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Hormone Therapy Does Not Worsen Lupus But May Increase Thrombosis Risk |
TLALPAN, Mexico—Women with systemic lupus erythematosus (SLE) are at increased risk for premature menopause, with its attendant risks of osteoporotic fracture, however, hormone therapy (HT) is a possible treatment.
Jorge Sánchez-Guerrero, MD, MS, and colleagues have conducted a double-blind, randomized, clinical trial allaying concerns that HT might worsen SLE activity but reinforcing fears that HT might add to an already elevated risk of thrombosis in women with SLE. The study is reported in Arthritis & Rheumatism.1
“We consider the real threat of menopause hormonal therapy in women with SLE to be the risk of developing thrombosis, not the effect of menopause hormonal therapy on disease activity.”—Jorge Sánchez-Guerrero, MD.“[W]e consider the real threat of menopause hormonal therapy in women with SLE to be the risk of developing thrombosis, not the effect of menopause hormonal therapy on disease activity. Whether this hazard can be diminished by alternative routes of estrogen administration or preparations of lower dosages needs to be explored,” says Dr. Sánchez Guerrero, with the department of immunology and rheumatology at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, in Tlalpan, Mexico.
This trial involved 106 women with SLE who were in the menopausal transition or in early or late postmenopause. Patients were randomized to a continuous-sequential estrogen-progestogen regimen of conjugated equine estrogens (Premarin® and Cycrin®) or to a biologically inert placebo identical in appearance and packaging size. SLE disease activity was assessed using the SLE Disease Activity Index (SLEDAI) at baseline, 1 through 3 months, then every third month from 6 to 24 months. Primary outcome measure was the area under the curve (AUC), as an estimate of global disease activity.
The primary outcome was not significantly different for the HT (n = 52) versus the placebo (n = 54) patients. Baseline SLEDAI scores were 3.5 versus 3.1 (P = .54). “There were no significant differences in the SLEDAI AUC or in the maximum SLEDAI score between the groups throughout the study period,” the investigators report. “SLEDAI scores remained mild and stable during the trial, and there were no significant differences between the groups.” [Table 1]
