scholarly journals FRI0190 COMPARATIVE EFFICACY AND SAFETY OF MYCOPHENOLATE MOFETIL VERSUS CYCLOPHOSPHAMIDE IN PATIENTS WITH ACTIVE ANTINEUTROPHIL CYTOPLASMIC ANTIBODY-ASSOCIATED VASCULITIS: A META-ANALYSIS OF RANDOMIZED TRIALS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 678.2-678
Author(s):  
Y. H. Lee ◽  
G. G. Song
Keyword(s):  
Mycophenolate Mofetil ◽  
Infection Rate ◽  
Relapse Rate ◽  
Meta Analysis ◽  
Antineutrophil Cytoplasmic Antibody ◽  
Remission Induction ◽  
Efficacy And Safety ◽  
Anca Associated Vasculitis ◽  
Significant Difference ◽  
Regression Test

Background:Cyclophosphamide (CYC) is effective for induction of remission of AAV, resulting in complete remission rates of around 70%. Thus, CYC has been the standard remission induction therapy for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV); however, it is toxic and causes infections, malignancies, and infertility. Therefore, other agents that are less toxic but that have similar efficacy were explored. Since the disease course of AAV usually requires long-term immunosuppression, mycophenolate mofetil (MMF), a less toxic agent compared to CYC, has been explored as an alternative to CYC.Objectives:The aim of this study is to assess the efficacy and safety of MMF versus cyclophosphamide CYC in patients with active AAV.Methods:We performed a meta-analysis of four randomized clinical trials (RCTs) (300 patients) to examine the relative efficacy and safety of MMF compared to CYC in patients with active AAV.Results:There was no significant difference in remission at 6 months between MMF and CYC (OR 1.311, 95% confidence interval [CI] 0.570 – 3.017,P= 0.524). Additionally, the relapse rate did not differ between the MMF group and CYC group (OR 1.331, 95% CI 0.497 – 3.568,P= 0.570). There was no significant difference in serious adverse event (SAE) (OR 1.232, 95% CI 0.754 – 2.014,P= 0.404) and infection rate (OR 0.958, 95% CI 0.561 – 1.634,P= 0.873) between the MMF and CYC groups. Some heterogeneity was found in the meta-analysis of remission and relapse rate (I2= 57.4%, 63.4%), but no between-study heterogeneity was found during the meta-analysis of the SAE and infection rate. Egger’s regression test showed no evidence of publication bias (Egger’s regression testP-values > 0.1).Conclusion:MMF was an equally effective alternative treatment to CYC, and MMF was comparable to CYC in patients with active AAV in terms of safety, suggesting that MMF can be used as an alternative to CYC for remission induction in AAV.References:[1]Han F, Liu G, Zhang X, Li X, He Q, He X, Li Q, Wang S, Wang H, Chen J (2011) Effects of mycophenolate mofetil combined with corticosteroids for induction therapy of microscopic polyangiitis. Am J Nephrol 33:185-192[2]Jones RB, Hiemstra TF, Ballarin J et al (2019) Mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA-associated vasculitis: a randomised, non-inferiority trial. Ann Rheum Dis 78:399-405[3]Tuin J, Stassen PM, Bogdan DI, Broekroelofs J, van Paassen P, Cohen Tervaert JW, Sanders JS, Stegeman CA (2019) Mycophenolate Mofetil Versus Cyclophosphamide for the Induction of Remission in Nonlife-Threatening Relapses of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: Randomized, Controlled Trial. Clin J Am Soc Nephrol 14:1021-1028[4]Hu W, Liu C, Xie H, Chen H, Liu Z, Li L (2008) Mycophenolate mofetil versus cyclophosphamide for inducing remission of ANCA vasculitis with moderate renal involvement. Nephrol Dial Transplant 23:1307-1312Disclosure of Interests:None declared

scholarly journals Efficacy and Safety of Mycophenolate Mofetil Therapy in Neuromyelitis Optica Spectrum Disorders: A Systematic Review and Meta-Analysis

