EMERGENCY CONTRACEPTION FOR UNINTENDED PREGNANCY- ROLE OF ULIPRISTAL, A NOVEL PROGESTERONE RECEPTOR MODULATOR

Author(s)

Aggarwal AHeron Health Private Ltd, Chandigarh, India

OBJECTIVES: Unintended pregnancies represent a global health problem with over 80 million annual pregnancies.  These are associated with an increased risk of morbidity and a considerable impact on women's quality-of-life. Globally, 38% of all pregnancies are unintended resulting in 42 million induced abortions and 34 million unintended births. This corresponds to 43% of all child-births worldwide. A novel drug “Ulipristal” was introduced in Europe in May 2009 with efficacy beyond 72 hours after unprotected coitus. The objective of this review was to determine the safety and efficacy profile of ulipristal compared to levonorgestrel. METHODS: A number of databases (PUBMED, EMBASE, POPLINE, CENTRAL and clinicaltrials.gov) were searched and the citations screened to identify randomised controlled trials (RCTs) reporting efficacy and safety outcomes of ulipristal. Grey literature was searched to identify the cost associated with unintended pregnancies. Summary-statistics (Random-Effects: DerSimonian-Laird) were used to assess pregnancy and adverse-events outcomes. RESULTS: Seven RCTs were identified and only two reported pregnancy outcomes. In a pooled analyses when compared to levonorgestrel, ulipristal showed better efficacy results in preventing pregnancy following unprotected coitus on day 1 and day 3 (Day 1, RR=0.435, [95%CI:0.148, 1.279] and Day 3, RR=0.376, [95%CI:0.110, 1.283]). However, these results were non-significant. Conversely, subgroup analysis showed that if administered on day 2, this trend was reversed with administration of levonorgestrel being associated with fewer pregnancies (RR=1.309, [95%CI: 0.572, 2.996]). The frequency of adverse events like nausea, headache, fatigue and dizziness was similar with both the drugs. Unintended pregnancies were found to be associated with huge costs that amounted up to US$ 5 billion in US during 2002 and £335 million in UK during 2001. CONCLUSIONS: Ulipristal appears as effective as levonorgestrel in preventing unintended pregnancies with similar safety profile. Substantial cost-savings can be expected with appropriate awareness programs about emergency contraceptives among women.

Conference/Value in Health Info

2010-11, ISPOR Europe 2010, Prague, Czech Republic

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PIH1

Topic

Clinical Outcomes, Epidemiology & Public Health

Topic Subcategory

Comparative Effectiveness or Efficacy, Safety & Pharmacoepidemiology

Disease

Pediatrics, Reproductive and Sexual Health

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