Intravenous ATP infusions can be safely administered in the home setting: a study in pre-terminal cancer patients.
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ABSTRACT:
SUBMITTER: Beijer S
PROVIDER: S-EPMC2039853 | biostudies-other | 2007 Dec
REPOSITORIES: biostudies-other
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Project description:Evolocumab has been shown to consistently reduce low-density lipoprotein cholesterol (LDL-C) across populations. The phase 3 studies included administration in the home-use and in-clinic settings but did not specifically evaluate the feasibility of home-use administration. Two clinical studies enrolled patients with hypercholesterolemia or mixed dyslipidemia on statin therapy and with/without ezetimibe received evolocumab in the home-use setting. Patients were randomized to self-administer evolocumab using one of two injection devices biweekly over 6 weeks (autoinjector or prefilled syringe; n = 149; ClinicalTrials.gov, NCT01849497) or monthly over 12 weeks (autoinjector or automated minidoser; n = 164; NCT01879319). The first self-administration occurred in the in-clinic setting, and two more were performed in the at-home setting. Patients were successful in self-administering evolocumab in the home-use setting in approximately 95 % of attempts and experienced LDL-C reductions from baseline to week 6 or the mean of weeks 10 and 12 of approximately 65 %. Rates of successful self-administration and LDL-C reduction were similar across dosing schedules and study devices. Adverse events were similar between randomized groups and generally mild in severity. In two clinical studies, therefore, patients were able to successfully self-administer evolocumab in both the in-clinic and at-home settings regardless of which dosing schedule or device they used.
| S-EPMC4783317 | biostudies-literature
Project description:ImportanceInfusion reactions occur in 7% to 20% of patients receiving biologics. Home infusions are convenient and incur lower costs but may be associated with more adverse events; the safety of receiving biologic infusions for immune-mediated diseases at home remains unclear.ObjectiveTo assess whether patients receiving home biologic infusions have increased adverse events requiring emergency department (ED) or hospital admission compared with patients receiving facility infusions.Design, setting, and participantsThis retrospective cohort study used administrative claims data from a large national insurer for adult patients who received biologic infusions for immune-mediated disease between January 2007 and December 2017. Patients with hematologic malignant neoplasms or bone marrow transplantation were excluded. Data were analyzed from August 2019 to October 2020.Main outcomes and measuresED or hospital admission on the same or next day after administration of a biologic infusion at home vs at a facility; secondary outcomes included discontinuation of the biologic after an ED or hospital admission and postinfusion mortality.ResultsOf a total of 57 220 patients (mean [SD] age, 50.1 [14.8] years; 512 314 [68.1%] women) who received 752 150 biologic infusions (34 078 home infusions [4.5%] to 3954 patients and 718 072 facility infusions [95.5%] to 54 770 patients), patients who received home infusions were younger (mean [SD] age, 43.2 [13.2] vs 51.3 [14.8] years), more likely to be men (14 031 [41.2%] vs 225 668 [31.4%]), and had a lower Charlson comorbidity score compared with patients who received facility infusions (mean [SD] score, 0.5 [1.0] vs 1.1 [1.3]). Home infusions were associated with 25% increased odds of ED or hospital admission on the same or next day after the infusion (odds ratio [OR], 1.25; 95% CI, 1.09-1.44; P = .002) and 28% increased odds of discontinuation of the biologic after the ED or hospital admission (OR, 1.28; 95% CI, 1.08-1.51; P = .005). There was no difference in postinfusion mortality between home or facility infusions. The rates of adverse events were highest with home infusions of tocilizumab (48 of 481 infusions [10.0%]), vedolizumab (150 of 2681 infusions [5.6%]), and infliximab (1085 of 20 653 infusions [5.3%]), although the number of tocilizumab and vedolizumab infusions was low.Conclusions and relevanceIn this study, biologic infusions administered at home, compared with those administered at a facility, were associated with increased adverse events requiring escalation of care. Because the number of home infusions has increased and is expected to continue to rise, the safety implications of administering biologic infusions at home needs to be further assessed.
