scholarly journals Steroid bursts associated with severe adverse events

2021 ◽  
Vol 236 ◽  
pp. 325-328
Author(s):  
Shih-Chieh Shao ◽  
Ching-Chi Chi
Keyword(s):  
Adverse Events ◽  
Severe Adverse Events

scholarly journals Levetiracetam versus fosphenytoin as a second-line treatment after diazepam for status epilepticus: study protocol for a multicenter non-inferiority designed randomized control trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kensuke Nakamura ◽  
◽  
Aiki Marushima ◽  
Yuji Takahashi ◽  
Akio Kimura ◽  
...  
Keyword(s):  
Status Epilepticus ◽  
Adverse Events ◽  
Controlled Trial ◽  
Insurance Coverage ◽  
Line Treatment ◽  
Second Line ◽  
Open Label ◽  
Consciousness Disturbance ◽  
Multicenter Randomized Controlled Trial ◽  
Severe Adverse Events

Abstract Background Status epilepticus (SE) is an emergency condition for which rapid and secured cessation is important. Phenytoin and fosphenytoin, the prodrug of phenytoin with less severe adverse effects, have been recommended as second-line treatments. However, fosphenytoin causes severe adverse events, such as hypotension and arrhythmia. Levetiracetam reportedly has similar efficacy and higher safety for SE; however, evidence to support its use for adult SE is lacking. In the present study, a non-inferiority designed multicenter randomized controlled trial (RCT) is being conducted to compare levetiracetam with fosphenytoin after diazepam as a second-line treatment for SE. Methods This multicenter, prospective, and open-label RCT is conducted in emergency departments. Between December 23, 2019, and March 31, 2023, 176 patients with convulsive SE transported to an emergency room will be randomized into a fosphenytoin group and levetiracetam group at a ratio of 1:1. The definition of SE is “continuous seizures longer than 5 min or discrete seizures longer than 2 min with intervening consciousness disturbance.” In both groups, diazepam is initially administered at 1–20 mg, followed by intravenous fosphenytoin at 22.5 mg/kg or intravenous levetiracetam at 1000–3000 mg. The primary outcome is the seizure cessation rate within 30 min. Seizure recurrence within 24 h, severe adverse events, and intubation rate within 24 h are secondary outcomes. Discussion The present study was approved and conducted as an initiative study of the Japanese Association for Acute Medicine. If non-inferiority is identified, the society will pursue an application for the national health insurance coverage of levetiracetam for SE via a public knowledge-based application. Trial registration Japan Registry of Clinical Trials jRCTs031190160. Registered on December 13, 2019

Tocilizumab in Giant Cell Arteritis: A Multicenter Retrospective Study of 34 Patients

2016 ◽  
Vol 43 (8) ◽  
pp. 1547-1552 ◽  
Author(s):  
Alexis Régent ◽  
Serge Redeker ◽  
Alban Deroux ◽  
Pierre Kieffer ◽  
Kim Heang Ly ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Side Effects ◽  
Adverse Events ◽  
Giant Cell Arteritis ◽  
Giant Cell ◽  
Multicenter Study ◽  
Efficacy And Safety ◽  
Severe Adverse Events ◽  
Retrospective Multicenter Study

Objective.To report the efficacy and safety of tocilizumab (TCZ) for giant cell arteritis (GCA).Methods.A retrospective multicenter study that included 34 patients receiving TCZ for GCA.Results.TCZ was effective in all but 6 patients, who still had mild symptoms. Mean glucocorticoid dose was tapered. One patient died and 3 patients had to stop TCZ therapy because of severe adverse events. Twenty-three patients stopped treatment; 8 of these experienced relapses after a mean of 3.5 ± 1.3 months.Conclusion.TCZ is effective in GCA. However, side effects occur. Whether this treatment has only a suspensive effect remains to be determined.

scholarly journals Efficacy of treatment with Ombitasvir, Paritaprevir / r + Dasabuvir over 8 versus 12 weeks in chronic HCV hepatitis genotype 1B

2021 ◽  
Vol 24 (1) ◽  
pp. 44-50
Author(s):  
Mircea Manuc ◽  
◽  
Carmen Monica Preda ◽  
Laura Iliescu ◽  
Doina Istratescu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Drop Out ◽  
Real World Data ◽  
Serious Adverse Events ◽  
Intention To Treat ◽  
Genotype 1B ◽  
Male Patients ◽  
Severe Adverse Events ◽  
Chronic Hcv

