Efficacy and safety profiles of mechanical and pharmacological thromboprophylaxis.
Ontology highlight
ABSTRACT:
SUBMITTER: Ganau M
PROVIDER: S-EPMC6789350 | biostudies-literature | 2019 Sep
REPOSITORIES: biostudies-literature
Publications
Efficacy and safety profiles of mechanical and pharmacological thromboprophylaxis.
Ganau Mario M Ligarotti Gianfranco K I GKI Meloni Marco M Chibbaro Salvatore S
Annals of translational medicine 20190901 Suppl 6
Similar Datasets
Project description:Thromboprophylaxis for venous thromboembolism is widely used in critically ill patients. However, only limited evidence exists regarding the efficacy and safety of the various thromboprophylaxis techniques, especially mechanical thromboprophylaxis. Therefore, we performed meta-analysis of randomized controlled trials (RCTs) that compared the overall incidence of deep vein thrombosis (DVT) for between unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), and intermittent pneumatic compression (IPC) in critically ill patients. A Bayesian random effects model for multiple treatment comparisons was constructed. The primary outcome measure was the overall incidence of DVT at the longest follow-up. The secondary outcome measure was the incidence of major bleeding, as defined by the original trials. Our analysis included 8,622 patients from 12 RCTs. The incidence of DVT was significantly lower in patients treated with UFH (OR, 0.45; 95% CrI, 0.22-0.83) or LMWH (OR, 0.38; 95% CrI, 0.18-0.72) than in patients in the control group. IPC was associated with a reduced incidence of DVT compared to the control group, but the effect was not statistically significant (OR, 0.50; 95% CrI, 0.20-1.23). The risk of DVT was similar for patients treated with UFH and LMWH (OR, 1.16; 95% CrI, 0.68-2.11). The risk of major bleeding was similar between the treatment groups in medical critically ill patients and also in critically ill patients with a high risk of bleeding. In critically ill patients, the efficacy of mechanical thromboprophylaxis in reducing the risk of DVT is not as robust as those of pharmacological thromboprophylaxis.
| S-EPMC5056218 | biostudies-literature
Project description:Obesity increases the risk for venous thromboembolism (VTE), but whether high-dose thromboprophylaxis is safe and effective in morbidly obese inpatients is unknown. It was the objective of this study to quantify the efficacy and safety of high-dose thromboprophylaxis with heparin or enoxaparin in inpatients with weight >?100 kilograms (kg) within the BJC HealthCare system. Ina retrospective cohort study, we analysed 9,241 inpatients with weight >?100 kg discharged from three hospitals in the BJC HealthCare system from 2010 through 2012. We compared the incidence of VTE in patients who received high-dose thromboprophylaxis (heparin 7,500 units three times daily or enoxaparin 40 mg twice daily) to those who received standard doses (heparin 5,000 units two or three times daily or enoxaparin 40 mg once daily). The primary efficacy outcome was hospital-acquired VTE identified by International Classification of Diseases (ICD)-9 diagnosis codes. The primary safety outcome was bleeding events identified by ICD-9 codes. Among the 3,928 morbidly obese inpatients (weight >?100 kg and body mass index [BMI] ? 40 kg/m²), high-dose thromboprophylaxis approximately halved the odds of symptomatic VTE (odds ratio [OR] 0.52, 95% confidence interval [CI] 0.27-1.00; p = 0.050). The rate of VTE was 1.48% (35/2,369) in these morbidly obese inpatients who received standard doses of thromboprophylaxis, compared to 0.77% (12/1,559) in those who received high doses. High-dose thromboprophylaxis did not increase bleeding (OR 0.84, 95% CI 0.66-1.07, p = 0.15). Independent predictors of VTE were surgery, male sex, cancer, and BMI. In conclusion, high-dose thromboprophylaxis nearly halves the rate of VTE in morbidly obese inpatients.
