Tapentadol Immediate Release (IR) versus Morphine Hydrochloride for Postoperative Analgesia of Patients Undergoing Total Abdominal Hysterectomy-A Prospective Cohort Study.

Background and Objectives: This study aimed to examine the efficacy of tapentadol immediate release (IR) and morphine hydrochloride in the treatment of acute postoperative pain after total abdominal hysterectomy, as well as to examine the frequency of opioid-related side effects in observed patients. Materials and Methods: The prospective observational study was conducted over five months, and it included a total number of 100 patients. The two cohorts had different types of postoperative analgesia, and the effects were observed for 24 h postoperatively, by following the pain scores on NRS (Numerical Pain Scale), contentment with analgesia, and opioid-related side effects. Results: Statistical significance was found when assessing pain 24 h after surgery while coughing, where patients in the tapentadol IR group had significantly higher mean pain scores (p < 0.01). The subjective feeling of satisfaction with postoperative analgesia was statistically significant in the tapentadol IR group (p = 0.005). Vertigo appeared significantly more in patients from the morphine group (p = 0.03). Conclusions: Tapentadol IR (immediate release) and morphine hydrochloride are both effective analgesics used in the first 24 h after total transabdominal hysterectomy. Overall satisfaction of patients with analgesia was good. The frequency of side effects was higher in the morphine group, with statistical significance regarding the vertigo.

Vertigo and Dizziness After Coronavirus Disease-2019 Vaccination: A Nationwide Analysis.

BACKGROUND: Side effects occurring after COVID-19 vaccination can include vertigo and dizziness. Despite its high incidence, few studies to date have assessed dizziness/vertigo after vaccination. The present study investigated the incidence of dizziness/vertigo after COVID-19 vaccination in South Korea. METHODS: Adverse reactions to COVID-19 vaccination reported to the Korea Disease Control and Prevention Agency from February 26, 2021, to July 31, 2022 (week 74) were analyzed. The incidence rates of dizziness/vertigo in subjects vaccinated with 5 COVID-19 vaccines, AZD1222 (AstraZeneca), BNT162b2 (Pfizer-BioNTech), JNJ-78436735 (Janssen), mRNA-1273 (Moderna), and NVX-CoV2373 (Novavax), were determined. RESULTS: A total of 126 725 952 doses of COVID-19 vaccine were administered, with 473 755 suspected adverse reactions (374 per 100 000 vaccinations) reported. Vertigo/dizziness was reported after the administration of 68 759 doses, or 54.3 per 100 000 vaccinations, making it the third most common adverse reaction after headache and muscle pain. CONCLUSION: Dizziness/vertigo was generally a mild adverse reaction after COVID-19 vaccination, but it was the third most common adverse reaction in Korea. Studies are necessary to clarify the causal relationship between vaccination and dizziness/vertigo and to prepare subjects for this possible adverse reaction.

Anti-calcitonin gene-related peptide monoclonal antibodies for the treatment of vestibular migraine: A prospective observational cohort study.

BACKGROUND: Vestibular migraine is considered the most common cause of recurrent vertigo for which specific treatments are missing. Monoclonal antibodies against calcitonin gene-related peptide,, are effective in preventing migraine. Since CGRP is also detected in human cochlear and vestibular organs it may also play a role in vestibular physiology. METHODS: This is a prospective observational cohort study, aiming at evaluating the efficacy of erenumab, fremanezumab or galcanezumab for the treatment of fifty vestibular migraine patients. We assessed mean monthly days with headache and dizziness/vestibular symptoms, pain intensity and migraine-related clinical burden occurring for 18 months. RESULTS: Response to treatment was excellent as 45 (90%) patients had at least a 50% reduction in vertigo frequency, 43 (86%) had at least a 50% reduction in headache frequency, and 40 (80%) a MIDAS reduction of at least 50%. Overall, 39 (78%) patients had a concomitant reduction of all three parameters. Mean monthly days with dizziness/vestibular symptoms showed an overall significant decrease from a mean of 10.3 ± 1.9 at baseline to 0.8 ± 0.3 days, difference 9.5 (CI 95% 3.6, 15.4; p < 0.001) after twelve months. CONCLUSION: We show that anti-CGRP mAbs may be effective in the treatment of Vestibular Migraine. Their use should be encouraged early in the disease course to allow for a better symptom control and quality of life improvement.

