scholarly journals Efficacy and safety of phentermine/topiramate in adults with overweight or obesity: A meta-analysis and systematic review

2020 ◽  
Author(s):  
Xiang-Guo Lei ◽  
Chen Lai ◽  
Ziyi Sun ◽  
Xi Yang
Keyword(s):  
Systematic Review ◽  
Weight Loss ◽  
Nervous System ◽  
Body Weight ◽  
Adverse Events ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Reduced Body

AbstractObjectiveTo examine the association between phentermine/topiramate therapy and weight loss and adverse events in adults with overweight problems or obesity by meta-analysis and systematic review.MethodsMedical Subject Headings (MeSH) and free-text terms related to phentermine/topiramate were selected to search for eligible trials in PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and EMBASE up to April 18, 2020. The quality of randomized controlled trials was evaluated by Cochrane risk-of-bias tool. Meta-analysis was performed using random-effect models. Our systematic review protocol, registered on PROSPERO (registration number CRD42020188324).ResultsPhentermine/topiramate therapy resulted in a weight loss of 7.73 kg (95% confidence interval [CI]: 6.60, 8.85) compared to placebo. For phentermine/topiramate subjects in different weight loss subgroups, the weight loss of subjects with ≥5%, ≥10%, and ≥15% baseline weight loss were 3.18 (95% CI: 2.75, 3.67), 5.32 (95% CI: 4.53, 6.25), and 5.65 (95% CI: 3.55, 9.01), respectively. Phentermine/topiramate reduced waist circumference, blood pressure, blood sugar levels, and lipid levels. The adverse effects associated with the treatment mainly included Dysgeusia, Paresthesia, Dry mouth.ConclusionsPhentermine/topiramate reduced body weight and was well tolerated. However, it increased the risk of nervous system-related adverse events to a certain extent, but the symptoms are not serious. Long-term clinical and pharmacological studies are needed to understand the long-term efficacy and safety of phentermine/topiramate.Study Importance QuestionsPhentermine/topiramate was approved by the FDA as an anti-obesity drug. However, the European Medicines Agency refused marketing authorization for phentermine/topiramate owing to safety concerns.Phentermine/topiramate reduced body weight and was well tolerated. However, it remarkably increased the risk of nervous system-related adverse events.In this study, the efficacy and incidence of adverse events of phentermine/topiramate were further evaluated through meta-analysis to provide reference for the clinical use of phentermine/topiramate.

Inhaled Levodopa (CVT-301) for the Treatment of Parkinson Disease: A Systematic Review and Meta-analysis of Randomized Controlled Trials

2021 ◽  
pp. 10.1212/CPJ.0000000000001143
Author(s):  
Glenardi Glenardi ◽  
Tutwuri Handayani ◽  
Jimmy Barus ◽  
Ghea Mangkuliguna
Keyword(s):  
Systematic Review ◽  
Placebo Group ◽  
Adverse Events ◽  
Respiratory Symptoms ◽  
Meta Analysis ◽  
Motor Fluctuation ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Improve Motor Function

ABSTRACTPurposeof Review: To investigate the efficacy and safety of CVT-301 for motor fluctuation in Parkinson’s disease (PD).Recent Findings:This study demonstrated that the CVT-301 group had a higher proportion of patients achieving an ON state than the placebo group (OR=2.68; 95% CI: 1.86-3.86; p<0.00001). Moreover, CVT-301 had also shown to improve motor function by UPDRS-III score (SMD=3.83; 95% CI: 2.44-5.23; p<0.00001) and promote an overall improvement of PD by PGIC self-rating (OR=2.95; 95% CI: 1.78-4.9; p<0.00001). The most common adverse events encountered were respiratory symptoms (OR=12.18; 95% CI: 5.01-29.62; p<0.00001) and nausea (OR=3.95; 95% CI: 1.01-15.41; p=0.05).Summary:CVT-301 had the potential to be an alternative or even a preferred treatment for motor fluctuation in PD patients.

scholarly journals Efficacy and safety of omalizumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e047344
Author(s):  
Qingwu Wu ◽  
Lianxiong Yuan ◽  
Huijun Qiu ◽  
Xinyue Wang ◽  
Xuekun Huang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Chronic Rhinosinusitis ◽  
Randomised Controlled Trials ◽  
Nasal Polyps ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomised Controlled