| S-EPMC4505726 | biostudies-literature
Project description:BackgroundThrombosis is a common complication in patients with cancer. Whether thromboprophylaxis could benefit patients with cancer is unclear. The aim of this systematic review was to determine the efficacy and safety of thromboprophylaxis in patients with cancer undergoing surgery or chemotherapy.MethodsWe searched the Cochrane Library, EMBASE, MEDLINE, EBSCOhost, and Web of Science for studies published before May 2018 to investigate whether thromboprophylaxis measures were more effective than a placebo in patients with cancer.ResultsIn total, 33 trials with 11,942 patients with cancer were identified. In patients with cancer undergoing surgery, the administration of thromboprophylaxis was associated with decreasing trends in venous thromboembolism (VTE) [relative risk (RR) 0.51, 95% confidence interval (CI) 0.32-0.81] and DVT (RR 0.53, 95% CI 0.33-0.87). In patients with cancer undergoing chemotherapy, the administration of thromboprophylaxis reduced the incidences of VTE, DVT, and pulmonary embolism compared with no thromboprophylaxis (RR 0.54, 95% CI 0.40-0.73; RR 0.47, 95% CI 0.31-0.73; RR 0.51, 95% CI 0.32-0.81, respectively). The pooled results regarding major bleeding showed no significant difference between prophylaxis and no prophylaxis in either the surgical or the chemotherapy groups (RR 2.35, 95% CI 0.74-7.52, p = 0.1482, I2 = 0%; RR 1.30, 95% CI 0.93-1.83, p = 0.1274, I2 = 0%, respectively).ConclusionThromboprophylaxis did not increase major bleeding events or the incidence of thrombocytopenia. All-cause mortality was not significantly different between those who received thromboprophylaxis and those who did not. This meta-analysis provides evidence that thromboprophylaxis can reduce the number of VTE and DVT events, with no apparent increase in the incidence of major bleeding in patients with cancer.
| S-EPMC7081475 | biostudies-literature
Project description:BACKGROUND:Lymphangioleiomyomatosis (LAM) is a rare, low-grade multisystem neoplastic disease. Most LAM patients are at a high risk of losing lung function at an accelerated rate and developing progressive dyspnea. Recently, several studies have reported their experience with pharmacological treatments for LAM. Therefore, we conducted a systematic review and meta-analysis to assess the efficacy and safety of these therapies. METHODS:PubMed (Medline), EMBASE, Cochrane Library, Web of Science and EBSCO Host were searched (until March 31, 2019) for eligible prospective studies regarding LAM patients treated with pharmacological treatments. Random effect models were used for quantitative analysis. RESULTS:Fourteen prospective studies regarding five pharmacological treatments (including sirolimus, everolimus, doxycycline, triptorelin, and a combination therapy of sirolimus and hydroxychloroquine) were enrolled in our systematic review, and ten of them were used for the meta-analysis. Seven prospective studies reported that sirolimus was effective at improving or stabilizing lung function and alleviating renal angiomyolipoma (AML) in LAM patients. Subsequent quantitative analyses showed that during sirolimus treatment, the pooled values of lung function and 6-min walk distance (6MWD) were not significantly changed (P > 0.05), with the pooled response rate of AML being 0.62 (95% confidence intervals [CIs]: 0.43 to 0.82, I2 = 65%). Regarding everolimus, three prospective studies reported similar effects to those of sirolimus with regard to preserving lung function and reducing AMLs. The meta-analysis showed that the changes in lung function during everolimus treatment were not statistically significant (P > 0.05), while the pooled response rate of AML was 0.78 (95% CI: 0.68 to 0.88, I2 = 8%). Neither the qualitative nor the quantitative results confirmed the benefits of doxycycline or triptorelin treatment, and the effects of the combination therapy were unclear in LAM patients. Most of the adverse events during pharmacological treatments were low or moderate grade and tolerable. CONCLUSIONS:Overall, sirolimus and everolimus were recommended for the treatment of LAM because they could stabilize lung function and alleviate renal AML. Doxycycline and triptorelin were not recommended for the treatment of LAM because no beneficial outcomes were consistently observed. The efficacy and safety of combination therapy remain to be further explored.
| S-EPMC7023761 | biostudies-literature
Project description:OBJECTIVE:Our purpose is to evaluate the efficacy and safety of pharmacologic thromboprophylaxis following caesarean section (CS). METHODS:We searched PubMed, Embase, and the Cochrane Library. Then the systematic review was performed by analysing studies that met the eligibility criteria. RESULTS:Seven studies with 1243 participants were included, including 6 RCTs and 1 prospective cohort. Results from the meta-analysis showed that low molecular weight heparin (LMWH) was associated with no obvious decrease in the risk of thrombus compared with UHF and negative control. However, LMWH was observed to be associated with a definite increase in the risk of bleeding or haematomas in comparison to negative control (RR: 8.47, CI: 1.52-47.11). CONCLUSION:According to current evidences, the efficacy of pharmacologic thromboprophylaxis which increases the risk of bleeding or hematomas remains controversial.