The safety of perampanel in different disorders and doses: A meta-analysis.

PURPOSE: To investigate the safety of perampanel in different disorders and doses. METHODS: Embase, the Cochrane Library, Medline, and ClinicalTrials.gov were searched from inception to July 2022 for randomized controlled trials (RCTs). The meta-analysis was performed by using Review Manager 5.3 and R 4.2.1 software. RESULTS: A total of 17 RCTs with 5711 subjects were included in the final analysis. The double-blind treatment phase was from 12 weeks to 48 weeks. Our results showed that 11 adverse events (aggression, ataxia, balance disorder, dizziness, fall, fatigue, irritability, rash, somnolence, vertigo, and weight increase) were statistically significantly associated with perampanel, and 4 of them (ataxia, dizziness, fatigue, and somnolence) showed a clear dose-response relationship. Psychiatric adverse events occurred most frequently among serious treatment-emergent adverse events (TEAEs). At 8 mg/day, seven adverse events (aggression, balance disorder, dizziness, fatigue, irritability, vertigo, and weight increase) occurred more frequently in patients with epilepsy than in patients with other disorders, whereas dose discontinuation rates due to adverse events were lower in patients with epilepsy than in patients with other disorders. CONCLUSION: The safety profile of perampanel is dependent on diseases and dose. The risk of adverse events was statistically significantly higher, with doses exceeding 4 mg/day. Despite a higher risk of adverse events, patients with epilepsy had a lower perampanel discontinuation rate than patients with other disorders.

Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression.

Objective: To describe the tolerability of esketamine nasal spray based on the adverse event profile observed during treatment sessions occurring early and later over the course of treatment.Methods: In 2 long-term, phase 3 studies (NCT02493868, October 1, 2015-February 16, 2018; NCT02497287, September 30, 2015-October 28, 2017), patients with treatment-resistant major depressive disorder (per DSM-5) and nonresponse to ≥ 2 oral antidepressants received esketamine nasal spray (56 or 84 mg) twice weekly during a 4-week induction phase, weekly for weeks 5-8, and weekly or every 2 weeks thereafter as maintenance treatment, in conjunction with a new oral antidepressant. A post hoc analysis using descriptive statistics evaluated occurrence (incidence, frequency, severity) and recurrence (incidence and severity) of events of specific interest.Results: In patients treated with esketamine nasal spray plus a newly initiated oral antidepressant (n = 928), spontaneously reported adverse events of dizziness, nausea, sedation, vertigo, and increased blood pressure were more likely to recur after the first week of treatment if they occurred more frequently (twice > once > none) during the first week. The same pattern was observed when these events were assessed by structured instruments. Incidences of dizziness, dissociation, increased blood pressure, nausea, vertigo, and sedation were highest in week 1 of treatment (20.6%, 16.7%, 4.3%, 14.0%, 12.1%, and 3.8%, respectively) and decreased thereafter. Initial occurrences and subsequent recurrences of events were mostly mild or moderate in severity.Conclusions: Adverse events during treatment with esketamine nasal spray plus an oral antidepressant generally become less frequent with ongoing treatment, and the majority are mild or moderate in severity.Trial Registration: ClinicalTrials.gov identifiers: NCT02493868; NCT02497287.

A Possible Mechanism for Flecainide Induced Dizziness.

OBJECTIVE: Flecainide is an oral class IC antiarrhythmic drug whose most common extracardiac adverse reactions are "dizziness" and "visual disturbances." We describe a case of flecainide associated- bilateral vestibulopathy and a literature review of this drug's effect on the vestibular system. PATIENT: Sixty-nine-year-old man with a 3-month history of unsteadiness and dizziness after an increase in the dose of flecainide. INTERVENTIONS: Otologic examination, video head-impulse test, vestibular evoked myogenic potentials, pure tone audiometry and high-resolution magnetic resonance imaging. RESULTS: Otologic examination, including the head-impulse test, and vestibular testing revealed bilateral vestibulopathy. CONCLUSIONS: Dizziness is a common extracardiac adverse reaction of Flecainide. Based on the clinical case that we present and the literature review carried out, we hypothesized that a possible mechanism by which flecainide might cause dizziness and visual disturbances is bilateral vestibulopathy.

Emergency medicine updates: Droperidol.