| S-EPMC8176330 | biostudies-literature
Project description:BackgroundSome institutions have implemented a daratumumab intravenous rapid-infusion protocol in which patients with multiple myeloma (MM) receive their third and subsequent infusions within ~ 90 min instead of ≥ 3 h.ObjectiveThis study sought to understand the utilization, effectiveness, and infusion reactions (IRs) observed in patients with MM who received daratumumab rapid infusions.MethodsElectronic medical records from Florida Cancer Specialists & Research Institute were used. Adult patients with MM who received one or more rapid daratumumab infusion (full dose in ≤ 110 min) at their third or later infusion of the first daratumumab-containing regimen (index date: 16 November 2015 to 15 March 2019) were included. IRs included events that (1) occurred ≤ 24 h post-daratumumab infusion or (2) were stated as an IR in the patient charts. Non-IR adverse events (AEs) were events attributed to daratumumab in patient charts that did not meet the IR definition.ResultsIn total, 147 patients received one or more rapid infusion in their first daratumumab-containing regimen. Median time from initial MM diagnosis to index date was 2.5 years. Non-IR AEs occurred in 10.2% of patients during treatment, and 36.7% experienced one or more IR after receiving a daratumumab infusion. No IRs occurred after a rapid infusion. The overall response rate was 91.1% (after rapid infusions only: 71.3%).ConclusionsThis study provides real-world evidence on the practice patterns of daratumumab rapid infusions in a large community-based oncology clinic system. These results suggest that treatment regimens including daratumumab rapid infusions at the third infusion or later were well-tolerated, and their effectiveness was comparable to that observed in clinical trials.
| S-EPMC8128966 | biostudies-literature
Project description:BackgroundThe administration of medication or fluids via the intravenous route is a common intervention for many hospital inpatients. However, little research has explored the safety and quality of intravenous therapy from the patient's perspective, despite the role of the patient in patient safety receiving increased attention in recent years.ObjectiveTo explore patients' perspectives on the perceived quality and safety of intravenous infusions and identify implications for practice.MethodQualitative semistructured interviews were conducted with 35 hospital patients receiving intravenous infusions in critical care, oncology day care, general medicine, and general surgery areas within 4 National Health Service hospitals in England. Data were analyzed thematically.ResultsFour underlying and interlinked themes were identified: knowledge about intravenous infusions, challenges associated with receiving intravenous infusions, the role of health-care professionals, and patients' attitudes toward receiving infusions.ConclusionsPatients were generally satisfied with receiving infusions; however, factors that contributed to decreased feelings of quality and safety were identified, suggesting areas for intervention. Issues to do with infusion pump alarms, reduced mobility, cannulation, and personal preferences for information, if given more attention, may improve patients' experiences of receiving intravenous infusions.
| S-EPMC7410139 | biostudies-literature
Project description:Venous access, a prerequisite for anesthesiological and surgical intervention in pediatric patients, is often difficult to establish and potentially painful. AV300 uses near infrared laser light to improve visibility of peripheral veins and could help cannulating them. The aim of this study was to examine if use of Accuvein(®) AV300 vein viewer could facilitate venous cannulation in children.From January to March 2011, 238 consecutive pediatric patients (0-17 years) preceding surgical interventions were included. All participants including newborns, infants and children were allocated to groups [control group (124 patients) and intervention group (114 patients)] in a non-random way. Randomization was not feasible because data was acquired retrospectively from a clinical quality management project. In control group, peripheral IV cannulation was performed without supporting device, in intervention group with support of AV300. Time and number of attempts until successful venous cannulation were defined as primary end points.Median time until successful cannulation was 2 min (range 0.1-20, quartiles: 25 %: 1; 75 %: 5) in the intervention group and 1 min (range 0.1-18, quartiles: 25 %: 0.2; 75 %: 2) in the control group (p < 0.01). Median number of attempts was higher in the intervention group (2; range 1-6, quartiles: 25 %: 1; 75 %: 3) than in the control group (1; range 1-6, quartiles: 25 %: 1; 75 %: 2, p < 0.01). Rate of cannulations successful at first attempt was 0.45 (51 of 114, 95 % CI 0.35-0.54) in the intervention group and 0.73 (90 of 124, 95 % CI 0.65-0.81) in the control group (p < 0.01).In our study we were not able to reduce neither time nor number of attempts until a successful venous cannulation in children using the vein viewer. Given certain limitations of our study as the lack of randomization and no control for inter-operator variability, the conclusions drawn from it are also limited, but by our results laser-supported cannulation cannot be recommended for standard procedures.ClinicalTrials.gov NCT01434537. Registered 29 July 2011.
