Pharmacokinetic study of praziquantel administered alone and in combination with cimetidine in a single-day therapeutic regimen

Jung, Hyejin; Medina, Roberto; Castro, Nelly; Corona, Teresa; Sotelo, Julio

doi:10.1128/aac.41.6.1256

Cited by 53 publications

(25 citation statements)

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“…The pathogenic role of the mutation is strongly supported by the following findings: 1) similar to most tRNA Leu(UUR) mutations described so far, this novel mutation is also associated with an isolated complex I deficiency; 2) the clinical features of our patient resemble in part those described with other mutations in the tRNA Leu(UUR) gene with myopathy, deafness, ataxia, encephalopathy, retinopathy, and cerebellar ataxia, 3 and, in addition, MRI changes were found in the basal ganglia and the periventricular white matter that resemble other mt encephalomyopathies; 3) the base change is heteroplasmic and presumably affects the anticodon stem formation by disrupting a Watson-Crick base pair; 4) the base change is not detected in at least 200 controls; and 5), most important, single-fiber experiments showed a higher load of the mutation in RRF than in histologically normal fibers. We have detected a novel heteroplasmic tRNA Leu(UUR) G3274A mutation in the skeletal muscle of a patient with a progressive neuropsychiatric disorder and a severe respiratory chain complex I deficiency.…”

Section: A Mutation In Mt Trnaleu (Uur) Causing a Neuropsychiatric Sysupporting

confidence: 80%

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Optimization of the single-day praziquantel therapy for neurocysticercosis

López-Gómez

Castro²,

Jung³

et al. 2001

Neurology

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In 1996, we described a schedule of single-day therapy with praziquantel for management of neurocysticercosis. This treatment resulted in 90% less total dose and costs and 93% less duration of treatment in comparison with the 2-week regimen, achieving similar clinical efficacy. 1 It also showed similar results compared with albendazole. 2 Recent reports in healthy volunteers have suggested that plasma levels of praziquantel increase with the administration of cimetidine 3 and also with a high-carbohydrate diet, 4 apparently due to inhibition of cytochrome p450. To investigate the potential clinical advantage of this effect, we compared the praziquantel single-day regimen administered either alone or in combination with cimetidine, and administered simultaneously with a high-carbohydrate diet.Methods. We studied 18 patients diagnosed with cysticercosis in brain parenchyma or subarachnoid space at the convexity. Age range was 17 to 64 years (mean 29.2); the study included 10 men and eight women. No patients with parenchymal cysts surrounded by edema and intense enhancing in contrasted studies were selected. No pregnant women were included. A diagnosis of cysticercosis was confirmed by ELISA in CSF and imaging studies (CT or MRI or both). All had seizures as the principal symptom. The mean time between the beginning of symptoms and treatment was 8 weeks. Informed consent was obtained from each patient. Subjects were randomly separated into three groups of six pa-tients each. Group 1 received three oral doses of 25 mg/kg of praziquantel at 2-hour intervals (at 7, 9, and 11 AM) after an overnight fast. Group 2 received the same three oral doses plus 400 mg of cimetidine administered 1 hour before each praziquantel dose. Group 3 received a high-carbohydrate diet (650 calories) 30 minutes before the first dose of praziquantel. All patients received dexamethasone (8 mg intramuscular) 6 hours after the last dose of praziquantel followed by the same dosage for the next 2 days. All patients remained in the hospital during treatment. Clinical evaluations were made 1, 2, 4, 8, 12, and 24 weeks after treatment, all by the same neurologist (M.L.). Follow-up CT scanning was performed 4, 12, and 24 weeks after treatment, and MRI was performed 24 weeks after treatment. Efficacy of treatment was evaluated by the individual disappearance of cysts and by the percentage of disappearance of lesions in every patient. Imaging studies were independently reviewed by a neurologist (T.C.) and a neuroradiologist blinded to treatment group source; interobserver results were identical. Blood samples were taken immediately before the last dose of praziquantel and were assayed by highperformance liquid chromatography. 5 The Mann-Whitney test was used to assess differences in the median percentage of cysts and to assess plasma levels. The SPSS-9 analytical program was used.