ObjectivesTo assess the efficacy and safety of omalizumab for chronic rhinosinusitis with nasal polyps (CRSwNP) and to identify evidence gaps that will guide future research on omalizumab for CRSwNP.DesignSystematic review and meta-analysis.Data sourcesA comprehensive search was performed in PubMed, Embase, Web of Science and the Cochrane Library on 13 October 2020.Eligibility criteriaRandomised controlled trials (RCTs) comparing omalizumab with placebo, given for at least 16 weeks in adult patients with CRSwNP.Data extraction and synthesisTwo independent authors screened search results, extracted data and assessed studies using the Cochrane risk of bias tool. Data were pooled using the inverse-variance method and expressed as mean differences (MDs) with 95% CIs. Heterogeneity was assessed by the χ2 test and the I2 statistic.ResultsA total of four RCTs involving 303 participants were identified. When comparing omalizumab to placebo, there was a significant difference in Nasal Polyps Score (MD=−1.20; 95% CI −1.48 to −0.92), Nasal Congestion Score (MD=−0.67; 95% CI −0.86 to −0.48), Sino-Nasal Outcome Test-22 (MD=−15.62; 95% CI −19.79 to −11.45), Total Nasal Symptom Score (MD=−1.84; 95% CI −2.43 to −1.25) and reduced need for surgery (risk ratio (RR)=5.61; 95% CI 1.99 to 15.81). Furthermore, there was no difference in the risk of serious adverse events ((RR=1.40; 95% CI 0.29 to 6.80), adverse events (RR=0.83; 95% CI 0.60 to 1.15) and rescue systemic corticosteroid (RR=0.52; 95% CI 0.17 to 1.61).ConclusionsThis was the first meta-analysis that identified omalizumab significantly improved endoscopic, clinical and patient-reported outcomes in adults with moderate to severe CRSwNP and it was safe and well tolerated.PROSPERO registration numberCRD42020207639.

scholarly journals Efficacy and safety of pirfenidone in the treatment of idiopathic pulmonary fibrosis patients: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e050004
Author(s):  
Wenjuan Wu ◽  
Lingxiao Qiu ◽  
Jizhen Wu ◽  
Xueya Liu ◽  
Guojun Zhang
Keyword(s):  
Systematic Review ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Adverse Events ◽  
Acute Exacerbation ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomised Controlled

ObjectivesIdiopathic pulmonary fibrosis (IPF) has been defined as a distinctive type of chronic fibrotic disease, characterised by a progressive decline in lung function and a common histological pattern of interstitial pneumonia. To analyse the efficacy and safety of pirfenidone in the treatment of IPF, a systematic review and meta-analysis was performed.DesignThis is a meta-analysis study.ParticipantsPatients were diagnosed as IPF.InterventionsUse of pirfenidone.Primary and secondary outcomeProgression-free survival (PFS), acute exacerbation and worsening of IPF and Impact on adverse events.MeasuresThe inverse variance method for the random-effects model was used to summarise the dichotomous outcomes, risk ratios and 95% CIs.ResultsA total of 9 randomised controlled trials with 1011 participants receiving pirfenidone and 912 controls receiving placebo were summarised. The pooled result suggested a statistically significant difference inall-cause mortality after pirfenidone use, with a summarised relative ratio of 0.51 (p<0.01). Longer PFS was observed in patients receiving pirfenidone compared with those who were given placebo (p<0.01). The IPF groups presented a high incidence of adverse events with a pooled relative ratio of 3.89 (p<0.01).ConclusionsPirfenidone can provide survival benefit for patients with IPF. Pirfenidone treatment was also associated with a longer PFS, a lower incidence of acute exacerbation and worsening of IPF.

Efficacy of interventions incorporating mobile applications in facilitating weight loss and health behavior change in the Asian population: a systematic review and meta-analysis (Preprint)

2021 ◽  
Author(s):  
Siew Min Ang ◽  
Juliana Chen ◽  
Jolyn Johal ◽  
Jia Huan Liew ◽  
Yock Young Dan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Weight Loss ◽  
Health Behavior ◽  
Weight Management ◽  
Weight Change ◽  
Meta Analysis ◽  
Asian Population ◽  
Health Behavior Change ◽  
Controlled Trials

