Hector H Garcia1, Isidro Gonzales, Andres G Lescano, Javier A Bustos, E Javier Pretell, Herbert Saavedra, Theodore E Nash. 1. Cysticercosis Unit, National Institute of Neurological Sciences, Lima, Peru; Department of Microbiology, School of Sciences, Cayetano Heredia Peruvian University, Lima, Peru; Center for Global Health - Tumbes, Cayetano Heredia Peruvian University, Lima, Peru; School of Public Health, Cayetano Heredia Peruvian University, Lima, Peru.
Abstract
OBJECTIVE:Neurocysticercosis (NCC) is a major cause of seizures and epilepsy in endemic countries. Antiparasitic treatment of brain cysts leads to seizures due to the host's inflammatory reaction, requiring concomitant steroids. We hypothesized that increased steroid dosing will reduce treatment-associated seizures. METHODS: Open-label randomized trial comparing 6 mg/day dexamethasone for 10 days (conventional) with 8 mg/day for 28 days followed by a 2-week taper (enhanced) in patients with NCC receivingalbendazole. Follow-up included active seizure surveillance and brain imaging. Study outcomes were seizure days and patients with seizures, both measured in days 11-42. Additional analyses compared days 1-10, 11-21, 22-32, 33-42, 43-60, and 61-180. RESULTS:Thirty-two individuals were randomized into each study arm; two did not complete follow-up. From days 11 to 42, 59 partial and 6 generalized seizure days occurred in 20 individuals, nonsignificantly fewer in the enhanced arm (12 vs. 49, p = 0.114). The numbers of patients with seizures in this period showed similar nonsignificant differences. In the enhanced steroid arm there were significantly fewer days and individuals with seizures during antiparasitic treatment (days 1-10: 4 vs. 17, p = 0.004, and 1 vs. 10, p = 0.003, number needed to treat [NNT] 4.6, relative risk [RR] 0.1013, 95% confidence interval [CI] 0.01-0.74) and early after dexamethasone cessation (days 11-21: 6 vs. 27, p = 0.014, and 4 vs. 12, p = 0.021, NNT 4.0, RR 0.33, 95% CI 0.12-0.92) but not after day 21. There were no significant differences in antiparasitic efficacy or relevant adverse events. SIGNIFICANCE: Increased dexamethasone dosing results in fewer seizures for the first 21 days during and early after antiparasitic treatment for viable parenchymal NCC but not during the first 11-42 days, which was the primary predetermined time of analysis. Wiley Periodicals, Inc.
RCT Entities:
OBJECTIVE:Neurocysticercosis (NCC) is a major cause of seizures and epilepsy in endemic countries. Antiparasitic treatment of brain cysts leads to seizures due to the host's inflammatory reaction, requiring concomitant steroids. We hypothesized that increased steroid dosing will reduce treatment-associated seizures. METHODS: Open-label randomized trial comparing 6 mg/day dexamethasone for 10 days (conventional) with 8 mg/day for 28 days followed by a 2-week taper (enhanced) in patients with NCC receiving albendazole. Follow-up included active seizure surveillance and brain imaging. Study outcomes were seizure days and patients with seizures, both measured in days 11-42. Additional analyses compared days 1-10, 11-21, 22-32, 33-42, 43-60, and 61-180. RESULTS: Thirty-two individuals were randomized into each study arm; two did not complete follow-up. From days 11 to 42, 59 partial and 6 generalized seizure days occurred in 20 individuals, nonsignificantly fewer in the enhanced arm (12 vs. 49, p = 0.114). The numbers of patients with seizures in this period showed similar nonsignificant differences. In the enhanced steroid arm there were significantly fewer days and individuals with seizures during antiparasitic treatment (days 1-10: 4 vs. 17, p = 0.004, and 1 vs. 10, p = 0.003, number needed to treat [NNT] 4.6, relative risk [RR] 0.1013, 95% confidence interval [CI] 0.01-0.74) and early after dexamethasone cessation (days 11-21: 6 vs. 27, p = 0.014, and 4 vs. 12, p = 0.021, NNT 4.0, RR 0.33, 95% CI 0.12-0.92) but not after day 21. There were no significant differences in antiparasitic efficacy or relevant adverse events. SIGNIFICANCE: Increased dexamethasone dosing results in fewer seizures for the first 21 days during and early after antiparasitic treatment for viable parenchymal NCC but not during the first 11-42 days, which was the primary predetermined time of analysis. Wiley Periodicals, Inc.
Authors: Héctor H Garcia; E Javier Pretell; Robert H Gilman; S Manuel Martinez; Lawrence H Moulton; Oscar H Del Brutto; Genaro Herrera; Carlton A W Evans; Armando E Gonzalez Journal: N Engl J Med Date: 2004-01-15 Impact factor: 91.245
Authors: D Botero; C S Uribe; J L Sanchez; T Alzate; G Velasquez; N E Ocampo; L A Villa Journal: Trans R Soc Trop Med Hyg Date: 1993 Sep-Oct Impact factor: 2.184
Authors: Jay S Hanas; James R Hocker; Govindan Ramajayam; Vasudevan Prabhakaran; Vedantam Rajshekhar; Anna Oommen; Josephine J Manoj; Michael P Anderson; Douglas A Drevets; Hélène Carabin Journal: Exp Parasitol Date: 2018-08-08 Impact factor: 2.011
Authors: S Purvey; K Lu; S K Mukkamalla; P Anandi; B Dumitriu; S Kranick; D A Hammoud; E O'Connell; A L Oh; J Barrett; S Mahanty; M Battiwalla Journal: Transpl Infect Dis Date: 2015-06-01 Impact factor: 2.228
Authors: A Clinton White; Christina M Coyle; Vedantam Rajshekhar; Gagandeep Singh; W Allen Hauser; Aaron Mohanty; Hector H Garcia; Theodore E Nash Journal: Clin Infect Dis Date: 2018-04-03 Impact factor: 9.079
Authors: Jesus Abanto; Daniel Blanco; Herbert Saavedra; Isidro Gonzales; Diego Siu; E Javier Pretell; Javier A Bustos; Hector H Garcia Journal: Am J Trop Med Hyg Date: 2021-07-07 Impact factor: 3.707