scholarly journals Safety of Denosumab Versus Zoledronic Acid in Patients with Bone-related Diseases A Systematic Review and Meta-analysis

Author(s):  
Wenhao Luo ◽  
Ye Li

IntroductionBoth Dmab and ZA have been widely used in the prevention and treatment of bone-related diseases, while which drug is an optimal treatment in terms of safety and efficacy remains controversial.Material and methodsPubMed, Embase, Web of Science, the Cochrane Central Library, and ClinicalTrials.gov were systematically searched up to 1st January 2021, and were evaluated by Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. Randomized controlled trials comparing Dmab versus ZA in patients with bone-related diseases were included.ResultsA total of 13 studies involving 21042 participants were included. The incidence of total adverse events was significantly lower in patients receiving Dmab treatment than in those undergoing ZA treatment(OR= 0.84, 95% CI = 0.75–0.94, P = 0.003). 9 trials comparing Dmab with ZA further showed that Dmab was significantly better than ZA in controlling serious adverse events (OR = 0.91, 95% CI = 0.85–0.99, P = 0.02). Compared to ZA, Dmab was correlated with a lower incidence of skeletal-related events (OR = 0.77, 95% CI = 0.70–0.85, P = 0.00001). However, no significant difference was found in the rate of infection events between Dmab and ZA (OR = 1.06, 95% CI = 0.93–1.20, P =0.39).ConclusionsThis study demonstrated superiority of Dmab over ZA in treating bone-related diseases in terms of safety and efficacy.

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Desye Gebrie ◽  
Desalegn Getnet ◽  
Tsegahun Manyazewal

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.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Bahman Amani ◽  
Ahmad Khanijahani ◽  
Behnam Amani

AbstractThe efficacy and safety of Hydroxychloroquine (HCQ) in treating coronavirus disease (COVID-19) is disputed. This systematic review and meta-analysis aimed to examine the efficacy and safety of HCQ in addition to standard of care (SOC) in COVID-19. PubMed, the Cochrane Library, Embase, Web of sciences, and medRxiv were searched up to March 15, 2021. Clinical studies registry databases were also searched for identifying potential clinical trials. The references list of the key studies was reviewed to identify additional relevant resources. The quality of the included studies was evaluated using the Cochrane Collaboration tool and Jadad checklist. Meta-analysis was performed using RevMan software (version 5.3). Eleven randomized controlled trials with a total number of 8161 patients were identified as eligible for meta-analysis. No significant differences were observed between the two treatment groups in terms of negative rate of polymerase chain reaction (PCR) (Risk ratio [RR]: 0.99, 95% confidence interval (CI) 0.90, 1.08; P = 0.76), PCR negative conversion time (Mean difference [MD]: − 1.06, 95% CI − 3.10, 0.97; P = 0.30), all-cause mortality (RR: 1.09, 95% CI 1.00, 1.20; P = 0.06), body temperature recovery time (MD: − 0.64, 95% CI − 1.37, 0.10; P = 0.09), length of hospital stay (MD: − 0.17, 95% CI − 0.80, 0.46; P = 0.59), use of mechanical ventilation (RR: 1.12, 95% CI 0.95, 1.32; P = 0.19), and disease progression (RR = 0.82, 95% CI 0.37, 1.85; P = 0.64). However, there was a significant difference between two groups regarding adverse events (RR: 1.81, 95% CI 1.36, 2.42; P < 0.05). The findings suggest that the addition of HCQ to SOC has no benefit in the treatment of hospitalized patients with COVID-19. Additionally, it is associated with more adverse events.


PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0254405
Author(s):  
Yingying Peng ◽  
Zhe Chen ◽  
Yanjiao Li ◽  
Qiu Lu ◽  
Huanmin Li ◽  
...  