BACKGROUND Smartphone applications (apps) have shown potential in enhancing weight management in the Western population in the short to medium term. With a rapidly growing obesity burden in the Asian populations, researchers are turning to apps as a service delivery platform to reach a greater target audience to efficiently tackle the problem. OBJECTIVE This systematic review and meta-analysis aimed to determine the efficacy of interventions incorporating apps in facilitating weight loss and health behavior change in the Asian population. METHODS Six databases were searched in June 2020. Eligible studies were controlled trials utilizing an app in the intervention in participants aged 18 years or above and from an Asian ethnicity. A meta-analysis to test intervention efficacy, subgroup analyses and post-hoc analyses were conducted to determine the effects of adding app to usual care and study duration. The primary outcome was absolute or percentage weight change while secondary outcomes were changes to lifestyle behaviors. RESULTS A total of 21 studies were included in this review and 17 were selected for the meta-analysis. The pooled effect size across 14 randomized controlled trials for weight change was small to moderate (Hedges’ g = -0.28, 95% CI = -0.44 to -0.12) however, this was not representative of long-term studies (more than a year). Stand-alone app interventions were inefficacious for weight loss but supplementing multi-component usual care with an app led to statistically significant weight change (Hedges’ g = -0.25 95% CI = -0.43 to -0.07). Asian apps were largely culturally adapted and multi-functional, with the most common app features being communication with health professionals and self-monitoring of behaviors and outcomes. CONCLUSIONS More evidence is required to determine the efficacy of apps in the long term and address app non-usage to maximize the potential of the intervention. Future research should determine the efficacy of each component of the multi-component intervention to facilitate study designs that are most effective and cost-efficient for weight management. CLINICALTRIAL PROSPERO REGISTRATION: CRD42020165240.

Efficacy and Safety of Adjunctive Trimetazidine Therapy for Acute Myocardial Infarction: A Systematic Review and Meta-Analysis

Cardiology ◽  
2016 ◽  
Vol 135 (3) ◽  
pp. 188-195 ◽  
Author(s):  
Yongyong Li ◽  
Dewei Wang ◽  
Chunxiao Hu ◽  
Peng Zhang ◽  
Dongying Zhang ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Systematic Review ◽  
Acute Myocardial Infarction ◽  
Adverse Events ◽  
Meta Analysis ◽  
Efficacy And Safety ◽  
Short Term ◽  
All Cause Mortality ◽  
Acute Mi

Background: Several lines of evidence support the clinical use of trimetazidine as an adjunctive therapy in cardioischemic patients. Therefore, we assessed here the efficacy and safety of adjunctive trimetazidine therapy in acute myocardial infarction (MI) patients by a systematic review and meta-analysis of the current literature. Methods: PubMed, the Cochrane Library, and the China National Knowledge Infrastructure databases were searched for clinical studies comparing adjunctive trimetazidine therapy against placebo in adult acute MI patients. Several clinical outcomes [early/short-term all-cause mortality, long-term all-cause mortality, total major adverse cardiac events (MACE), recurrent nonfatal MI, in-hospital adverse events, target vessel revascularization (TVR), and coronary artery bypass graft (CABG)] were analyzed by the intention-to-treat principle. Odds ratios (OR) and their 95% confidence intervals (CI) were derived from the number of outcome events in each study arm to estimate the association between adjuvant trimetazidine administration and the various clinical outcomes. A random-effects model was applied for all meta-analyses. Results: We found that adjunctive trimetazidine therapy showed a significant effect upon total MACE (OR = 0.33, 95% CI = 0.15-0.74; p = 0.007) but showed no significant effect upon early/short-term all-cause mortality, long-term all-cause mortality, recurrent nonfatal MI, in-hospital adverse events, TVR, or CABG (p > 0.05). Conclusions: This is the first meta-analysis to report that adjunctive trimetazidine therapy has a beneficial effect upon total MACE in acute MI patients. Clinical investigators should consider further trials on adjunctive trimetazidine therapy in order to better define its risks and benefits in acute MI patients.

scholarly journals Comparative Efficacy and Safety of Dopamine Agonists in Advanced Parkinson's Disease With Motor Fluctuations: A Systematic Review and Network Meta-Analysis of Double-Blind Randomized Controlled Trials

2021 ◽  
Vol 15 ◽  
Author(s):  
Xinglin Ruan ◽  
Fabin Lin ◽  
Dihang Wu ◽  
Lina Chen ◽  
Huidan Weng ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Dopamine Agonists ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Motor Fluctuations ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Troublesome Dyskinesia

