ZOLADEX (GOSERELIN ACETATE) AND THE ANEMIC PATIENT - RESULTS OF A MULTICENTER FIBROID STUDY

Objective: To compare the effects of goserelin acetate treatment with or without iron with iron alone. Design: Multinational, multicenter, p rospective, randomized, double-blind study. Patients: Premenopausal wo men with menorrhagia or metrorrhagia and anemia associated with uterin e leiomyomata awaiting hysterectomy. Intervention: Patients were rando mized to one of three 12-week treatment groups namely goserelin acetat e 3.6 mg once monthly plus placebo iron; 3.6 mg goserelin acetate once monthly plus 600 mg/d iron; or sham injection once monthly plus 600 m g/d iron. Main Outcome Measure: Preoperative hemoglobin concentration; preoperative uterine and fibroid volumes and operative blood loss. Re sults: Considering the entry and preoperative hemoglobin concentration s, there was a difference in least square means of just over 1 g/dL be tween the goserelin acetate plus iron and iron only groups and 2.6 g/d L between the goserelin acetate plus iron and goserelin acetate only g roup. These differences were both statistically significant. Uterine a nd fibroid volumes were decreased in the goserelin acetate-treated pat ients by between 37% and 40% and 44% and 47%, respectively, compared w ith 7% decreases for both in the iron only group. The differences in a bsolute changes were statistically significant for both the goserelin acetate-treated groups versus the iron-treated group. The least square geometric mean operative blood loss was greatest in the iron only gro up. Conclusion: In the patient with uterine leiomyomata and anemia, go serelin acetate in combination with iron therapy has shown significant advantages over iron alone in restoring hematologic normality, decrea sing uterine and fibroid volumes, and reducing operative blood loss.