scholarly journals Safety of Amiodarone in Ventricular Arrhythmia in Patients Admitted in Bangabandhu Sheikh Mujib Medical University

2021 ◽  
Vol 17 (2) ◽  
pp. 118-121
Author(s):  
Sujoy Kumar Saha ◽  
Manzoor Mahmood ◽  
Dipal Krishna Adhikary ◽  
Syed Ali Ahsan ◽  
Chaudhury Meshkat Ahmed ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Effects ◽  
Pulmonary Toxicity ◽  
Ventricular Arrhythmias ◽  
Common Adverse Event ◽  
Hepatic Toxicity ◽  
Conduction Disturbance ◽  
Daily Dose ◽  
Medical University ◽  
Thyroid Toxicity

Background: Amiodarone is the most effective antiarrhythmic medications available today for the treatment of both atrial and ventricular arrhythmias. It is an iodinated benzofuran derivative with demonstrated efficacy against a range of cardiac arrhythmias, including atrial fibrillation, paroxysmal supraventricular tachycardias, and life-threatening ventricular arrhythmias. Objective: To evaluation the status of amiodarone with therapeutic dose in Bangladeshi population. Materials and Methods: The quasi experimental study was conducted in the Department of Cardiology in Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbagh, Dhaka during April, 2019 to March, 2020 Patients got admitted in the Department of Cardiology, BSMMU, consecutive patients who had been treated with amiodarone for arrhythmia were included in this study. Patients without an amiodarone prescription were assumed and patients who will not give informed written consent were excluded in this study. Results: The most common adverse event was bradycardia or conduction disturbance (9.0%) followed by 4(2.2%) thyroid toxicity, 3(1.7%) hepatic toxicity, 2(1.1%) eye toxicity and 1(0.6%) pulmonary toxicity. In multi variable logistic regression, bradycardia or conduction disturbance, amiodarone daily dose (≥300 mg) and duration of amiodarone (>4 month) was found to be significantly (p<0.05) associated with adverse effects of amiodarone. Conclusion: The most common adverse event was bradycardia or conduction disturbance followed by thyroid toxicity, hepatic toxicity, eye toxicity and pulmonary toxicity. Bradycardia or conduction disturbance, amiodarone daily dose (≥300 mg) and duration of amiodarone (>4 month) was found to be significantly associated with adverse effects of amiodarone. University Heart Journal Vol. 17, No. 2, Jul 2021; 118-121

scholarly journals Characteristics of voluntary reporting of adverse drug events related to antipsychotics in Australia: 14-year analysis

2021 ◽  
Vol 12 ◽  
pp. 204209862110128
Author(s):  
Hanan Khalil ◽  
Dimi Hoppe ◽  
Nabil Ameen
Keyword(s):  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Neuroleptic Malignant Syndrome ◽  
Antipsychotic Drug ◽  
Antipsychotic Drugs ◽  
Common Adverse Event ◽  
Drug Misuse ◽  
Large Databases ◽  
Chi Squared

Background: Retrospective analyses of large databases of treated patients can provide useful links to the presence of drug misuse or rare and infrequent adverse effects, such as agranulocytosis, diabetic ketoacidosis or neuroleptic malignant syndrome. The aim of this study is to describe the adverse effects to antipsychotics reported in the Australian Database of Adverse Event Notifications (DAEN). Methods: Data were collected from the DAEN – a spontaneous reporting database. The database, which covered the period from January 2004 to December 2017, was obtained from the Therapeutic Goods Administration (TGA) website ( www.TGA.gov ). The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. All data were analysed descriptively. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: A total of 7122 adverse events associated with the antipsychotics aripiprazole, clozapine, haloperidol, olanzapine, paliperidone, pimozide, quetiapine and risperidone were reported to the TGA between January 2004 and December 2017. On average, there were 2.6 adverse events reported for each case. The most common adverse event reported for antipsychotics was neuroleptic malignant syndrome. There were no significant differences in the number of co-medications, formulations, indications, therapeutic dose, hospital admission and overdose among the antipsychotics between paediatric and adult populations. However, there were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years) ( p < 0.05, chi squared test). Conclusion: The antipsychotic drug associated with the highest adverse events in adults was clozapine, followed by olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. Plain language summary Adverse events reported of antipsychotics Background: Retrospective analyses of large databases of treated patients can provide useful clues to the presence of drug misuse or rare and infrequent adverse effects associated with antipsychotics. The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. Methods: All data were analysed descriptively and investigated for any associations between the variables collected. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: The antipsychotic drug associated with the highest adverse events was clozapine, followed by olanzapine. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. Conclusion: There were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years).Keywords: Antipsychotics, adverse effects, adverse events, safety