INTRODUCTION: Droperidol is a butyrophenone that has recently been reintroduced after a United States Food and Drug Administration (US FDA) black box warning in 2001. Evidence demonstrates utility in a variety of clinical conditions. OBJECTIVE: This paper provides evidence-based updates concerning the use of droperidol for the emergency clinician. DISCUSSION: Droperidol received a black box warning by the US FDA in 2001 due to concerns for QT prolongation and torsades de pointes; however, reevaluation of the available data suggests droperidol is a safe and efficacious medication. It can be used in the emergency department (ED) setting for many conditions, including acute agitation, headaches, vertigo, nausea, and vomiting. Extensive literature supports that the QT-prolonging effects are transient and that the risk of torsades de pointes is rare with doses utilized in the ED. An electrocardiogram does not need to be routinely obtained before droperidol use but should be considered in patients at high risk for QT prolongation. CONCLUSIONS: Current evidence suggests that droperidol is a safe and effective medication for treating nausea and vomiting, headache, vertigo, and agitation in the ED setting.

Complications and prognosis associated with intra-tympanic steroid injection to treat sudden sensorineural hearing impairment.

PURPOSE: The purpose of this study was to measure the incidence of complications in sudden sensorineural hearing loss (SSNHL) patients treated with intra-tympanic steroid injection (ITSI) and compare hearing recovery rates. MATERIALS AND METHODS: 123 patients with unilateral SSNHL receiving ITSIs were included in this study. Post-ITSI complications were documented including otalgia, dysgeusia, vertigo (duration>1 h), and persistent eardrum perforation. The pain intensity was evaluated with visual analog scale (VAS). Hearing was measured before ITSI and at 1 month after the final ITSI. We compared our patients' hearing threshold between presence and absence of different complications. RESULTS: 47.2% patients experienced post-injection otalgia with the average VAS score 3.2 (range 2-6). Five (4.1%) and six (4.9%) patients exhibited vertigo and persistent eardrum perforations, respectively. The patients were divided into three groups based on the absence of complications and the presence of vertigo and eardrum perforation. The hearing threshold improvements did not differ significantly among the three groups (p = 0.366). Although the difference was not significant (p = 0.664), the proportion of patients experiencing post-ITSI vertigo who were on contemporaneous oral steroids was lower than the proportion of non-vertigo patients on such steroids. CONCLUSION: The incidences of otalgia, vertigo, and persistent eardrum perforation in SSNHL patients treated with ITSI were 47.2%, 4.1% and 4.9%, respectively. We found no association between concurrent oral steroid use and the incidence of post-ITSI eardrum perforation or vertigo. Although statistical significance was lacking, patients who did not take contemporaneous oral steroids may have a higher rate of prolonged post-ITSI vertigo.

Drug-induced diseases in otolaryngology - causes, clinical signs, treatment.

In the daily practice of an otolaryngologist, we encounter cases where the symptoms are not the result of disease but result from pharmacotherapy. In the case of symptoms such as hearing loss, tinnitus, or dizziness, polytherapy may be used as the basis for their occurrence, which, due to the lack of rationality in combining drugs, leads to symptoms that the patient and the doctor very often interpret as a new disease syndrome. The aim of the study is to show and to raise awareness of the fact that the symptoms of hearing organ impairment are frequently drug-related and only a modification of the currently used pharmacotherapy is a rational procedure in such cases. This paper describes 30 cases who developed side effects of polypharmacy in the form of hearing disorders, dizziness, and tinnitus. The causes of drug-related complications were discussed, as well as effective methods of their prevention.

Case of COVID-19-induced vestibular neuritis in a child.

Since the outbreak of the COVID-19 pandemic, there has been a growing need to fully understand all the possible clinical features of the epidemic, which often presents with unusual manifestations, especially in children. In this report, we describe the case of a child with a COVID-19 infection and suffering exclusively from vertigo and fever. Altogether, considering the clinical manifestation, laboratory tests and imaging, given the patient's positivity to SARS-CoV-2 infection and its neurotropic potential, we assumed that the child had COVID-19-induced vestibular neuritis, which, in consideration of the spontaneous improvement of symptoms, did not require any therapeutic adjustments, apart from the natural compensation of the central nervous system.This case suggests the importance of having an index of suspicion for a COVID-19 infection in patients with paediatrics presenting with vertigo and adds valuable information to the limited literature on COVID-19 presentation and management in children.