| S-EPMC6287903 | biostudies-literature
Project description:ImportanceVenous thromboembolism (VTE) is a leading cause of morbidity and mortality after bariatric surgery. Clinical end point studies on thromboprophylaxis with direct oral anticoagulants in patients undergoing bariatric surgery are lacking.ObjectiveTo assess the efficacy and safety of a prophylactic dose of 10 mg/d of rivaroxaban for both 7 and 28 days after bariatric surgery.Design, setting, and participantsThis assessor-blinded, phase 2, multicenter randomized clinical trial was conducted from July 1, 2018, through June 30, 2021, with participants from 3 academic and nonacademic hospitals in Switzerland.InterventionPatients were randomized 1 day after bariatric surgery to 10 mg of oral rivaroxaban for either 7 days (short prophylaxis) or 28 days (long prophylaxis).Main outcomes and measuresThe primary efficacy outcome was the composite of deep vein thrombosis (symptomatic or asymptomatic) and pulmonary embolism within 28 days after bariatric surgery. Main safety outcomes included major bleeding, clinically relevant nonmajor bleeding, and mortality.ResultsOf 300 patients, 272 (mean [SD] age, 40.0 [12.1] years; 216 women [80.3%]; mean body mass index, 42.2) were randomized; 134 received a 7-day and 135 a 28-day VTE prophylaxis course with rivaroxaban. Only 1 thromboembolic event (0.4%) occurred (asymptomatic thrombosis in a patient undergoing sleeve gastrectomy with extended prophylaxis). Major or clinically relevant nonmajor bleeding events were observed in 5 patients (1.9%): 2 in the short prophylaxis group and 3 in the long prophylaxis group. Clinically nonsignificant bleeding events were observed in 10 patients (3.7%): 3 in the short prophylaxis arm and 7 in the long prophylaxis arm.Conclusions and relevanceIn this randomized clinical trial, once-daily VTE prophylaxis with 10 mg of rivaroxaban was effective and safe in the early postoperative phase after bariatric surgery in both the short and long prophylaxis groups.Trial registrationClinicalTrials.gov Identifier: NCT03522259.
| S-EPMC10214035 | biostudies-literature
Project description:Objective To evaluate the cost-effectiveness of using mechanical thromboprophylaxis for patients undergoing a cesarean delivery in Brazil. Methods A decision-analytic model built in TreeAge software was used to compare the cost and effectiveness of intermittent pneumatic compression to prophylaxis with low-molecular-weight heparin or no prophylaxis from the perspective of the hospital. Related adverse events were venous thromboembolism, minor bleeding, and major bleeding. Model data were sourced from peer-reviewed studies through a structured literature search. A willingness-to-pay threshold of R$15,000 per avoided adverse event was adopted. Scenario, one-way, and probabilistic sensitivity analyses were performed to evaluate the impact of uncertainties on the results. Results The costs of care related to venous thromboembolism prophylaxis and associated adverse events ranged from R$914 for no prophylaxis to R$1,301 for low-molecular-weight heparin. With an incremental cost-effectiveness ratio of R$7,843 per adverse event avoided. Intermittent pneumatic compression was cost-effective compared to no prophylaxis. With lower costs and improved effectiveness, intermittent pneumatic compression dominated low-molecular-weight heparin. The probabilistic sensitivity analyses showed that the probability of being cost-effective was comparable for intermittent pneumatic compression and no prophylaxis, with low-molecular-weight heparin unlikely to be considered cost-effective (0.07). Conclusions Intermittent pneumatic compression could be a cost-effective option and is likely to be more appropriate than low-molecular-weight heparin when used for venous thromboembolism prophylaxis for cesarean delivery in Brazil. Use of thromboprophylaxis should be a risk-stratified, individualized approach.
