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Part 1: Document Description
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Citation |
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Title: |
Replication data for: Revisiting the Loa loa microfilaremia thresholds above which serious adverse events may occur with ivermectin treatment (Cameroon) |
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Identification Number: |
doi:10.23708/4GVQIJ |
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Distributor: |
DataSuds |
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Date of Distribution: |
2025-03-04 |
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Version: |
1 |
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Bibliographic Citation: |
Boullé, Charlotte; Pion, Sébastien; Gardon, Jacques; Gardon-Wendel, Nathalie; Fokom Domgue, Joël; Kamgno, Joseph; Chesnais, Cédric; Boussinesq, Michel, 2025, "Replication data for: Revisiting the Loa loa microfilaremia thresholds above which serious adverse events may occur with ivermectin treatment (Cameroon)", https://doi.org/10.23708/4GVQIJ, DataSuds, V1, UNF:6:ibS817Wds6hX+S6k9UOsdg== [fileUNF] |
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Citation |
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Title: |
Replication data for: Revisiting the Loa loa microfilaremia thresholds above which serious adverse events may occur with ivermectin treatment (Cameroon) |
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Identification Number: |
doi:10.23708/4GVQIJ |
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Authoring Entity: |
Boullé, Charlotte (UMI TransVIHMI - IRD, INSERM, Univ. Montpellier - France) |
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Pion, Sébastien (UMI TransVIHMI - IRD, INSERM, Univ. Montpellier - France) |
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Gardon, Jacques (UMR HSM - CNRS, Univ. Montpellier, IRD - France) |
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Gardon-Wendel, Nathalie (Centre Pasteur - Cameroon) |
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Fokom Domgue, Joël (Department of Epidemiology, The University of Texas M.D. Anderson Cancer Center - USA) |
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Kamgno, Joseph (Faculty of Medicine and Biomedical Sciences/University of Yaounde I - Cameroon) |
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Chesnais, Cédric (UMI TransVIHMI - IRD, INSERM, Univ. Montpellier - France) |
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Boussinesq, Michel (UMI TransVIHMI - IRD, INSERM, Univ. Montpellier - France) |
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Distributor: |
DataSuds |
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Access Authority: |
Boullé, Charlotte |
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Depositor: |
Boullé, Charlotte |
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Date of Deposit: |
2025-01-27 |
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Holdings Information: |
https://doi.org/10.23708/4GVQIJ |
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Study Scope |
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Keywords: |
Medicine, Health and Life Sciences, Loiasis, ivermectin, serious adverse events |
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Topic Classification: |
Health: generalities |
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Abstract: |
<p>Data: data from two clinical trials conducted in Cameroon where L. loa MFD were determined before IVM administration.<p> <p>References:<p> <p>Gardon J, Gardon-Wendel N, Demanga-Ngangue, Kamgno J, Chippaux J-P, Boussinesq M. Serious reactions after mass treatment of onchocerciasis with ivermectin in an area endemic for Loa loa infection. Lancet. 1997;350: 18–22. doi:10.1016/S0140-6736(96)11094-1<p> <p>Fokom-Domgue J, Pion SD, Gounoue R, Akame J, Nguipdop-Djomo P, Twum-Danso NAY, et al. Absence of an Association Between Plasmodium falciparum Infection and Post-Ivermectin Loa-Related Non-Neurologic Serious Adverse Events. Am J Trop Med Hyg. 2014;90: 335–338. doi:10.4269/ajtmh.13-0189</p> <p>Background: Loiasis was long deemed to be a benign condition, but individuals with high Loa loa microfilarial densities (MFD) are at risk of serious adverse events (SAEs) including encephalopathy following ivermectin (IVM) administration. The risk of marked AE or SAE is usually considered when MFD exceeds 8000 microfilariae (mf)/mL or 30,000 mf/mL, respectively. There are no international guidelines on the treatment of loiasis, resulting in a variety of practices worldwide for the treatment of infected individuals outside endemic areas. Our objective was to determine the probabilities of SAEs after IVM administration at the usual thresholds, and to refine those thresholds using individual characteristics such as age and sex.</p> <p>Methods: We used data from two clinical trials conducted in Cameroon where L. loa MFD were determined before IVM administration. The risk of SAE was modeled as a logistic function of age, sex, and MFD transformed as a first-order fractional polynomial. Principal Findings: SAEs probabilities were found to be <104 for MFD<2000 mf/mL, > 1‰ for MFD >8000 mf/mL, >1% for MFD>20,000 mf/mL, and >2.5% for MFD>30,000 mf/mL. We showed that specific categories may be at a higher risk of SAE than expected. Specifically, in order not to exceed 1% risk, the corresponding thresholds would be 18,000 mf/mL for females in the 31-40 age group; 16,000 mf/mL for males in the 21-30 age group; 12,000 mf/mL for males in the 31-40 age group; and 19,000 mf/mL for males in the 41-50 age group.</p> <p>Conclusions: Our study suggests that IVM should be used with caution for males or individuals in specific age categories with a high L. loa MFD. For these high risk groups, lowering the thresholds to 8000 mf/mL should be considered. The increased risk in males requires further investigation to understand the pathophysiological phenomena involved that are crucial to prevent and manage SAEs.</p> |
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Date of Collection: |
1995-01-01-2005-12-31 |
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Country: |
Cameroon |
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Notes: |
Data Type: Experimental data |
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Methodology and Processing |
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Sources Statement |
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Data Access |
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Notes: |
This dataset is sensitive because it contains personal health data. Any attempt to re-identify participants is strictly prohibited. Data is available upon request to the authors. Access to the data is subject to approval and a data sharing agreement. This dataset may only be used for scientific research purposes directly related to the approved project. Users must cite the dataset in any publication or presentation based on its use. |
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Other Study Description Materials |
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Related Publications |
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Citation |
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Title: |
Revisiting the Loa loa microfilaremia thresholds above which serious adverse events may occur with ivermectin treatment [accepted for publication in Plos NTD ont March,3rd, 2025] |
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Bibliographic Citation: |
Revisiting the Loa loa microfilaremia thresholds above which serious adverse events may occur with ivermectin treatment [accepted for publication in Plos NTD ont March,3rd, 2025] |
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File Description--f45910 |
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File: IVM_SAE.tab |
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Notes: |
UNF:6:tqkmhZPx/qJ/AQogYLZUNw== |
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File Description--f45909 |
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File: IVM_SAE_dictionary.tab |
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Notes: |
UNF:6:ltQ5yZeR2M0mG6wjkbhtEA== |
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List of Variables: |
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Variables |
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f45909 Location: |
Variable Format: character Notes: UNF:6:nJDJa9Kf3KU3kWs+B/+fcg== |
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f45909 Location: |
Variable Format: character Notes: UNF:6:D0EmXxXoi0Sv239pNymIvQ== |
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f45909 Location: |
Variable Format: character Notes: UNF:6:pUXWzBwELqeWPYzN9QouUw== |
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f45909 Location: |
Variable Format: character Notes: UNF:6:hdCxbvsGmsFbS+nShxkJqg== |
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Label: |
Loa_EIG_Data_Use_Agreement_Template.docx |
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Text: |
A template to be filled in and signed by the data requester to access the data |
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Notes: |
application/vnd.openxmlformats-officedocument.wordprocessingml.document |
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Label: |
ReadMe.txt |
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Text: |
Dataset citation, description and terms of use |
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Notes: |
text/plain |