Epidemiology of cannabidiol related cases reported in the National Poison Data System - 2019-2020.

INTRODUCTION: Cannabidiol (CBD) has become a popular supplement in consumer products in recent years, resulting in part from normalization of the cultivation of low THC cannabis in 2018. However, the actual content of CBD-labeled products is frequently uncertain, as oversight of such products is minimal. To date, there is little pragmatic knowledge regarding exposures to products labeled as containing CBD. METHODS: Cases reported to Poison Control Centers from April 1, 2019 and March 31, 2020, the first year in which CBD was identified uniquely as a substance in the National Poison Data System, were analyzed for demographic, temporal, and clinical trends. RESULTS: Poison Control Centers handled 1581 cases exposures to CBD-containing products between April 1, 2019 and March 31, 2020. There was a significant trend of over 5 additional cases related to this substance per month (linear regression coefficient = 5.2, 95% CI: 1.52-8.98). Patients under age 13 years made up 44.0% of reported exposures. Mild CNS depression (10.3%), tachycardia (5.7%), dizziness/vertigo (5.3%), vomiting (4.9%), nausea (4.5%), and agitation (4.4%) were the most frequently reported symptoms. 13% of cases were coded as having "moderate" or "severe" medical outcomes. There were no fatalities. CONCLUSIONS: Cases reported to Poison Control Centers regarding exposures to CBD-labeled products have been increasing, representing an emerging trend of interest to Poison Control Center professionals, clinicians, and public health officials. Further monitoring of this trend is recommended.

Efficacy and safety of cenobamate in patients with uncontrolled focal seizures: A meta-analysis.

OBJECTIVE: To investigate the efficacy and safety of adjunctive cenobamate for treatment of uncontrolled focal seizures. METHODS: We performed a systematic search of Web of Science, MEDLINE (Ovid and PubMed), Cochrane Library, EMBASE and Google Scholar to identify eligible studies. We included randomized placebo-controlled trials (RCTs) for uncontrolled focal seizures. We calculated the risk ratio (RR) of ≥50%, ≥75% and 100% reduction in seizure frequency from baseline, as well as dropout and serious adverse events related to treatment. Quality of included trials was assessed using the Cochrane Collaboration's tool. RESULTS: Two RCTs with a total of 658 patients were included. A significantly larger proportion of patients allocated to cenobamate achieved 50% seizure reduction (RR 2.06, 95% CI 1.70-2.51, p < 0.001) as compared to placebo, subgroup analysis demonstrated that the most effective dose was at 400 mg (RR 2.28, 95% CI 1.57-3.32, p < 0.001). Patients achieving seizure-freedom during the treatment period were 14.9% with cenobamate and 4.5% with placebo (RR 5.32, 95% CI 2.94-9.62, p < 0.001). Dropouts (RR 1.40, 95% CI 1.01-1.94, p = 0.05) and incidence of serious adverse events (RR 1.48, 95% CI 0.93-2.33, p = 0.1) were not significantly higher in patients receiving cenobamate. However, subgroup analyses based on doses suggested that patients exposed to 400 mg cenobamate were more likely to dropout than placebo (RR 2.09, 95% CI 1.17- 3.71, p = 0.012). CONCLUSION: Cenobamate demonstrated favourable efficacy for treatment of uncontrolled focal seizures and showed a dose-related fashion. Cenobamate could be well tolerated, the most common adverse events associated with cenobamate were dizziness, somnolence, fatigue, headache and nausea. Nevertheless, majority of them were mild to moderate in severity.

Lasmiditan in patients with common migraine comorbidities: a post hoc efficacy and safety analysis of two phase 3 randomized clinical trials.