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Section: A Mutation In Mt Trnaleu (Uur) Causing a Neuropsychiatric Sysupporting

confidence: 80%

“…3 All patients were asymptomatic in the follow-up period. Sixteen patients were asymptomatic and two had hemiparesis due to localization of cysts that recovered completely after treatment.…”

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confidence: 93%

Optimization of the single-day praziquantel therapy for neurocysticercosis

López-Gómez

Castro²,

Jung³

et al. 2001

Neurology

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“…The bioavailability of praziquantel is increased by the simultaneous administration of substances that inhibit cytochrome P450 activities. For instance, cimetidine causes a 100% increase (Metwally et al 1995;Jung et al 1997) and has been used in association with praziquantel especially for the treatment of neurocysticercosis, where high drug concentrations are required. Similar increases can be effected by 17 alpha-ethynylestradiol and diphenylhydramine, whereas the opposite effect is observed after the simultaneous administration of antiepileptics or corticosteroids, especially carbamazepine, phenytoin or dexamethasone (Na-Bangchang et al 1995;Sotelo and Jung 1998).…”

Section: Pharmacokinetics and Clearancementioning

confidence: 99%

Praziquantel

Cioli¹,

2003

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“…Conversely, co-administration of the histamine H 2 -receptor antagonist cimetidine was demonstrated to prolong exposure of praziquantel, suggesting the possibility for further improvement of efficacy of this single-day therapy [73]. …”

Section: Resultsmentioning

confidence: 99%

Lack of Clinical Pharmacokinetic Studies to Optimize the Treatment of Neglected Tropical Diseases: A Systematic Review

Verrest

Dorlo

2016

Clin Pharmacokinet

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IntroductionNeglected tropical diseases (NTDs) affect more than one billion people, mainly living in developing countries. For most of these NTDs, treatment is suboptimal. To optimize treatment regimens, clinical pharmacokinetic studies are required where they have not been previously conducted to enable the use of pharmacometric modeling and simulation techniques in their application, which can provide substantial advantages.ObjectivesOur aim was to provide a systematic overview and summary of all clinical pharmacokinetic studies in NTDs and to assess the use of pharmacometrics in these studies, as well as to identify which of the NTDs or which treatments have not been sufficiently studied.MethodsPubMed was systematically searched for all clinical trials and case reports until the end of 2015 that described the pharmacokinetics of a drug in the context of treating any of the NTDs in patients or healthy volunteers.ResultsEighty-two pharmacokinetic studies were identified. Most studies included small patient numbers (only five studies included >50 subjects) and only nine (11 %) studies included pediatric patients. A large part of the studies was not very recent; 56 % of studies were published before 2000. Most studies applied non-compartmental analysis methods for pharmacokinetic analysis (62 %). Twelve studies used population-based compartmental analysis (15 %) and eight (10 %) additionally performed simulations or extrapolation. For ten out of the 17 NTDs, none or only very few pharmacokinetic studies could be identified.ConclusionsFor most NTDs, adequate pharmacokinetic studies are lacking and population-based modeling and simulation techniques have not generally been applied. Pharmacokinetic clinical trials that enable population pharmacokinetic modeling are needed to make better use of the available data. Simulation-based studies should be employed to enable the design of improved dosing regimens and more optimally use the limited resources to effectively provide therapy in this neglected area.Electronic supplementary materialThe online version of this article (doi:10.1007/s40262-016-0467-3) contains supplementary material, which is available to authorized users.

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Pharmacokinetic study of praziquantel administered alone and in combination with cimetidine in a single-day therapeutic regimen

Cited by 53 publications

References 17 publications

Optimization of the single-day praziquantel therapy for neurocysticercosis

Optimization of the single-day praziquantel therapy for neurocysticercosis

Praziquantel

Lack of Clinical Pharmacokinetic Studies to Optimize the Treatment of Neglected Tropical Diseases: A Systematic Review

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