scholarly journals Obinutuzumab plus fludarabine/cyclophosphamide or bendamustine in the initial therapy of CLL patients: the phase 1b GALTON trial

Blood ◽  
2015 ◽  
Vol 125 (18) ◽  
pp. 2779-2785 ◽  
Author(s):  
Jennifer R. Brown ◽  
Susan O’Brien ◽  
C. Daniel Kingsley ◽  
Herbert Eradat ◽  
John M. Pagel ◽  
...  
Keyword(s):  
Adverse Event ◽  
Initial Treatment ◽  
Initial Therapy ◽  
Common Adverse Event ◽  
Clinical Activity ◽  
Key Points ◽  
Infusion Reactions ◽  
Phase 1B

Key Points In this phase 1b study, obinutuzumab plus FC or B had acceptable safety, with infusion reactions the most common adverse event. Obinutuzumab plus FC or B showed promising clinical activity in the initial treatment of CLL, with no relapses to date.

scholarly journals Peginesatide to Manage Anemia in Chronic Kidney Disease Patients on Peritoneal Dialysis

2015 ◽  
Vol 35 (4) ◽  
pp. 481-489 ◽  
Author(s):  
Raja Zabaneh ◽  
Simon D. Roger ◽  
Mohamed El-Shahawy ◽  
Michael Roppolo ◽  
Grant Runyan ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Adverse Event ◽  
Peritoneal Dialysis ◽  
Kidney Disease ◽  
Common Adverse Event ◽  
Erythropoietin Receptor ◽  
Open Label ◽  
Evaluation Period ◽  
Red Blood Cell Transfusions ◽  
The Mean

♦BackgroundPeginesatide is a novel, synthetic, peptide-based pegylated erythropoiesis-stimulating agent that is designed specifically to stimulate the erythropoietin receptor. The purpose of the present study was to assess, for the first time, the efficacy and safety of peginesatide in chronic kidney disease (CKD) patients receiving peritoneal dialysis (PD) and previously on epoetin treatment.♦MethodsIn this open-label multicenter study, 59 PD patients with CKD were converted from epoetin (alfa or beta) to once-monthly peginesatide. Doses were titrated to maintain hemoglobin levels between 10 g/dL and 12 g/dL during the 25 weeks of the study. The primary endpoint was change from baseline in mean hemoglobin values during the evaluation period (weeks 20 – 25).♦ResultsThe mean hemoglobin value during the evaluation period was 11.3 ± 1.07 g/dL, and the mean change from baseline was 0.10 ± 1.15 g/dL (95% confidence limits: –0.24, 0.44 g/dL). During the evaluation period, most patients maintained hemoglobin levels between 10 g/dL and 12 g/dL (63.0%) and within ±1.0 g/dL of baseline (60.9%). The median weekly epoetin dose at baseline was 96.0 U/kg, and the median starting peginesatide dose was 0.047 mg/kg. Forty-three patients (72.9%) completed the study. Six patients (10.2%) received red blood cell transfusions. The observed adverse event profile was consistent with underlying conditions in the PD patient population. The most common adverse event was peritonitis (20.3%), a complication commonly associated with PD. Four deaths occurred during the study (2 related to septic shock, and 1 each to myocardial ischemia and myasthenia gravis).♦ConclusionsIn this study, once-monthly peginesatide maintained hemoglobin levels in PD patients after conversion from epoetin.

