Abstract 046: PCSK9 Inhibitors in Familial Hypercholesterolemia: a Meta-analysis of 9 Randomized Controlled Trials

Author(s):  
Avinainder Singh ◽  
Simon C Gaviria ◽  
Lourdes Chada ◽  
Omar Abu Qamar ◽  
Omar Soliman ◽  
...  

Background: The prevalence of Familial Hypercholesterolemia (FH) is estimated to be 1 in 250 US adults. The advent of PCSK9 inhibitors has led a to a paradigm shift in the management of these patients. The purpose of this study was to analyze the efficacy of PCSK9 inhibitors in patients with heterozygous or homozygous FH. Methods: Pubmed, EMBASE and clinicaltrials.gov were searched for randomized controlled trials of PCSK9 inhibitors. Trials that exclusively recruited FH patients or those that reported data separately for FH patients were included. The primary outcome of this analysis was mean difference in LDL-C in patients treated with a PCSK9 inhibitor compared with placebo. Secondary endpoints were change in other lipids and incidence of adverse events. A random effects model was used to analyze the pooled estimates. Results: A pooled analysis of 9 trials with a total of 1361 patients was performed. Overall the mean difference in LDL-C reduction with PCSK9 inhibition was -48.6% (95% CI: -51.3 to -45.9; p<0.001), as compared with placebo. There was no significant difference in LDL-C reduction between trials using alirocumab vs. those using evolocumab. There was significant heterogeneity among the included trials I 2 =75.9%. The risk of bias in all included studies was low. Conclusions: Among patients with FH, PCSK9 inhibitors were highly effective and reduced LDL-C levels by nearly 50% compared with placebo. No differences in magnitude of reduction were observed between alirocumab and evolocumab.

BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Liping Gou ◽  
Zhenghao Wang ◽  
Ye Zhou ◽  
Xiaofeng Zheng

Abstract Background A systematic review and meta-analysis was conducted to compare the safety and efficiency of nephroscopy and cystoscopy in transurethral cystolithotripsy (TUCL) for bladder stones (BS). Methods The PubMed, Web of Science, Embase, EBSCO, and Cochrane Library databases were searched up to January 2021 for studies assessing the effect of different types of endoscopes among patients who underwent TUCL. The search strategy and study selection process were in accordance with the PRISMA statement. Results Five randomized controlled trials were included in the meta-analysis. The results showed no difference in stone-free rate (RR = 1.00, CI = 0.98–1.02, p = 1.00) between the two groups and nonsignificant heterogeneity (I2 = 0%, p = 1.00), and all patients were rendered stone free. Use of the nephroscope significantly shortened the operative time compared with the cystoscope group (RR= − 26.26, CI = − 35.84 to − 16.68, p < 0.00001), and there was significant heterogeneity (I2= 87%, p < 0.00001). There was no significant difference in mean urethral entries (RR = 0.66, CI = − 0.71 to − 2.04, p = 0.35), hospitalization (MD = 0.08, 95% CI = − 0.07 to 0.23, p = 0.31) or total complication rate (RR=1.37, 95% CI = 0.47–4.00, p = 0.56) between the two groups. Conclusions In conclusion, this systematic review demonstrates that both nephroscopy and cystoscopy have high stone clearance efficiency, low rates of complications and short hospitalizations. The mean urethral entries depend on the treatment method for large stone fragments. However, the use of nephroscopy can significantly reduce the operative time.


2011 ◽  
Vol 96 (1) ◽  
pp. 21-27 ◽  
Author(s):  
M. R. S. Siddiqui ◽  
M. S. Sajid ◽  
A. Nisar ◽  
H. Ali ◽  
A. Zaborszky ◽  
...  

Abstract We conducted a meta-analysis of published literature comparing outcomes after aspirating (ASP) the gallbladder versus nonaspiration (NASP). Electronic databases were searched from January 1985 to November 2009. A meta-analysis was performed to obtain a summative outcome. Two randomized, controlled trials involving 360 patients were analyzed. A total of 180 patients were in the ASP group, and 180 were in the NASP group. There was no significant increase in operative time in the ASP group compared with the NASP group [random-effects model: standardized mean difference, −0.72; 95% confidence interval (CI), −2.16, 0.71; z  =  0.99; df  =  1; P  =  0.32], but there was significant heterogeneity among trials (Q  =  42.4; P &lt; 0.001; I2  =  98%). Patients undergoing ASP were less likely to have a gallbladder perforation [random-effects model: risk ratio (RR), 0.42; 95% CI, 0.19, 0.96; z  =  2.05; df  =  1; P &lt; 0.05], but no difference was found regarding the loss of gallstones (random-effects model: RR, 1.33; 95% CI, 0.30, 5.85; z  =  0.38; df  =  1; P  =  0.70). No difference was seen for liver bed bleeding (P  =  0.43) or overall 30-day infection rates (P  =  0.66). After aspiration, gallbladder perforation rates may be lower. This does not appear to translate into decreased loss of gallstones or infection rates. There was no significant difference between techniques in blood loss from the liver bed. Further randomized, controlled trials and follow-up studies are required to confirm these results and to establish long-term sequelae.


