Should foam made with physiologic gases be the standard in sclerotherapy?

2014 ◽  
Vol 30 (9) ◽  
pp. 580-586 ◽  
Author(s):  
M Wong

Objectives The aim of this paper is to look at the pros and cons of using physiologic gas to produce foam for use in sclerotherapy. With the expanding use of foam sclerotherapy, there have been increased reports of transient neurologic adverse events such as visual disturbance. Although rare, increased numbers of serious adverse events such as transient ischemic attacks (TIAs) and stroke have been described. These events are seen more often in patients who have migraine with aura and those with a right-to-left shunt. Methods A literature search of the databases Ovid and Google Scholar was performed for studies looking specifically at neurologic side effects associated with sclerotherapy and use of physiologic foams. Included studies were randomized controlled trials, meta-analyses, review articles, observational studies and case studies. Results Although physiologic gases have been shown in several studies to reduce the incidence of visual disturbance, increasing evidence from recent studies suggest endothelin, rather than gas bubbles to be the cause of these side effects. The cause of stroke and TIA has not been proven and occlusion of cerebral arterioles from gas emboli should still be considered. Many authors state that only good quality foam be injected and volumes should be kept low in an attempt to prevent these rare, but potentially serious events. Foam made with physiologic gases are more biocompatible compared to air-based foam and have been found to be at least as effective in sclerotherapy as foam made with room air. Conclusion The use of physiologic gases should be considered for those at increased risk of neurologic side effects such as migraineurs with aura and those with a known PFO. Additionally, as there are few disadvantages to the use of physiologic foam, the use of CO2 or CO2/O2 foam should be considered in all patients receiving foam sclerotherapy.

2015 ◽  
Vol 2015 ◽  
pp. 1-8
Author(s):  
Yaqin Chen ◽  
Gang Wu ◽  
Hongmin Zhang ◽  
Hua Xu ◽  
Hong Li ◽  
...  

Background. Graft reinfection with hepatitis C (HCV) after liver transplantation is a significant problem in transplant hepatology. This meta-analysis was performed to compare the effectiveness and risk of adverse events of interferon-based therapy with no treatment after liver transplantation.Methods. We searched electronic databases up to July 31, 2013, to obtain relevant research reports that satisfied the inclusion criteria. Meta-analyses were done on randomized controlled trials (RCTs) and nonrandomized trials.Results. A meta-analysis was performed on 2 RCTs and 2 cohort studies comprising a total of 326 patients (171 of whom accepted interferon-based antiviral therapy). The treatment group was found to have higher virological response (VR) rates than controls at 12, 24, 48, and 72 weeks. Patients in the antiviral group had higher sustained virological response (SVR) rates and lower mean alanine aminotransferase levels relative to controls at 48 weeks, but more total serious adverse events (AEs) than controls.Conclusions. Interferon-based treatment has some efficacy in the treatment of HCV graft reinfection following liver transplantation.


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 73-73 ◽  
Author(s):  
Raphael Brandao Moreira ◽  
Marcio Debiasi ◽  
Fernando C. Maluf ◽  
Joaquim Bellmunt ◽  
Andre Poisl Fay ◽  
...  

73 Background: Abiraterone and enzalutamide are currently approved for mCRPC patients. Both drugs have distinct mechanisms of action and may have different toxicity profile. There are limited data comparing the side effects of abiraterone and enzalutamide. We performed a meta-analysis of randomized controlled trials (RCT) to better characterize the risk of adverse events associated with both drugs. Methods: We performed a literature search on MEDLINE for studies reported from January 1966 to July 31, 2015. Abstracts presented at ASCO meetings from 2004 to 2015 were selected manually. Phase III RCT were included in analysis. We assessed the risk of adverse events reported in RCT by performing two meta-analysis: abiraterone-prednisone vs. placebo-prednisone (2,283 pts) and enzalutamide vs. placebo (2,914 pts). Summary of incidence, relative-risks (RR), and 95% confidence intervals (CI) were calculated using random-effects or fixed-effects models based on the heterogeneity of included studies. Results: Overall, enzalutamide was not associated with all-grade (RR 1.06 - 95% CI 0.67-1.65) or grade ≥3 (RR 0.81 - 95% CI 0.28-2.33) cardiovascular events, but was associated with increased risk of all-grade fatigue (RR 1.29 - 95% CI 1.15-1.44). On the other hand, abiraterone was associated with increased risk of all-grade (RR 1.28 - 95% CI 1.06-1.55) and grade ≥3 (RR 1.76 - 95% CI 1.12-2.75) cardiovascular events, but was not associated with all-grade (RR 0.85 - 95% CI 0.58-1.23) or grade ≥3 (RR 1.07 - 95% CI 0.97-1.19) fatigue. No evidence of publication bias was observed. Conclusions: In this meta-analysis, abiraterone was associated with an increased risk of cardiovascular events, while enzalutamide was associated with an increased risk of fatigue.


