Safety and Tolerability of Mass Diethylcarbamazine and Albendazole Administration for the Elimination of Lymphatic Filariasis in Kenya: An Active Surveillance Study

Khaemba, Christabel; Barry, Abbie; Omondi, Wyckliff P.; Bota, Kefa; Matendechero, Sultani; Wandera, Cecilia; Siyoi, Fred; Kirui, Elvis; Oluka, Margaret; Nambwa, Pamela; Parthasarathi, G; Njenga, Sammy M.; Guantai, Anastacia; Aklillu, Eleni

doi:10.3390/ph14030264

Cited by 8 publications

(16 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…We found no significant association of AEs with age groups, the use of traditional medicines or the number of Ivermectin tablets taken. This finding is somehow different from a study done in Kenya that reported an increased number of diethylcarbamazine tablets (≥3 tablets) was significantly correlated with increased risk for AEs [ 19 ]. Nonetheless, our study drugs were the IA combination used during MDA campaigns in Tanzania as compared to the diethylcarbamazine containing regimen used in Kenya.…”

Section: Discussioncontrasting

confidence: 97%

“…Safety studies conducted elsewhere using diverse study designs, target populations, and treatment indications reported varying incidence rates of mild-to-moderate AEs in the first two days of treatment [ 25 , 26 , 27 , 28 ]. A higher incidence (>15%) of mild-to-moderate AEs following MDA with diethylcarbamazine containing triple therapy (diethylcarbamazine + ivermectin + albendazole) or dual therapy (diethylcarbamazine + albendazole) is reported [ 19 , 29 , 30 , 31 ]. The relatively lower incidence of AEs in our study indicates a better safety profile of IA combination chemotherapy than diethylcarbamazine containing dual or triple chemotherapy for the elimination of LF.…”

Section: Discussionmentioning

confidence: 99%

“…The safety profile of drugs used in public health programs vary between individuals and populations due to host-genetic and environmental factors, including coinfection, comorbidity, and drug-interactions and the use of traditional medicines, which is common in Africa [ 19 , 20 , 21 , 22 , 23 ]. Poor safety surveillance of medicines during MDA campaigns and the under-reporting rate of AEs in SSA makes it challenging to accurately estimate the risks of drugs used in MDA to inform healthcare policy and practice.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Safety and Tolerability of Ivermectin and Albendazole Mass Drug Administration in Lymphatic Filariasis Endemic Communities of Tanzania: A Cohort Event Monitoring Study

et al. 2022

Self Cite

View full text Add to dashboard Cite

Ivermectin and albendazole (IA) combination preventive chemotherapy to all at-risk populations is deployed to eliminate lymphatic filariasis. Although safety monitoring is imperative, data from Sub-Saharan Africa is scarce. We conducted a large-scale active safety surveillance of adverse events (AEs) following IA mass drug administration (MDA) to identify the type, incidence, and associated risk factors in Tanzania. After recording sociodemographic, clinical, and medical histories, 9640 eligible residents received single-dose IA combination preventive chemotherapy. Treatment-associated AEs were actively monitored through house-to-house visits on day 1, day 2, and day 7 of MDA. Events reported before and after MDA were cross-checked and verified to identify MDA-associated AEs. 9288 participants (96.3%) completed the seven-day safety follow-up, of whom 442 reported 719 MDA-associated AEs. The incidence of experiencing one or more type of MDA-associated AE was 4.8% (95% CI = 4.3–5.2%); this being significantly higher among those with Pre-MDA clinical events than those without (8.5% versus 4.1%, p < 0.001). AEs were mild (83.8%), moderate (15.9%), and severe (0.3%), and most resolved within 72 h. The incidence of experiencing one, two, ≥ three types of AEs were 2.8%, 1.3%, and 0.6%, respectively. The most common AEs were headache (1.23%), drowsiness (1.15%), fever (1.12%), and dizziness (1.06%). A chronic illness, or clinical manifestation of lymphatic filariasis, or being female or pre-existing clinical symptoms were independent significant predictors of AEs. IA combination preventive chemotherapy is safe and tolerable, and associated AEs are mild-to-moderate and transient, with few severe AEs. Safety monitoring during MDA campaigns in individuals with underlying clinical conditions is recommended for timely detection and management of AEs.

show abstract

Section: Discussioncontrasting

confidence: 97%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Safety and Tolerability of Ivermectin and Albendazole Mass Drug Administration in Lymphatic Filariasis Endemic Communities of Tanzania: A Cohort Event Monitoring Study

et al. 2022

Self Cite

View full text Add to dashboard Cite

show abstract

“…Interestingly, children who had a fatty or high protein diet before MDA had a higher risk of experiencing more AEs than those who had a carbohydrate meal. In line with our findings, a recent study reported the association of having a fatty or high protein meal before MDA with a higher incidence of AEs following mass diethylcarbamazine and albendazole administration for the elimination of lymphatic filariasis in Kenya [38]. Altered drug absorption and bioavailability with a fatty or high protein diet has been previously reported [47].…”

Section: Discussionsupporting

confidence: 92%

“…On the other hand, we found that children who reported pre-MDA events experienced more post-MDA AEs (28%) compared with children who did not report pre-MDA events (19%). The association of having pre-MDA clinical symptoms with higher incidence of MDA-associated AEs has also been reported recently [38,39]. Therefore, children with underlying clinical symptoms should be closely monitored after MDA.…”