| S-EPMC10309987 | biostudies-literature
Project description:Chagas disease remains a neglected tropical disease, causing significant burden in the Americas and countries that receive immigrants from endemic nations. Current pharmaceutical treatments are suboptimal, not only varying drastically in efficacy, depending on the stage of disease, but also presenting significant risk of adverse events. The objective of this review is to provide a timely update on the efficacy and safety of current trypanocidals. Eligible studies published from January 2015 to December 2020 were retrieved by one reviewer from six electronic databases. Ana-lysis was done with review management software and risk of bias was assessed using tools appropriate for the type of study (i.e., experimental or observational). Thirteen studies (10 observational and three RCTs) were included in the analysis. All 13 studies tested Benznidazole (BNZ) or Nifurtimox (NFX), and two studies also tested Posaconazole (POS) or E1224 (Ravucanazole). BNZ was found to be the most efficacious trypanocidal drug compared to Nifurtimox, POS, and E1224; it also resulted in the highest percentage of adverse effects (AEs) and treatment discontinuation due to its toxicity. Adults experienced higher frequency of neurological AEs while taking BNZ or NFX compared to children. Children had a higher frequency of general AEs compared to adults while taking BNZ. Overall, BNZ is still the most efficacious, but development of new, less toxic drugs is paramount for the quality of life of patients. Studies testing combination therapies and shorter regimens are needed, as is the devising of better clinical parameters and laboratory biomarkers to evaluate treatment efficacy. Considering the variability in methodology and reporting of the studies included in the present analysis, we offer some recommendations for the improvement and replicability of clinical studies investigating pharmacological treatment of Chagas disease. These include full disclosure of methodology, standardization of outcome measures, and always collecting and reporting data on both the efficacy of trypanocidals and on safety outcomes.
| S-EPMC8293415 | biostudies-literature
Project description:Background: Given their changing pathophysiology, elderly patients carry a high risk of embolism and bleeding events; hence, use of appropriate anticoagulants is very important. Low molecular weight heparin (LMWH) is one of the most widely used anticoagulants although LMWHs differ in their anti-Xa, antithrombin, and anticoagulant activities. To date, no study has directly compared the safety and efficacy of different LMWHs in the elderly. We aimed to compare such differences by conducting a network meta-analysis. Methods: We searched the Pubmed, Embase, and Cochrane databases for randomized controlled trials (RCTs) of LMWHs that included patients ≥60 years old up to July 22, 2020. Safety outcomes included venous thromboembolism (VTE) or VTE-related death, deep thrombus embolism, and pulmonary embolism. Safety outcomes were clinically relevant bleeding, major bleeding, minor bleeding, and all-cause death. We calculated relative ratios (RR) and 95% confidence intervals (CI) for all outcomes. The cumulative ranking probabilities (SUCRA) were conducted to rank the comparative effects and safety of all LMWHs. Results: We included 27 RCTs (30,441 elderly), comprising five LMWHs. LMWH was more effective than placebo in preventing VTE or VTE-related death (RR 0.36, 95% CI 0.25-0.53) but less effective than a novel oral anticoagulant (RR 1.59, 95% CI 1.33-1.91) and safer than acenocoumarol regarding risk of clinically relevant bleeding (RR 0.67, 95% CI 0.49-0.90). However, indirect comparison of efficacy and safety of the five LMWHs showed no significant difference in our network analysis, and the subgroup analyses (such as in patients with deep venous thrombosis, cardiac disease, or age >65 years old) supported the results. The SUCRA showed that tinzaparin performed best in preventing VTE or VTE-related death (SUCRA 68.8%, cumulative probability 42.3%) and all-cause death (SUCRA 84.2%, cumulative probability 40.7%), whereas nadroparin was predominant in decreasing the risk of clinically relevant bleeding (SUCRA 84.8%, cumulative probability 77.0%). Conclusions: On present evidence, there are no significant differences in the efficacy and safety of different LMWHs for the elderly. According to the rank probability analysis, nadroparin seems to be safer for the elderly with a high risk of bleeding, whereas tinzaparin is more effective for those with low bleeding risk.
| S-EPMC8703065 | biostudies-literature
Project description:17 patients with myelofibrosis contributed paired research samples; the time points were pre-study and 12 weeks after commencing study treatment with CYT387.Gene expression analysis was investigated to study the effects of drug treatment. Additional analysis invesitigated differences in expression patterns in groups of anemia responders and non-responders following drug treatment. 34 samples representing 17 patients. Each patient submitted 1 pre-treatment sample and 1 post 12 weeks of treatment.
2013-01-14 | E-GEOD-40841 | biostudies-arrayexpress