Author(s):  
Steve Barash ◽  
Verena Ramirez Campos ◽  
Xiaoping Ning ◽  
Maurice T. Driessen ◽  
Lynda J. Krasenbaum ◽  
...  

AbstractRecently, Gao et al. published an article titled “Monthly versus quarterly fremanezumab for the prevention of migraine: a systemic review and meta-analysis from randomized controlled trials” which concluded that monthly administration of fremanezumab led to significant reduction in monthly migraine days (MMD) when compared to quarterly fremanezumab. We have noted a critical flaw in Gao et al. meta-analysis wherein the authors have mistakenly utilized standard error values in place of standard deviation values in performing their pooled analyses. This error directly impacts the study results and conclusions. In this brief communication, we present revised analysis using correct methods. Using the correct SD values, our pooled analysis showed no significant difference in mean change from baseline in MMD between the two fremanezumab dosing regimens (P = 0.17). Furthermore, in the corrected subgroup analyses by type of migraine, there were no significant differences in mean change from baseline in MMD between monthly fremanezumab and quarterly fremanezumab (chronic migraine, P = 0.50; episodic migraine, P = 0.69). Overall, results from our corrected meta-analyses show that there is no significant difference in migraine prevention efficacy between monthly and quarterly fremanezumab dosing.


2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Xiaosheng Dong ◽  
Zhenguo Shi ◽  
Meng Ding ◽  
Xiangren Yi

Background. Hypertension has been a global public health problem. Qigong as a complementary and alternative therapy is often used to reduce blood pressure. The aim of this meta-analysis was to investigate the effects of Qigong on blood pressure in hypertensive patients. Methods. Six electronic resource databases were searched from inception to January 2019, and randomized controlled trials of Qigong on hypertension were retrieved. Meta-analysis was conducted according to the guidelines of the Cochrane Collaboration, and Review Manager 5.3 was applied. Two researchers independently identified articles to include based on inclusion/exclusion criteria, data extraction, and quality evaluation. Results. Fourteen studies, with 829 individuals, were included. The meta-analysis demonstrates that, compared with no exercise, Qigong has significant positive effects on systolic blood pressure (mean difference = −8.90, 95% CI (−12.13, −5.67), P < 0.00001 ) and diastolic blood pressure (mean difference = −5.02, 95% CI (−7.88, −2.17), P < 0.00001 ). There is, however, no significant difference between Qigong and other aerobic exercises in reducing blood pressure. Conclusion. Qigong can effectively reduce blood pressure levels. Longer-term engagement in the practice has an even better effect in hypertension patients. However, the conclusion of this study still needs to be verified by more high-quality studies.


2015 ◽  
Vol 44 (7) ◽  
pp. 1888-1895 ◽  
Author(s):  
Raman Mundi ◽  
Asheesh Bedi ◽  
Linda Chow ◽  
Sarah Crouch ◽  
Nicole Simunovic ◽  
...  

Background: Focal cartilage defects of the knee are a substantial cause of pain and disability in active patients. There has been an emergence of randomized controlled trials evaluating surgical techniques to manage such injuries, including marrow stimulation (MS), autologous chondrocyte implantation (ACI), and osteochondral autograft transfer (OAT). Purpose: A meta-analysis was conducted to determine if any single technique provides superior clinical results at intermediate follow-up. Study Design: Systematic review and meta-analysis of randomized controlled trials. Methods: The MEDLINE, EMBASE, and Cochrane Library databases were systematically searched and supplemented with manual searches of PubMed and reference lists. Eligible studies consisted exclusively of randomized controlled trials comparing MS, ACI, or OAT techniques in patients with focal cartilage defects of the knee. The primary outcome of interest was function (Lysholm score, International Knee Documentation Committee score, Knee Osteoarthritis Outcome Score) and pain at 24 months postoperatively. A meta-analysis using standardized mean differences was performed to provide a pooled estimate of effect comparing treatments. Results: A total of 12 eligible randomized trials with a cumulative sample size of 765 patients (62% males) and a mean (±SD) lesion size of 3.9 ± 1.3 cm2 were included in this review. There were 5 trials comparing ACI with MS, 3 comparing ACI with OAT, and 3 evaluating different generations of ACI. In a pooled analysis comparing ACI with MS, there was no difference in outcomes at 24-month follow-up for function (standardized mean difference, 0.47 [95% CI, –0.19 to 1.13]; P = .16) or pain (standardized mean difference, –0.13 [95% CI, –0.39 to 0.13]; P = .33). The comparisons of ACI to OAT or between different generations of ACI were not amenable to pooled analysis. Overall, 5 of the 6 trials concluded that there was no significant difference in functional outcomes between ACI and OAT or between generations of ACI. Conclusion: There is no significant difference between MS, ACI, and OAT in improving function and pain at intermediate-term follow-up. Further randomized trials with long-term outcomes are warranted.


