The Efficacy and Safety Profile of Generic Intravenous Levetiracetam in a Real-World Setting.

BACKGROUND: There are 3 main epileptic conditions in hospital settings that may require intravenous antiepileptic treatment: status epilepticus, acute repetitive convulsive seizures, and postoperative seizures. Generic intravenous levetiracetam (IV LEV) (Focale; Great Eastern Drug Co, Bangkok, Thailand), has been reported to have comparable efficacy to original IV LEV for treating status epilepticus and acute repetitive convulsive seizures in a randomized controlled trial. At present, there are limited data on the efficacy and tolerability of generic intravenous LEV in real-world situations. OBJECTIVE: This study aimed to evaluate the clinical outcomes of generic IV LEV in a real-world setting. METHODS: A retrospective study and analyses were conducted. All adult patients who used IV LEV at University Hospital, Khon Kaen University, Thailand from June 1, 2019, until February 15, 2020, were included. Data were analyzed and reported in terms of the efficacy and tolerability of generic IV LEV. RESULTS: Ninety-three patients received IV LEV by 3 indications: status epilepticus, acute repetitive convulsive seizures, and postoperative seizures. The proportions of these 3 indications were 41.94% (39 patients), 9.67% (9 patients), and 48.39% (45 patients), respectively. The average seizure control rate at 24 hours was 89.25%. The seizure control rate was significantly higher in the acute repetitive convulsive seizures and postoperative seizure groups than in the status epilepticus group when generic IV LEV was given as the first-line treatment (75.00%; 88.37% vs 50.00%; P 0.035). The average length of hospital stay was 18.24 (25.40) days. There was no significant discharge status among the 3 groups (P = 0.348). Moreover, the average mortality rate was 5.38%. Side effects were reported in 14 patients (15.05%). The 2 most common side effects were vomiting and bronchospasm (3 patients; 3.22%). There were 10 patients with uncontrolled seizures at 24 hours (10.75%). The only factor associated with uncontrolled seizures at 24 hours was a history of epilepsy. The uncontrolled seizure group had a higher proportion of epilepsy patients than the seizure-controlled group (70.00% vs 33.73%; P = 0.037). Poor discharge status (not improved/death) was 18.28% (17 patients). There was no significant factor between those with an improved or poor discharge status. CONCLUSIONS: Generic IV LEV was effective and relatively well tolerated in the 3 clinical settings (ie, status epilepticus, acute repetitive convulsive seizures, and postoperative seizures). Further clinical data are still required to confirm the results of this study.(Curr Ther Res Clin Exp. 2022; 83:XXX-XXX).

Efficacy of Generic Atorvastatin in a Real-World Setting.

BACKGROUND: The ability of statins to reduce LDL-c plays an important role in both primary and secondary prevention of atherosclerotic cardiovascular diseases. Such treatment can often be costly, but using generic atorvastatin may reduce cost by up to US$2635. In addition, a previous 8-week study found that it exhibited comparable efficacy to the brand-name medication. This study aimed to evaluate the efficacy of generic atorvastatin over a longer period of six months in a real-world setting. METHODS: This was a retrospective cohort study in adult patients who had received brand-name atorvastatin for at least three months and then had switched to generic atorvastatin for at least six months. Lipid and safety profiles were evaluated at six months after switching. Adjusted analyses for age, sex, co-morbid disease, dosage, and indications for statin therapy were also performed. RESULTS: During the study period, there were 488 patients who met the study criteria. The mean (SD) age of the patients was 60.97 (12.26) years, and 48.36% were male (236 patients). At six months, average total cholesterol, HDL-c, and LDL-c were all lower, from 174.43 to 166.15 mg/dL, from 51.64 to 49.51 mg/dL, and from 110.08 to 100.78 mg/dL (p < 0.001), respectively. There were no significant differences in terms of any other laboratory test results. LDL-c exhibited the highest significant reduction at 9.30 mg/dL. Stratified analyses by age, sex, co-morbid disease, dose, and indications for statin therapy revealed similar decreases in HDL-c and LDL-c as in the study population as a whole. CONCLUSION: Generic atorvastatin resulted in significantly lower LDL-c than name-brand atorvastatin but less of an increase in HDL-c.

A Fast-Track Care by a Nursing Case Management Concept Improved Status Epilepticus Outcomes.

BACKGROUND: Status epilepticus (SE) is an emergency neurological condition, which is life-threatening, results in high morbidity and mortality rates, and needs to be diagnosed and promptly cared for. This study aimed to develop and evaluate the SE fast-track care using a nursing case management concept on SE outcomes. METHODS: Quasi-experimental study conducted in adult patients with SE admitted in 15 emergency and intensive critical/intermediate care wards. SE outcomes were evaluated and compared between preintervention and postintervention. RESULTS: Time to treatment was reduced from 30 minutes to 3.5 minutes (P < .001). Similarly, the seizure control rate increased from 65.7% to 94.4% (P = .009). The mortality rate was reduced but did not reach statistical significance (8.6% vs 0%; P = .115). The intervention also reduced average waiting time for receiving antiepileptic drugs from the pharmacy department from 13.09 minutes to < 1 minute. CONCLUSION: The development of the fast-track care system for SE patients by nursing case management is at the core of management for coordinating multidisciplinary teams. This can improve outcomes by reducing the time to diagnosis and treatment time, therefore reducing mortality rates in SE patients.