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).

Vernonia cinerea pastilles is effective for smoking cessation.

BACKGROUND AND AIM: Vernonia cinerea (VC) is a herb that can alleviate nicotine addiction, potentially aiding in smoking cessation. Previous studies have examined four-to eight-week treatments using VC, but have found it to be ineffective. This study aimed to evaluate the smoking cessation effects of VC in addicted smokers over a longer treatment duration with pastilles. EXPERIMENTAL PROCEDURE: This was a randomized double-blinded controlled trial conducted at a community pharmacy. The inclusion criteria were age between 18 and 60 years, intention to quit smoking, and low to moderate level of nicotine addiction. All eligible participants were stratified according to nicotine addiction level and then randomly assigned either VC treatment or placebo. The VC group received two pastilles three times daily, while the control group received a placebo for 12 weeks. The outcomes were continuous abstinence rate (CAR) and point abstinence rate (PAR) at four and 12 weeks. RESULTS: There were 121 eligible participants; 10 participants were not willing to participate. In total, there were 111 eligible participants, 54 of whom were treated with VC (48.65%) and 57 of whom were given a placebo (51.35%). Baseline characteristics were comparable between the two groups. The VC group had a significantly higher chance of smoking cessation at 2.01 (95% CI of 1.03, 3.92) compared with the placebo group at the end of the study. There were no significant side effects in either group. CONCLUSION: The VC pastille group had significantly higher CAR than the placebo group at week 12.

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.

Can Generic Intravenous Levetiracetam Be Used for Acute Repetitive Convulsive Seizure or Status Epilepticus? A Randomized Controlled Trial.

INTRODUCTION: Intravenous levetiracetam (IV LEV) is approved for treatment status epilepticus (SE). However, the drug's high cost must be considered when deciding on a treatment strategy. This study aimed to compare the efficacy of brand-name and generic IV LEV for acute repetitive convulsive seizure (ARCS) or SE. METHODS: Forty patients aged 18 years or older who had been diagnosed with SE or ARCS were included in this double-blind study. Patients were randomly assigned at a 1:1 ratio (via computer-generated code) to receive either brand-name or generic IV LEV. The primary outcomes were seizure control and the number of seizure exacerbations during the 24 h after drug administration, while the secondary outcomes were electroencephalographic (EEG) findings, serious adverse events, and clinical outcome at hospital discharge. RESULTS: Forty patients were randomly assigned administration with either brand-name IV LEV (10 SE and 10 ARCS patients) or generic IV LEV; 7 SE and 13 ARCS patients). There was no significant difference in patients' baseline characteristics. The seizure control rate was 75% in the brand-name IV LEV group and 65% in the generic IV LEV group (p value: 0.490). Five (25%) patients in the brand-name IV LEV group, and six (30%) patients in the generic IV LEV group developed seizure exacerbations within 24 h after drug administration (p value 0.723). There were no reports of drug-related adverse events. Two of the patients taking brand-name IV LEV and one taking the generic IV LEV died (p value > 0.999). CONCLUSION: Treatment with the generic IV LEV had comparable outcomes with brand-name IV LEV. The generic IV LEV may be an alternative medication for the treatment of SE and ARCS to reduce treatment costs. TRIAL REGISTRATION: TCTR20190513001. FUNDING: Great Eastern Drug Company.

Factors predicting the outcomes of elderly hospitalized myasthenia gravis patients: a national database study.

BACKGROUND: Myasthenia gravis (MG) in elderly populations is increasing. This study aimed to evaluate predictors for treatment outcomes in elderly hospitalized MG patients using the national database. METHODS: We collected data of elderly hospitalized MG patients from the National Health Security Office from October 2009 to September 2010. Predictors for treatment outcomes were examined. RESULTS: During the study period, 1,948 identified MG patients were admitted to hospitals throughout Thailand. Of those, 441 patients (22.64%) were aged ≥ 60 years. There were 66 patients (14.97%) who had poor outcomes. There were only three significant factors in the final model. Presence of pneumonia, use of mechanical ventilators, and septicemia had adjusted odds ratios (95% confidence interval) of 2.83 (1.03, 7.75), 5.33 (2.24, 12.72), and 4.47 (1.86, 10.75), respectively. CONCLUSION: Pneumonia, being on a mechanical ventilator, and septicemia were independent factors associated with poor treatment outcomes in elderly hospitalized MG patients according to national data.

Status epilepticus in the elderly patients: A national data study in Thailand.

