ABSTRACT
Background Escitalopram is widely used for the management of the major depressive disorder and generalized anxiety disorder, but there is no to very limited data available regarding efficacy and safety in Pakistani patients. This study was conducted to evaluate the efficacy and safety of escitalopram oral drops to manage the major depressive disorder and generalized anxiety disorder in a local cluster within Pakistan. Methods This prospective multicenter observational study was conducted in the department of psychiatry from August 2018 - August 2019. Eighty-five patients meeting the selection criteria were included in the study. Adolescent, adult, and geriatric patients of either gender with generalized anxiety disorder having Hamilton Anxiety Rating Scale (HAM-A) rate ≥ 10 and major depressive disorder having Montgomery-Asberg Depression Rating Scale (MADRS) rate ≥ 7 or patients with co-morbid generalized anxiety disorder (GAD), major depressive disorder (MDD) were selected for the study. We are reporting patients' improvement from baseline, response rate, and remission rate. Data analysis is performed by using SPSS version 21 (IBM Inc, Armonk, USA). Results Among enrolled patients, 42 were adolescents, 22 were adults, and 21 were geriatric. The mean age of an adolescent, adult, and geriatric patients was 14.92 ± 2.04, 44.54 ± 12.08, and 64.61 ± 3.16 years, respectively. Among enrolled patients, the mean change in a total score of HAM-A for anxiety and MADRS for depression were -10.04 ± 4.32 and -17.67 ± 14.42, respectively. At the end of the study, the remission rate and response rate for depression were 82 % and 75%, respectively. Similarly, the remission rate and the response for anxiety were 76% and 81%, respectively. Mean HAM-A and MADRS scores were significantly improved for adolescent, adult, and geriatric patients. Adverse events were reported in eight (9.41%) patients with six having gastrointestinal (GI) disturbance and two having to worsen anxiety. All reported adverse events were of mild severity. Conclusion Escitalopram oral drops are found effective and tolerable in reducing both anxiety and depression over the duration of study in all age groups, including adolescents, adults, and geriatrics.
ABSTRACT
Background In Pakistan, there is a paucity of published clinical data regarding the efficacy of sofosbuvir-velpatasvir in the management of patients with hepatitis C without cirrhosis or with compensated cirrhosis. Methods A prospective, open-label, multicenter, interventional trial was conducted in patients with hepatitis C without cirrhosis or with compensated cirrhosis. Hepatitis C patients without cirrhosis or with compensated cirrhosis were screened, and 133 patients were enrolled in the study. They received sofosbuvir 400 mg plus velpatasvir 100 mg combination once daily for 12 weeks. Patients were followed up for six months after the start of therapy. Hepatitis C viral load was assessed at baseline, at week 12, and after 24 weeks following the start of the treatment. The trial was prospectively registered with the Iranian Registry of Clinical Trials (IRCT) with the identification number IRCT20170614034526N4. Results Among enrolled patients, 79 were male, and 54 were female. Ninety-five (71.4%) patients were without cirrhosis, and 38 had compensated cirrhosis. Patients without cirrhosis had a mean age of 45.90 ±10.99 years, and patients with compensated cirrhosis had a mean age of 52.60 ±12.29 years. As per the intention-to-treat analysis, all patients without cirrhosis and 35 (92.1%) patients with compensated cirrhosis achieved undetectable viral load hepatitis C virus (HCV) ribonucleic acid (RNA) of <15 IU/mL at 12 weeks from the start of treatment. Eighty-six (90.5%) patients without cirrhosis achieved sustained virologic response 12 weeks after the end of therapy. Patients with compensated cirrhosis experienced more adverse events (31.5%) than patients without cirrhosis (20.15%). Conclusion Direct-acting antiviral therapy using sofosbuvir and velpatasvir combination is effective and safe in HCV patients without cirrhosis and patients with compensated cirrhosis.
ABSTRACT
BACKGROUND AND PURPOSE: There is sparsity of quality evidence for the use of drugs after first-line benzodiazepines in convulsive status epilepticus in children. The aim of the study was to compare the clinical efficacy and safety of intravenous levetiracetam versus intravenous phenytoin as second-line drugs in the management of generalized convulsive status epilepticus in children. METHODS: This open-label randomized controlled trial was conducted in the Emergency Department of The Children's Hospital and The Institute of Child Health, Multan, Pakistan over a period of 4 years and 6 months from January 2014 to June 2018. This study included 600 children with generalized convulsive status epilepticus: 300 in the 40 mg/kg levetiracetam group, and 300 in the 20 mg/kg phenytoin group. Cessation of a clinical seizure (seizure cessation rate) within 30 minutes after the end of drug administration was the primary outcome in this study, and the presence or absence of adverse effects was noted as the secondary outcome. Data were analyzed using SPSS (version 20.0). RESULTS: The children in the levetiracetam and phenytoin were aged 3.5±0.2 and 3.4±0.2 years (mean±SD), respectively, their seizure durations before the start of treatment were 25.1±0.6 and 23.8±0.4 minutes, and their treatment efficacies were 278/300 (92.7%) and 259/300 (83.3%). Levetiracetam was significantly more effective than phenytoin (p=0.012), with no significant difference in safety. Adverse events were observed in eight children in the phenytoin group. CONCLUSIONS: Levetiracetam is significantly more effective than phenytoin for the treatment of convulsive status epilepticus in children who have failed to respond to benzodiazepines.