2020 ◽  
Author(s):  
Sakdipat Songwisit ◽  
Punchika Kosiyakul ◽  
Jiraporn Jitprapaikulsan ◽  
Naraporn Prayoonwiwat ◽  
Patompong Ungprasert ◽  
...  
Keyword(s):  
Systematic Review ◽  
Mycophenolate Mofetil ◽  
Disease Severity ◽  
Relapse Rate ◽  
Neuromyelitis Optica ◽  
Meta Analysis ◽  
Neuromyelitis Optica Spectrum Disorders ◽  
Efficacy And Safety ◽  
Number Of Patients ◽  
Spectrum Disorders

Abstract Background: Neuromyelitis optica spectrum disorders (NMOSD) is an autoimmune demyelinating disease of the central nervous system characterized by severe attacks of optic nerve and spinal cord. Mycophenolate mofetil (MMF) is an immunosuppressive agent (IS) which is widely prescribed for NMOSD patients. This systematic review and meta-analysis aims to assess the efficacy and safety of MMF in controlling relapse and disease severity.Methods: Studies were obtained from the EMBASE and Ovid MEDLINE databases. Eligible studies were the studies of NMOSD patients treated with MMF which reported treatment outcomes as Annualized Relapse Rate (ARR) or Expanded Disability Status Scale (EDSS) before and after treatment. Case reports, case series less than 3 patients, and reviews were excluded.Results: Fifteen studies included 1047 patients, of whom 915 (87.4%) were aquaporin-4 immunoglobulin seropositive. The total number of patients that received MMF was 799. Meta-analysis on ARR and EDSS were conducted in 4 studies with a total of 200 patients and 3 studies with a total of 158 patients, respectively. The result showed a significant improvement with a mean reduction of 1.13 (95% confidence interval (CI), 0.60 to 1.65) in ARR and a mean reduction of 0.85 (95% CI, 0.36 to 1.34) in EDSS after MMF therapy. Adverse drug reactions occurred in 106 (17.8%) of 594 patients that were documented having side effects during MMF therapy.Conclusion: This systematic review and meta-analysis showed that using MMF as a preventive therapy in NMOSD patients can significantly reduce relapse rate and improve disease severity with an acceptable tolerability.

scholarly journals The Role of Mycophenolate Mofetil for the Induction of Remission in ANCA-Associated Vasculitis: A Meta-Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Anji Xiong ◽  
Chen Xiong ◽  
Guancui Yang ◽  
Yu Shuai ◽  
Deng Liu ◽  
...  
Keyword(s):  
Mycophenolate Mofetil ◽  
Induction Therapy ◽  
Remission Rate ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Renal Involvement ◽  
Random Effect ◽  
Cochrane Library ◽  
Remission Induction ◽  
Anca Associated Vasculitis

Objectives: The successful introduction of mycophenolate mofetil (MMF) as a treatment for renal allograft reduced the incidence of acute rejection. The inspiring effects obtained by the MMF have led to an evaluation of its therapeutic potency on ANCA-associated vasculitis (AAV). However, there is little evidence of the MMF's efficacy on the AAV. The meta-analysis is carried out to evaluate the efficacy of MMF as a remission induction therapy in AAV.Methods: Up to June 30th, 2020, PubMed, Cochrane Library, and Embase have been searched comprehensively. According to heterogeneity, the pooled remission rates are synthesized by either fixed-effect or random-effect models.Results: The eight included studies comprising 230 patients who were treated with MMF as induction therapy are included in our analysis. The pooled overall remission rate is 74% (95% CI: 0.68–0.80). The remission rate, the infection rate and the rate of leukopenia of four randomized controlled trials aimed at comparing the effects of MMF with cyclophosphamide (CYC) during induction therapy for AAV have no statistical significance (P > 0.05).Conclusion: MMF may be an alternative to CYC for remission induction therapy in AAV with MPO-ANCA, mild to moderate renal involvement and non-life-threatening state. Whether to observe the effect of MMF in AAV or to compare the difference between MMF and CYC in the future studies, risk stratification and subgrouping of AAV patients should be first carried out to correctly identify the AAV subgroup suitable for MMF.