Background and aims. For the 8-week OPrD regimen, real world data are insufficient. This study aims to compare the efficacy of the two types of regimens (12-week versus 8-week) in a real world cohort of patients with genotype 1b. Material and methods. We analysed a multicentric retrospective cohort enrolling 1436 patients who started HCV therapy in 2018-2019. Liver fibrosis was staged in all subjects by Fibromax. Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12). Results. Out of the 1436 analysed patients, 112 received 8 weeks therapy and 1324 received 12 weeks. In this cohort the proportion of male patients was 25.2%, the median age 61 years, 28.2% were interferon pre-treated, and the rate of co-morbidities was 47%. 42% of the subjects had F2 fibrosis, 29% F1 fibrosis, 16% F3 and 12% F4. The SVR rate was comparable in both groups of patients (97% in those treated with OPrD 12 weeks vs 96.4% in those that received OPrD 8 weeks) (by intention-to-treat). In the 12 weeks arm, the drop-out rate was 0.8% and the rate of severe adverse events was 1%, while in the arm of 8 weeks therapy there were no severe adverse events reported and no drop-out (p = 0.25). The only predictive factor for non-response in both treatment arms was the male sex. Conclusions. OPrD 8 weeks proved to be highly efficient in our patients with a 96.4% SVR. No serious adverse events and no drop out were reported.

Abstract 459: The TripleCPR 16 Study: Does Rhythm Truly Needed to Be Checked Every 2 Minutes in Cardiopulmonary Arrest Patients?

Circulation ◽  
2019 ◽  
Vol 140 (Suppl_2) ◽  
Author(s):  
Ryosuke Takegawa ◽  
Tadahiko Shiozaki ◽  
Mitsuo Ohnishi ◽  
Arisa Muratsu ◽  
Jotaro Tachino ◽  
...  
Keyword(s):  
Adverse Events ◽  
Aortic Dissection ◽  
Chest Compression ◽  
Cardiopulmonary Arrest ◽  
Cardiac Activity ◽  
Type A ◽  
Type A Aortic Dissection ◽  
Shockable Rhythm ◽  
Mechanical Chest Compression ◽  
Severe Adverse Events

Purpose: Current guidelines recommend rhythm checks every 2 minutes during CPR, but evidence for this recommendation is insufficient. Recent reports identified regional cerebral oxygen saturation (rSO 2 ) monitoring as useful in detecting ROSC and that coronary and cerebral perfusion decrease with the 2-minute rhythm check. On the basis of our previous study, we began the TripleCPR 16 study, which omits 2-minute rhythm checks because stopping chest compression to check rhythm may increase cerebral damage and decrease the ROSC. Methods: The multicenter, prospective TripleCPR 16 study began in January 2017. The inclusion criterion is a cardiopulmonary arrest patient aged ≥16 years with a non-shockable rhythm on hospital arrival. Subjects are divided into 3 groups based on their mean cerebral rSO 2 value in the first minute of arrival: ≥50%, <50% to 40%, and <40%. Continuous mechanical chest compression is performed on all subjects for 16 minutes or until their rSO 2 value exceeds the initial value by 10%, 20%, or 35%, respectively. We are comparing the TripleCPR 16 study results with our previous hospital data obtained from 86 patients with non-shockable rhythm who underwent every 2-minute rhythm checks and mechanical chest compression. Result: Currently, 218 patients are registered. Rates of ROSC were 34.9% for these patients and 39.5% for the previous 86 patients (p=0.51). There were no severe adverse events. Subanalysis of the data of Osaka University Hospital alone showed no significant increase of rSO 2 value in the 48 patients with non-sonographic cardiac activity and 26 patients with Stanford type A aortic dissection diagnosed by CT scan, and only two patient in each group achieved ROSC. When excluding the patients with Stanford type A aortic dissection, rates of ROSC was 47.8% for the patients in this study and 39.0% for the previous 86 patients (p=0.26). Conclusion: The TripleCPR 16 study is ongoing without severe adverse events. In the patients with non-sonographic cardiac activity or Stanford type A aortic dissection, rSO 2 values did not increase and it was difficult to achieve ROSC. A simpler CPR protocol could be devised that omits the 2-minute rhythm check in patients with a non-shockable rhythm.

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