“Second Line Medications” for Supraventricular Arrhythmias in Children: In‐Hospital Efficacy and Adverse Events During Treatment Initiation of Sotalol and Flecainide

2021 ◽  
Author(s):  
Peter C. Kahr ◽  
Brady S. Moffett ◽  
Christina Y. Miyake ◽  
Jeffrey J. Kim ◽  
Santiago O. Valdes
Keyword(s):  
Adverse Events ◽  
Treatment Initiation ◽  
Second Line ◽  
Supraventricular Arrhythmias

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

Gemcitabine Plus Nab-Paclitaxel as Second-Line Chemotherapy following FOLFIRINOX in Patients with Unresectable Pancreatic Cancer: A Single-Institution, Retrospective Analysis

Chemotherapy ◽  
2021 ◽  
pp. 1-7
Author(s):  
Kotone Hayuka ◽  
Hiroyuki Okuyama ◽  
Akitsu Murakami ◽  
Yoshihiro Okita ◽  
Takamasa Nishiuchi ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Events ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Unresectable Pancreatic Cancer ◽  
Line Treatment ◽  
Second Line ◽  
Free Survival ◽  
Common Grade ◽  
Grade 3

<b><i>Introduction:</i></b> Patients with advanced pancreatic cancer have a poor prognosis. FOLFIRINOX (FFX) and gemcitabine plus nab-paclitaxel (GnP) have been established as first-line treatment, but they have not been confirmed as second-line treatment after FFX. The aim of this study was to evaluate the safety and efficacy of GnP as second-line therapy after FFX in patients with unresectable pancreatic cancer. <b><i>Methods:</i></b> Twenty-five patients with unresectable pancreatic cancer were enrolled. The patients were treated with GnP after FFX between September 2015 and September 2019. Tumor response, progression-free survival (PFS), overall survival (OS), and incidence of adverse events were evaluated. <b><i>Results:</i></b> The response rate, disease control rate, median PFS, and median OS were 12%, 96%, 5.3 months, and 15.6 months, respectively. The common grade 3 or 4 adverse events were neutropenia (76%) and anemia (16%). <b><i>Conclusions:</i></b> GnP after FOLFIRINOX is expected to be one of the second-line recommendations for patients with unresectable pancreatic cancer.

scholarly journals Adverse Events among HIV/MDR-TB Co-Infected Patients Receiving Antiretroviral and Second Line Anti-TB Treatment in Mumbai, India

PLoS ONE ◽  
2012 ◽  
Vol 7 (7) ◽  
pp. e40781 ◽  
Author(s):  
Petros Isaakidis ◽  
Bhanumati Varghese ◽  
Homa Mansoor ◽  
Helen S. Cox ◽  
Joanna Ladomirska ◽  
...  
Keyword(s):  
Adverse Events ◽  
Second Line ◽  
Tb Treatment ◽  
Mdr Tb

Nivolumab and ipilimumab for second-line therapy in elderly patients with advanced esophageal squamous cell cancer: Safety interim analysis of the RAMONA trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4029-4029
Author(s):  
Nicolai Hartel ◽  
Nadja M Meindl-Beinker ◽  
Martin Maenz ◽  
Wolfgang Hiegl ◽  
Johannes Betge ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Interim Analysis ◽  
Treatment Duration ◽  
Safety Assessment ◽  
Squamous Cell Cancer ◽  
Cell Cancer ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy

4029 Background: Advanced esophageal squamous cell cancer (ESCC) is frequently diagnosed in elderly patients (pts) with additional comorbidities. Limited treatment options are available. We report the safety interim analysis of a phase II clinical trial evaluating nivolumab and ipilimumab as second-line therapy for advanced ESCC in elderly pts. Methods: RAMONA is a multicenter open-label phase II trial assessing nivolumab/ipilimumab combination therapy in elderly pts (≥65 years). The geriatric status of the pts was assessed using the G8 screening tool and the Deficit Accumulation Frailty Index (DAFI). After a run-in phase of 3 cycles nivolumab (240mg Q2W), cohort assignment was based on a safety assessment. Pts with toxicities grade ≤2 were considered eligible for escalation to nivolumab (240mg Q2W)/ipilimumab (1mg/kg Q6W) combination therapy (cohort B). Other pts remained on nivolumab monotherapy (cohort A). Primary endpoint is overall survival (OS). Key secondary endpoint is time to Quality of Life deterioration defined as a loss of ≥ 10 points in the EORTC QLQ-C30 compared to baseline. Adverse events were assessed according to NCI-CTCAE version 4.03. Results: From February 2018 until February 2020, 69 pts entered the study. 61 pts were eligible for safety interim analysis. Median age of the pts was 71.9 yrs (± 5.4), median KPS score was 80% (50-100%). In 73.8% of the pts, metastases were detected at the time of study inclusion. Most pts received the IO therapy in ≥ 2nd line (91.8%). The mean G8-score at screening was 11.9 points (46 pts ≤ 14 points, 75.4%) (mean DAFI: 0.19). Based on safety assessment, 42 pts were escalated to nivolumab/ipilimumab, while 9 pts remained on nivolumab monotherapy. 10 pts were not allocated at the time of analysis. Median numbers of cumulative doses were 3.0 [1.0 - 3.0] for the run-in phase (nivolumab), 6.0 [1.0 – 48.0] for nivolumab therapy (cohort A/B) and 2.5 [1.0 – 16.0] for ipilimumab (cohort B). Median treatment duration was 144.5 days (56-781 days) in cohort A and 231 days (85-484 days) in cohort B. Frailty indices remained stable after 3 cycles of nivolumab with limited toxicity at the time of the safety assessment. Drug-related treatment emergent adverse events (AEs) were observed in 42 pts (68.9%); 29/42 in cohort A, 8/9 in cohort B, and 5/10 pts not allocated at the time of analysis. Grade ≥3 AEs were detected in 9 pts of 42 in cohort A and 4 of 9 pts in cohort B. Drug-related treatment emergent serious adverse events (SAEs) were detected in 12 pts (19.7%); 8/42 in cohort A, 2/9 pts in cohort B, and 2/10 pts not yet allocated. Conclusions: Combined nivolumab/ipilimumab is a safe and feasible second-line therapy for elderly pts with advanced ESCC. Most pts could be escalated to nivolumab/ipilimumab. Treatment duration was exceptional long for a subset of pts. Clinical trial information: NCT03416244.

scholarly journals Empiric “Three-in-One” Bismuth Quadruple Therapy for Second-Line Helicobacter pylori Eradication: An Intervention Study in Southern Italy

Antibiotics ◽  
2022 ◽  
Vol 11 (1) ◽  
pp. 78
Author(s):  
Giuseppe Losurdo ◽  
Ilaria Lacavalla ◽  
Francesco Russo ◽  
Giuseppe Riezzo ◽  
Irene Vita Brescia ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Adverse Events ◽  
Eradication Rate ◽  
Sequential Therapy ◽  
Second Line ◽  
Capsule Formulation ◽  
Second Line Therapy ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
Line Therapy

The eradication of Helicobacter pylori (H. pylori) may be difficult due to antibiotic resistance. Indeed, after one failure, a second-line therapy is needed and a bismuth containing quadruple therapy (BQT) with a three-in-one capsule formulation is becoming very popular. Therefore, we aimed to evaluate effectiveness and safety of BQT as a second-line therapy. We recruited consecutive patients with one therapy failure. For ten days patients received the three-in-one BQT Pylera® therapy, in combination with a proton-pump inhibitor (PPI), decided at the choice of the investigator, at full dose bid. The eradication rate was calculated by intention-to-treat (ITT) and per-protocol (PP)analyses and 95% confidence intervals (CI) were calculated. Seventy-three patients were recruited, 41 females and 32 males (mean age 53.0±13.1 years). Fifty-five patients failed triple therapy with amoxicillin and clarithromycin and the remaining 18 received sequential therapy. Seventy-two patients consumed at least 90% of the capsules, while only one did not complete the therapy due to adverse events (nausea and diarrhea). By ITT analysis, BQT was successful in 62 subjects (eradication rate 84.9%, 95%CI 76.7–93.1%). By PP analysis, the eradication rate was 86.1% (95%CI 78.1–94.1%).Adverse events were observed in 14 subjects (20.5%).In conclusion, our report confirmed that BQT is effective as an empiric second-line regimen.

scholarly journals How Much Time Should Be Waited and What Are the Main Findings to Evaluate the Hepatocellular Carcinoma Response to Regorafenib? A Real-Life Experience

2021 ◽  
Vol 2021 ◽  
pp. 1-5
Author(s):  
Gustavo Hideki Kawanami ◽  
Leopoldo Katsuda ◽  
Thiara Barcelos Rocha ◽  
Fabio da Silva Yamashiro ◽  
Leonardo Pelafsky ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Kinase Inhibitors ◽  
Life Experience ◽  
Real Life ◽  
Treatment Modalities ◽  
Screening Methods ◽  
Second Line ◽  
Imaging Findings ◽  
Sorafenib Treatment