OBJECTIVE: Determine whether common migraine comorbidities affect the efficacy and safety of lasmiditan, a 5-HT1F receptor agonist approved in the United States for the acute treatment of migraine. METHODS: In SPARTAN and SAMURAI (double-blind Phase 3 clinical trials), patients with migraine were randomized to oral lasmiditan 50 mg (SPARTAN only), 100mg, 200 mg, or placebo. Lasmiditan increased the proportion of pain-free and most bothersome symptom (MBS)-free patients at 2 h after dose compared with placebo. Most common treatment-emergent adverse events (TEAEs) were dizziness, paraesthesia, somnolence, fatigue, nausea, muscular weakness, and hypoesthesia. Based upon literature review of common migraine comorbidities, Anxiety, Allergy, Bronchial, Cardiac, Depression, Fatigue, Gastrointestinal, Hormonal, Musculoskeletal/Pain, Neurological, Obesity, Sleep, and Vascular Comorbidity Groups were created. Using pooled results, efficacy and TEAEs were assessed to compare patients with or without a given common migraine comorbidity. To compare treatment groups, p-values were calculated for treatment-by-subgroup interaction, based on logistic regression with treatment-by-comorbidity condition status (Yes/No) as the interaction term; study, treatment group, and comorbidity condition status (Yes/No) were covariates. Differential treatment effect based upon comorbidity status was also examined. Trial registration at clinicaltrials.gov: SAMURAI (NCT02439320) and SPARTAN (NCT02605174). RESULTS: Across all the Comorbidity Groups, with the potential exception of fatigue, treatment-by-subgroup interaction analyses did not provide evidence of a lasmiditan-driven lasmiditan versus placebo differential treatment effect dependent on Yes versus No comorbidity subgroup for either efficacy or TEAE assessments. CONCLUSIONS: The efficacy and safety of lasmiditan for treatment of individual migraine attacks appear to be independent of comorbid conditions.

Reversible Splenial Lesion Syndrome with Some Novel Causes and Clinical Manifestations.

Objective Reversible splenial lesion syndrome (RESLES) is a clinical radiological syndrome characterized by a reversible lesion of the splenium of the corpus callosum with a decreased apparent diffusion coefficient (ADC) value. The clinical manifestations of RESLES are diverse. Methods Fifteen cases of adult RESLES patients (10 males and 5 females) were retrospectively selected from the radiology system using the key word "corpus callosum" at a university-affiliated tertiary care hospital between May 1, 2015 and December 31, 2019. The possible precipitating factors, clinicoradiological findings and modified Rankin Scale (mRS) on follow-up were then analyzed. Results The patient ages ranged from 22 to 53 years old. The mean age was 34 years old. The most common neurological symptoms included headache (3/15), dizziness (3/15), first onset of seizure (3/15), paroxysmal blurred vision (2/15), vertigo (2/15), amnesia (2/15), and confused consciousness without seizure (2/15), followed by drowsiness (1/15), paresthesia (1/15), dysmetria (1/15) and dysarthria (1/15). The precipitating factors included infection, seizure, anti-epileptic treatment with levetiracetam, carbamazepine, valproate, hyperglycemia, hypoglycemia, cerebral venous sinus thrombosis, and rabies vaccine injection prior to the onset of RESLES. All cases were carefully followed up and had excellent prognoses. Conclusion RESLES manifests as variety of symptoms with less specificity and precipitating factors. Paroxysmal blurred vision may be a relatively specific symptom of RESLES. Levetiracetam, carbamazepine or valproate could be the cause of RESLES, exposure to the rabies vaccine could be another predisposing factors for RESLES as well. RESLES type 1 was therefore found to be highly "reversible" with an excellent prognosis.

Short-term efficacy and safety of lasmiditan, a novel 5-HT1F receptor agonist, for the acute treatment of migraine: a systematic review and meta-analysis.

