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Volume 80, Issue 1, Pages 95-100 (July 2009)


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Meta-analysis of 200 or 600 mg mifepristone in association with two prostaglandins for termination of early pregnancy☆☆

Michel LièvreaCorresponding Author Informationemail address, Regine Sitruk-Wareb

Received 24 April 2008; received in revised form 26 January 2009; accepted 26 January 2009. published online 12 March 2009.

Abstract 

Background

There is unsettled controversy about the respective efficacy and safety of 200 and 600 mg mifepristone in combination with two prostaglandins for the termination of pregnancy up to 63 days' gestation.

Study Design

We performed a meta-analysis of randomized controlled trials (RCTs) of direct comparisons between the two dose regimens. End points were complete abortion, continuing pregnancy and side effects.

Results

Four RCTs (3482 patients) were found. Noninferiority of 200 mg mifepristone compared with 600 mg was proven for complete abortion [difference, 0.4%; 95% confidence interval (CI)=−1.4% to 2.3%]. Noninferiority was not proven for continuing pregnancy (difference, 0.4%; 95% CI=−0.3% to 1.0%). Two hundred milligrams may therefore result in 1% more continuing pregnancies than 600 mg when used with the approved prostaglandin regimens. Sensitivity analyses confirmed the findings. There was no difference in adverse events between both doses of mifepristone.

Conclusions

Although 200 or 600 mg of mifepristone with two prostaglandins probably results in similar rates of complete abortion, the substitution of 200 mg for 600 mg may lead to an increased continuing pregnancy rate.

a Department of Pharmacology, Université Lyon 1, UMR5558, Hospices Civils de Lyon, F-69003 France

b Population Council and Rockefeller University, New York, NY 10065, USA

Corresponding Author InformationCorresponding author. Service de Pharmacologie Clinique, Faculté de médecine RTH Laennec, 69372 Lyon Cedex 08, France. Tel.: +33 0 478785759; fax: +33 0 478776917.

 Exelgyn SA, a marketer of mifepristone, funded this study.

☆☆ M.L.'s institution has received a grant from Exelgyn for the meta-analysis. R.S.-W. was previously Director of Research at Exelgyn.

 The content of this article reflects the personal views of R.S.-W. and not necessarily that of the organizations to which she is affiliated.

PII: S0010-7824(09)00032-8

doi:10.1016/j.contraception.2009.01.011


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