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For the week ending February 3, 2012
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Last week 472 articles were evaluated via DynaMed's Systematic Literature Surveillance and 224 were added to DynaMed content.
Based on the editors' criteria of selecting "articles most likely to change clinical practice," one article of significant interest was selected for the DynaMed Weekly Update.
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| Feature Article | |
Ulipristal Acetate Controls Uterine Bleeding and Reduces Discomfort in Women with Symptomatic Fibroids
Uterine fibroids can cause pain and heavy bleeding and are a common indication for hysterectomy, but little evidence exists to guide fibroid management (AHRQ Research Report, Mar 2011). The gonadotropin-releasing hormone agonist leuprolide acetate has been shown to reduce uterine volume and fibroid size prior to surgery (Cochrane Library 2001 Issue 2:CD000547), but it may also increase the incidence of hot flashes and reduce bone mineral density. Two recent trials, PEARL I and PEARL II, evaluated the efficacy of ulipristal acetate, a selective progesterone receptor modulator, in women planning to have surgery for symptomatic fibroids.
In the PEARL I trial, 242 women (mean age 42 years) with excessive uterine bleeding were randomized to ulipristal acetate (5 mg vs. 10 mg orally once daily) vs. placebo for up to 13 weeks. All women received iron supplementation and were eligible to have fibroid surgery after end of the treatment period. Excessive uterine bleeding was defined as a score of > 100 on the pictorial blood loss assessment chart (PBAC) (0 to > 500 scale with higher score indicating greater bleeding). At 13 weeks, uterine bleeding was controlled (defined as PBAC score < 75) in 91% of women taking ulipristal 5 mg, in 92% taking ulipristal 10 mg, and in 19% taking placebo (p < 0.001, NNT 2 for each ulipristal dose vs. placebo) (level 1 [likely reliable] evidence). Amenorrhea rates (PBAC ≤ 2) were 73% for ulipristal 5 mg, 82% for ulipristal 10 mg, and 6% for placebo (p < 0.001, NNT 2 for each ulipristal dose vs. placebo). Both ulipristal doses were associated with reduced discomfort (p ≤ 0.001). There were no significant differences in surgical rates or adverse events. The most common adverse events reported in the ulipristal groups were headache and breast pain (N Engl J Med 2012 Feb 2;366(5):409).
The PEARL II trial compared the same 2 daily doses of oral ulipristal for 13 weeks vs. 3 monthly intramuscular injections of leuprolide acetate 3.75 mg in 301 women (mean age 40 years) with symptomatic fibroids. Women received supplemental iron at the discretion of the treating physician and were eligible for surgery after treatment. Rates of controlled uterine bleeding were non-significantly higher for ulipristal: 90% for ulipristal 5 mg, 94% for ulipristal 10 mg, and 86% for leuprolide (not significant) in an intention-to-treat analysis (level 1 [likely reliable] evidence). The 10 mg ulipristal dose was associated with significantly greater bleeding control vs. leuprolide in a per-protocol analysis (p = 0.03, NNT 12). Incidence of hot flashes was significantly lower in both ulipristal groups (11% for ulipristal 5 mg, 10% for ulipristal 10 mg, 40% for leuprolide, p < 0.001, NNT 4 for each ulipristal dose vs. leuprolide). There were no significant differences in pain reduction, surgical rates, or severe adverse events. Leuprolide was associated with significantly greater reduction in uterine volume (N Engl J Med 2012 Feb 2;366(5):421). Neither trial was designed to address differences in surgery rates or surgical outcomes after treatment. Ulipristal is currently available only in a 30 mg tablet.
For more information, see the Leiomyoma topic in DynaMed.
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CME Information
CREDITS
Physicians: 0.25 AMA PRA Category I Credit(s)™
Family Physicians: 0.25 Prescribed credits
Nurse Practitioners: 0.25 Contact hours
Release Date: February 8, 2012
Expiration Date: February 8, 2013
Estimated Completion Time:
15 minutes
There is no fee for this activity.
To Receive Credit
In order to receive your certificate of participation, you should read the information about this activity, including the disclosure statements, review the entire activity, take the post-test, and complete the evaluation form. You may then follow the directions to print your certificate of participation. To begin, click the CME icon at the end of the article.
Program Overview
Learning Objectives
Upon successful completion of this educational program, the reader should be able to:
1. Discuss the significance of this article as it relates to your clinical practice.
2. Be able to apply this knowledge to your patient's diagnosis, treatment and management.
Faculty Information Alan Ehrlich, MD - Assistant Clinical Professor in Family Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA; Deputy Editor, DynaMed, Ipswich, Massachusetts, USA Michael Fleming, MD, FAAFP - Assistant Clinical Professor of Family Medicine and Comprehensive Care, LSU Health Science Center School of Medicine, Shreveport, Louisiana, USA; Assistant Clinical Professor of Family Medicine, Department of Family and Community Medicine, Tulane University Medical School, New Orleans, Louisiana, USA; Chief Medical Officer, Amedisys, Inc. & Antidote Education Company
Disclosures
Dr. Ehrlich, Dr. Fleming, DynaMed Editorial Team members, and the staff of Antidote Education Company have disclosed that they have no relevant financial relationships or conflicts of interest with commercial interests related directly or indirectly to this educational activity.
No commercial support has been received for this activity.
Accreditation Statements
ACCME: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Antidote Education Company and EBSCO Publishing. Antidote is accredited by the ACCME to provide continuing medical education for physicians. Antidote Education Company designates this educational activity for a maximum of 0.25 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
AAFP: This activity, DynaMed Weekly Update 2011, has been reviewed and is acceptable for up to 13 Prescribed credits by the American Academy of Family Physicians. AAFP accreditation begins March 2, 2011. Term of approval is for one year from this date. Each Weekly Update is approved for 0.25 Prescribed credits. Credit may be claimed for one year from the date of each Weekly Update. AANP: This program is approved for 0.25 contact hour of continuing education by the American Academy of Nurse Practitioners. Program ID 1102071X.
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