scholarly journals A156 LOW COMPLICATION RATE IN THE OUTPATIENT INTRAJEJUNAL LEVODOPA/CARBIDOPA INTESTINAL GEL CLINICAL PROGRAM

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 20-21
Author(s):  
N Al Yatama ◽  
C H Parker ◽  
Y Tse ◽  
T Naranian ◽  
A Fasano ◽  
...  
Keyword(s):  
Data Collection ◽  
Adverse Events ◽  
Hospital Admissions ◽  
Retrospective Chart Review ◽  
Current Method ◽  
Final Analysis ◽  
Outpatient Setting ◽  
Fistula Formation ◽  
Serious Adverse Events

Abstract Background Levodopa/carbidopa intestinal gel (LCIG) is a formulation that is delivered continuously through a percutaneous endoscopy gastro-jejunal tube (PEG-J) for the treatment of patients with advanced Parkinson’s disease (PD). LCIG significantly reduces periods of increased motor symptoms without troublesome dyskinesia. Adverse events related to this treatment have been attributed to PEG-J insertion and the device used for LCIG delivery, rather than to the LCIG preparation itself. To date, the data evaluating long-term efficacy and safety of PEG-J insertion for LCIG administration in the outpatient setting is limited. Aims The aim of this study is to describe short and long-term adverse events (AEs) associated with outpatient PEG-J tube insertion for LCIG administration at our centre. Methods A retrospective chart review was performed of all PD patients who underwent PEG-J insertion for LCIG therapy at Toronto Western Hospital from March 2011 to October 2019. All AEs associated with PEG-J insertion were collected including procedure and tube related complications, hospital admissions, emergency room (ER) visits and deaths. Data was analyzed using descriptive statistics. Results A total of 58 patients were identified and included in the final analysis. 37 (64%) male, with a mean age of 74 years +/-6.17. The mean duration of PD diagnosis prior to PEG-J insertion was 16.5 years +/-2.0. Mean time from PEG-J insertion to data collection was 37.5 months +/- 19.3. 30 (51%) patients had post-procedural abdominal pain or site pain. This pain improved with over the counter analgesics. 9 (16%) had possible site infection; 6 received oral antibiotics and 3 had the tube replaced. 19 (33%) developed granulation tissue, with only 2 patients requiring tube exchange. 32 (55%) had their tube removed or exchanged secondary to PEG-J malfunction. No ER visits related to the PEG-J were recorded. During the data collection period, 12 (21%) patients died for reasons unrelated to PEG-J insertion. There were no reported serious adverse events (SAEs), including post-procedure perforation, bleeding, fistula formation, development of intra-abdominal collections or buried bumper syndrome. Conclusions This study demonstrates the absence of serious AEs associated with outpatient PEG-J insertion for LCIG administration in patients with advanced PD. The most common short-term AE was post-procedural pain. The most common long-term AE was related to PEG-J malfunction requiring replacement. This study supports that the current method of outpatient PEG-J insertion for the administration of LCIG is safe in patients with advanced PD. Funding Agencies None

scholarly journals IV fosphenytoin in obese patients

2016 ◽  
Vol 7 (1) ◽  
pp. 45-52 ◽  
Author(s):  
Sarah L. Clark ◽  
Megan R. Leloux ◽  
Ross A. Dierkhising ◽  
Gregory D. Cascino ◽  
Sara E. Hocker
Keyword(s):  
Body Weight ◽  
Adverse Events ◽  
Vital Signs ◽  
Drug Distribution ◽  
Retrospective Chart Review ◽  
Current Method ◽  
Liver Function Tests ◽  
Excess Body Weight ◽  
Obese Patients ◽  
Bonferroni Adjustment

