Efficacy of combined antiparasitic therapy with praziquantel and albendazole for neurocysticercosis: a double-blind, randomised controlled trial
| Autor: | Herbert Saavedra, Martin Gavidia, E. Javier Pretell, Andres G. Lescano, Javier A. Bustos, Diego Escalante, Mirko Zimic, Lourdes Rodriguez, Hugo Umeres, Isidro Gonzales, Enrique Najar, Hector H. Garcia |
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| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Drug-Related Side Effects and Adverse Reactions Anthelmintics/adverse effects/therapeutic use Neurocysticercosis Albendazole/adverse effects/therapeutic use purl.org/pe-repo/ocde/ford#3.03.08 [https] Albendazole Gastroenterology Article Praziquantel law.invention Placebos Young Adult Double-Blind Method Randomized controlled trial law Praziquantel/adverse effects/therapeutic use Internal medicine medicine Placebos/administration & dosage Humans Adverse effect Aged Anthelmintics Neurocysticercosis/drug therapy business.industry Cysticercosis Middle Aged Interim analysis medicine.disease Surgery Treatment Outcome Infectious Diseases Concomitant Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology Female business medicine.drug |
| Popis: | Summary Background Neurocysticercosis causes a substantial burden of seizure disorders worldwide. Treatment with either praziquantel or albendazole has suboptimum efficacy. We aimed to establish whether combination of these drugs would increase cysticidal efficacy and whether complete cyst resolution results in fewer seizures. We added an increased dose albendazole group to establish a potential effect of increased albendazole concentrations. Methods In this double-blind, placebo-controlled, phase 3 trial, patients with viable intraparenchymal neurocysticercosis were randomly assigned to receive 10 days of combined albendazole (15 mg/kg per day) plus praziquantel (50 mg/kg per day), standard albendazole (15 mg/kg per day), or increased dose albendazole (22·5 mg/kg per day). Randomisation was done with a computer generated schedule balanced within four strata based on number of cysts and concomitant antiepileptic drug. Patients and investigators were masked to group assignment. The primary outcome was complete cyst resolution on 6-month MRI. Enrolment was stopped after interim analysis because of parasiticidal superiority of one treatment group. Analysis excluded patients lost to follow-up before the 6-month MRI. This trial is registered with ClinicalTrials.gov, number NCT00441285. Findings Between March 3, 2010 and Nov 14, 2011, 124 patients were randomly assigned to study groups (41 to receive combined albendazole plus praziquantel [39 analysed], 43 standard albendazole [41 analysed], and 40 increased albendazole [38 analysed]). 25 (64%) of 39 patients in the combined treatment group had complete resolution of brain cysts compared with 15 (37%) of 41 patients in the standard albendazole group (rate ratio [RR] 1·75, 95% CI 1·10–2·79, p=0·014). 20 (53%) of 38 patients in the increased albendazole group had complete cyst resolution at 6-month MRI compared with 15 (37%) of 41 patients in the standard albendazole group (RR 1·44, 95% CI 0·87–2·38, p=0·151). No significant differences in adverse events were reported between treatment groups (18 in combined treatment group, 11 in standard albendazole group, and 19 in increased albendazole group). Interpretation Combination of albendazole plus praziquantel increases the parasiticidal effect in patients with multiple brain cysticercosis cysts without increased side-effects. A more efficacious parasiticidal regime without increased treatment-associated side-effects should improve the treatment and long term prognosis of patients with neurocysticercosis. Funding National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health. |
| Databáze: | OpenAIRE |
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