Background: Movement fluctuations are the main complication of Parkinson's disease (PD) patients receiving long-term levodopa (L-dopa) treatment. We compared and ranked the efficacy and safety of dopamine agonists (DAs) with regard to motor fluctuations by using a Bayesian network meta-analysis (NMA) to quantify information from randomized controlled trials (RCTs).Methods and Findings: We carried out a systematic review and meta-analysis, and only RCTs comparing DAs for advanced PD were included. Electronic databases (PubMed, Embase, and Cochrane Library) were systematically searched for relevant studies published until January 2021. Two reviewers independently extracted individual study data and evaluated studies for risk of bias using the Cochrane Risk of Bias tool. Network meta-analyses using a Bayesian framework were used to calculate the related parameters. The pre-specified primary and secondary outcomes were efficacy (“ON” time without troublesome dyskinesia, “OFF” time, “ON” time, “UPDRS-III,” and “UPDRS-II”) and safety [treatment-emergent adverse events (TEAE) and other adverse events] of DAs. The results are presented as the surface under the cumulative ranking (SUCRA) curve. A total of 20 RCTs assessing 6,560 patients were included. The general DA effects were ranked from high to low with respect to the amount of “ON” time without troublesome dyskinesia as follows: apomorphine (SUCRA = 97.08%), pramipexole_IR (probability = 79.00%), and ropinirole_PR (SUCRA = 63.92%). The general safety of DAs was ranked from high to low with respect to TEAE as follows: placebo (SUCRA = 74.49%), pramipexole_ER (SUCRA = 63.6%), sumanirole (SUCRA = 54.07%), and rotigotine (SUCRA = 53.84%).Conclusions: This network meta-analysis shows that apomorphine increased “ON” time without troublesome dyskinesia and decreased “OF” time for advanced PD patients. The addition of pramipexole, ropinirole, or rotigotine to levodopa treatment in advanced PD patients with motor fluctuations increased “ON” time without troublesome dyskinesia, improved the UPDRS III scores, and ultimately ameliorated the UPDRS II scores, thereby maximizing its benefit. This NMA of pramipexole, ropinirole, and rotigotine represents an effective treatment option and has an acceptable safety profile in patients with advanced PD.

scholarly journals Efficacy and safety of edaravone for acute intracerebral haemorrhage: protocol for a systematic review and meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e039366
Author(s):  
Luda Feng ◽  
Ning Liang ◽  
Tingting Li ◽  
Qinyu Yang ◽  
Ping Jiang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Intracerebral Haemorrhage ◽  
Meta Analysis ◽  
Grey Literature ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Routine Treatment ◽  
Manual Search

IntroductionIntracerebral haemorrhage (ICH) is a life-threatening condition with no effective internal treatment options. However, edaravone is a promising therapeutic agent, although its beneficial effects are inconclusive based on previous systematic reviews and meta-analyses. While several trials in the last 8 years have reported the favourable long-term functional outcomes, a few reports indicated edaravone to be associated with an increase in adverse events.Methods and analysisThis protocol was performed in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. We will perform the comprehensive and manual search for published articles, ongoing trials, dissertations and grey literature. The following databases will be searched from inception to 23 April 2020: Medline, Embase, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Chinese scientific periodical database of VIP INFORMATION, Wanfang Data and SinoMed, with no language restrictions. All randomised controlled trials that (1) compared edaravone with placebo or no treatment, and (2) compared edaravone plus routine treatment or cointervention with routine treatment or cointervention for treating acute ICH will be included. Mortality and long-term dependency will be the primary outcomes. The incidence of adverse events will be assessed for safety evaluation. Two reviewers in pairs will independently carry out the article selection, data extraction and quality assessment. Assessment of the risk of bias and data synthesis will be performed using software Review Manager V.5.3. Finally, we will use the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the quality of the overall evidence.Ethics and disseminationThere are no ethical considerations associated with this updated systematic review and meta-analysis. The findings will be disseminated in peer-reviewed journals or conference presentations.PROSPERO registration numberCRD42019147801.

scholarly journals Sodium-Glucose Co-Transporter-2 Inhibitors in Non-Diabetic Adults With Overweight or Obesity: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Hanrui Zheng ◽  
Min Liu ◽  
Sheyu Li ◽  
Qingyang Shi ◽  
Shengzhao Zhang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Body Weight ◽  
Placebo Group ◽  
Meta Analysis ◽  
Sglt2 Inhibitors ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Quality Evidence ◽  
Overweight Or Obesity

