PROVE—Phase IV Study of Perampanel in Real-World Clinical Care of Patients with Epilepsy: Interim Analysis in Pediatric Patients

PROVE is a retrospective, phase IV study assessing retention, dosing, efficacy, and safety of perampanel when administered to patients during routine clinical care. We report an interim analysis of preadolescent (1 to <12 years) and adolescent (12 to <18 years) patients. Data were obtained from medical records of patients with epilepsy initiating perampanel after January 1, 2014; cut-off date for this analysis was October 10, 2018. Overall, 151 preadolescent and 183 adolescent patients were included. Retention rates following 24 months on perampanel were 42.5% (preadolescent subgroup; n = 31/73) and 55.7% (adolescent subgroup; n = 54/97). Treatment-emergent adverse events occurred in 53 (35.1%) preadolescent (most common: aggression, irritability, and somnolence) and 78 (42.6%) adolescent patients (most common: somnolence, aggression, and dizziness). These data indicate that daily oral doses of perampanel are generally well tolerated during routine clinical care, with favorable retention rates for ≤2 years, in patients aged 1 to <18 years.

Blood Supply Management Amidst COVID -19 Pandemic

AIMS AND OBJECTIVES: The mandatory lockdown restrictions and curtailment strategies towards mass gatherings imposed by the government amid the COVID-19 outbreak, the organization of the voluntary blood donation camps were suspended and in house donations were limited leading to scarcity of blood With this we intend to assess the effect of this mass lockdown on our blood supply management in four phases [phase-I prior to the outbreak] ,phase-II[during the outbreak], Phase-III: The declining phase [Oct20-Feb21] and Phase IV: The second wave [March21-may21] MATERIALS AND METHOD : This is a retrospective study of twenty months of a blood bank supplying to a 1200 bedded multi-specialty Tertiary Care Academic Hospital in Lucknow. The study was divided into four phases namely: • Phase-I: Pre-pandemic phase [Oct’19 to Feb’20] • Phase-II: The full-blown pandemic phase [Mar 20-Sep 20] • Phase-III: The declining phase [Oct20-Feb21] • Phase IV: The second wave [March21-may21] Details of the blood units collected both in-house as well as in the VBDC’s were used for the study. The date of collection, expiry and date of issue for each packed red blood cell [PRBC] units were noted. The components prepared from the whole blood was also noted. The average In-house donations were tabulated. The various components issued month wise was also noted. The supply of Convalescent plasma in all the three phases was tabulate RESULT: The average whole blood collection pre pandemic was 1103 units (55%), 768units (51%) in pandemic phase, 1219units (61%) in declining phase and only 692units (21%) in second wave of the pandemic. In Phase I 27 VBDC collected 1153 units (58%) and in Phase III 8 VBDC collected 236units(12%) Due to restrictions in mass gatherings and lockdown enforced, the whole blood collections from Phase II and Phase IV was 93units (6.5%) and 76units (2.2%) only. In Phase I, the average In House Donation was 33.6%, In Phase II it was12%, In Phase III was 5.75% and lastly in Phase IV was 5.4% The PRBC issued on an average in the four phases was 59%, 48%, 55% and 26% respectively. Similarly the FFP issued in Phase I , II, III and IV was 62%,34%,58% and 20%. Lastly the RDP issued was 15%, 13%, 19% and 4.5% in all the various phases. CONCLUSION: Our study concluded that COVID 19 pandemic had a negative impact on total number of In-house donations, voluntary blood donation camps, blood stock inventory and transfusion recipients along with taking a major toll on health and safety of our blood bank staff as well. With little insight of the disease and everyday learning, by motivating more voluntary donors and health care workers the efficient chain of blood supply and demand can be maintained as the virus is to stay with us for a long time.

Effectiveness and Safety of Intradetrusor OnabotulinumtoxinA Injection for Neurogenic Detrusor Overactivity and Overactive Bladder Patients in Taiwan—A Phase IV Prospective, Interventional, Multiple-Center Study (Restore Study)

We conducted a phase IV, pre/post multi-center study to evaluate the efficacy and safety of intradetrusor onabotulinumtoxinA injection in patients with neurogenic detrusor overactivity (NDO, n = 119) or overactive bladder (OAB, n = 215). Patients received either 200U (i.e., NDO) and 100U (i.e., OAB) of onabotulinumtoxinA injection into the bladder, respectively. The primary endpoint for all patients was the change in the PPBC questionnaire score at week 4 and week 12 post-treatment compared with baseline. The secondary endpoints were the changes in subjective measures (i.e., questionnaires: NBSS for patients with NDO and OABSS for those with OAB) at week 4 and week 12 post-treatment compared with baseline. Adverse events included symptomatic UTI, de novo AUR, gross hematuria and PVR > 350mL were recorded. The results showed that compared with baseline, PPBC (3.4 versus 2.4 and 2.1, p < 0.001) and NBSS (35.4 versus 20.4 and 18.1, p < 0.001) were significantly improved at 4 weeks and 12 weeks in NDO patients. In addition, compared with baseline, PPBC (3.5 versus 2.3 and 2.0, p < 0.001) and OABSS (9.1 versus 6.2 and 5.7, p < 0.001) were significantly improved at 4 weeks and 12 weeks in OAB patients. Eight (6.7%) had symptomatic UTI and 5 (4.2%) had de novo AUR in NDO patients. Twenty (9.3%) had symptomatic UTI but no de novo AUR in OAB patients. In conclusion, we found that intradetrusor onabotulinumtoxinA injections were safe and improved subjective measures related to NDO or OAB in our cohort.

ALLERGIC RHINITIS SYMPTOMS PREVALENCE IN CHILDREN OF KHARKIV CITY

The purpose of the study was to identify the prevalence of allergic rhinitis (AR) symptoms in children of Kharkiv city and to establish the dynamics of symptoms since 1998. The study is phase IV of the international ISAAC program. It was conducted in 2015-2017. 5735 children were interviewed, including 3238 children aged 6-7 years old and 2197 children aged 13-14 years old. The incidence of non-cold-related sneezing was found in 14.7% and 16.1%, respectively; during the past 12 months similar problems with nose breathing were noted in 9.1% and 9.9%; accompanied by conjunctivitis – in 3.4% and 4.8% of children 6-7 and 13-14 years, respectively. Most patients had seasonal exacerbations and mild / moderate rhinitis. The AR diagnosis was verified in 12.2% and 11.3% of children, respectively. The decreasing of AR symptoms prevalence was found in children of all ages. The dynamics of the AR symptoms prevalence, "eye" symptoms over the past 20 years show a probable decrease in all indicators, which can be explained by the widespread introduction in medical practice of screening methods for the disease diagnosing, activation of primary and secondary prevention.