| S-EPMC4576370 | biostudies-literature
Project description:Acute myeloid leukemia (AML) cells meet the higher energy, metabolic, and signaling demands of the cell by increasing mitochondrial biogenesis and mitochondrial protein translation. Blocking mitochondrial protein synthesis through genetic and chemical approaches kills human AML cells at all stages of development in vitro and in vivo. Tigecycline is an antimicrobial that we found inhibits mitochondrial protein synthesis in AML cells. Therefore, we conducted a phase 1 dose-escalation study of tigecycline administered intravenously daily 5 of 7 days for 2 weeks to patients with AML. A total of 27 adult patients with relapsed and refractory AML were enrolled in this study with 42 cycles being administered over seven dose levels (50-350 mg/day). Two patients experienced DLTs related to tigecycline at the 350 mg/day level resulting in a maximal tolerated dose of tigecycline of 300 mg as a once daily infusion. Pharmacokinetic experiments showed that tigecycline had a markedly shorter half-life in these patients than reported for noncancer patients. No significant pharmacodynamic changes or clinical responses were observed. Thus, we have defined the safety of once daily tigecycline in patients with refractory AML. Future studies should focus on schedules of the drug that permit more sustained target inhibition.
| S-EPMC5119957 | biostudies-literature
Project description:Amantadine is an antiviral drug available in oral and intravenous forms. Oral amantadine is used to treat the motor symptoms of early Parkinson's disease (PD) and to ameliorate dyskinesia in late-stage disease. However, the long-term influence of intravenous amantadine on motor symptoms and dyskinesias in PD has not been investigated. The aim of the present study was to examine the long-term effect of repeated boosts of intravenous amantadine in patients with PD with and without response fluctuations and dyskinesias. Twelve patients diagnosed with PD, six with levodopa intolerance or insufficient response to antiparkinson medications, and six with response fluctuations and dyskinesias, were treated with intravenous amantadine for 6 months: three sequential infusions over 3 days in the first month followed by five once-monthly infusions. Changes in motor function and involuntary movements were evaluated with the Unified Parkinson Disease Rating Scale (UPDRS) and Abnormal Involuntary Movement Scale (AIMS; dyskinesia group). A significant immediate improvement in motor scores was documented in both groups after amantadine infusion. However, the difference in mean UPDRS motor score from before the first infusion to after 6 months of treatment was not statistically significant. In patients with dyskinesias, there was a significant improvement in AIMS scores between the first and the last visits (6.3 ± 2.7 vs. 1.6 ± 1.3; P = 0.014). In conclusion, continuous treatment with intravenous amantadine can be useful in patients with PD for immediate relief of motor symptoms and in patients with dyskinesias for progressive reduction of involuntary movements.
