scholarly journals Association of adverse events and associated cost with efficacy for approved relapsed and/or refractory multiple myeloma regimens: A Bayesian network meta‐analysis of phase 3 randomized controlled trials

Cancer ◽  
2020 ◽  
Vol 126 (12) ◽  
pp. 2791-2801 ◽  
Author(s):  
Binod Dhakal ◽  
Ravi K. Narra ◽  
Smith Giri ◽  
Aniko Szabo ◽  
Timothy L. Smunt ◽  
...  
2020 ◽  
Author(s):  
Minjie Gao ◽  
Xiao Yan ◽  
Fei Li ◽  
Kaihong Xu ◽  
Qitian Mu ◽  
...  

Abstract Background Triplet therapy has become the standard of care for relapsed or refractory multiple myeloma (RRMM) over the past few years. Prior to that, doublet therapy including dexamethasone and an immunomodulatory were standard. Several systematic studies have been conducted and many combinations with variable triplet therapies but have not always used the former standard therapy as a benchmark. The objective of this meta-analysis was to evaluate the efficacy and safety of triplet combinations that included dexamethasone and an immunomodulatory drug versus a doublet combination of just dexamethasone and an immunomodulatory for the treatment of RRMM. Methods A comprehensive literature search (PubMed, EMBASE, Cochrane Library) for phase III randomized controlled trials for efficacy and safety of triplet versus doublet combinations that specifically included dexamethasone and an immunomodulatory drug for treatment of RRMM. Efficacy (ORR, PFS, OS) and adverse events (≥ grade 3) were assessed using traditional statistical measures for aggregate data. Results Of 235 potential reports, 6 met the inclusion criteria (N = 115–792 participants). The methodological quality was ≥ 4 Jadad score for each. Triplet treatment had higher ORR (HR = 0.74, 95%CI: 0.65–0.84, P ≤ 0.001), PFS (HR = 0.63, 95%CI: 0.52–0.75, P ≤ 0.001), and OS (HR = 0.74, 95%CI: 0.65–0.84, P ≤ 0.001). The incidence of ≥ grade 3 diarrhea and fatigue were significantly higher in the triplet combination group. There was a trend toward increased incidence of ≥ grade 3 neutropenia, thrombocytopenia, thromboembolism, and peripheral neuropathy in the triplet therapy group. Notably, triplet therapy had a significantly lower rate of anemia compared to doublet therapy. Conclusions This study reinforces current guidelines and recommendations for triplet combinations containing dexamethasone and an immunomodulatory drug.


Author(s):  
Changjun Chen ◽  
Mohammed Alqwbani ◽  
Jie Chen ◽  
Ruitong Yang ◽  
Songgang Wang ◽  
...  

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.


2022 ◽  
pp. 112972982110701
Author(s):  
Yunfeng Li ◽  
Zhenwei Shi ◽  
Yunyun Zhao ◽  
Zhanjiang Cao ◽  
Zhengli Tan

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.


2021 ◽  
Vol 2021 ◽  
pp. 1-14
Author(s):  
Liuting Zeng ◽  
Ganpeng Yu ◽  
Yang Wu ◽  
Wensa Hao ◽  
Hua Chen

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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