AbstractBackground:Previous studies evaluated the disposition of IV phenytoin loading doses and found that obese patients had increased drug distribution into excess body weight, larger volumes of distribution, and longer half-lives when compared to their nonobese counterparts. We assess the safety and efficacy of fosphenytoin loading doses in patients with different body mass indices (BMIs).Methods:A retrospective chart review was conducted in 410 patients who received fosphenytoin. Patients were divided into 2 groups: BMI <30 (nonobese) and BMI ≥30 (obese). Patient demographics, fosphenytoin dose administered in mg/kg body weight, renal and liver function tests, fosphenytoin drug levels, and pre- and post-fosphenytoin administration vital signs were collected to assess for adverse events. Necessity of additional antiepileptic loading doses was used as a surrogate for clinical efficacy.Results:The median dose of fosphenytoin administered was 19 mg/kg (interquartile range 15–20). The most frequently encountered adverse event was hypotension, which occurred in 39% of the cohort. Using a Bonferroni adjustment for multiple comparisons, there were no differences in adverse events between the 2 groups. The need for additional antiepileptic loading doses was not different between the 2 groups (p = 0.07).Conclusions:The incidence of adverse events and the need for repeat loading antiepileptic medications was similar between the 2 groups. From our findings, the patients in our study did not receive empiric loading dose adjustments and the current method of loading fosphenytoin achieves similar outcomes, regardless of the patient's BMI.

Retrospective Chart Review of Cryopreserved Amniotic Membrane for Knee Pain

2020 ◽  
Author(s):  
Ruben Berrocal Timmons
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Amniotic Membrane ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Final Analysis ◽  
Mean Values ◽  
Number Of Patients ◽  
The Impact

Objective: Treatment of joint pain with an injection of the amniotic membrane has not been adequately studied. This study retrospectively reviewed Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analgesic usage data from patients treated with the injection of cryopreserved amniotic membrane (CAM) in their knees to determine the impact of treatment on patients’ pain, quality of life, and analgesic usage. Methods: Chart review was conducted on 40 patients. Institutional Review Board (IRB) approval was obtained prior to initiation of the project. The membrane was utilized as per the FDA guidance of 21CFR1271. Retrospective data, including demographics, medical history, pain score, quality of life score, analgesic usage and adverse events, were collected from their medical records for each consenting patient through 6 months after CAM injection. Results: A total of 40 patients were considered in the final analysis. Mean VAS for pain level improved from 7.0 to 2.6 (p<0.001). WOMAC daily activity function score improved from a mean score of 52 to 28 (p<0.001). Opioid and non-steroidal anti-inflammatory drug (NSAID) usage decreased from 97% to 25% (p<0.001). No adverse events were reported. Conclusion: Mean values for VAS and WOMAC scores significantly improved at all time points and the number of patients who used analgesics decreased as compared to baseline. CAM injection into painful knee joints decreases pain, improves physical function, and decreases the use of analgesics in the absence of adverse events.

scholarly journals Reducing the Toxicity of Long-Term Glucocorticoid Treatment in Large Vessel Vasculitis

2020 ◽  
Vol 22 (12) ◽  
Author(s):  
Andriko Palmowski ◽  
Frank Buttgereit
Keyword(s):  
Adverse Events ◽  
Takayasu Arteritis ◽  
Term Treatment ◽  
Large Vessel Vasculitis ◽  
Large Vessel ◽  
Serious Adverse Events ◽  
Glucocorticoid Treatment ◽  
Long Term Treatment ◽  
Higher Doses

Abstract Purpose While glucocorticoids (GCs) are effective in large vessel vasculitis (LVV), they may cause serious adverse events (AEs), especially if taken for longer durations and at higher doses. Unfortunately, patients suffering from LVV often need long-term treatment with GCs; therefore, toxicity needs to be expected and countered. Recent Findings GCs remain the mainstay of therapy for both giant cell arteritis and Takayasu arteritis. In order to minimize their toxicity, the following strategies should be considered: GC tapering, administration of conventional synthetic (e.g., methotrexate) or biologic (e.g., tocilizumab) GC-sparing agents, as well as monitoring, prophylaxis, and treatment of GC-related AEs. Several drugs are currently under investigation to expand the armamentarium for the treatment of LVV. Summary GC treatment in LVV is effective but associated with toxicity. Strategies to minimize this toxicity should be applied when treating patients suffering from LVV.

scholarly journals A Systematic Review of Pediatric and Adult In-Flight Medical Emergencies

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Christina Sul ◽  
Sherif M. Badawy
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Health Outcomes ◽  
Pediatric Population ◽  
Air Travel ◽  
Serious Adverse Events ◽  
Significant Events ◽  
Medical Emergencies ◽  
The Subject

In-flight medical emergencies (IMEs) are acute onboard events of illnesses or injuries with potential immediate risk to a passenger’s short- or long-term health, or life. IMEs are significant events that are related to public safety concerns. With the increasing amount of annual air travel every year, it is expected that the number of encountered IMEs will continue to grow. Thus, it will be critical to develop and implement appropriate measures to manage IMEs with the best possible outcome. Despite the fact that most IMEs are self-limited with no serious adverse events, serious IME can lead to death, disability, or other unfavorable health outcomes, particularly as a result of suboptimal medical care. In this article, we systematically reviewed the published up-to-date evidence on the subject of in-flight emergencies with a specific focus on pediatric population.