Background Mycoplasma pneumoniae is one of the main causes of community-acquired pneumonia. Due to the imperfect immune system of children, this also causes Mycoplasma pneumoniae pneumonia (MPP) to be more common in children. Globally, the incidence of MPP in children is gradually increasing. This study was the first to systematically review the clinical efficacy and safety of Shuanghuanglian (SHL) oral preparations combined with azithromycin in the treatment of MPP in children. Methods This study fully retrieved 3 Chinese databases and 5 English databases to search the randomized controlled trials (RCTs) of SHL oral preparations combined with azithromycin in the treatment of children with MPP. The search time is from the inception to September 2020. Data extraction and risk bias evaluation were performed independently by two researchers. We conducted a Meta-analysis of all the outcome indicators. Besides, Meta-regression, subgroup analysis, and heterogeneity analysis were used for the primary outcomes to find the possible potential confounding factors. Results Finally, we included 27 RCTs involving 2884 patients. SHL oral preparations combined with azithromycin were better than azithromycin alone in response rate (RR = 1.14, 95% CI[1.11, 1.18]; low certainty evidence), disappearance time of fever(MD = -1.72, 95% CI[-2.47, -0.97]; low certainty evidence), disappearance time of cough (MD = -2.95, 95% CI[-3.55, -2.34]; low certainty evidence), and disappearance time of pulmonary rales (MD = -2.13, 95% CI[-2.88, -1.38]; low certainty evidence). The Meta-regression results showed that the course of disease, age, and method of administration may be the source of heterogeneity. Subgroup analysis and sensitivity analysis have found that the results were stable. For other related clinical symptoms, T lymphocytes, and Serum inflammatory factors, SHL oral preparations combined with azithromycin was better than azithromycin alone, and the difference was statistically significant. For adverse events with low certainty evidence, safety needs further verification. Conclusion Based on the results of meta-analysis with low certainty evidence, we believed that SHL oral preparations combined with azithromycin likely be effectively improved clinical symptoms compared with azithromycin alone. Low certainty evidence showed that SHL may safety with no serious adverse events. Due to these limitations, the safety needs further verification. More high-quality, multicenter, and large-sample RCTs should be tested and verified in the future.


2020 ◽  
Author(s):  
Yun Zhu ◽  
Zhaowei Teng ◽  
Lirong Yang ◽  
Shuanglan Xu ◽  
Jie Liu ◽  
...  

AbstractBACKGROUNDRemdesivir, an inhibitor of viral RNA-dependent RNA polymerases, has been identified as a candidate for COVID-19 treatment. However, the therapeutic effect of remdesivir is controversial.METHODSWe searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials, from inception to June 11, 2020 for randomized controlled trials on the clinical efficacy of remdesivir. The main outcomes were discharge rate, mortality, and adverse events. This study is registered at INPLASY (INPLASY202060046).RESULTSData of 1075 subjects showed that remdesivir significantly increased the discharge rate of patients with COVID-19 compared with the placebo (50.4% vs. 45.29%; relative risk [RR] 1.19 [95% confidence interval [CI], 1.05–1.34], I2 = 0.0%, P = 0.754). It also significantly decreased mortality (8.18% vs. 12.70%; RR 0.64 [95% CI, 0.44–0.92], I2 = 45.7%, P = 0.175) compared to the placebo. Data of 1296 subjects showed that remdesivir significantly decreased the occurrence of serious adverse events (RR 0.77 [95% CI, 0.63–0.94], I2 = 0.0%, P = 0.716).CONCLUSIONRemdesivir is efficacious and safe for the treatment of COVID-19.TRIAL REGISTRATION NUMBERThis study is registered at the International Platform of Registered Systematic Review and Meta-analysis Protocols (INPLASY202060046).


Antibiotics ◽  
2019 ◽  
Vol 8 (4) ◽  
pp. 233 ◽  
Author(s):  
Shao-Huan Lan ◽  
Wei-Ting Lin ◽  
Shen-Peng Chang ◽  
Li-Chin Lu ◽  
Chih-Cheng Lai ◽  
...  

This meta-analysis assessed the efficacy and safety of novel tetracyclines for treating acute bacterial infections. Data from PubMed, Web of Science, EBSCO, Cochrane databases, Ovid Medline, and Embase databases were accessed until 11 July 2019. Only randomized controlled trials (RCTs) comparing the efficacy of novel tetracyclines with that of other antibiotics for treating acute bacterial infections were included. Primary outcomes included the clinical response, microbiological response, and risk of adverse events (AEs). A total of eight RCTs were included, involving 2283 and 2197 patients who received novel tetracyclines and comparators, respectively. Overall, no significant difference was observed in the clinical response rate at test of cure between the experimental and control groups (for modified intent-to-treat [MITT] population, risk ratio [RR]: 1.02, 95% confidence interval [CI]: 0.99–1.05; for clinically evaluable [CE] population, RR: 1.02, 95% CI: 1.00–1.04; and for microbiological evaluable [ME] population, RR: 1.01, 95% CI: 0.99–1.04). No significant difference in the microbiological response at the end of treatment was observed between the experimental and control groups (for ME population, RR: 1.01, 95% CI: 0.99–1.03; for microbiological MITT population, RR: 1.01, 95% CI: 0.96–1.07). No difference was observed concerning the risk of treatment-emergent adverse events (TEAEs), serious adverse events, and discontinuation of treatment due to TEAEs and all-cause mortality between the two groups. In conclusion, clinical efficacy and safety profile for novel tetracyclines in the treatment of acute bacterial infections were found to be similar to those for other available antibiotics.


