Overall results of evidence on the safety of praziquantel for treatment of schistosomiasis in at-risk populations
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Treatment with praziquantel is well tolerated across all age groups, when treating any Schistosoma species, and in uninfected persons.
Certainty of evidence. The overall certainty of evidence for the safety of praziquantel for treatment of schistosomiasis in at-risk populations was moderate.
Balance of benefits and harms. The morbidity and mortality of schistosomiasis are well documented, as previously described. Any infected individual should be treated, regardless of age. The potential harms described for preventive chemotherapy with praziquantel are based upon adverse events from giving the medicine both to those who are infected (who benefit) and those who are uninfected (who do not benefit). The evidence synthesized demonstrates the safety of praziquantel, with documented transient, mild adverse events such as abdominal pain, headache, dizziness and diarrhoea (83, 66, 84, 85); persistent mild, moderate and severe adverse events were uncommon (59'66). People with infections of high intensity also had a higher incidence of mild adverse events, but would also be expected to benefit most from treatment (59, 60). The concern for harm is of greatest consequence in people who are not infected but are nevertheless treated, given the public health approach of preventive chemotherapy, and therefore bear a risk of adverse events without immediate personal benefit (although with lower risk of those adverse events than among those who are infected at the time of treatment). Case reports of more serious adverse effects exist, although causality remains uncertain. Given the limited number of pregnant women at first trimester included in the available study (86) and on the basis of exercising maximum precaution, the GDG decided to recommend exclusion of pregnant women in the first trimester from preventive chemotherapy campaigns even though the study did not report risk on adverse pregnancy outcomes. There remains a poorly characterized concern for treatment with praziquantel when a person has another concurrent infection such as neurocysticercosis, although associated adverse effects have not been noted in practice. Patients with neurocysticercosis are treated routinely with doses of praziquantel (for example, 50 mg/kg per day for 10 consecutive days) that are many times higher than those used in annual MDA programmes for schistosomiasis, suggesting the drug is well tolerated in such individuals. However, out of an abundance of caution, in areas co-endemic for Taenia solium, MDA with praziquantel should not include people with signs compatible with neurocysticercosis, such as seizures, and active surveillance should be conducted and include post-MDA neurological side-effects. Finally, there remains a concern around choking or aspiration during administration of medications, especially in younger children, with that concern rising where treatments are more frequent and total doses are higher (67).
Values and preferences. The GDG agreed that there was likely variability in the value that populations assigned to safety of praziquantel used in preventive chemotherapy programmes to control schistosomiasis. Some people may be more averse to experiencing adverse effects than others. Yet, as far as we know, these adverse events are generally not serious, and well-informed individuals will likely place high value on treating people infected with schistosomiasis and accept the trade-off of experiencing transient mild symptoms related to treatment in order to reduce prevalence and morbidity (see previous discussion of values and preferences).
Acceptability. When the status of infection is proven, in health facility-based treatment the need for treatment tends to overcome the fear of any potential side-effects.
Preventive chemotherapy against schistosomiasis is generally widely accepted by relevant stakeholders, as previously discussed.
Resource implications. The GDG agreed that the implementation of routine treatment in health facilities, and preventive chemotherapy with praziquantel against schistosomiasis in at-risk populations, would both carry a favourable ratio of required resources relative to expected benefit. This would require the heath system to make praziquantel available for treatment of infected individuals in health facilities of endemic areas. A review of the literature concluded that a strategy of preventive chemotherapy against schistosomiasis has favourable cost'effectiveness (9, 70, 71).
Equity. The GDG agreed that more preventive chemotherapy with praziquantel would yield greater reductions in schistosomiasis disease burden and could improve health equity.
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Schistosomiasis is a disease that disproportionately affects poor, vulnerable populations and those who are unable to obtain health services. For this reason, the medication used to treat this infection in a public health programme is necessarily required to have a robust safety profile. Given high efficacy and typically mild, transient adverse events, individual treatment or preventive chemotherapy with praziquantel would likely provide better control of individual- or population-level disease burden that could yield improved equity by benefiting especially the marginalized populations that are most affected.
Feasibility. The GDG agreed that individual treatment and preventive chemotherapy with praziquantel are both technically feasible. Annual preventive chemotherapy programmes for schistosomiasis have been ongoing in many countries for a number of years.
The feasibility of preventive chemotherapy with praziquantel would depend upon the at-risk population of interest. For treatment of SAC, school-based delivery systems would be appropriate, which are supported by ministries of health and education. For children not attending schools, adolescents and at-risk adults, community-based distribution channels are required. The medications have been administered through preventive chemotherapy programmes without the presence of a medical doctor and without significant adverse reactions being documented. The favourable safety profile of praziquantel ensures easier feasibility of administration. Part of the praziquantel remaining after MDA could be allocated for routine treatment of infected individuals presenting to health facilities of endemic areas.
Overall, the decision-making process of the GDG was informed by the following considerations:
The evidence assessed indicated that use of praziquantel is safe in children aged 2 years and older, as well as in adults, pregnant women after the first trimester and lactating women, as indicated in recommendation 1 . However, due to data limitations in children aged under 2 years, the GDG determined that clinical judgement should be exercised in these cases, as outlined in recommendation 4
People across all age groups infected with Schistosoma spp. benefit significantly from treatment with praziquantel to cure the infection or reduce worm burden and other schistosomiasis-related morbidities.
Preventive chemotherapy with praziquantel is well tolerated, with typically transient mild adverse events reported such as abdominal pain, headache and dizziness.
Preventive chemotherapy with praziquantel is well tolerated across all age groups, in pregnant women, in treatment across Schistosoma species, and in those who are not infected with Schistosoma.
Preventive chemotherapy with praziquantel is well accepted among children, parents, teachers, health workers and members of the community, is technically feasible and remains a cost-effective intervention.
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