Cessation of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation

Heart ◽  
2020 ◽  
pp. heartjnl-2020-317418
Author(s):  
Melissa E Middeldorp ◽  
Aashray Gupta ◽  
Adrian Elliott ◽  
Kadhim Kadhim ◽  
Anand Thiyagarajah ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Vitamin K ◽  
Oral Anticoagulants ◽  
Female Gender ◽  
Vitamin K Antagonist ◽  
Serious Adverse Events ◽  
Care Clinic ◽  
Multivariable Analyses

ObjectiveTo characterise the rate, causes and predictors of cessation of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF).Patients and methodsConsecutive patients with AF with a long-term anticoagulation indication treated with NOACs (dabigatran, apixaban and rivaroxaban) in our centre from September 2010 through December 2016 were included. Prospectively collected data with baseline characteristics, causes of cessation, mean duration-to-cessation and predictors of cessation were analysed.ResultsThe study comprised 1415 consecutive patients with AF, of whom 439 had a CHA2DS2-VASc≥1 and were on a NOAC. Mean age was 71.9±8.7 years and 37% were females. Over a median follow-up of 3.6 years (IQR=2.7–5.3), 147 (33.5%) patients ceased their index-NOAC (113 switched to a different form of OAC), at a rate of 8.8 per 100 patient-years. Serious adverse events warranting NOAC cessation occurred in 28 patients (6.4%) at a rate of 1.6 events per 100 patient-years. The mean duration-to-cessation was 4.9 years (95% CI 4.6 to 5.1) and apixaban had the longest duration-to-cessation with (5.1, 95% CI 4.8 to 5.4) years, compared with dabigatran (4.6, 95% CI 4.2 to 4.9) and rivaroxaban (4.5, 95% CI 3.9 to 5.1), pairwise log-rank p=0.002 and 0.025, respectively. In multivariable analyses, age was an independent predictor of index-NOAC cessation (HR 1.03, 95% CI 1.01 to 1.05; p=0.006). Female gender (HR 2.2, 95% CI 1.04 to 4.64; p=0.04) independently predicted serious adverse events.ConclusionIn this ‘real world’ cohort, NOAC use is safe and well-tolerated when prescribed in an integrated care clinic. Whether apixaban is better tolerated compared with other NOACs warrants further study.

A Practical Approach to the Use of Acitretin for the Treatment of Psoriasis

2010 ◽  
Vol 16a (2) ◽  
pp. 62-68
Author(s):  
Tina Bhutani ◽  
Kristine Busse
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Maintenance Therapy ◽  
Plaque Psoriasis ◽  
Practical Approach ◽  
Serious Adverse Events ◽  
Oral Retinoid ◽  
Systemic Agents ◽  
Term Maintenance

This clinical review outlines a practical approach to the use of acitretin in the treatment of psoriasis. Acitretin is approved by the Food and Drug Administration for the treatment of adult patients with chronic moderate to severe plaque psoriasis. It is an oral retinoid and is the only systemic agent that is not clinically immunosuppressive; it works primarily by enhancing differentiation and maturation of cells. Side effects associated with this medication are usually mild and manageable; serious adverse events are rare. Therefore, it can be used for long-term maintenance therapy or in combination with other topical or systemic agents and phototherapy.

scholarly journals Evaluation of Serum Creatinine Changes With Integrase Inhibitor Use in Human Immunodeficiency Virus-1 Infected Adults

2016 ◽  
Vol 3 (2) ◽  
Author(s):  
Tara A. Lindeman ◽  
Joan M. Duggan ◽  
Eric G. Sahloff
Keyword(s):  
Human Immunodeficiency Virus ◽  
Clinical Trials ◽  
Adverse Events ◽  
Serum Creatinine ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Integrase Inhibitor ◽  
Serious Adverse Events ◽  
Immunodeficiency Virus ◽  
Human Immunodeficiency Virus 1

Abstract This retrospective chart review evaluated changes in serum creatinine and creatinine clearance (CrCl) after initiation of an integrase inhibitor (INSTI)-based regimen as initial treatment in human immunodeficiency virus-infected adults. Serum creatinine and CrCl changes were similar to those seen in clinical trials for INSTIs. No renal-related serious adverse events or discontinuations occurred.