scholarly journals Efficacy of mycophenolate mofetil as a remission induction therapy in antineutrophil cytoplasmic antibody: associated vasculitis—a meta-analysis

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e001195 ◽  
Author(s):  
Kentaro Kuzuya ◽  
Takayoshi Morita ◽  
Atsushi Kumanogoh
Keyword(s):  
Mycophenolate Mofetil ◽  
Induction Therapy ◽  
Therapeutic Efficacy ◽  
Remission Rate ◽  
Meta Analysis ◽  
Antineutrophil Cytoplasmic Antibody ◽  
Cochrane Library ◽  
Remission Induction ◽  
The Difference ◽  
Randomised Controlled

ObjectivesA few studies on antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) treatments have shown the therapeutic efficacy of mycophenolate mofetil (MMF). However, the therapeutic efficacy of MMF compared with that of cyclophosphamide (CYC) in patients with AAV has not been established. We conducted a systematic review and meta-analysis to assess the efficacy of MMF as a remission induction therapy in patients with AAV comparing it with the efficacy of CYC.MethodsWe searched randomised controlled trials (RCTs) comparing the efficacy of MMF with that of CYC in patients with AAV on three different websites: PubMed, Cochrane Library and Google Scholar. We compared the difference in the relative risk (RR) of each outcome based on a Mantel-Haenszel random-effects model.ResultsWe analysed data from four RCTs with 300 patients for the study. The 6-month remission rate (RR 1.09, 95% CI 0.86 to 1.38, p=0.48), the 6-month ANCA negativity (RR 1.31, 95% CI 0.91 to 1.90, p=0.15) and the long-term relapse rate (RR 1.36, 95% CI 0.80 to 2.31, p=0.26) were all similar between the two treatments. The rates of death, infection and leucopenia were also similar between the two groups (RR 1.05, 95% CI 0.40 to 2.74, p=0.93; RR 1.26, 95% CI 0.79 to 2.01, p=0.33; RR 0.45, 95% CI 0.16 to 1.32, p=0.15, respectively).ConclusionsWe found no difference between the therapeutic efficacy of MMF and that of CYC in patients with AAV. MMF may be an alternative remission induction therapy in patients with non-life-threatening AAV.

scholarly journals Mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA-associated vasculitis: a randomised, non-inferiority trial

2019 ◽  
Vol 78 (3) ◽  
pp. 399-405 ◽  
Author(s):  
Rachel B Jones ◽  
Thomas F Hiemstra ◽  
Jose Ballarin ◽  
Daniel Engelbert Blockmans ◽  
Paul Brogan ◽  
...  
Keyword(s):  
Mycophenolate Mofetil ◽  
Controlled Trial ◽  
Antineutrophil Cytoplasmic Antibody ◽  
Risk Difference ◽  
Remission Induction ◽  
Group 13 ◽  
Anca Associated Vasculitis ◽  
Serious Infections ◽  
Registration Number ◽  
Randomised Controlled

