scholarly journals Organ-Specific Immune-Related Adverse Events Associated With Immune Checkpoint Inhibitor Monotherapy Versus Combination Therapy in Cancer: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 10 ◽  
Author(s):  
Lijun Da ◽  
Yuanjun Teng ◽  
Na Wang ◽  
Karen Zaguirre ◽  
Yating Liu ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitor ◽  
Checkpoint Inhibitor ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Organ Specific

scholarly journals Risk of ophthalmic adverse events in patients treated with immune checkpoint inhibitor regimens: A systematic review and meta-analysis

2019 ◽  
Author(s):  
Yan-li Hou ◽  
Di-ya Wang ◽  
Ru-yue Tian ◽  
Jie-xuan Hu ◽  
Wei Wang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Combination Therapy ◽  
Adverse Events ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitor ◽  
Checkpoint Inhibitors ◽  
Meta Analysis ◽  
Randomized Controlled ◽  
Comprehensive Search ◽  
Ophthalmic Treatment

Abstract Background We performed a systematic review and meta-analysis to evaluate the risks of ophthalmic adverse events (AEs) associated with immune checkpoint inhibitors (ICIs) in patients with solid tumors.Methods Eligible studies were selected after a comprehensive search of multiple databases including phase II/III randomized controlled trials (RCTs) investigating ICIs in patients with the solid tumor. The data was analyzed by R software.Results After exclusion of ineligible studies, 21 RCTs met our strict inclusion criteria for the meta-analysis, included 11930 patients. Compared with chemotherapy, the odds ratio of all-grade ophthalmic treatment-related adverse events (trAEs) were significantly lower for PD-L1 inhibitors (OR: 0.18; 95% CI: 0.08-0.39; p<0.0001) and PD-1 inhibitors (OR 0.44, 95% CI: 0.23-0.83, p<0.050). The combination therapy of PD-1 plus CTLA-4 inhibitors significantly increased the risks of all-grade ophthalmic trAEs (OR 5.29, 95% CI: 1.59-17.57, p<0.05) and all-grade ophthalmic immune-related AEs (irAEs) ( OR: 3.67; 95%CI: 1.08-12.50; p<0.05) compared with PD-1 or CTLA-4 inhibitors monotherapy. The combination therapy of ICIs plus chemotherapy also significantly increased the risks of all-grade ophthalmic trAEs (OR, 3.44; 95%CI, 1.72-6.88; p<0.001) and all-grade ophthalmic irAEs ( OR: 3.69; 95%CI: 1.32-10.32; p<0.05) compared with chemotherapy. The risks of high-grade ophthalmic AEs had no difference in any subgroup compared with control.Conclusions Our meta-analysis demonstrated that compared with chemotherapy, PD-L1/PD-1 inhibitors had lower risks of all-grade ophthalmic trAEs and non-specific ophthalmic trAEs (NS-trAEs) but had the same risk of ophthalmic irAEs. Combination therapy of ICIs plus chemotherapy had higher risks of all-grade ophthalmic trAEs and irAEs. Compared with PD-1 or CTLA-4 inhibitors monotherapy, PD-1 plus CTLA-4 inhibitors combination therapy had significantly higher risks of all-grade ophthalmic trAEs and irAEs.

scholarly journals Role of Infliximab in Immune Checkpoint Inhibitor-Induced Pneumonitis

2020 ◽  
Vol 3 (4) ◽  
pp. 172-174
Author(s):  
Kathryn A. Lai ◽  
Ajay Sheshadri ◽  
Andres M. Adrianza ◽  
Mikel Etchegaray ◽  
Diwakar D. Balachandran ◽  
...  
Keyword(s):  
Adverse Events ◽  
Immune Checkpoint ◽  
Retrospective Cohort ◽  
Clinical Characteristics ◽  
Immune Checkpoint Inhibitor ◽  
Checkpoint Inhibitor ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Grade 3

ABSTRACT Introduction Since immune checkpoint inhibitor (ICI) blockade has become standard therapy for many cancers, immune-related adverse events (irAEs) have increased. ICI-pneumonitis is infrequent but potentially fatal. In cases not responsive to corticosteroids, additional immunosuppression is recommended. Data for use of infliximab in ≥ grade 3 pneumonitis is sparse. Materials and Methods A retrospective review of patients who received infliximab for ICI-pneumonitis from March 2016 to October 2018 was performed. Clinical characteristics were reviewed. Results Nine patients (44% women) with ≥ grade 3 pneumonitis were included. Concurrent/prior irAEs were present in 55%. Bronchoscopy was performed in 67%. Median corticosteroid dose was 1.2 mg/kg prior to infliximab, and time from administration of corticosteroids to infliximab ranged from 2 to 34 days. Four patients improved, but the remainder died. Conclusion We report improvement of ICI-pneumonitis with infliximab in 4 out of 9 patients in a small, retrospective cohort. Further prospective randomized controlled trials are needed.