2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 194-194
Author(s):  
Usama Waqar ◽  
Shaheer Ahmed ◽  
Hasan Tauqeer ◽  
Masaab Zaman Khan ◽  
Kaleem Sohail Ahmed ◽  
...  

194 Background: There has been an increase in the use of minimally invasive approaches for complex cancer operations. However, its benefit has not been clearly demonstrated for esophageal cancers when compared to open procedures. The purpose of this meta-analysis was to compare operative and postoperative outcomes for partial minimally invasive esophagectomy (MIE) versus open esophagectomy (OE) for patients with esophageal carcinoma. Methods: We conducted a systematic review using CENTRAL, PubMed, Global Index Medicus, ClinicalTrials.gov, EU Clinical Trials Register, and WHO ICTRP until August 30, 2020 without restrictions on publication date, language, or publication status. We included randomized controlled trials evaluating MIEs and partial MIEs including laparoscopic approach with OE for esophageal cancer. All trials including any one of our primary outcome measures -mortality and morbidity- were included. Two authors assessed trials for inclusion. Meta-analyses were conducted for categorical outcomes when heterogeneity was low ( I2< 50%). We reported risk ratios with 95% confidence intervals and GRADE quality of evidence based on our risk of bias assessment. Results: Of 5638 retrieved studies, 10 studies representing 6 trials consisting of 951 patients were included. 347 underwent partial MIE, 106 total MIE, and 498 OE. These were categorized into four cohorts:Co-A: Partial MIE versus OE (4 trials); Co-B: Partial MIE with thoracotomy versus OE (2 trials); Co-C: Partial MIE with cervical incision versus OE (2 trials); Co-D: Complete MIE versus OE (2 trials). Co-A revealed that partial MIE was associated with lower risk of serious adverse events (0.54[0.36-0.83]; 3 trials; 471 participants; I2= 48%), with specifically lower rates of delayed gastric emptying (0.32[0.13-0.80]; 3 trials; 666 participants; I2= 0%), pulmonary complications (0.49[0.29-0.84]; 3 trials; 471 participants; I2= 27%), and mortality (0.67[0.54-0.83]; 4 trials; 692 participants; I2= 0%). Co-B revealed that partial MIE with thoracotomy was associated with lower risk of pulmonary complications (0.61[0.38-0.99]; 2 trials; 231 participants; I2= 0%) and mortality (0.66[0.50-0.87]; 2 trials; 231 participants; I2= 0%). Co-C revealed that partial MIE with cervical incisions were associated with lower risk of serious adverse events (0.38[0.22-0.64]; 1 trial; 240 participants), including pulmonary complications (0.29[0.13-0.65]); 1 trial; 240 participants) and mortality (0.68[0.50-0.94]; 2 trials; 461 participants). Co-D revealed no significant differences between MIE and OE. All significant findings reported originated from high-quality evidence. Conclusions: When compared with completely open esophagectomy, partial MIE is associated with lower risk of mortality and serious adverse events, especially delayed gastric emptying and pulmonary complications.