ObjectivesCyclophosphamide induction regimens are effective for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), but are associated with infections, malignancies and infertility. Mycophenolate mofetil (MMF) has shown high remission rates in small studies of AAV.MethodsWe conducted a randomised controlled trial to investigate whether MMF was non-inferior to cyclophosphamide for remission induction in AAV. 140 newly diagnosed patients were randomly assigned to MMF or pulsed cyclophosphamide. All patients received the same oral glucocorticoid regimen and were switched to azathioprine following remission. The primary endpoint was remission by 6 months requiring compliance with the tapering glucocorticoid regimen. Patients with an eGFR <15 mL/min were excluded from the study.ResultsAt baseline, ANCA subtype, disease activity and organ involvement were similar between groups. Non-inferiority was demonstrated for the primary remission endpoint, which occurred in 47 patients (67%) in the MMF group and 43 patients (61%) in the cyclophosphamide group (risk difference 5.7%, 90% CI −7.5% to 19%). Following remission, more relapses occurred in the MMF group (23 patients, 33%) compared with the cyclophosphamide group (13 patients, 19%) (incidence rate ratio 1.97, 95% CI 0.96 to 4.23, p=0.049). In MPO-ANCA patients, relapses occurred in 12% of the cyclophosphamide group and 15% of the MMF group. In PR3-ANCA patients, relapses occurred in 24% of the cyclophosphamide group and 48% of the MMF group. Serious infections were similar between groups (26% MMF group, 17% cyclophosphamide group) (OR 1.67, 95% CI 0.68 to 4.19, p=0.3).ConclusionMMF was non-inferior to cyclophosphamide for remission induction in AAV, but resulted in higher relapse rate.Trial registration numberNCT00414128.

Efficacy and safety of doxycycline for the management of small abdominal aortic aneurysms- a meta analysis

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
A Abdul Razzack ◽  
D Rocha Castellanos ◽  
A Lopez Mendez ◽  
M Fernando Perez Paz ◽  
S Pothuru ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Abdominal Aortic Aneurysms ◽  
Abdominal Aortic Aneurysm Repair ◽  
Mean Difference ◽  
Aortic Aneurysms ◽  
Efficacy And Safety ◽  
Funding Sources ◽  
Abdominal Aortic ◽  
Significant Difference ◽  
Aneurysm Repair

Abstract Funding Acknowledgements Type of funding sources: None. Background- Patients with small Abdominal Aortic Aneurysms are managed with surveillance as there is currently insufficient evidence to recommend surgical aneurysm repair. Hence, there is a dire need and interest in pharmacotherapy like tetracycline antibiotics to reduce the need for aneurysm repair. Purpose- To determine the efficacy and safety of doxycycline in the management of small abdominal aortic aneurysms. Methods- Electronic databases (PubMed, Scopus, Embase, Cochrane) were searched until 25th November 2020.The primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to Abdominal aortic aneurysm repair in each group. Results- A total of three studies with 572 participants (Doxycycline = 290; Placebo = 282 ) were included in our analysis. Average follow up was a period of 18 months. For AAA expansion, the combined results demonstrated a statistically significant mean difference in expansion rates favoring the placebo groups over the intervention (WMD-0.75, 95%CI 0.12-1.38; p = 0.02;I2 = 0%) There was no statistically significant difference in the efficacy and safety of doxycycline as opposed to placebo groups for referral to AAA surgery (OR 1.01, 95%CI 0.61-1.69; p = 0.96, I2 = 0%) and all-cause mortality(OR 0.51; 95%CI 0.18-1.43; p = 0.20, I2 =0%) Conclusion- Amongst patients with small abdominal aortic aneurysms, doxycycline did not significantly reduce aneurysm growth. Abstract Figure. A) AAA expansion B)Surgery C)Mortality

scholarly journals Efficacy and safety of Si-Jun-Zi-Tang-based therapies for functional (non-ulcer) dyspepsia: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yaping Wang ◽  
Bin Liu ◽  
Xiuqiong Fu ◽  
Tiejun Tong ◽  
Zhiling Yu
Keyword(s):  
Relapse Rate ◽  
Large Scale ◽  
Primary Outcome ◽  
Response Rate ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Efficacy And Safety ◽  
History Of ◽  
Non Ulcer Dyspepsia