Effects of Teriparatide versus Salmon Calcitonin Therapy for the Treat-ment of Osteoporosis in Asia: A Meta-analysis of Randomized Controlled Trials

2020 ◽  
Vol 20 ◽  
Author(s):  
Changjun Chen ◽  
Mohammed Alqwbani ◽  
Jie Chen ◽  
Ruitong Yang ◽  
Songgang Wang ◽  
...  
Keyword(s):  
Femoral Neck ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Salmon Calcitonin ◽  
Bone Markers ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Asian Patients ◽  
Teriparatide Treatment

Objective: The objective of this meta-analysis was to compare the efficacy and safety of teriparatide versus salmon calcitonin for the treatment of osteoporosis in Asian patients and to investigate whether the results of global studies could be applicable to Asian patients. Methods: PubMed, OVID, Cochrane Central Register of Controlled Trials (CENTRAL) and EMBASE up to December 2018 were searched. Eligible randomized controlled trials (RCTs) that compared teriparatide versus salmon calcitonin in Asian osteoporosis popula-tion were included. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used for data synthe-sis, and Cochrane Collaboration software Review Manager 5.3 was used to analyze the pooled data. Results: Three RCTs involving 529 patients were included (mean age 68.7 yr; 93.4% females; mean follow-up 6 months); outcome measures included bone mineral density (BMD) of the femoral neck, total hip and lumbar spine; bone markers and adverse events. We found that the period of 6-months of teriparatide treatment was helpful for the improvement of the BMD of lumbar vertebra, however, the improvement of BMD was not significant in femoral neck and total hip join. There was a positive correlation between bone-specific alka-line phosphatase (BSAP) and osteocalcin (OCN) and the response of Asian patients to subcutaneous injection of 20 micrograms per day of teriparatide. And the proportion of the occurrence of adverse effect was more obvious in teriparatide group compared with salmon calciton-in, but there was no significant difference. Conclusion: Results suggested that the use of teriparatide could improve the lumbar BMD by short-term (six months) application in Asian osteoporosis patients, which is beneficial to the patients who cannot tolerate adverse events of long-term treatment. The BSAP and OCN bone markers could be useful to monitor the responses of Asian osteoporosis patients to teriparatide treatment. Finally, both of teriparatide and salmon calcitonin were well tolerated by Asian patients.

scholarly journals Cardiovascular safety and efficacy of metformin-SGLT2i versus metformin-sulfonylureas in type 2 diabetes: systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Desye Gebrie ◽  
Desalegn Getnet ◽  
Tsegahun Manyazewal
Keyword(s):  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Combination Therapy ◽  
Adverse Events ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Sodium Glucose Cotransporter

AbstractDiabetes is a serious threat to global health and among the top 10 causes of death, with nearly half a billion people living with it worldwide. Treating patients with diabetes tend to become more challenging due to the progressive nature of the disease. The role and benefits of combination therapies for the management of type 2 diabetes are well-documented, while the comparative safety and efficacy among the different combination options have not been elucidated. We aimed to systematically synthesize the evidence on the comparative cardiovascular safety and efficacy of combination therapy with metformin-sodium-glucose cotransporter-2 inhibitors versus metformin-sulfonylureas in patients with type 2 diabetes. We searched MEDLINE-PubMed, Embase, Cochrane Library, and ClinicalTrials.gov up to 15 August 2019 without restriction in the year of publication. We included randomized controlled trials of patients with type 2 diabetes who were on metformin-sodium-glucose cotransporter-2 inhibitors or metformin-sulphonylureas combination therapy at least for a year. The primary endpoints were all-cause mortality and serious adverse events, and the secondary endpoints were cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, hypoglycemia, and changes in glycated hemoglobin A1c (HbA1c), body weight, fasting plasma glucose, blood pressure, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol. We used a random-effects meta-analysis model to estimate mean differences for continuous outcomes and risk ratio for dichotomous outcomes. We followed PICOS description model for defining eligibility and the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 guidelines for reporting results. Of 3,190 citations, we included nine trials involving 10,974 participants. The pooled analysis showed no significant difference in all-cause mortality (risk ration [RR] = 0.93, 95% CI [0.52, 1.67]), serious adverse events (RR = 0.96, 95% CI [0.79, 1.17]) and adverse events (RR = 1.00, 95% CI [0.99, 1.02]) between the two, but in hypoglycemia (RR = 0.13, 95% CI [0.10, 0.17], P < 0.001). Participants taking metformin-sodium glucose cotransporter-2 inhibitors showed a significantly greater reduction in HbA1c (mean difference [MD] = − 0.10%, 95% CI [− 0.17, − 0.03], body weight (MD = − 4.57 kg, 95% CI [− 4.74, − 4.39], systolic blood pressure (MD = − 4.77 mmHg, 95% CI [− 5.39, − 4.16]), diastolic blood pressure (MD = − 2.07 mmHg, 95% CI [− 2.74, − 1.40], and fasting plasma glucose (MD = − 0.55 mmol/L, 95% CI [− 0.69, − 0.41]), p < 0.001. Combination therapy of metformin and sodium-glucose cotransporter-2 inhibitors is a safe and efficacious alternative to combination therapy of metformin and sulphonylureas for patients with type 2 diabetes who are at risk of cardiovascular comorbidity. However, there remains a need for additional long-term randomized controlled trials as available studies are very limited and heterogeneous.

Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials

2022 ◽  
pp. 112972982110701
Author(s):  
Yunfeng Li ◽  
Zhenwei Shi ◽  
Yunyun Zhao ◽  
Zhanjiang Cao ◽  
Zhengli Tan
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Balloon Angioplasty ◽  
Meta Analysis ◽  
Primary Patency ◽  
Controlled Trials ◽  
Technical Success ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Drug Coated Balloon

Purpose: To compare all-cause mortality and primary patency with drug-coated balloon angioplasty (DCBA) compared with plain balloon angioplasty (PBA) in people with hemodialysis-related stenosis. Materials and methods: PubMed, Embase, and Cochrane Library databases were searched from November 1966 to February 2021 to identify randomized controlled trials (RCTs) that assessed the use of DCBA versus PBA for stenosis in hemodialysis circuits. Data extracted from the articles were integrated to determine all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), 30-day adverse events, and technical success for the two approaches. We performed meta-analysis on these results using a fixed-effects model to evaluate odds ratios (ORs) and 95% confidence intervals (CIs) where I2 < 50% in a test for heterogeneity, or a random-effect model if otherwise. Sensitivity and subgroup analyses were also performed. Results: Sixteen RCTs of 1672 individuals were included in our meta-analysis, of which 839 individuals received DCBA and 833 received PBA. The pooled outcome showed no statistical difference between DCBA and PBA in all-cause mortality at 6 months (OR = 1.29, 95% CI = 0.72–2.32, p = 0.39, I2 = 4%), 12 months (OR = 1.02, 95% CI = 0.68–1.53, p = 0.91, I2 = 0%), and 24 months (OR = 1.50, 95% CI = 0.87–2.57, p = 0.15, I2 = 0%), 30-day adverse events (OR = 1.09, 95% CI = 0.30–3.98, p = 0.90, I2 = 66%), and technical success (OR = 0.18, 95% CI = 0.02–1.92, p = 0.16, I2 = 65%). The DCBA had significantly better outcomes versus PBA in TLPP at 6 months (OR = 2.37, 95% CI = 1.84–3.04, p < 0.001, I2 = 44%) and 12 months (OR = 1.77, 95% CI = 1.22–2.56, p = 0.002, I2 = 56%), and CAPP at 6 months (OR = 2.07, 95% CI = 1.21–3.54, p = 0.008, I2 = 67%) and 12 months (OR = 1.66, 95% CI = 1.29–2.15, p < 0.001, I2 = 0%). Conclusion: In hemodialysis circuit stenosis, DCBA appears to have similar safety but greater efficacy than PBA.

scholarly journals The Effectiveness and Safety of Probiotic Supplements for Psoriasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Preclinical Trials

2021 ◽  
Vol 2021 ◽  
pp. 1-14
Author(s):  
Liuting Zeng ◽  
Ganpeng Yu ◽  
Yang Wu ◽  
Wensa Hao ◽  
Hua Chen
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Intestinal Flora ◽  
Controlled Trials ◽  
Skin Thickness ◽  
Randomized Controlled ◽  
Probiotic Treatment ◽  
Preclinical Trials

Background. Patients with psoriasis need long-term medication to control their condition. Recent studies suggest that changing the intestinal flora may be a potential treatment. Methods. The databases were utilized to search the randomized controlled trials (RCTs) and preclinical trials about probiotic supplement in the treatment of psoriasis. The retrieval time is from the establishment of these databases to December 2020. RevMan5.3 was used for the risk assessment of bias and meta-analysis. This systematic review was registered in PROSPERO (CRD42021232756). Results. A total of 3 RCTs involving 164 participants were included. Two RCTs showed that probiotics can improve PASI and thereby improve the condition. For inflammation-related indicators, only one RCT showed that probiotics can improve the levels of CRP and TNF-α but have no obvious improvement effect on IL6. One RCT demonstrated the total effective rate of probiotics in the treatment of psoriasis. For adverse events, one RCT showed that the incidence of adverse events of probiotic treatment was low. Preclinical studies showed that continuous intervention with oral probiotics can significantly improve the progression of psoriasis and reduce the expression of inflammatory factors. The meta-analysis showed that the PASI between two groups was of no statistical significance (SMD 1.83 [-0.41, 4.07], P = 0.11 ). Meanwhile, probiotics may improve skin thickness (SMD -5.87 [-11.34, -0.41], P = 0.04 ) in animal model. Conclusion. Prebiotics may have a positive effect on alleviating the clinical symptoms of psoriasis, but a large sample of RCTs is still needed to support its therapeutic effect in psoriasis.

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