scholarly journals Adverse outcome of methotrexate and mini pulse betamethasone in the treatment of lichen planus

2013 ◽  
Vol 39 (1) ◽  
pp. 22-27 ◽  
Author(s):  
SC Hazra ◽  
AM Choudhury ◽  
ATM Asaduzzaman ◽  
HK Paul
Keyword(s):  
Adverse Effects ◽  
Lichen Planus ◽  
Adverse Outcome ◽  
Adverse Outcomes ◽  
Haematological Parameter ◽  
Morning Dose ◽  
Group A ◽  
Laboratory Investigations ◽  
Group B ◽  
Medical University

The objectives of this study were to compare the adverse outcome of methotrexate and mini pulse betamethasone therapy in the treatment of lichen planus. It was a clinical trial conducted in the department of Dermatology and Venereology, Bangabandhu Sheikh Mujib Medical University, Dhaka, from January 2009 to December 2010. Forty four patients of lichen planus were included in the study. Patients in Group-A, (n=23) were treated with methotrexate (10 mg) single morning dose and group-B (n=21) were treated with mini pulse betamethasone (5mg) single morning dose on 2 consecutive days during the period of 12 weeks. Adverse outcomes were measured by clinical examination and laboratory investigations during follow up visits. Anemia 3(14.2%) and edema 12(57.1%) developed in group-B but none in group-A. In group-B, dyspepsia 15(71.4%), acne 10(47.6%), mooning face 8(38.1%), striae 8(38.1%) and hypertrichosis 4(19.0%) developed but none in group-A. Intermittent diarrhoea, headache, nausea and fatigue complained in both groups of patients but the percentage of complaints was higher amog group-B compared to group-A. Menstrual abnormality developed in group-B 5(71.4%) but none in group-A. Laboratory investigations showed abnormality in platelet count and SGPT in group-A but none in group-B. The adverse effects of methotrexate on haematological parameter and liver functions were mild and could be prevented by reducing the dose but the adverse effects of betamethasone were unavoidable. The overall adverse effects were less in group-A than group-B. Therefore, methotrexate can be used as an alternative safer option for the treatment of lichen planus. DOI: http://dx.doi.org/10.3329/bmrcb.v39i1.15806 Bangladesh Med Res Counc Bull 2013; 39: 22-27

scholarly journals P330 Long-term outcomes following a switch from originator adalimumab to the biosimilar SB5 (Imraldi) in IBD

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S353-S354
Author(s):  
L Derikx ◽  
H Dolby ◽  
N Plevris ◽  
L Lucaciu ◽  
C Rees ◽  
...  
Keyword(s):  
Adverse Event ◽  
Disease Activity ◽  
Injection Site ◽  
Cost Savings ◽  
Common Adverse Event ◽  
Prescription Database ◽  
Long Term Outcomes ◽  
Faecal Calprotectin