BACKGROUND: Migraine has been recognized as one of common diseases in the world whose current treatment options are not ideal. Lasmiditan, an oral 5-hydroxytryptamine (HT)1F receptor agonist, appears more promising for the acute treatment of migraine because of considerably better effect profiles with no severe adverse events (AEs). This review aimed to systematically evaluate the efficacy and safety of lasmiditan from the results of randomized controlled trials (RCTs). METHODS: PubMed, Cochrane Library, Embase were searched on lasmiditan for the acute treatment of migraine from inception of the databases to Feb 1, 2020. Pain free and pain relief, global impression (very much/much better), and no/mild disability at 2 h in efficacy; total treatment-emergent adverse events (TEAEs), dizziness, nausea, fatigue, paraesthesia and somnolence in safety were extracted from the included studies. A systematic review and meta-analysis was performed using Review Manager Software version 5.3 (RevMan 5.3). RESULTS: Four RCTs with a total of 4960 subjects met our inclusion criteria. The overall effect estimate showed that lasmiditan was significantly superior to placebo in terms of pain free (RR 1.71, 95% CI 1.55-1.87), pain relief (RR 1.40, 95% CI 1.33-1.47), global impression (very much/much better) (RR 1.55, 95% CI 1.44-1.67), and no/mild disability (RR 1.15, 95% CI 1.10-1.20) at 2 h. For the safety, significant number of patients experienced TEAEs with lasmiditan than with placebo (RR 2.77, 95% CI 2.53-3.03), most TEAEs were central nervous system (CNS)-related and included dizziness (RR 5.81, 95% CI 4.72-7.14), nausea (RR 2.58, 95% CI 1.87-3.57), fatigue (RR 5.38, 95% CI 3.78-7.66), paraesthesia (RR 4.48, 95% CI 3.33-6.02), and somnolence (RR 2.82, 95% CI 2.18-3.66). CONCLUSIONS: This meta-analysis suggests that lasmiditan is effective for the acute treatment of migraine with a higher incidence of CNS-related adverse reactions compared with placebo. Long-term, open-label, multi-dose trials are required to verify the current findings.

The evaluation of the use of isotretinoin on vestibular system by using vHIT.

AIM: The aim of the present study was to evaluate the effect of isotretinoin (ISO) on peripheral vestibular system using vHIT. MATERIAL AND METHOD: This is a prospective study in which 30 patients administered ISO treatment with the diagnosis of acne vulgaris was evaluated. Following ear nose and throat, examination, audiological and vestibular evaluations were carried out. vHIT tests were conducted before and three months after the use of ISO (0.5-0.75 mg/kg/day). In addition, all participants underwent perceptual vertigo and dizziness tests before and three months after the use of ISO. RESULTS: In vHIT evaluation of all patients, no overt saccade, covert saccade and spontaneous nystagmus finding was observed. Gain and asymmetry were compared before and after the use of ISO: No significant difference was found between lateral semicircular canal, anterior, and posterior semi-circular and symmetry measurements made before ISO use and those made three months after it (p = 1.00; p = 0.99; p = 0.66). Similarly, there was no significant difference in asymmetry values of vertical semicircular canals measured before ISO and three months after it (p = 0.90; p = 0.76). No statistically significant difference was found in vertigo, nausea and dizziness in terms of responses before and 3 months after ISO use (p = 0.063; p = 0.031; p = 0.063). CONCLUSION: Although the studies demonstrating the effect of ISO on cochlea and symptoms occurring during treatment such as nausea, vomiting and vertigo suggest that it may exert effects on peripheral vestibular system, the present study indicates that it has no short terms effects on structures in peripheral vestibular system and vestibuloocular reflex pathways.

Experience with Omalizumab for the treatment of chronic spontaneous urticaria in a tertiary center: real life experience.

PURPOSE: Chronic spontaneous urticaria (CSU) is defined as urticaria and/or angioedema that appears spontaneously due to known or unknown causes and lasts for at least 6 weeks. Omalizumab, an anti-IgE antibody that binds circulating free IgE, has recently emerged as a promising treatment for CSU, a condition which impairs patients' quality of life. We aimed to contribute real life data by reporting our experience with omalizumab in the treatment of intractable CSU. METHODS: Of 140 patients treated with omalizumab in our clinic between September 2013 and January 2018, 86 CSU patients with available current data were retrospectively evaluated in terms of sex, age, urticaria duration, urticaria activity score over 7 days (UAS7) before and after omalizumab, relapses and time to relapse, length of remission after omalizumab cessation, adverse events, and comorbidities. RESULTS: The mean age of the patients was 45.5 ± 14.3 years and 73.3% were women. Mean duration of urticaria before initiation of omalizumab therapy was 54.5 ± 67 months. All patients had used antihistamines before starting omalizumab treatment. The mean number of omalizumab doses was 11.9 ± 9.3. The mean duration of omalizumab treatment was 13.3 ± 10.4 months. Mean UAS7 score was 38.9 ± 4.1 before the start of omalizumab treatment, and 7.9 ± 10.5 after treatment. Treatment was discontinued in 10 patients (11.6%) due to nonresponse or loss of effect. Four patients (4.65%) experienced adverse events. Treatment was discontinued in 1 patient (1.16%) due to side effects. Of the 55 patients whose treatment was discontinued after their symptoms resolved, 31 (56.3%) relapsed after omalizumab cessation. Twenty-four patients (43.6%) did not relapse after omalizumab cessation. CONCLUSIONS: Our results show that omalizumab was an effective treatment for intractable CSU and did not cause any serious adverse effects other than asthenia, vertigo, and injection site reaction in four patients. These findings are relevant because they reflect real-life data.