Abstract Background The traditional Chinese medicine formula Si-Jun-Zi-Tang (SJZT) has a long history of application in the treatment of functional dyspepsia (non-ulcer dyspepsia, FD)-like symptoms. SJZT-based therapies have been claimed to be beneficial in managing FD. This study aimed to assess the efficacy and safety of SJZT-based therapies in treating FD by meta-analysis. Methods Systematic searches for RCTs were conducted in seven databases (up to February 2019) without language restrictions. Data were analyzed using Cochrane RevMan software version 5.3.0 and Stata software version 13.1, and reported as relative risk (RR) or odds ratio (OR) with 95% confidence intervals (CIs). The primary outcome was response rate and the secondary outcomes were gastric emptying, quality of life, adverse effects and relapse rate. The quality of evidence was evaluated according to criteria from the Cochrane risk of bias. Results A total of 341 potentially relevant publications were identified, and 12 RCTs were eligible for inclusion. For the response rate, there was a statically significant benefit in favor of SJZT-based therapies (RR = 1.23; 95% CI 1.17 to 1.30). However, the benefit was limited to modified SJZT (MSJZT). The relapse rate of FD patients received SJZT-based therapies was lower than that of patients who received conventional medicines (OR = 0.23; 95% CI 0.10 to 0.51). No SJZT-based therapies-related adverse effect was reported. Conclusion SJZT-based prescriptions may be effective in treating FD and no serious side-effects were identified, but the effect on response rate appeared to be limited to MSJZT. The results should be interpreted with caution as all the included studies were considered at a high risk of bias. Standardized, large-scale and strictly designed RCTs are needed to further validate the benefits of SJZT-based therapies for FD management. Trial registration Systematic review registration: [PROSPERO registration: CRD42019139136].

scholarly journals Efficacy and Safety of Topical Timolol Eye Drops in the Treatment of Myopic Regression after Laser In Situ Keratomileusis: A Systematic Review and Meta-Analysis

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Xiaochen Wang ◽  
Guiqiu Zhao ◽  
Jing Lin ◽  
Nan Jiang ◽  
Qian Wang ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Treated Group ◽  
Laser In Situ Keratomileusis ◽  
Control Group ◽  
Eye Drops ◽  
Efficacy And Safety ◽  
China National Knowledge Infrastructure ◽  
Knowledge Infrastructure ◽  
Significant Difference

Aims. The aim of this study was to assess the efficacy and safety of timolol in the treatment of myopic regression after laser in situ keratomileusis (LASIK).Methods. We searched MEDLINE, CENTRAL, EMBASE, China National Knowledge Infrastructure (CNKI), and Chinese Biological Medicine (CBM) from the inception to July 2015 for relevant randomized controlled trials that examined timolol therapy for myopic regression. The methodological quality of the studies included was assessed using the Revman 5.3 software.Results. We included six clinical trials involving 483 eyes in this review, including 246 eyes in treated group and 237 eyes in controlled group. We observed statistically significant improvements on the postoperative SE in the 3 months. However, the change of CCT was not statistically different between the control group and the experimental group. There were fewer cases of IOP, UDVA, and CDVA in treated group having significant difference from the controlled group.Conclusions. Topical timolol could be an effective treatment for reduction of myopic regression especially the spherical errors after myopic LASIK. Further RCTs with larger sample sizes for these trials are warranted to determine the efficacy and limitation for myopic regression after LASIK.

scholarly journals Efficacy and safety of trimethoprim-sulfamethoxazole for the prevention of pneumocystis pneumonia in human immunodeficiency virus-negative immunodeficient patients: A systematic review and meta-analysis

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0248524
Author(s):  
Rui Li ◽  
Zhiyong Tang ◽  
Fu Liu ◽  
Ming Yang
Keyword(s):  
Human Immunodeficiency Virus ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Pneumocystis Pneumonia ◽  
Control Group ◽  
Drug Discontinuation ◽  
Efficacy And Safety ◽  
Significant Difference ◽  
Immunodeficiency Virus ◽  
Hiv Negative