Abstract Background Multiple adalimumab (ADA) biosimilars, including SB5 (Imraldi) and ABP 501 (Amgevita), are now approved for use in IBD. Data about biosimilar ADA in IBD remain scarce. We therefore aimed to investigate long-term outcomes of the biosimilar SB5 in IBD patients following a switch from the ADA originator (Humira) or after start of SB5 as their first ADA-therapy. Methods We performed a retrospective cohort study in a tertiary IBD referral centre. All IBD patients treated with Humira underwent an elective switch to SB5 regardless of IBD phenotype, disease activity and ADA dosing. All patients were reviewed regularly in the virtual biologics clinic with protocol driven collection of clinical disease activity, blood tests, TDM and faecal calprotectin. We identified all patients on SB5 in a biologic prescription database that prospectively registered all ADA by brand name and start and stop dates. Results 441 patients were treated with SB5, including 234 who switched from Humira to SB5 (CD=209, 89.3%; median IBD duration 10 years, IQR 6-16) and 207 who started on SB5 as their first ADA-therapy (CD=162, 78.3%; median IBD duration 6 years, IQR 1-16.8). 107/234 (45.7%) patients who switched to SB5 used infliximab before ADA. These patients were treated for a median of 32 months (IQR 17-57) with Humira prior to switching. At Humira – SB5 switch, 60.1% (140/234) received 40mg ADA every other week and 39.1% (91/234) once weekly. The median duration of follow up was 13 months (IQR 8-14). At week 26 and week 52, 194/231 (84.1%) and 148/215 (70.3%) patients remained on SB5, respectively (Figure 1). 81/234 patients (35.0%) discontinued SB5, mostly due to adverse events (n=40/81) or secondary loss of response (n=35/81). Pain at the injection site was the most frequently reported adverse event (n=31); all these patients switched to Amgevita. 30/31 patients with a double biosimilar continued Amgevita until the end of follow up (median 30 months), resulting in 172/215 (81.3%) patients that remained on ADA at week 52 (Figure 1). Proportions of patients in biochemical remission and clinical remission were similar at baseline, week 26 and week 52 following switch (Figure 2). Median ADA trough levels were similar before (10.2 ug/ml, IQR 7.4-13.5) and after switch 10.3 (IQR 7.4-13.1). 17/234 (7.3%) patients developed antibodies during SB5 treatment. Conclusion Switching from Humira to SB5 appeared effective and safe in this study with over 12 months of follow up. The most common adverse event was injection site pain; these patients were successfully moved on to Amgevita providing the first data about a double biosimilar switch. Over the 24 months of this biosimilar ADA program substantial cost savings were effected.

Amiodarone-Induced Skin Pigmentation and Pulmonary Fibrosis

2002 ◽  
Vol 37 (6) ◽  
pp. 615-618 ◽  
Author(s):  
Pilar González ◽  
María-José Otero ◽  
Miguel Barrueco ◽  
Alfonso Domínguez-Gil
Keyword(s):  
Pulmonary Fibrosis ◽  
Early Diagnosis ◽  
Pulmonary Toxicity ◽  
Ventricular Arrhythmias ◽  
Skin Pigmentation ◽  
Active Role ◽  
Clinical Use ◽  
Toxicity Profile ◽  
Appropriate Treatment

Amiodarone is a valuable drug for the treatment of supraventricular and ventricular arrhythmias. However, toxicity involving a variety of organs and tissues that limits the agent's clinical use is not uncommon. This article presents the case of a patient who developed amiodarone-induced pulmonary fibrosis and blue-gray facial pigmentation. The authors emphasize awareness of amiodarone's toxicity profile and the importance of appropriate treatment and followup care. Patients should be educated to take an active role in this process by monitoring themselves for symptoms of amiodarone-induced pulmonary toxicity, to aid in early diagnosis and help prevent fatal outcomes.

scholarly journals Difference in Neutropenia due to Administration Schedule of TAS-102

2017 ◽  
Vol 10 (1) ◽  
pp. 226-229 ◽  
Author(s):  
Yoichiro Yoshida ◽  
Naoya Aisu ◽  
Ai Mogi ◽  
Akira Komono ◽  
Ryohei Sakamoto ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Bone Marrow ◽  
Overall Survival ◽  
Adverse Event ◽  
Metastatic Colorectal Cancer ◽  
Common Adverse Event ◽  
Bone Marrow Suppression ◽  
Effective Prevention ◽  
Administration Method ◽  
Prevention Method

TAS-102 significantly improves overall survival in patients with metastatic colorectal cancer. The most common adverse event of TAS-102 is bone marrow suppression, which leads to neutropenia. The incidence of neutropenia is high, and there is no known effective prevention method. Furthermore, the administration method of TAS-102 is complicated. We reported that neutropenia could be avoided by changing to a simple administration method of TAS-102.

