The Frequency of Ovarian Hyperstimulation Syndrome and Thromboembolism with Originator Recombinant Human Follitropin Alf
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REVIEW
The Frequency of Ovarian Hyperstimulation Syndrome and Thromboembolism with Originator Recombinant Human Follitropin Alfa (GONAL-f) for Medically Assisted Reproduction: A Systematic Review Erica Velthuis . Julie Hubbard . Salvatore Longobardi . Thomas D’Hooghe Received: June 26, 2020 / Accepted: September 19, 2020 The Author(s) 2020
ABSTRACT Background: Recombinant human follitropin alfa (r-hFSH) is used for ovarian stimulation as part of medically assisted reproduction. There is Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12967055. Electronic Supplementary Material The online version of this article (https://doi.org/10.1007/s12325020-01512-w) contains supplementary material, which is available to authorized users. E. Velthuis (&) Global Patient Safety, Merck KGaA, Darmstadt, Germany e-mail: [email protected] J. Hubbard Global Development and Medical, EMD Serono Research and Development Institute, Billerica, MA, USA S. Longobardi Global Clinical Development, Merck Serono SpA, Rome, Italy T. D’Hooghe Global Medical Affairs Fertility, R&D Biopharma, Merck KGaA, Darmstadt, Germany T. D’Hooghe Department of Development and Regeneration, Biomedical Sciences Group, KU Leuven (University of Leuven), Leuven, Belgium T. D’Hooghe Department of Obstetrics and Gynecology, Yale University, New Haven, USA
a risk for ovarian hyperstimulation syndrome (OHSS) with r-hFSH treatment, and an increased risk for thromboembolic events in the presence of pregnancy with OHSS. Objectives: To report the frequency of OHSS and thromboembolism with originator follitropin alfa (GONAL-f) based on the Global Safety Database of Merck KGaA, Darmstadt, Germany and a systematic review of published data. Data Sources: Reports of OHSS and thromboembolism were obtained from the Global Safety Database of Merck KGaA, Darmstadt, Germany from 20 October 1995 to 19 October 2018. The systematic review was based on MEDLINE and Embase searches from inception to 19 October 2018. Study Eligibility Criteria: Patients receiving GONAL-f for ovulation induction or ART, with a starting dose within the range included in the prescribing information and providing information on the occurrence of OHSS and/or thromboembolism. Study Appraisal and Synthesis Matches: In the Global Safety Database of Merck KGaA, Darmstadt, Germany there were an estimated 16,525,975 treatment cycles since 20 October 1995; 1110 reported cases of OHSS and 80 reported cases of thromboembolic events (reporting rates 6.7 and 0.48 per 100,000 treatment cycles, respectively). The systematic review identified 45 studies (5186 patients exposed to GONAL-f; 5240 treatment cycles).
Adv Ther
There were 272 reports of OHSS (5190 [5.19%] per 100,000 treatment cycles), including 10 cases of severe OHSS (191 [0.19%] per 100,000 treatment cycles). Limitations: There may be the potential for under-reporting of safety outcomes in the literature, and under-reporting is a well-known phenomenon in spontaneous reporting databases. Concl
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