2020 ◽  
Vol 32 (S1) ◽  
pp. 132-132
Author(s):  
Liliana P. Ferreira ◽  
Núria Santos ◽  
Nuno Fernandes ◽  
Carla Ferreira

Objectives: Alzheimer's disease (AD) is the most common cause of dementia and it is associated with increased mortality. The use of antipsychotics is common among the elderly, especially in those with dementia. Evidence suggests an increased risk of mortality associated with antipsychotic use. Despite the short-term benefit of antipsychotic treatment to reduce the behavioral and psychological symptoms of dementia, it increases the risk of mortality in patients with AD. Our aim is to discuss the findings from the literature about risk of mortality associated with the use of antipsychotics in AD.Methods: We searched Internet databases indexed at MEDLINE using following MeSH terms: "Antipsychotic Agents" AND "Alzheimer Disease" OR "Dementia" AND "Mortality" and selected articles published in the last 5 years.Results: Antipsychotics are widely used in the pharmacological treatment of agitation and aggression in elderly patients with AD, but their benefit is limited. Serious adverse events associated with antipsychotics include increased risk of death. The risk of mortality is associated with both typical and atypical antipsychotics. Antipsychotic polypharmacy is associated with a higher mortality risk than monotherapy and should be avoided. The mortality risk increases after the first few days of treatment, gradually reducing but continues to increase after two years of treatment. Haloperidol is associated with a higher mortality risk and quetiapine with a lower risk than risperidone.Conclusions: If the use of antipsychotics is considered necessary, the lowest effective dose should be chosen and the duration should be limited because the mortality risk remains high with long-term use. The risk / benefit should be considered when choosing the antipsychotic. Further studies on the efficacy and risk of adverse events with antipsychotics are needed for a better choice of treatment and adequate monitoring with risk reduction.


2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i7-i11
Author(s):  
P Hanlon ◽  
E Butterly ◽  
J Lewsey ◽  
S Siebert ◽  
F S Mair ◽  
...  

Abstract Introduction Frailty is common in clinical practice, but trials rarely report on participant frailty. Consequently, clinicians and guideline-developers assume frailty is largely absent from trials and have questioned the relevance of trial findings to frail people. Therefore, we examined frailty in phase 3/4 industry-sponsored clinical trials of pharmacological interventions for three exemplar conditions: type 2 diabetes mellitus (T2DM), rheumatoid arthritis (RA), and chronic obstructive pulmonary disease (COPD). Methods We constructed a 40-item frailty index (FI) in 19 clinical trials (7 T2DM, 8 RA, 4 COPD, mean age 42–65 years) using individual-level participant data. Participants with a FI &gt;0.24 were considered “frail”. Baseline disease severity was assessed using HbA1c for T2DM, Disease Activity Score-28 (DAS28) for RA, and % predicted FEV1 for COPD. Using generalised gamma regression, we modelled FI on age, sex and disease severity. In negative binomial regression we modelled serious adverse event rates on FI, and combined results for each index condition in a random-effects meta-analysis. Results All trials included frail participants: prevalence 7–21% in T2DM trials, 33–73% in RA trials, and 15–22% in COPD trials. Increased disease severity and female sex were associated with higher FI in all trials. Frailty was associated with age in T2DM and RA trials, but not in COPD. Across all trials, and after adjusting for age, sex, and disease severity, higher FI predicted increased risk of serious adverse events; the pooled incidence rate ratios (per 0.1-point increase in FI scale) were 1.46 (95% CI 1.21–1.75), 1.45 (1.13–1.87) and 1.99 (1.43–2.76) for T2DM, RA and COPD, respectively. Conclusion Frailty is identifiable and prevalent among middle aged and older participants in phase 3/4 drug trials and has clinically important safety implications. Trial data may be harnessed to better understand chronic disease management in people living with frailty.


2020 ◽  
Author(s):  
Yuan Lu ◽  
Yu Yang ◽  
Yong Fan ◽  
Chenzong Li ◽  
Min Zhang ◽  
...  