039 Rates of lymphopenia in years 1–4 in patients with relapsing multiple sclerosis treated annually with cladribine tablets

2018 ◽  
Vol 89 (6) ◽  
pp. A16.2-A16 ◽  
Author(s):  
Stuart Cook ◽  
Giancarlo Comi ◽  
Gavin Giovannoni ◽  
Peter Rieckmann ◽  
Per Soelberg Sorensen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Event ◽  
Mechanism Of Action ◽  
Cumulative Dose ◽  
Common Adverse Event ◽  
Annual Treatment ◽  
Grade 3 ◽  
Experienced Grade ◽  
Relapsing Multiple Sclerosis ◽  
Time Point

IntroductionThe CLARITY and CLARITY Extension studies demonstrated the efficacy of cladribine tablets in patients with relapsing multiple sclerosis. The most common adverse event was lymphopenia, consistent with the mechanism of action of cladribine tablets. Objective was to evaluate whether lymphopenia persists following annual treatment with cladribine tablets.MethodsLymphopenia by grade (NCI CTCAE v3.0) for patients randomised to cladribine tablets 3.5 mg/kg in CLARITY and re-randomised to cladribine tablets 3.5 mg/kg in CLARITY Extension (7 mg/kg cumulative dose over 4 years; n=186) are reported. Patients with Grade 0 lymphopenia (≥1.0×109 cells/L) before the first course of cladribine tablets and Grade 0/1 (≥0.8×109 cells/L) prior to administration in Years 2, 3 and 4 were included in the analysis.Results176 patients were Grade 0 at CLARITY baseline and 167 were Grade 0/1 at CLARITY Extension baseline. Grade 3 lymphopenia was observed in 1% of patients at Week 13 in Year 1, and in 7%, 11% and 12% at Week 12 in Years 2, 3 and 4, respectively. By Week 24 in Years 1, 2, 3 and 4, Grade 3 lymphopenia was observed in 1%, 4%, 4% and 4% of patients, respectively. By Week 36 in Years 1, 2, 3 and 4, Grade 3 lymphopenia was observed in 1%, 2%, 2% and 2% of patients, respectively. Grade 3 lymphopenia was only observed in Week 48 of Year 2 (1% of patients). Grade 3 lymphopenia was reported in <18% of patients at any time point. No patients had Grade 4 lymphopenia at the end of any years.ConclusionNo patients included in this analysis experienced Grade 4 lymphopenia at the end of any treatment year. Grade 3 lymphopenia was uncommon. This study demonstrates the effectiveness of lymphocyte-based treatment criteria in minimising the incidence of severe, sustained lymphopenia during treatment with cladribine tablets.

Pulmonary toxicity of cytotoxic agents: A meta-analysis

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19573-19573
Author(s):  
Y. Takiguchi ◽  
Y. Tada ◽  
K. Kurosu ◽  
S. Sakao ◽  
K. Tatsumi ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Comparative Studies ◽  
Pulmonary Toxicity ◽  
Literature Search ◽  
Meta Analysis ◽  
Best Supportive Care ◽  
Cytotoxic Agents ◽  
Published Data ◽  
Toxicity Data ◽  
Anti Cancer

19573 Background: Pulmonary toxicity is one of the most serious adverse effects of cytotoxic agents, and affected patients require discontinuation of the anti-cancer therapy, and it even proves fatal in many cases. Its incidence, however, may be considerably biased, as it may be influenced by many factors such as intercurrent medications or co-morbidities. The purpose of our study was to evaluate the incidences of pulmonary toxicity by cytotoxic agents in published data relating to prospective randomized comparative studies. Methods: A Medline literature search was conducted to extract prospective randomized comparative studies (either phase II or III) that included docetaxel, paclitaxel, irinotecan, vinorelbine and gemcitabine. Comparisons had to be performed between regimens with and without one of these agents, in addition to best supportive care with or without other common agent(s), so as to be able to clearly attribute the toxicity to the agent. Reports lacking detailed toxicity data were excluded. Results: The table below summarizes the results of the finally evaluated 47 studies (5 to 12 per agent) fulfilling the criteria. As many studies showed no pulmonary toxicity, standard statistical methods for meta-analysis were not applicable. Conclusions: The present study analyzing data in prospective randomized comparative studies might minimize bias of the relative incidence of pulmonary toxicity. Pulmonary toxicity was rarely encountered in randomized comparative studies. No increase in frequency was shown by the inclusion of any of the five cytotoxic agents. [Table: see text] No significant financial relationships to disclose.

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