Section: Discussionmentioning

confidence: 72%

Safety of Praziquantel and Albendazole Coadministration for the Control and Elimination of Schistosomiasis and Soil-Transmitted Helminths Among Children in Rwanda: An Active Surveillance Study

et al. 2022

Self Cite

View full text Add to dashboard Cite

Introduction School-based preventive chemotherapy (Deworming) with praziquantel and albendazole to control and eliminate schistosomiasis and soil-transmitted helminths as public health problems is recommended by the World Health Organization (WHO). Safety monitoring during mass drug administration (MDA) is imperative but data from sub-Saharan Africa are scarce. Objective The aim of this active safety surveillance study was to identify the incidence, type, severity, and risk factors for adverse events (AEs) following mass administration of praziquantel and albendazole. Methods Overall, 8037 school children aged 5-15 years in Rwanda were enrolled. Baseline sociodemographic, medical history and any pre-existing clinical symptoms were recorded. Participants received a single dose of praziquantel and albendazole during MDA. AEs were actively monitored on days 1, 2, and 7 post MDA. Results Overall, 3196 AEs were reported by 1658 children; 91.3%, 8.4%, and 0.3% of the AEs were mild, moderate, and severe, respectively, and most resolved within 3 days. Headache (21%), dizziness or fainting (15.2 %), nausea (12.8%) and stomach pain (12.2%) were the most common AEs. The overall cumulative incidence of experiencing at least one type of AE was 20.6% (95% confidence interval [CI] 19.7-21.5%), being significantly higher (p < 0.001) in children with pre-MDA clinical events (27.5%, 95% CI 25.4-29.6%) than those without (18.7%, 95% CI 17.7-19.7%). Females, older age, having pre-MDA events, types of food taken before MDA and taking two or more praziquantel tablets were significant predictors of AEs. Conclusions Praziquantel and albendazole MDA is safe and well-tolerated; however, one in five children experience transient mild to moderate, and in few cases severe, AEs. The incidence of AEs varies significantly between sex and age groups. Pharmacovigilance in the MDA program is recommended for timely detection and management of AEs.

show abstract

Comparative Safety Surveillance of Triple (IDA) Versus Dual Therapy (DA) in Mass Drug Administration for Elimination of Lymphatic Filariasis in Kenya: A Cohort Event Monitoring Study

et al. 2023

Self Cite

View full text Add to dashboard Cite

Introduction Dual diethylcarbamazine and albendazole (DA) therapy is the standard mass drug administration (MDA) regimen for lymphatic filariasis in Kenya. Following the recent World Health Organization recommendation, Kenya piloted triple therapy with ivermectin, diethylcarbamazine, and albendazole (IDA) in MDA. Objective We conducted a community-based, observational, cohort event monitoring study to compare the types, frequency, severity, and predictors of adverse events following dual versus triple therapy in 20,421 eligible residents. Methods Residents in Kilifi ( n = 10,010) and Mombasa counties ( n = 10,411) received DA and IDA through MDA campaigns, respectively. Adverse events were actively monitored through house-to-house visits on days 1, 2, and 7 after MDA. Any clinical events reported before and after MDA were cross-checked and verified to differentiate pre-existing events from MDA-associated adverse events. Results Overall, 5807 and 3102 adverse events were reported by 2839 and 1621 individuals in the IDA and DA groups, respectively. The incidence of experiencing one or more adverse events was significantly higher ( p < 0.0001) in the IDA group (27.3%; 95% confidence interval [CI] 26.4–28.2) than in the DA group (16.2%; 95% CI 15.5–16.9). Dizziness (15.9% vs 5.9%) and drowsiness (10.1% vs 2.6%) were the most common adverse events and significantly higher in the IDA group compared with the DA group ( p < 0.0001). Most adverse events were mild or moderate with a few severe cases (IDA = 0.05%; 95% CI 0.35–0.78, DA = 0.03%; 95% CI 0.14–0.60). Female sex, obesity, taking three or more diethylcarbamazine or ivermectin tablets, and having pre-existing clinical symptoms were significant predictors of adverse events following IDA treatment. Conclusions Ivermectin, diethylcarbamazine, and albendazole as a combination is as safe and well tolerated as DA to use in MDA campaigns with no serious life-threatening adverse events. Systemic mild-to-moderate adverse events with a few severe cases and transient adverse events are more common with IDA treatment than with DA treatment. Hence, integrating pharmacovigilance into a MDA program is recommended for the timely detection and management of adverse events.

show abstract

Safety and Tolerability of Mass Diethylcarbamazine and Albendazole Administration for the Elimination of Lymphatic Filariasis in Kenya: An Active Surveillance Study

Cited by 8 publications

References 29 publications

Safety and Tolerability of Ivermectin and Albendazole Mass Drug Administration in Lymphatic Filariasis Endemic Communities of Tanzania: A Cohort Event Monitoring Study

Safety and Tolerability of Ivermectin and Albendazole Mass Drug Administration in Lymphatic Filariasis Endemic Communities of Tanzania: A Cohort Event Monitoring Study

Safety of Praziquantel and Albendazole Coadministration for the Control and Elimination of Schistosomiasis and Soil-Transmitted Helminths Among Children in Rwanda: An Active Surveillance Study

Comparative Safety Surveillance of Triple (IDA) Versus Dual Therapy (DA) in Mass Drug Administration for Elimination of Lymphatic Filariasis in Kenya: A Cohort Event Monitoring Study

Contact Info

Product

Resources

About