Abstract Background Sodium-glucose cotransporter-2 inhibitors (SGLT-2i) are significantly effective in reducing cardiovascular events in patients with type 2 diabetes mellitus (T2DM). However, the magnitude of the effect of SGLT-2i on cardiovascular outcomes in established heart failure (HF) patients with T2DM remains undefined. Methods We systematically searched the PubMed, Embase, Cochrane Central and Web of Science databases for articles published prior to 09 April 2020 to identify randomized controlled trials that compared SGLT-2i with placebo in patients with heart failure concomitant with T2DM. Efficacy outcomes included the composite of cardiovascular death (CVD) or hospitalization for heart failure (HHF), individual CVD, individual HHF, and all-cause mortality (ACM). Hazard ratios (HRs) with 95% confidence intervals (95% CIs) were pooled across trials by using the generic inverse variance method. Sensitivity analyses were conducted by excluding specific studies or using risk ratios (RRs) with 95% CIs as measures of the effect size. Serious adverse events served as safety outcomes. Results A total of 5 large trials comprising 6945 patients with HF and T2DM were enrolled. Pooled data demonstrated that SGLT-2i significantly reduced the risk for the primary composite outcome of CVD or HHF by 13% (HR: 0.87, 95% CI: 0.83–0.91, I2: 0%, P < 0.00001) in patients with HF concomitant with T2DM. Similarly, the use of SGLT-2i was associated with a statistically significant 14% reduction in HHF (pooled HR: 0.86, 95% CI: 0.81–0.91, I2: 0%, P < 0.00001) and a 10% reduction in ACM (pooled HR: 0.90, 95% CI: 0.86–0.96, I2: 16%, P < 0.0005) but was not significantly associated with a reduction in CVD (HR: 0.91, 95% CI: 0.81–1.02, I2: 60%, P = 0.11). Sensitivity analyses indicted consistent results. Compared with placebo plus standard care, the SGLT-2i group had a lower proportion of serious adverse events (weighted proportions: 44.3% vs 50.3%; RR 0.88, 95% CI 0.82–0.95, I2: 22%, p = 0∙006). Conclusions SGLT-2i significantly reduced the risk of HHF and ACM in a broad range of HF patients concomitant with T2DM. Compared with standard care, SGLT-2i plus standard therapy was associated with a reduction in serious adverse events.


2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Laanani ◽  
A Weill ◽  
P O Blotière ◽  
J Pouchot ◽  
F Carbonnel ◽  
...  

Abstract Background More than one million colonoscopies are performed every year in France. They are associated with risks of mechanical and systemic serious adverse events (SAEs) which can be associated with patient, procedure, endoscopist, and facility characteristics. We tried to identify the factors associated with colonic perforation, gastrointestinal bleeding, splenic injury, shock, myocardial infarction, stroke, pulmonary embolism, acute renal failure, and urolithiasis after colonoscopy. Methods We analysed data from the French national claims databases (SNDS). A total of 4,088,799 patients, 30 years or older, undergoing a first screening or diagnostic colonoscopy between 2010 and 2015 were identified. SAE rates were estimated, and risk factors associated with SAEs were identified using multilevel logistic regression models, adjusted for patient, colonoscopy, endoscopist, and facility characteristics. Results Increasing age was associated with an increasing incidence of mechanical and systemic SAEs. Cancer and cardiovascular comorbidities were associated with mechanical SAEs, and a higher number of pre-existing conditions was associated with shock and acute renal failure. Polypectomy, especially of polyps larger than 1 cm, was associated with an increased risk of perforation (OR = 4.1; 95% CI, 3.4-5.0) and bleeding (OR = 13.3; 95% CI, 11.7-15.1). Mechanical SAEs were associated with the endoscopist’s experience, while systemic SAEs were more frequent in public hospitals than in private clinics. Conclusions SAEs related to colonoscopy were more frequent in older patients and in those with comorbidities. Mechanical SAEs were more frequent when colonoscopy was performed by less experienced endoscopists. Systemic SAEs were more frequent in public hospitals, reflecting patient selection processes. The risk of both mechanical and systemic SAEs should be taken into account when deciding to perform colonoscopy, particularly in older patients with multiple pre-existing conditions. Key messages Systemic SAEs are not uncommon after colonoscopy and, together with intestinal SAEs, should be considered when considering the need for colonoscopy. Patients at risk of SAEs should be identified and colonoscopy should be performed by experienced endoscopists in these patients. Less invasive alternatives should also be considered in these patients.


