Ulipristal acetate versus leuprolide acetate for uterine fibroids. Donnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E, for the PEARL II Study Group. NEJM. 2012 Feb 2, 366(5): 421-32.
Reviewed by Dr. John Preston Parry, M.D., M.P.H.
This double blinded randomized controlled trial compared the effect on fibroids of daily ulipristal acetate (5 mg or 10 mg) to monthly leuprolide acetate (3.75 mg) over 3 months. Though symptomatic uterine bleeding improved in all 3 groups, leuprolide acetate was more effective in reducing overall uterine volume (47% for leuprolide vs 20% for 5 mg & 22% for 10 mg, statistically significant) and total volume of the largest three myomas (53% vs 36% & 42% respectively, statistical significance not directly addressed). However, there were fewer moderate to severe hot flashes in the ulipristal groups with 11% for 5 mg and 10% for 10 mg relative to 40% in the leuprolide acetate group. The authors conclude that ulipristal acetate is noninferior to leuprolide acetate for controlling uterine bleeding and was superior for moderate to severe side effects.
Comments by Dr. Steven R. Lindheim, M.D.
Leuprolide acetate and ullipristal are effective treatments preoperatively for reducing fibroid and uterine volume. Intra- and post- operative outcomes need to be further evaluated including issues relative to capsular degeneration, though ullipristal may offer a more cost effective alternative.
The above review and commentary on this article were written by SRS members. Publication of these summaries does not reflect endorsement of any particular procedure or treatment. Views expressed in these summaries do not necessarily reflect the views of SRS or ASRM.