Schistosomiasis and soil-transmitted helminthiasis preventive chemotherapy: Adverse events in children from 2 to 15 years in Bengo province, Angola

Abstract

Preventive chemotherapy campaigns with praziquantel and albendazole are being implemented in Angola, as a high priority public health intervention. However, there are no published data regarding adverse events associated with these medications. In this context, we analysed adverse events due to co-administration of praziquantel and albendazole in endemic areas of schistosomiasis and soil-transmitted helminths in Bengo, Angola. In the context of a targeted drug administration, between December 2012 and September 2013, we conducted two surveys after co-administrating single oral doses of praziquantel and albendazole tablets to children 2 to 15 years of age. About 24 hours after each treatment, participants answered a questionnaire about adverse events. At baseline, 605 children (55.0% male; mean age: 9.7 years) were treated; 460 were interviewed and 257 (55.9%) reported at least one adverse event, 62.3% (160/257) of children being infected with schistosoma haematobium. After six months of treatment, among 339 children surveyed, 184 (54.3%) reported adverse events, with 49.5% (91/184) of infected children. Adverse events were most common in preschoolaged children, with no significant difference between genders. The most frequent adverse events in the two surveys were abdominal pain (18.5%, 25.7%), headache (20.9%, 23.0%) and dizziness (15.7%, 19.8%). Children aged 12 to 15 years (adjusted OR = 0.40, p = 0.040) and those with mixed infection (adjusted OR = 0.04, p = 0.011) had lower odds of adverse events. After the second treatment, those with heavy infection (adjusted OR = 2.72, p = 0.018) and aged 9-11 years (adjusted OR = 2.01, p = 0.049) had significantly fewer adverse events. About 2.0% of children experienced severe adverse events. This study adds evidence that preventive chemotherapy for schistosomiasis and soil-transmitted helminths control is safe, but cases of adverse events are expected. Standardized methodologies to discriminate drug-related adverse events from the clinical manifestations of the infections are needed.

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

“…A meta-analysis that evaluated the clinical efficacy and tolerability of praziquantel in the treatment of intestinal and urinary schistosomiasis reported that the incidence of AEs ranged from 2.3% for urticaria to 31.1% for abdominal pain [ 40 ]. The most observed AEs in our study were headache (21%), dizziness or fainting (15.2%), nausea (12.8%), and stomach pain (12.2%), as similarly reported by other studies from Angola, Ethiopia, Kenya, and Tanzania [ 19 , 24 , 25 , 34 ]. Wide interindividual variations in plasma praziquantel concentrations partly due to pharmacogenetic variations has recently been reported [ 41 , 42 ].…”

“…Different studies from SSA reported varying incidence rates of AEs associated with mass praziquantel and albendazole administration. Studies conducted in Kenya (25.3%), Tanzania (28.5%), Angola (55.9%), and Ethiopia (83%) reported higher incidences than our study finding [ 19 , 24 , 25 , 34 ]. Differences in the reported incidence of AEs can be due to variation in the studies, such as data collection methods, AE definition, and/or infection status of the study population (treatment in infected children versus preventive chemotherapy in the target population with unknown infection status).…”

“…Children with moderate to heavy infection intensity are more likely to experience AEs compared with those with light infection intensity [18][19][20]. AEs may be induced by drugs or immunologic reaction due to the killing of the parasites mostly in heavy infection intensity [25,35]. The occurrence of AEs could be influenced by other factors such as age, co-infections or comorbidities, concomitant medication, nutritional status, socioeconomic conditions, and environmental exposure [25,36,37].…”

“…AEs may be induced by drugs or immunologic reaction due to the killing of the parasites mostly in heavy infection intensity [25,35]. The occurrence of AEs could be influenced by other factors such as age, co-infections or comorbidities, concomitant medication, nutritional status, socioeconomic conditions, and environmental exposure [25,36,37]. A recent study from Kenya reported concomitant medications and chronic illness as significant risk factors for developing AEs following diethylcarbamazine citrate and albendazole MDA [38].…”

“…Few studies that assessed the safety profiles of albendazole and praziquantel in different settings reported transient AEs such as abdominal pain, nausea, vomiting, diarrhea, headache, dizziness, and fainting [18,20,[24][25][26]. Safety surveillance studies in various target populations are important since local factors such as comorbidities, nutritional status, genetic and environment differences affect variability in drug responses [27,28].…”