Background: Epilepsy affects about 50 million people worldwide and around 30% of these patients have refractory epilepsy, with potential consequences regarding quality of life, morbidity and premature mortality. Objective: The aim of treatment with antiseizure medications (ASMs) is to allow patients to remain without seizures, with good tolerability. Levetiracetam is a broad-spectrum ASM with a unique mechanism of action that differs it from other ASMs. It has been shown to be effective and safe for treating adults and children with epilepsy. Methods: This was a phase III, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of levetiracetam in children and adults (4-65 years) as an adjuvant treatment for focal-onset seizures. It was conducted among 114 patients undergoing treatment with up to three ASMs. The primary efficacy analysis was based on the proportion of patients who achieved a reduction of ≥ 50% in the mean number of focal seizures per week, over a 16-week treatment period. The patients were randomized to receive placebo or levetiracetam, titrated every two weeks from 20 mg/kg/day or 1,000 mg/day up to 60 mg/kg/day or 3,000 mg/day. Results: Levetiracetam was significantly superior to placebo (p = 0.0031); 38.7% of the participants in the levetiracetam group and 14.3% in the control group shows reductions in focal seizures. Levetiracetam was seen to have a favorable safety profile and an adverse event rate similar to that of placebo. Conclusion: Corroborating the results in the literature, levetiracetam was shown to be effective and safe for children and adults with refractory focal-onset epilepsy.
Objective: To comparatively evaluate the pharmacokinetic profile of galantamine hydrobromide present in the test drug (8 mg of galantamine hydrobromide in extendedrelease hard gelatinous capsule, Aché Laboratórios Farmaceuticos S.A.) and the reference drug (8 mg of galantamine hydrobromide in extended-release hard gelatinous capsule, Janssen Ortho LLC). Methods: Two bioequivalence studies were carried out, one in fasting state and the other post-prandial. Both studies were conducted in a cross-sectional, randomized, open-ended design with healthy research participants (n = 74 participants age: 18-50 years) after single dose administration of the test and reference drugs. To conclude the pharmacokinetic equivalence between the treatments, the ratio of the geometric means of the pharmacokinetic parameters should be between 80% and 125%, as well as the 90% confidence interval. Results: The mean values obtained for the pharmacokinetic parameters Cmax and ASC0-t, both for the fasting study and for the study conducted under standardized feeding, were within the range determined for the conclusion of bioequivalence (Cmax 106.65% -120.14% for the fasting study and 101.41% -112.40% for the post-prandial study and ASC0-t 91.96% -99.23% for the fasting study and 93.88% -101.31% for the feeding study). The power of the test was 100% in all cases and the confidence intervals are within the limits of acceptance of bioequivalence. Conclusions: Considering the results obtained, it was possible to observe that the drugs evaluated are bioequivalent both in fasting and in post-prandial condition and, therefore, interchangeable in medical practice.
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