| S-EPMC6853147 | biostudies-literature
Project description:BackgroundIntravenous immunoglobulin (IVIG) is a biological product with adverse effects that appears to vary considerably among different IVIG preparations.ObjectivesTo describe the adverse events of patients given intravenous immunoglobulin infusions.MethodData was collected on all patients receiving IVIG infusion at a tertiary hospital from January 2001 to December 2010. Descriptive statistics was used.Results77 patients (45 males, 32 females) received IVIG infusions. Thirty two percent (n = 25) experienced adverse reactions. The most common indication was Kawasaki disease (85.7%) followed by immunodeficiency disorders (7.8%). Majority of the patients were children, with the highest frequency of infusions among those aged 2 to 8 years old (52%). 36 infusions were associated with occurrence of adverse effects. Fever was the most common adverse event (n = 11, 30.6%), followed by rash (n = 8, 22.2%) and chills (n = 7, 19.4%). Other adverse events were cyanosis (n = 3, 8.3%), hypotension (n = 2, 5.6%), hypothermia (n = 2, 5.6%), irritability (n = 1, 2.8%), vomiting (n = 1, 2.8%), and chest pain (n = 1, 2.8%). Adverse events were observed to occur most frequently within 1 to 6 h from onset of IVIG infusion. Among the various IVIG preparations available locally (Gammagard, Kiovig, Gamimune, Veno-S & IV Globulin S), Gammagard was the brand frequently used (50.7%). It also has the most number of adverse events, with 17 out of 41 (41.5%) infusions resulting in adverse reactions. Most of the reactions occurred with fast infusion rates, and clinical manifestations subsided when the rate of infusion was reduced.ConclusionIn this study, thirty two percent of patients given IVIG infusions experienced adverse events. Fever was the most common manifestation. Symptoms occurred within 1 to 6 h from onset of infusion, were affected by fast infusion rates, and managed by reducing the rate of infusion.
| S-EPMC3826603 | biostudies-literature
Project description:AimsIntravenous (IV) iron infusions have been associated with hypophosphataemia (HP) and hypersensitivity reactions (HSRs). No studies have compared the side effects of ferric carboxymaltose (FCM) with those of isomaltoside 1000 (ISM). This study aimed to describe the occurrence of HP and HSRs following the administration of either FCM or ISM.MethodsData on 231 outpatients treated with IV iron infusions, between November 2011 and April 2014, were collected. During that period, the department made a switch from FCM to ISM and then back to FCM. Of the 231 patients, 39 received both FCM and ISM during the period. The prevalences of HP and HSRs were compared between the two drugs.ResultsWe found more HP events when FCM was given (64 vs. 9; P < 0.01). In contrast, more patients had mild HSRs when ISM was given (2.5% vs. 10.7%; P < 0.01). A comparison of the two drugs in the subpopulation who received both drug types (n = 39) revealed a difference in phosphate decrease (P < 0.01), with the most marked decrease occurring with FCM. Nine patients who had HSRs were exposed to both drugs. No potential HSR crossover between the two drugs was found.ConclusionWe found a higher risk of HP with FCM administration when compared to ISM administration. Conversely, we found a higher risk of mild HSRs with ISM administration when compared to FCM administration. The impacts of the two types of side effects should be considered when choosing an IV iron drug.
| S-EPMC5401972 | biostudies-literature
Project description:The clinical application of cytokine therapies for cancer treatment remains limited due to severe adverse reactions and insufficient therapeutic effects. Although cytokine localization by intratumoral administration could address both issues, the rapid escape of soluble cytokines from the tumor invariably subverts this effort. We find that intratumoral administration of a cytokine fused to the collagen-binding protein lumican prolongs local retention and markedly reduces systemic exposure. Combining local administration of lumican-cytokine fusions with systemic immunotherapies (tumor-targeting antibody, checkpoint blockade, cancer vaccine, or T cell therapy) improves efficacy without exacerbating toxicity in syngeneic tumor models and the BrafV600E /Ptenfl/fl genetically engineered melanoma model. Curative abscopal effects on noncytokine-injected tumors were also observed as a result of a protective and systemic CD8+ T cell response primed by local therapy. Cytokine collagen-anchoring constitutes a facile, tumor-agnostic strategy to safely potentiate otherwise marginally effective systemic immunotherapies.
| S-EPMC7811803 | biostudies-literature