Various Aspects of Tiagabine Effectiveness as Add-on Therapy in Patients with Refractory Epilepsy.

The aim of the present study was to investigate various aspects of tiagabine (TGB) effectiveness in Bulgarian patients with drug-resistant epilepsy. This open, prospective study recruited the patients with epilepsy attending the Clinic of Neurology at the University Hospital of Plovdiv, Bulgaria. The patients completed diaries about the seizure frequency, severity, and adverse events. There were regular documented visits at 3 or 6 months during the first year of treatment with TGB and at 6 months or 1 year afterwards, with dynamic assessment of seizure frequency, severity, adverse events, and EEG recordings. TGB was applied as an add-on treatment in 43 patients (24 males, mean age 39 years). There was relatively mild and transient dynamic improvement of seizure severity, satisfactory seizure frequency reduction in 32.6% of participants, stable mean seizure frequency reduction (40-50%) from month 6 to month 24 and a stable response rate (52.3-50%) during the same period. New seizure types (myoclonic, myoclonic-atonic) occurred in 2 patients. The final clinical efficacy was higher in patients with initial monotherapy. There were adverse events (dizziness/vertigo, sedation, memory impairment, loss of appetite and weight, confusion, psychosis, insomnia, transient diplopia, lymphadenomegaly, rash, nausea, depression, anxiety, tremor of hands, unstable gait, legs edema, thrombocytopenia, cervical muscles tightening) in 26.19% of patients. In conclusion, TGB treatment is associated with low and transient improvement of seizure severity, good and stable improvement of seizure frequency, possible worsening of seizure control, possible appearance of new seizure types, and acceptable safety and tolerability.

'Have we missed reporting adverse drug reactions under Revised National TB Control Programme?' - A mixed method study in Bengaluru, India.

OBJECTIVE: Prompt identification, reporting and management of ADRs during anti tuberculosis treatment can ensure better compliance and treatment outcomes. The study was conducted to identify the gaps and associated factors in reporting of ADRs under RNTCP; assess knowledge, attitude and practice of RNTCP staff regarding pharmacovigilance programme and explore the barriers in reporting of ADRs from provider's perspective. METHODS: Mixed method research with sequential explanatory design was carried out in Tuberculosis Units of RNTCP administrative district of Bangalore city during July to December 2017. Quantitative study was carried out among 222 patients on intensive phase of Category I and Category II DOTS to study the incidence, severity and causality of ADRs; and records of these patients were analysed for gaps in reporting. Knowledge, attitude and practice (KAP) regarding recording and reporting aspect of pharmacovigilance programme was assessed among RNTCP staff. As part of the qualitative study, focus group discussion was carried out among RNTCP staff to study barriers for reporting ADRs from the provider's perspective. RESULTS: Record analysis at the time of recruitment showed documentation of ADRs in only five patients. Subsequent analysis of patient records during the middle and end of the intensive phase (IP) did not show documentation of any ADRs. Simultaneously interviews with patients revealed 116 (52.2%), 72 (32.4%) and 53 (23.8%) patients reported one or more symptoms of ADRs. The commonest ADR symptom reported were fatigability and gastrointestinal symptoms followed by musculoskeletal symptoms. KAP among 25 RNTCP staff showed that 96% of them felt reporting of ADRs was necessary and 92% reported the ADRs to their seniors, however 12% were scared to report. The main reason expressed for non-reporting was 'managing ADRs is more important than reporting' (52%). Also, 32% felt the need for retraining of staff on reporting and documentation. Barriers to reporting of ADRs were both health-system related like insufficient training and inadequate guidelines provided to RNTCP staff and patient-related factors like lack of awareness and reluctance to report ADRs. CONCLUSION: Successful implementation of RNTCP and achievement of TB elimination requires provision of adequate information regarding ADRs to patients and intense follow-up and probing at each contact by programme staff to effectively manage ADRs.