Registration Dossier

Toxicological information

Health surveillance data

Currently viewing:

Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2004-2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
information on human exposure during pregnancy - sodium stibogluconaate

Data source

Reference
Reference Type:
publication
Title:
A comparison of liposomal amphotericin B with sodium stibogluconate for the treatment of visceral leishmaniasis in pregnancy in Sudan
Author:
Marius Mueller, Manica Balasegaram, Youssif Koummuki1, Koert Ritmeijer, Muriel Ramirez Santana and Robert Davidson
Year:
2006
Bibliographic source:
Journal of Antimicrobial Chemotherapy (2006) 58, 811–815

Materials and methods

Study type:
medical monitoring
Principles of method if other than guideline:
retrospective analysis of pregnant Visceral leishmaniasis patients treated with different regimen of Sodium stibogluconate
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Specific details on test material used for the study:
sodium stibogluconate 20mg/kg im for 30 days

Method

Type of population:
general
Ethical approval:
not applicable
Details on study design:
retrospective analysis of 39 pregnant VL patients were from Gedaref or neighbouring Sennar states.
Thirteen (33%) women were in the first trimester, 16 (41%) in the second and 10 (26%) in the last.
Three groups: 1/ sodium stibogluconate (20 mg/kg intramuscularly once daily for 30 days); 2. four doses of AmBisome 3–7 mg/kg daily on days 1, 6, 11 and 16, followed by 20 mg/kg sodium stibogluconate intramuscularly once daily for 30 days; 3 AmBisome 3–7 mg/kg on days 1, 2, 3, 5, 10 and 15.

Results and discussion

Results:
sodium stibogluconate ( n=23), spontaneous aborted during treatment (n=13- 57%) , all in first or second trimester, none in third trimester. between day 13 and 30 of treatment. p <0,002.
combination (n=4) ; no spontanoud abortion
AmBisone (n=12): no spontanous abortion

Applicant's summary and conclusion

Conclusions:
Pentavalent antimony ( sodium stibogluconate ) - 20mg/kg /day can induce abortion during first and second trimester in pregnant women.
Executive summary:

Objectives: Little is known about the treatment of visceral leishmaniasis (VL) in pregnancy, especially in resource-poor settings. We present a series of pregnant women with VL treated with either sodium stibogluconate or liposomal amphotericin B (AmBisome), or both, in eastern Sudan over 16 months.

Methods: We did a retrospective analysis of all pregnant VL patients treated in the Me ́decins sans Frontie`res (MSF) Um el Kher centre between January 2004 and April 2005. We diagnosed VL with laboratory confirmation of clinical suspects, and recorded the outcomes of treatment for pregnant women and their foetuses. We carried out a manual search of relevant publications and a systematic search of the literature in the MEDLINE database.

Results: We treated 23 women with sodium stibogluconate, 4 with AmBisome and sodium stibogluconate and 12 with AmBisome alone. There were 13 (57%) spontaneous abortions in the sodium stibogluconate monotherapy group, and none in either of the other two groups. All spontaneous abortions occurred in the first two trimesters. All patients, except one in the sodium stibogluconate group who defaulted, were discharged as cured in good clinical condition.

Conclusions: AmBisome treatment for VL appears to be safe and effective for pregnant women and their foetuses. We recommend the use of AmBisome as first-line treatment for these patients.