA 92037.
Drs. Grossman and Hahn: University of California, Los Angeles, 1000 Veteran Avenue, Los Angeles, CA 90095.
Dr. Merrill: Oklahoma Medical Research Foundation, 825 Northeast 13th, Oklahoma City, OK 73104.
Drs. Sammaritano and Lockshin: Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021.
Dr. Alarcón: University of Alabama-Birmingham, 510 20th Street South, FOT 830, Birmingham, AL 35294.
Dr. Manzi: University of Pittsburgh, 200 Lothrop Street, Pittsburgh, PA 15261.
Dr. Dooley: University of North Carolina-Chapel Hill, 3330 Thurston Building, Chapel Hill, NC 27599.
Dr. Von Feldt: University of Pennsylvania, 3600 Spruce Street, Philadelphia, PA 19104.
Dr. McCune: University of Michigan Medical Center, Box 0358, Ann Arbor, MI 48109.
Dr. Friedman: University of Texas-Houston Health Science Center, 6410 Fannin Street, #1100, Houston, TX 77030.
Dr. Wachs: 3220 Fairfield Avenue, Riverdale, NY 10463.
Dr. Cronin: Medical College of Wisconsin, 9200 West Wisconsin Avenue, Milwaukee, WI 53226.
Dr. Hearth-Holmes: Louisiana State University, 1501 Kings Highway, Shreveport, LA 71130.
Dr. Tan: 222 Middle Country Road, Suite 312, Smithtown, NY 11787.
Dr. Licciardi: New York University School of Medicine, 660 First Avenue, New York, NY 10016.
Author Contributions: Conception and design: J.P. Buyon, M.A. Petri, M.Y. Kim, K.C. Kalunian, B.H. Hahn, J.T. Merrill, L. Sammaritano, F. Licciardi.
Analysis and interpretation of the data: J.P. Buyon, M.A. Petri, M.Y. Kim, K.C. Kalunian, J.T. Merrill, A. Friedman, F. Licciardi.
Drafting of the article: J.P. Buyon, M.A. Petri, M.Y. Kim, J.T. Merrill, S. Manzi, F. Licciardi.
Critical revision of the article for important intellectual content: J.P. Buyon, M.A. Petri, M.Y. Kim, B.H. Hahn, J.T. Merrill, L. Sammaritano, G.S. Alarcón, A. Friedman, F. Licciardi.
Final approval of the article: J.P. Buyon, M.A. Petri, M.Y. Kim, K.C. Kalunian, J. Grossman, B.H. Hahn, J.T. Merrill, L. Sammaritano, M. Lockshin, S. Manzi, H.M. Belmont, A.D. Askanase, M.A. Dooley, J. Von Feldt, W.J. McCune, J. Wachs, M. Cronin, M. Hearth-Holmes, M. Tan, F. Licciardi.
Provision of study materials or patients: J.P. Buyon, M.A. Petri, K.C. Kalunian, J. Grossman, B.H. Hahn, J.T. Merrill, L. Sammaritano, M. Lockshin, G.S. Alarcón, S. Manzi, H.M. Belmont, A.D. Askanase, M.A. Dooley, J. Von Feldt, W.J. McCune, A. Friedman, J. Wachs, M. Cronin, M. Hearth-Holmes, M. Tan.
Statistical expertise: M.Y. Kim.
Obtaining of funding: J.P. Buyon.
Administrative, technical, or logistic support: J.P. Buyon, M.A. Petri, L. Sammaritano, A.D. Askanase, L. Sigler.
Collection and assembly of data: J.P. Buyon, M.A. Petri, J. Grossman, L. Sammaritano, M. Lockshin, A.D. Askanase, L. Sigler, A. Friedman.
Buyon JP, Petri MA, Kim MY, Kalunian KC, Grossman J, Hahn BH, et al. The Effect of Combined Estrogen and Progesterone Hormone Replacement Therapy on Disease Activity in Systemic Lupus Erythematosus: A Randomized Trial. Ann Intern Med. 2005;142:953-962. doi: 10.7326/0003-4819-142-12_Part_1-200506210-00004
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Published: Ann Intern Med. 2005;142(12_Part_1):953-962.
Since systemic lupus erythematosus (SLE) exhibits a female bias, disease activity may be sex-determined or hormonally regulated. Exogenous estrogens are generally not prescribed for women with SLE because of the widely held view that these medications can activate disease. Concern is based on the 10-fold greater incidence of SLE in women than men (1), disease onset after menarche and before menopause, skewing of estrone metabolism toward more feminizing 16-hydroxylated metabolites (2-3), exacerbation of murine lupus by estrogens (4), anecdotes of disease flares during exogenous hormone therapy (5-13), a retrospective study in patients with preexisting renal disease (14), and the ability of estrogens to augment murine B-cell survival and autoreactivity (15). However, health issues specific to women warrant attention and need to be confronted in patients with SLE. Although long-term HRT is not currently recommended, short-term salutary effects include treatment of hot flashes and vaginal dryness. Because of premature ovarian failure secondary to cyclophosphamide treatment, some women with SLE may require longer exposures to HRT. A further consideration is increased risk for osteoporosis after exposure to glucocorticoids or secondary to the disease itself.
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Infectious Disease, Rheumatology, Lupus Erythematosus, Prevention/Screening.
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