Imatinib Long Term Effects (ILTE) Study: An Independent, International Study in CML Patients.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1099-1099
Author(s):  
Carlo Gambacorti-Passerini ◽  
Dong-Wook Kim ◽  
François-Xavier Mahon ◽  
Giuseppe Saglio ◽  
Fabrizio Pane ◽  
...  
Keyword(s):  
Adverse Events ◽  
International Study ◽  
Imatinib Treatment ◽  
Long Term Effects ◽  
First Line ◽  
Eligibility Criteria ◽  
Serious Adverse Events ◽  
Second Cancers

Abstract Imatinib is an effective first line therapy for chronic myeloid leukemia (CML) and has substantially changed its biological and clinical behavior. Durable complete cytogenetic responses (CCyR) were reported in the majority of patients, with a rather benign side effect profile, despite the ‘off target’ inhibition of several other kinases, including Kit, PDGFR and Lck. Since available information is largely based on industry-sponsored trials and long-term field studies are lacking, the ILTE study was conceived as an industryindependent, academic, multicenter trial supported by the Italian Drug Safety Agency (AIFA). ILTE is an international study on a retrospective cohort and includes 31 centers in Europe, North/South America, Africa and Asia; therefore it is uniquely positioned to present a global picture of imatinib long-term effects. Consecutive patients with Ph+ CML who started imatinib between 01 September 1999 and 31 December 2004 were eligible if they were in Complete Cytogenetic Response (CCyR) after two years of imatinib treatment. Study endpoints were survival, serious adverse events (SAE, including second cancers), toxicities not qualifying as SAE (NSAE) but judged by the referring physician as substantially impacting quality of life, loss of CCyR, and development of PCR negativity. A total of 957 patients were enrolled, 92% of which met eligibility criteria. The median age of eligible patients was 50 (range 15–92) years; 59% of patients were males and the median follow-up was 3.1 years (excluding the first 2 years of treatment). As of Dec. 31 2007, 2564 person years were available for analysis. Eleven deaths were observed (only 3 of them caused by relapsed CML), with a standardized rate of 0.4/100 person years and an observed/expected ratio of 0.48 (95% CI = 0.24–0.85). One-hundred SAE were recorded (rate 3.9/100 person years, most frequent type “heart failure”), with 21% being considered related to imatinib. Second cancers were documented in 28 patients (rate 1.1/100 person years), with an observed/expected ratio of 1.27 (95% CI = 0.84–1.84). Among the 576 NSAE recorded (0.65/patient) the most frequent types were “edema, cramps, skin fragility, diarrhea”; 71% of them were related to imatinib. A total of 12 patients (1.4 %) discontinued imatinib because of toxicities during the period of observation. Thirty-four patients lost CCyR, corresponding to a rate of 1.4/100 person years (1.0 in patients with imatinib as first-line treatment, 1.5 in patients who were treated with imatinib &gt;6 months after diagnosis), with stable or increasing rates over time. Finally, 214 patients (24.5%) developed durable (&gt; 1 year) PCR negativity. In conclusion, the first report from ILTE shows that CML patients on imatinib die unfrequently of CML related causes, do not appear to have substantially higher second cancer rates than the general population, have mortality rates lower than expected in an age/sex matched population and do not show new types of imatinib-related adverse events. They also experience a low but steady rate of loss of CCyR and develop PCR negativity in approximately ¼ of cases. Follow-up and further analysis are ongoing. (Presented on behalf of the ILTE Investigators group)