There are limited data in terms of incidence, clinical features, and outcomes in elderly patients with status epilepticus (SE) in national level. We retrospectively explored national data in Thailand for reimbursement of all SE in elderly patients admitted in the fiscal year 2004-2012. SE in elderly patients (age>60years old) were diagnosed and searched based on ICD 10 (G41) from the national database of from the National Health and Security Office. There were 3326 SE in elderly patients. The national incidence of SE was highest at 8.78patients/100,000/year in 2012. The average age was 72.02years and most were males (1379 patients; 58.8%). At discharge, 66% of patients had improved and in-hospital mortality rate was 14.5%. Predictors of poor outcomes were older age≥80years, being female, hospital levels, chronic renal failure, central nervous system infection, respiratory failure, pneumonia, septicemia, shock, acute renal failure, and hyperkalemia. In conclusion, the number of cases of SE in elderly patients in Thailand has been increasing annually. Increasing age was associated with poor outcome in admitted elderly SE patients.

Incidences and outcomes of status epilepticus: A 9-year longitudinal national study.

INTRODUCTION: The national database of status epilepticus (SE) in Thailand is limited in terms of the characteristics of the demographics, outcome, and prognostic factors. MATERIALS AND METHODS: We retrospectively explored national data in Thailand for reimbursement of all adult patients with SE admitted in the fiscal year 2004-2012. Patients with SE were diagnosed and searched based on ICD 10 (G41) from the national database of the Universal Health Coverage Insurance office. RESULTS: There were 12,367 patients with SE. The average age was 48.14 years, and 8119 patients were males (65.7%). At discharge, 75.2% of patients were improved, while 16.4% were not improved, and in-hospital mortality rate was 8.4%. The first three most common comorbid conditions were hypertension (1790 patients, 14.5%), diabetes mellitus (1064 patients, 8.6%), and previous stroke (819 patients, 6.6%). The common complications were respiratory failure (3990 patients, 32.3%), pneumonia (1201 patients, 9.7%) and septicemia (876 patients, 7.1%). The mean (SD) hospital stay was 5.48 (11.44) days. Patients with SE with age over 60 years, female patients, and patients at primary care hospitals had higher proportions of poor outcomes at 36.1%, 39.6%, and 40.9%. Out of 11 comorbid conditions, six of them were significantly associated with poor outcomes. Additionally, 5 complications and two procedures were significant factors of poor outcomes. CONCLUSIONS: Factors associated with poor outcome in admitted patients with SE by the national data were age, gender, hospital level, comorbid conditions, complications of SE, and procedural intervention. This article is part of a Special Issue entitled "Status Epilepticus".

Prevalence of factors associated with poor outcomes of hospitalized myasthenia gravis patients in Thailand.

OBJECTIVE: To examine the prevalence of hospitalized myasthenia gravis (MG), and to determine the factors associated with poor outcomes of hospitalized MG patients at a national level. METHODS: This study was based on a retrospective design. We collected data of hospitalized MG adults recorded by the National Health Security Office, Bangkok, Thailand between October 2009 and September 2010. Clinical data and treatment outcomes were examined. RESULTS: The total number of hospitalized MG patients was 936 cases. The prevalence rate of hospitalized MG patients was 2.17/100,000 population. The average age (SD) was 44.93 (14.16) years. Regarding the discharge status of MG patients, 845 cases (90.3%) had improved. The total hospital charge of MG patients was 64,332,806 baht (USD 2,144,426.87) or an average of 68,731.63 baht/admission (USD 2,291.05), with an average length of stay of 10.45 days. There were 3 significant factors associated with poor outcomes in hospitalized MG patients; namely, hospital category, pneumonia, and respiratory failure. CONCLUSION: The prevalence of admission in MG patients was 2.17 persons/100,000 population. Hospital category, pneumonia, and respiratory failure were significant factors associated with poor outcomes.

Moving the self-esteem of people with epilepsy by supportive group: a clinical trial.

INTRODUCTION: People with epilepsy (PWE) face physical and mental illness, and social stigma, which affect their self-esteem and quality of life. The purpose of this study was to examine the effects of a support group on the self-esteem of PWE. METHODS: A Quasi-experimental study was performed on 120 PWE in the Epilepsy Clinic at Srinagarind Hospital.  The experimental group (N=60) attended the support group before receiving regular health care services. The control group (N=60) received only regular healthcare services. Data was collected by using the Rosenberg self-esteem scale scoring before and after the experiment. The score was analyzed by using a paired t-test and an independent t-test. RESULTS: The study showed that before the experiment, the self-esteem score of the control group was significantly higher than the experimental group. After the experiment, the scores of the control group and the experimental group showed a significant statistical difference. The score in the control group was significantly lower than the experimental group, while the score in the experimental group was significantly higher than before the experiment. CONCLUSION: The support group improves the self-esteem of PWE. Medical personnel should set up a support group for PWE to enhance their self-esteem.