2021 ◽  
Author(s):  
Liping Gou ◽  
Zhenghao Wang ◽  
Ye Zhou ◽  
Xiaofeng Zheng

Abstract Background: A systematic review and meta-analysis was conducted to compare the safety and efficiency of nephroscope and cystoscope in transurethral cystolithotripsy (TUCL) for bladder stones. Methods: PubMed, Web of Science, Embase, EBSCO, and the Cochrane library databases (updated January 2021) were searched for studies that assessed the efficacy of different types of endoscopes in TUCL cases. The search strategy and study selection process was managed according to the PRISMA statement. Results: Five randomized controlled trials were included in the meta-analysis. Our result showed no significant differences in the stone free rate (SFR) across the studies (RR= 1.00; CI 0.98–1.02, p = 1.00). The study heterogeneity (I2 = 0%, P = 1.00) was not significant as all patients were rendered stone free. Using nephroscope can significantly shorten operation times compared to the use of cystoscopy (RR= -26.26; CI -35.84 – -16.68, p < 0.00001) with significant heterogeneity (I2 =87%, p < 0.00001). There was no significant difference between mean urethral entries (RR= 0.66; CI -0.71 – -2.04, p = 0.35), hospitalization (MD = 0.08, 95% CI = -0.07-0.23; P=0.31) and the total complication rate (RR = 1.37, 95% CI = 0.47-4.00, p=0.56). Conclusions: This systematic review demonstrated that using are highly efficient approaches in the clearance of bladder stones and result in a low rate of complication and short hospitalization times. The mean urethral entries are dependent on the treatment method for large stone fragments. However, using nephroscope can significantly reduce operation times. Key words: bladder stones; transurethral; endoscopic treatments; cystoscope; nephroscope


2020 ◽  
Vol 27 (3) ◽  
pp. 291-298
Author(s):  
Yinyin Guo ◽  
Yanxin Luo ◽  
Hui Zhao ◽  
Liangliang Bai ◽  
Juan Li ◽  
...  

Background. A substantial proportion of patients undergoing colorectal surgery receive a temporary stoma, and the timing for stoma closure remains unclear. The aim of this study was to evaluate the safety and feasibility of early stoma closure (ESC) compared with routine stoma closure (RSC) after colorectal surgery. Methods. We comprehensively searched PubMed, Embase, and the Cochrane Library for randomized controlled trials that compared ESC and RSC after colorectal surgery. Results. A total of 7 randomized controlled trials with 814 enrolled patients were identified for this meta-analysis. There were no significant differences between the ESC and RSC groups regarding the complications of stoma closure (26.8% and 16.6%, respectively; odds ratio [OR]: 1.30; 95% confidence interval [CI]: 0.89-1.90; P = .17). A subgroup analysis was conducted by Clavien-Dindo grade of complication, and no significant difference was observed in any subgroup ( P > .05). However, the ESC group had a significantly higher risk of wound complications than the RSC group (17.6% and 7.8%, respectively; OR: 2.61; 95% CI: 1.43-4.76; P = .002), and the RSC group had more cases of small bowel obstruction than the ESC group (3.1% and 8.4%, respectively; OR: 0.37; 95% CI: 0.15-0.87; P = .02). Conclusions. ESC is a safe and effective therapeutic approach in patients who have undergone colorectal surgery; it is associated with a reduced risk of bowel obstruction but a higher risk of wound complications.