2018 ◽  
Vol 89 (7) ◽  
pp. 741-753 ◽  
Author(s):  
Emily Stockings ◽  
Dino Zagic ◽  
Gabrielle Campbell ◽  
Megan Weier ◽  
Wayne D Hall ◽  
...  

Review evidence for cannabinoids as adjunctive treatments for treatment-resistant epilepsy. Systematic search of Medline, Embase and PsycINFO was conducted in October 2017. Outcomes were: 50%+ seizure reduction, complete seizure freedom; improved quality of life (QoL). Tolerability/safety were assessed by study withdrawals, adverse events (AEs) and serious adverse events (SAEs). Analyses were conducted in Stata V.15.0. 36 studies were identified: 6 randomised controlled trials (RCTs), 30 observational studies. Mean age of participants was 16.1 years (range 0.5–55 years). Cannabidiol (CBD) 20 mg/kg/day was more effective than placebo at reducing seizure frequency by 50%+(relative risk (RR) 1.74, 95% CI 1.24 to 2.43, 2 RCTs, 291 patients, low Grades of Recommendation, Assessment, Development and Evaluation (GRADE) rating). The number needed to treat for one person using CBD to experience 50%+ seizure reduction was 8 (95% CI 6 to 17). CBD was more effective than placebo at achieving complete seizure freedom (RR 6.17, 95% CI 1.50 to 25.32, 3 RCTs, 306 patients, low GRADE rating), and improving QoL (RR 1.73, 95% CI 1.33 to 2.26), however increased risk of AEs (RR 1.24, 95% CI 1.13 to 1.36) and SAEs (RR 2.55, 95% CI 1.48 to 4.38). Pooled across 17 observational studies, 48.5% (95% CI 39.0% to 58.1%) of patients reported 50%+ reductions in seizures; in 14 observational studies 8.5% (95% CI 3.8% to 14.5%) were seizure-free. Twelve observational studies reported improved QoL (55.8%, 95% CI 40.5 to 70.6); 50.6% (95% CI 31.7 to 69.4) AEs and 2.2% (95% CI 0 to 7.9) SAEs. Pharmaceutical-grade CBD as adjuvant treatment in paediatric-onset drug-resistant epilepsy may reduce seizure frequency. Existing RCT evidence is mostly in paediatric samples with rare and severe epilepsy syndromes; RCTs examining other syndromes and cannabinoids are needed.PROSPERO registration numberCRD42017055412.


2013 ◽  
Vol 22 (3) ◽  
pp. 223-233 ◽  
Author(s):  
F. Cheng ◽  
P. B. Jones

Aims.The introduction of second generation antipsychotic (SGA) medication over a decade ago led to changes in prescribing practices; these drugs have eclipsed their predecessors as treatments for schizophrenia. However, the metabolic side effects of these newer antipsychotics have been marked and there are increasing concerns as to whether these novel drugs really are superior to their predecessors in terms of the balance between risks and benefits. In this article, we review the literature regarding comparisons between first generation antipsychotic (FGA) and SGA in terms of clinical effectiveness.Methods.Large (n > 150) randomized-controlled trials (RCTs) comparing the effectiveness (efficacy and side effects) of FGA and SGA medications other than clozapine were reviewed, as were meta-analyses that included smaller studies.Results.The superiority in efficacy and reduced extrapyramidal side effects (EPSE) of SGAs is modest, especially when compared with low-dose FGAs. However, the high risk of weight gain and other metabolic disturbances associated with certain SGAs such as olanzapine is markedly higher than the risk with FGAs at the doses used in the trials.Conclusions.The efficacy profiles of various FGAs and SGAs are relatively similar, but their side effects vary between and within classes. Overall, large pragmatic trials of clinical effectiveness indicate that the care used in prescribing and managing drug treatments to ensure tolerability may be more important than the class of drug used.


2010 ◽  
Vol 16a (2) ◽  
pp. 62-68
Author(s):  
Tina Bhutani ◽  
Kristine Busse

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.


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