In a major study funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the National Institutes of Health (NIH), women with either inactive or stable systemic lupus erythematosus (lupus) a disease in which the body's immune system mistakenly attacks and damages healthy tissues of the skin, joints and internal organs were able to take oral contraceptives without increased risk of flares, or periods of increased disease activity, that characterize the disease.

Safe and effective contraception is an issue that many women of childbearing age face. But for women with lupus, doctors have often been hesitant to prescribe one of the most effective forms of contraception oral contraceptives, or the "pill" for fear that it might increase disease activity.

In the 15-center study of 183 women with inactive or stable lupus, those taking oral contraceptives (triphasic 35 g.ethinylestradiol/0.5-1 mg norethindrone for twelve 28-day cycles) had no statistically significant difference in the occurrence of flares than those taking a placebo. Severe flares occurred in about 7 percent of the women, regardless of whether they received oral contraceptives or placebo. A severe flare was defined by several criteria, including the presence of new or worsening central nervous system involvement; inflammation of the blood vessels (vasculitis), kidneys (nephritis) and/or muscles (myositis); and/or blood problems, including low platelet count (thrombocytopenia) and destruction of the red blood cells (hemolytic anemia).

Mild-to-moderate flares and disease complications were similar between the two groups over the 12-month follow-up as well. Mild-to-moderate flares included fevers and inflammation of the skin, joints, the sac of fibrous tissue that surrounds the heart (pericarditis), and mucous membranes lining the nose and mouth.

Reluctance to prescribe oral contraceptives and other hormones for women with l
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Contact: Ray Fleming
flemingr@mail.nih.gov
301-496-8190
NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases
22-Dec-2005

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