BackgroundSodium-glucose-cotransporter-2 (SGLT2) inhibitors have proven to be effective in improving glycemic control and lowering body weight in patients with type 2 diabetes mellitus. However, the efficacy and safety on weight loss in adults with overweight or obesity but not diabetes remain unclear. In this article, we aimed to identify the efficacy and safety of SGLT2 inhibitors in adults with overweight or obesity but not diabetes in randomized controlled studies (RCTs).MethodsWe searched for RCTs concerning SGLT2 inhibitors in adults with overweight or obesity but not diabetes in Medline (Ovid SP), Embase (Ovid SP), Cochrane Central Register of Controlled Trials (Ovid SP), and ClinicalTrials.gov up to February 2021. The primary outcomes were changes in body weight and body mass index (BMI). Trial sequential analysis (TSA) was used to test the reliability of the primary outcomes. We analyzed the data using Review Manager 5.3 and pooled data to calculate the mean differences (MDs) or the relative risk (RR). We assessed the evidence quality of evidence of outcomes according to GRADE.ResultsSix randomized controlled trials involving 872 individuals were included in the meta-analysis. Compared to the placebo group, the SGLT2 inhibitors group had statistically significant reductions in absolute changes in body weight (MD: -1.42 kg, 95% CI: -1.70 to -1.14; P&lt;0.00001) and BMI (MD: -0.47 kg/m2, 95% CI: -0.63 to -0.31; P&lt;0.00001) in SGLT2 inhibitors group, as indicated by TSA. However, no significant benefits were observed in the SGLT2 inhibitors group in terms of waist circumference (MD: -1.34 cm, 95%CI: -2.75 to 0.07; Z=1.86, P=0.06) compared with the placebo group. The GRADE profiles indicated very low-quality evidence for body weight change and low-quality evidence for BMI change. SGLT2 inhibitors were generally safe and well tolerated.ConclusionSGLT2 inhibitors could be used in selected adults with overweight and obesity but not diabetes if they are at low risk of genital infection and urinary infection. Further studies are warranted to confirm the efficacy and safety of SGLT2 inhibitors in adults with overweight or obesity but not diabetes for long-term weight management.Systematic Review Registration[https://www.crd.york.ac.uk/prospero/#loginpage], identifier [PROSPERO, CRD42021252931]

scholarly journals Efficacy and Safety of EUS-Guided Choledochoduodenostomy Using Electrocautery-Enhanced Lumen-Apposing Metal Stents (ECE-LAMS) in the Treatment of Biliary Obstruction: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Zuxiang Peng ◽  
Shan Li ◽  
Yongliang Tang ◽  
Wanjie Wei ◽  
Ruxian Pi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Biliary Obstruction ◽  
Clinical Success ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Metal Stents ◽  
Efficacy And Safety ◽  
Short Term

Background. Electrocautery-enhanced lumen-apposing metal stents (ECE-LAMS) have been newly developed to perform EUS-guided choledochoduodenostomy (EUS-CDS), but its benefits and harms remain obscure. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of EUS-CDS using ECE-LAMS. Method. In the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), we searched PubMed, Embase, and Scopus databases through January 1, 2001, and April 27, 2020. The primary outcomes of the pooled analysis were to determine the technical success, clinical success, and overall adverse events rates. The secondary outcomes were pooled rates of short-term and long-term adverse events. Results. Six studies with 270 patients were finally included in this meta-analysis. The pooled rates of technical, clinical success, and adverse events were 95.1% (95% CI = 90.6–97.5%, I2 = 25%), 93.3% (95% CI = 87.4–96.5%, I2 = 28%), and 15.3% (95% CI = 10.6–21.6%, I2 = 13%), respectively. The pooled rates of short-term and long-term adverse events were 3.6% (95% CI = 1.3–9.6%, I2 = 0%) and 11.3% (95% CI = 7.6–16.5%, I2 = 0%), respectively. Conclusion. EUS-CDS using ECE-LAMS provides favorable outcomes in patients with biliary obstruction. It has been associated with a higher success rate and a lower rate of adverse events when compared with the biliary drainage approaches previously used. Large and randomized controlled observational studies are required to further refine the findings in the present analysis.

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