2020 ◽  
Vol 9 (10) ◽  
pp. 3151
Author(s):  
Chang-Hoon Koo ◽  
Jin-Woo Park ◽  
Jung-Hee Ryu ◽  
Sung-Hee Han

Virtual reality (VR), a technology that provides a stimulated sensory experience, has recently been implemented in various fields of medicine. Several studies have investigated the efficacy of VR on preoperative anxiety. The purpose of this meta-analysis was to validate whether VR could relieve preoperative anxiety in patients undergoing surgery. Electronic databases were searched to identify all randomized controlled trials (RCTs) investigating the effect of VR on preoperative anxiety. The primary outcome was defined as the preoperative anxiety scores. We estimated the effect size using the standard mean difference (SMD) with a 95% confidence interval (CI) using a random effect model. Ultimately, 10 RCTs, with a total of 813 patients, were included in the final analysis. Preoperative anxiety was significantly lower in the VR group than in the control group (SMD −0.64, 95% CI −1.08 to −0.20, p = 0.004). In a subgroup analysis, the preoperative anxiety scores were lower in the VR group than in the control group in pediatric patients (SMD −0.71, 95% CI −1.14 to −0.27, p = 0.002), whereas a significant difference was not observed between the two groups in adult patients (p = 0.226). The results of this meta-analysis indicated that VR could decrease preoperative anxiety, especially in pediatric patients.


2021 ◽  
Vol 8 ◽  
Author(s):  
Alberto Domínguez-Rodríguez ◽  
Pedro Abreu-González ◽  
Néstor Báez-Ferrer ◽  
Russel J. Reiter ◽  
Pablo Avanzas ◽  
...  

Myocardial ischemia/reperfusion (IR) injury represents a critical problem associated with interventional approaches for coronary reperfusion. Pharmacological cardioprotective interventions are advocated to ameliorate IR injury. Melatonin is an anti-inflammatory and antioxidant agent with a wide range of therapeutic properties that may contribute to its cardioprotective effects. No systematic review or meta-analysis has compared melatonin vs. placebo as a cardioprotective agent in humans. The present study, based on a systematic review and meta-analysis, was carried out to assess melatonin's efficacy as a cardioprotective treatment. We performed a systematic review of the available literature. Randomized controlled trials (RCTs) were identified and information was extracted using predefined data extraction forms. The primary outcomes were (a) left ventricular ejection fraction (LVEF) and (b) blood troponin levels in patients who underwent myocardial revascularization and were randomized to melatonin or placebo. The inverse-variance random-effects method was used to pool the estimates. Heterogeneity and publication bias were assessed. Weighted mean differences or standardized mean differences were calculated. A total of 283 records were screened and seven RCTs met all the inclusion criteria. After the pooled analysis, the results on LVEF were consistent across all studies, and a significant heterogeneity was found in the results on troponin levels. The melatonin-treated patients had on average higher LVEF than the placebo-treated individuals with a weighted mean difference = 3.1% (95% CI 0.6–5.5, p = 0.01). Five works compared the levels of troponin after melatonin or placebo treatment. The melatonin-treated patients had lower levels of troponin with a standardized mean difference = −1.76 (95% CI −2.85 to −0.67, p = 0.002). The findings of this meta-analysis revealed that melatonin administration in humans as a cardioprotective agent attenuated heart dysfunction with a favorable effect on the LVEF.


2018 ◽  
Vol 7 (8) ◽  
pp. 208 ◽  
Author(s):  
I-Ling Cheng ◽  
Yu-Hung Chen ◽  
Chih-Cheng Lai ◽  
Hung-Jen Tang

This meta-analysis aims to compare intravenous colistin monotherapy and colistin-based combination therapy against carbapenem-resistant gram-negative bacteria (GNB) infections. PubMed, Embase, and Cochrane databases were searched up to July 2018. Only randomized controlled trials (RCTs) evaluating colistin alone and colistin-based combination therapy in the treatment of carbapenem-resistant GNB infections were included. The primary outcome was all-cause mortality. Five RCTs including 791 patients were included. Overall, colistin monotherapy was associated with a risk ratio (RR) of 1.03 (95% confidence interval (CI), 0.89–1.20, I2 = 0%) for all-cause mortality compared with colistin-based combination therapy. The non-significant difference was also detected in infection-related mortality (RR, 1.23, 95% CI, 0.91–1.67, I2 = 0%) and microbiologic response (RR, 0.86, 95% CI, 0.72–1.04, I2 = 62%). In addition, no significant difference was observed in the subgroup analysis—high or low dose, with or without a loading dose, carbapenem-resistant Acinetobacter baumannii infections, and in combination with rifampicin. Finally, colistin monotherapy was not associated with lower nephrotoxicity than colistin combination therapy (RR, 0.98; 95% CI, 0.84–1.21, I2 = 0%). Based on the analysis of the five RCTs, no differences were found between colistin monotherapy and colistin-based combination therapy against carbapenem-resistant GNB infections, especially for A. baumannii infections.


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