Background. Hepatocellular carcinoma is a relevant cause of mortality worldwide, mainly among patients who have a prior liver disease. In spite of clear recommendations regarding surveillance and screening methods, most patients are still diagnosed only when they are no longer candidates to curative treatment modalities, while others do not achieve the goals of such treatments, thus increasing the need of anticancer drugs. Moreover, when cirrhotic patients begin to receive these drugs, many types of adverse events are seen as a reason to withdrawal, even when there are findings suggesting a good response to the treatment. Case Summary. This case report is about a cirrhotic patient who received many types of treatment, from surgery and chemoembolization during early stages to first- and second-line systemic therapy when the disease turned to be advanced. Since he had no signs of liver dysfunction and suffered tumor progression during sorafenib treatment, regorafenib was initiated. The main findings that make this case important are the adverse events after taking this second-line agent, which would certainly be considered unacceptable and would lead to the drug withdrawal. The reasons why regorafenib was maintained are explained based on clinical and imaging findings, showing how this decision led to an excellent response. Conclusions. The knowledge of the main adverse events described in the pilot clinical trials can avoid unnecessary withdrawal of regorafenib. In addition, some clinical and imaging findings can be deemed as predictors of good response to tyrosine kinase inhibitors.

Stent-over-sponge (SOS): a novel technique complementing endosponge therapy for foregut leaks and perforations

Endoscopy ◽  
2017 ◽  
Vol 50 (02) ◽  
pp. 148-153 ◽  
Author(s):  
Piero Valli ◽  
Joachim Mertens ◽  
Arne Kröger ◽  
Christoph Gubler ◽  
Christian Gutschow ◽  
...  
Keyword(s):  
Adverse Events ◽  
Success Rate ◽  
Vacuum Therapy ◽  
Line Treatment ◽  
Second Line ◽  
Metal Stent ◽  
First Line ◽  
Novel Technique ◽  
Upper Gastrointestinal ◽  
First Line Treatment

Abstract Background and study aims Endoluminal vacuum therapy (EVT) has evolved as a promising option for endoscopic treatment of foregut wall injuries in addition to the classic closure techniques using clips or stents. To improve vacuum force and maintain esophageal passage, we combined endosponge treatment with a partially covered self-expandable metal stent (stent-over-sponge; SOS). Patients and methods Twelve patients with infected upper gastrointestinal wall defects were treated with the SOS technique. Results Indications for SOS were anastomotic leakage after surgery (n = 11) and chronic foregut fistula (n = 1). SOS treatment was used as a first-line treatment in seven patients with a success rate of 71.4 % (5/7) and as a second-line treatment after failed previous EVT treatment in five patients (success rate 80 %; 4/5). Overall, SOS treatment was successful in 75 % of patients (9/12). No severe adverse events occurred. Conclusion SOS is an effective method to treat severely infected foregut wall defects in patients where EVT has failed, and also as a first-line treatment. Comparative prospective studies are needed to confirm our preliminary results.

Economic evaluation of crizotinib, alectinib, ceritinib, and brigatininb in anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) as second-line treatment.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21104-e21104
Author(s):  
Nimer S. Alkhatib ◽  
Briana Choi ◽  
Hala Halawah ◽  
Matthias Calamia ◽  
Dexter Gulick ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Adverse Events ◽  
Incremental Cost ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Reference Drug ◽  
First Line Therapy ◽  
Line Therapy ◽  
Life Years