Background Pneumocystis pneumonia (PCP) has a significant impact on the mortality of immunocompromised patients. It is not known whether the prophylactic application of trimethoprim-sulfamethoxazole (TMP-SMZ) can reduce the incidence of PCP and mortality in the human immunodeficiency virus (HIV)-negative immunodeficient population. The safety profile is also unknown. There have been few reports on this topic. The aim of this study was to systematically evaluate the efficacy and safety of the use of TMP-SMZ for the prevention of PCP in this population of patients from the perspective of evidence-based medicine. Methods A comprehensive search without restrictions on publication status or other parameters was conducted. Clinical randomized controlled trials (RCTs) or case-control trials (CCSs) of TMP-SMZ used for the prevention of PCP in HIV-negative immunocompromised populations were considered eligible. A meta-analysis was performed using the Mantel-Haenszel fixed-effects model or Mantel-Haenszel random-effects model, and odds ratios (ORs) with 95% confidence intervals (CIs) were calculated and reported. Results Of the 2392 records identified, 19 studies (n = 4135 patients) were included. The efficacy analysis results indicated that the PCP incidence was lower in the TMP-SMZ group than in the control group (OR = 0.27, 95% CI (0.10, 0.77), p = 0.01); however, the rate of drug discontinuation was higher in the TMP-SMZ group than in the control group (OR = 14.31, 95% CI (4.78, 42.91), p<0.00001). In addition, there was no statistically significant difference in the rate of mortality between the two groups (OR = 0.54, 95% CI (0.21, 1.37), p = 0.19). The safety analysis results showed that the rate of adverse events (AEs) was higher in the TMP-SMZ group than in the control group (OR = 1.92, 95% CI (1.06, 3.47), p = 0.03). Conclusions TMP-SMZ has a better effect than other drugs or the placebo with regard to preventing PCP in HIV-negative immunocompromised individuals, but it may not necessarily reduce the rate of mortality, the rate of drug discontinuation or AEs. Due to the limitations of the research methodologies used, additional large-scale clinical trials and well-designed research studies are needed to identify more effective therapies for the prevention of PCP.

scholarly journals Efficacy and Safety of Intranasal Ketamine for Acute Pain Management in the Emergency Setting: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 10 (17) ◽  
pp. 3978
Author(s):  
Yee Sin Seak ◽  
Junainah Nor ◽  
Tuan Hairulnizam Tuan Kamauzaman ◽  
Ariff Arithra ◽  
Md Asiful Islam
Keyword(s):  
Systematic Review ◽  
Pain Management ◽  
Acute Pain ◽  
Meta Analysis ◽  
Emergency Setting ◽  
Efficacy And Safety ◽  
Acute Pain Management ◽  
Significant Difference ◽  
Mean Differences ◽  
Randomised Controlled

Due to overcrowding, personnel shortages, or problematic intravenous (IV) cannulation, acute pain management is often sub-optimal in emergency departments (EDs). The objective of this systematic review and meta-analysis was to evaluate the efficacy and safety of intranasal (IN) ketamine for adult acute pain in the emergency setting. We searched and identified studies up to 21 May 2021 via PubMed, Scopus, Web of Science, Cochrane Database, and Google Scholar. The random-effects model with 95% confidence intervals (CIs) was used to estimate mean differences (MDs) and odds ratios (ORs). The I2 statistic and Cochran’s Q test were used to determine heterogeneity. The protocol was registered in PROSPERO (CRD42020213391). Seven randomised controlled trials were included with a total of 1760 patients. There was no significant difference in pain scores comparing IN ketamine with IV analgesics or placebo at 5 (MD 0.94, p = 0.26), 15 (MD 0.15, p = 0.74), 25 (MD 0.24, p = 0.62), 30 (MD −0.05, p = 0.87), and 60 (MD −0.42, p = 0.53) minutes. There was also no significant difference in the need for rescue analgesics between IN ketamine and IV analgesics (OR 1.66, 95% CI: 0.57−4.86, p = 0.35, I2 = 70%). Only mild adverse effects were observed in patients who received IN ketamine. Our results suggest that IN ketamine is non-inferior to IV analgesics and may have a role in acute pain management among adults in the ED.

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