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1. Children infected with T. trichiura treated with oxantel pamoate-albendazole achieved a significantly higher cure rate than those treated with mebendazole alone.
2. In treating hookworm, albendazole monotherapy was superior, and adding oxantel pamoate did not increase the efficacy.
Evidence Rating Level: 1 (Excellent)
Study Rundown: In this randomized, double-blind trial involving children aged 6 to 14 years from two schools on Pemba Island, Tanzania, the authors assessed the efficacy and safety profile of oxantel pamoate, which has been marketed as a veterinary drug since 1974. More than 1 billion people globally are infected with soil-transmitted helminths, including Ascaris lumbricoides, hookworm, and Trichuris trichiura, also known as whipworm. Global efforts are currently oriented towards period administration of antihelmintic drugs, such as albendazole or mebendazole, with the goal of eliminating childhood illness caused by these infections, and to reduce prevalence of moderate or heavy helminth infection to less than 1%.
The study’s findings suggest that combination therapy with oxantel pamoate and albendazole offers significantly higher cure rates in treating T. trichiura compared to monotherapy with albendazole or mebendazole. These gains were in the context of a relatively benign side effect profile. These findings are promising for potentially including oxantel pamoate alongside other medications better suited to treat hookworm, such as albendazole. Strengths of the study include its well-balanced treatment arms comparing combination therapy to three separate monotherapy arms, as well as formulation of endpoint results in terms of WHO goals for global control of soil-transmitted heminthiasis. One potential drawback is the fact that the group sizes were small enough that there were no children with heavy infection with A. lumbricoides in the oxantel pamoate or mebendazole monotherapy groups, limiting sub-group analysis of this secondary endpoint.
Click to read the study, published today in NEJM
Relevant Reading: Soil-transmitted helminth infections: ascariasis, trichuriasis, and hookworm
In-Depth [randomized, controlled trial]: This trial randomly assigned 480 children, 6 to 14 years of age, on Pemba Island, Tanzania to 1 of 4 treatment groups: oxantel pamoate and albendazole, or monotherapy with oxantel pamoate, albendazole, or mebendazole; complete data were available for 458 children. Inclusion criteria included testing positive for either T. trichiura or hookworm, but patients coinfected with both were enrolled with highest priority; those with systematic illness including malaria or schistosomiasis were excluded. The primary end point was efficacy and safety profile in the treatment of T. trichiura infection, measured by cure rate and egg-reduction rate; secondary end points dealt with A. lumbricoides and hookworm.
Those children infected with T. trichiura in the oxantel pamoate-albendazole group achieved a significantly higher cure rate than those treated with mebendazole alone (31.2% vs. 11.8%, P=0.001); oxantel pamoate alone was also associated with a significantly higher cure rate than mebendazole monotherapy (26.3% vs. 11.8%, P=0.01). These estimates remained after adjusting for school, sex, and weight. The cure rate for albendazole (2.6%) was significantly lower than the rate with mebendazole (P=0.02). Among children with moderate or heavy T. trichiura infection at baseline, 84.9% had either no or light infection at the end, compared with 58.5% and 46.8% in the mebendazole and albendazole groups respectively. In treating hookworm, albendazole monotherapy was superior, and adding oxantel pamoate did not increase the efficacy (cure rate of 59.8% with albendazole alone vs. 51.4% with the combination, P=0.21). Oxantel pamoate-albendazole combination achieved a cure rate of 94.4% in those infected with A. lumbricoides, compared to 92.0% and 91.2% in the albendazole and mebendazole groups.
In terms of safety profile, 12.4% of children across all groups had symptoms (most commonly abdominal cramps and headache) prior to treatment; 13.8% of children in the oxantel pamoate groups had symptoms prior to treatment. 24 hours following oxantel pamoate treatment, 15.8% of children reported adverse events including headache and abdominal cramps; there were no serious adverse events.
By Matthew Growdon and Xu Gao
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