Time to grade ≥3 adverse events in pts receiving trifluridine/tipiracil (TAS-102).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 788-788 ◽  
Author(s):  
Eric Van Cutsem ◽  
Atsushi Ohtsu ◽  
Natividad Lopez Busto ◽  
Akira Kanehisa ◽  
Ronan Fougeray ◽  
...  
Keyword(s):  
Adverse Events ◽  
Rest Period ◽  
Outpatient Setting ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Safety Population ◽  
End Of Treatment ◽  
Grade 3 ◽  
Post Hoc ◽  
Clinical Trial Information

788 Background: The phase 3 RECOURSE showed that treatment with trifluridine/tipiracil in patients (pts) with refractory metastatic colorectal cancer was associated with significantly improved survival versus placebo (7.1 versus 5.3 months, respectively; HR for death 0.68, 95% CI 0.58–0.81, p < 0.001), with few serious adverse events. Trifluridine/tipiracil is administered in 4-week cycles comprising 2 weeks with 5 days at 35 mg/m2 bid followed by 2 rest days, and then a 2-week rest period. Exploration of timing for AEs, particularly within the first cycle of treatment, is important for pt monitoring in the outpatient setting. Methods: We performed a post hoc analysis of the RECOURSE safety population (533 trifluridine/tipiracil; 265 placebo) to explore timing of hematological and nonhematological AEs. Results: Grade ≥ 3 adverse events (AEs) were more frequent with trifluridine/tipiracil than placebo for both hematological AEs (38% vs 0% neutropenia; 4% vs 0% febrile neutropenia; 18% vs 3% anemia; and 5% vs < 1% thrombocytopenia) and nonhematological AEs (2% vs 1% nausea; 2% vs < 1% vomiting; and 3% vs < 1% diarrhea). The median time to nadir in cycle 1 for hematological events was 28 days (17–31) for grade ≥ 3 neutropenia, 22 days (9–39) for grade ≥ 3 anemia, and 18 days (9–33) for grade ≥ 3 thrombocytopenia; similar values were obtained in subsequent cycles. The median times to nadir and values at nadir over the whole treatment duration (all cycles) are presented in the table for hematological and nonhematological AEs. Conclusions: Hematological and nonhematological AEs with trifluridine/tipiracil appear to be most intense towards the end of treatment cycles, which is reassuring for its use in the outpatient setting. Clinical trial information: NCT01607957. [Table: see text]

scholarly journals Long-term follow-up on effectiveness and safety of etanercept in juvenile idiopathic arthritis: the Dutch national register

2008 ◽  
Vol 68 (5) ◽  
pp. 635-641 ◽  
Author(s):  
F H M Prince ◽  
M Twilt ◽  
R ten Cate ◽  
M A J van Rossum ◽  
W Armbrust ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Adverse Events ◽  
Rheumatoid Factor ◽  
Serious Adverse Events ◽  
American College Of Rheumatology ◽  
Systemic Jia ◽  
Long Term Follow Up ◽  
Remission Criteria

Objective:We undertook an observational study to obtain a complete overview of the long-term effectiveness and safety of etanercept in patients with different juvenile idiopathic arthritis (JIA) subtypes.Methods:At baseline we collected patient and disease characteristics of all Dutch patients with JIA who started treatment with etanercept. Disease activity was evaluated (at start of the study, after 3 months and then yearly) according to the JIA core set of the American College of Rheumatology paediatric definition for 30, 50 and 70% improvement (ACR Pedi 30, 50 and 70). Use of etanercept and concomitant drugs was monitored. Adverse events were recorded.Results:We included 146 patients with JIA with a median follow-up of 2.5 years per patient (range 0.3–7.3). JIA subtypes represented: 27% systemic, 8% polyarticular rheumatoid factor positive, 38% polyarticular rheumatoid factor negative, 19% oligoarticular extended, 3% enthesitis-related and 5% psoriatica. Most patients (77%) met the criteria of the ACR Pedi 30 in the first 3 months of treatment. For the majority of patients this improvement was sustained; 53 (36%) of all patients met the remission criteria. No other second-line agents were needed in 43 patients. Although patients with systemic JIA responded initially less to etanercept therapy than patients from other subtypes, those who did respond showed equal effectiveness in the long term. Serious adverse events rate was low (0.029 per patient year).Conclusions:Etanercept is effective and safe in JIA, even for a large proportion of the patients with systemic JIA. The greatest improvement occurred in the first 3 months of treatment, and was sustained for a long time in most patients (up to 75 months).

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