e21104 Background: Crizotinib, alectinib, ceritinib, and brigatinib are approved as second line treatment for ALK+ NSCLC. Crizotinib was the first ALK inhibitor for first line therapy approved by Food and Drug Administration (2011) then ceritinib (2014), alectinib (2015), and brigatinib (2017) were approved as second line drugs. Following more data, these agents were approved as the first line therapy (2017 for ceritinib and alectinib; 2020 for brigatinib). These remain as a treatment option in patients who fail the first line therapy. Cost-effectiveness/utility analyses were conducted to assess clinical efficacy with varying costs of the agents. Methods: A three state Markov model were assumed (progression free, progression and death). Progression free survival (PFS) curves were digitized and fitted with exponential function. US payer perspective, a lifetime horizon, and discount rate of 3% were applied. Drug costs were Redbook wholesale acquisition cost. Other costs included were monitoring, adverse events and disease progression from published data (US$ 2020). Adverse events reported >5% in patients were included. Measured outcomes were PFS life years (PFSLY) and quality adjusted life years (PFSQALY). Crizotinib was the reference drug. Incremental cost-effectiveness and utility ratios (ICER/ICUR) of PFSLY and PFSQALY gained (PFSLYG, PFSQALYG) and lost were estimated. Base case (BCA) and probabilistic sensitivity analyses (PSA) were conducted. Results: Crizotinib was the reference drug for the following outcomes. For alectinib, with the decremental cost of -$14,653 (-$14,712), the incremental PFSLY of 0.16 (0.16) and PFSQALY of 0.05 (0.05) resulted in an ICER / PFSLYG of -$89,337 (-$88,604) and an ICUR / PFSQALYG of -$269,835 (-$266,510). For brigatinib, with the decremental cost of -$14,975 (-$14,954), the incremental PFSLY of 0.01 (0.01) and PFSQALY of ̃0.01 (0.02) yielded an ICER / PFSLYG of -$1,982,962 (-$1,431,631) and an ICUR / PFSQALYG of -$2,140,534 (-$570,538). For ceritinib, with the incremental cost of $7,590 ($7,514), there were decremental PFSLY of -0.01 (-0.01) and PFSQALY of -0.03 (-0.03). Conclusions: As second line treatment, crizotinib, ceritinib, and brigatinib had comparable PFSLYs and PFSQALYs while alectinib had the most PFSLY and PFSQALY and the lowest cost. Therefore, alectinib is the most cost-effective treatment for treating ALK+ NSCLC as the second line therapy.[Table: see text]

Biweekly Raltitrexed in Combination with Irinotecan (RIR) as Second-Line Therapy for Patients with Metastatic Colorectal Cancer: A Non-Randomized, Open-Label Phase II Trial.

2020 ◽  
Author(s):  
Ke Cheng ◽  
Yu-Wen Zhou ◽  
Ye Chen ◽  
Zhi-Ping Li ◽  
Meng Qiu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Overall Response Rate ◽  
Progression Free Survival ◽  
Second Line ◽  
Open Label ◽  
Second Line Therapy ◽  
Free Survival ◽  
Common Grade ◽  
Open Label Phase ◽  
Grade 3

Abstract Background Irinotecan-based doublet chemotherapy strategy was standard second-line backbone treatment for patients with oxaliplatin‑refractory metastatic colorectal cancer(mCRC). The aim of this study was to evaluate tolerability and efficacy of raltitrexed combined with irinotecan biweekly administered as the second-line therapy for mCRC patients.Methods The study was a single-center, non-randomized, open-label phase II trial. Patients with mCRC after failure with first-line treatment of oxaliplatin and fluoropyrimidine or its derivatives were enrolled. Irinotecan (180 mg/m2) and raltitrexed (2.5 mg/m2) were given intravenously on day 1. Cycles were repeated every 2 weeks. The primary endpoint was progression-free survival, and the secondary endpoints included overall response rate, disease control rate, overall survival and treatment related adverse events. Results Between December 2012 and October 2016, 35 patients were enrolled. 33 and 35 patients were assessed for response and safety, respectively. The overall response rate (ORR) was 8.6 %, and the disease control rate (DCR) was 71.4%. The median progression-free survival (PFS) was 4.5 months (95% CI 3.8–5.2). The median overall survival was 12.0 months (95% CI 8.5–15.5). Four patients received conversion therapy to no evidence of disease (NED), and 2 patients were still alive with beyond 24 months survival. The most common grade 3/4 hematological adverse events were leukopenia (8.6%), neutropenia (5.7%). The most common grade 3/4 nonhematological adverse events were anorexia (14.3%), vomiting (14.3%), nausea (11.4%) and fatigue (8.6%). Two patients discontinued the protocol treatment because of treatment-related gastrointestinal adverse events. No one died from treatment-related events. The incidence and severity of toxicity was irrelevant to UGT1A1 status.Conclusions The combination of irinotecan with raltitrexed is an active, convenient and acceptable toxic regimen for second-line treatment for mCRC patients, which needs further study as a chemotherapy backbone to be combined with targeted agents in mCRC.Trial registration No. ChiCTR-ONC-12002767. The study was registered with the Chinese Clinical Trial Registry at 29 Octorber 2012, http://www.chictr.org.cn/index.aspx.

Adverse events with second-line sulfonylureas

2018 ◽  
Vol 1713 (1) ◽  
pp. 7-7
Keyword(s):  
Adverse Events ◽  
Second Line
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