2017 ◽  
Vol 112 ◽  
pp. S345-S347
Author(s):  
Vineet S. Rolston ◽  
Jessica Kimmel ◽  
Lisa B. Malter ◽  
David P. Hudesman ◽  
Brian P. Bosworth ◽  
...  

2021 ◽  
pp. jim-2021-002001
Author(s):  
Samiksha Gupta ◽  
Rana Prathap Padappayil ◽  
Agam Bansal ◽  
Salim Daouk ◽  
Brent Brown

Tocilizumab is an interleukin receptor inhibitor that has been used in patients with COVID-19 pneumonia. There are recent randomized controlled trials (RCTs) that evaluated the efficacy and safety of tocilizumab in hospitalized patients with COVID-19 pneumonia. We performed a systematic review and meta-analysis of RCTs that evaluated the effectiveness of tocilizumab in hospitalized patients with COVID-19 not requiring mechanical ventilation. RCTs comparing tocilizumab with the standard of care treatment in hospitalized patients with COVID-19 pneumonia not requiring mechanical ventilation at the time of administration were included for analysis. The primary outcome was a composite of mechanical ventilation or 28-day mortality and the secondary outcomes were 28-day mortality and major adverse events. A total of 6 RCTs were included for the analysis. Tocilizumab was associated with a statistically significant reduction in the primary composite outcome of mechanical ventilation or 28-day mortality (risk ratio (RR): 0.83 (95% CI: 0.74 to 0.92, I2=0, tau2=0). Treatment with tocilizumab did not show a statistically significant reduction in 28-day mortality (RR: 0.90 (95% CI: 0.76 to 1.07), I2=0, tau2=0) and rate of serious adverse events (RR: 0.82 (95% CI: 0.62 to 1.10), I2=0, tau2=0). Tocilizumab was associated with a decrease in the incidence of primary outcome, that is, mechanical ventilation or death at 28 days in hospitalized patients with COVID-19 pneumonia.


2020 ◽  
Author(s):  
Xueli Shi ◽  
Xuejing Yu ◽  
Jinhui Wang ◽  
Jianzhong Zhou

Abstract Background Oral sGC stimulators are novel treatments for heart failure (HF). Since individual studies are limited to confirm the efficacy and safety of sGC stimulators in patients with HF, we provide a meta-analysis based on published clinical randomized controlled trials. Methods Embase, PubMed, Cochrane and Medline were applied to search for randomized controlled trials (published before March 29, 2020 without language restrictions) by comparing oral sGC stimulators to placebos. Main endpoints were efficacy outcomes, including all-cause mortality, incidence of cardiovascular-events related death or hospitalization, alterations of EQ-5D index, and N-terminal (NT)-pro hormone BNP(NT-proBNP); and safety outcomes included incidence of serious adverse events (SAEs), symptomatic hypotension and syncope. Results Six trials were enrolled (N=6255 participants), sGC stimulators yielded a lower incidence of cardiovascular-events related death or hospitalization (OR=0.88, 95% CI=0.79 to 0.98), an improvement in EQ-5D scores (SMD=0.44, 95% CI=0.24 to 0.63), and a lower relative risk of SAEs (OR=0.90, 95% CI=0.81 to 1.00) compared with placebos. Furthermore, NT-proBNP was decreased by riociguat (SMD=-0.79, 95% CI=-1.10 to -0.49), but not by vericiguat (SMD=0.04, 95% CI=-0.18 to 0.25). There was no significant difference in all-cause mortality (OR=0.95, 95% CI=0.83 to 1.09), incidence of symptomatic hypotension (OR=1.15, 95% CI=0.95 to 1.40) and syncope (OR=1.15, 95% CI=0.87 to 1.53) between sGC stimulators and placebos. Conclusion Oral sGC stimulators may be beneficial for HF with a good tolerance, further studies are also needed to establish the optimal approach in clinical practice.


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