Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors and Ezetimibe on Risk of New-Onset Diabetes: A Systematic Review and Meta-Analysis of Large, Double-Blinded Randomized Controlled Trials

2020 ◽  
Vol 25 (5) ◽  
pp. 409-417
Author(s):  
Sarah W. Chiu ◽  
Cristina M. Pratt ◽  
Richard Feinn ◽  
Saurav Chatterjee
Keyword(s):  
Randomized Controlled Trials ◽  
Incident Diabetes ◽  
Controlled Trials ◽  
Diabetes Incidence ◽  
Proprotein Convertase ◽  
Randomized Controlled ◽  
Onset Diabetes ◽  
Meta Analyses ◽  
Double Blinded ◽  
New Onset

Background: Previous meta-analyses have shown that statins may cause incident diabetes. This article reviews randomized controlled trials using proprotein convertase subtilisin/kexin 9 inhibitors (PCSK9i) or ezetimibe on the risk of new-onset diabetes. Methods: Eight trials involving PCSK9i and 3 trials of ezetimibe were selected for review. PubMed, Cochrane Central Register of Controlled Trials, and Clinicaltrials.gov were thoroughly searched for relevant trials. Inclusion criteria included at least 100 patients per treatment arm, follow-up of at least 52 weeks, and at least double-blinded study design. Exclusion criteria included patients with previously diagnosed diabetes, nonrandomized, placebo-controlled, open-label, and crossover trials. The primary outcome was the number of incident diabetes cases. A random effects model was used. Heterogeneity in effect sizes was measured with I 2 parameter and the Q statistic was used to test for excessive between-study heterogeneity. Results: A total of 52 214 participants for the PCSK9i and a total of 20 084 for the ezetimibe meta-analyses were included. Participants randomized to PCSK9i did not differ from the control patients in diabetes incidence (risk ratio [RR] = 0.99, P = .87, 95% CI = 0.92-1.07). Participants randomized to ezetimibe did not differ from the control patients in diabetes incidence (RR = 1.05, P = .37, 95% CI = 0.95-1.15). Discussion: The use of PCSK9i and ezetimibe does not appear to impact the risk of incident diabetes mellitus when added to guideline-directed medical therapy.

scholarly journals Pre-Procedural Lumbar Neuraxial Ultrasound—A Systematic Review of Randomized Controlled Trials and Meta-Analysis

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 479
Author(s):  
Tatiana Sidiropoulou ◽  
Kalliopi Christodoulaki ◽  
Charalampos Siristatidis
Keyword(s):  
Systematic Review ◽  
Lumbar Spine ◽  
Randomized Controlled Trials ◽  
Success Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Technical Failure ◽  
Obese Patients ◽  
Randomized Controlled ◽  
Meta Analyses

A pre-procedural ultrasound of the lumbar spine is frequently used to facilitate neuraxial procedures. The aim of this review is to examine the evidence sustaining the utilization of pre-procedural neuraxial ultrasound compared to conventional methods. We perform a systematic review of randomized controlled trials with meta-analyses. We search the electronic databases Medline, Cochrane Central, Science Direct and Scopus up to 1 June 2019. We include trials comparing a pre-procedural lumbar spine ultrasound to a non-ultrasound-assisted method. The primary endpoints are technical failure rate, first-attempt success rate, number of needle redirections and procedure time. We retrieve 32 trials (3439 patients) comparing pre-procedural lumbar ultrasounds to palpations for neuraxial procedures in various clinical settings. Pre-procedural ultrasounds decrease the overall risk of technical failure (Risk Ratio (RR) 0.69 (99% CI, 0.43 to 1.10), p = 0.04) but not in obese and difficult spinal patients (RR 0.53, p = 0.06) and increase the first-attempt success rate (RR 1.5 (99% CI, 1.22 to 1.86), p < 0.0001, NNT = 5). In difficult spines and obese patients, the RR is 1.84 (99% CI, 1.44 to 2.3; p < 0.0001, NNT = 3). The number of needle redirections is lower with pre-procedural ultrasounds (SMD = −0.55 (99% CI, −0.81 to −0.29), p < 0.0001), as is the case in difficult spines and obese patients (SMD = −0.85 (99% CI, −1.08 to −0.61), p < 0.0001). No differences are observed in procedural times. Ιn conclusion, a pre-procedural ultrasound provides significant benefit in terms of technical failure, number of needle redirections and first attempt-success rate. Τhe effect of pre-procedural ultrasound scanning of the lumbar spine is more significant in a subgroup analysis of difficult spines and obese patients.

scholarly journals A guide to do randomized controlled trials in the field of otolaryngology

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Sameh M. Zamzam ◽  
Mosaad Abdel-Aziz ◽  
Ahmed Atef ◽  
Usama Abdel-Naseer ◽  
Mostafa Hamoda ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Study Groups ◽  
Controlled Trials ◽  
Main Body ◽  
Main Research ◽  
Randomized Controlled ◽  
New Treatment ◽  
Meta Analyses ◽  
Based Medicine

Abstract Background Randomized controlled trials (RCTs) are prospective comparative studies in which study groups are allocated randomly to intervention or serve as controls. RCT is the mainstay to achieve evidence in the literature in clinical research. A RCT is the main research design to study the effect of an intervention and the only way to confirm the value of a new treatment. Main body RCT also gives the way to generate meta-analyses and systematic reviews giving a stronger evidence for clinical practice. Evidence-based medicine (EBM) is crucial for safe, effective, and standardized patient care. Although there is an agreement on the importance of performing RCT, it can be challenging to do it efficiently including different aspects like study design, funding, randomization, blinding, follow-up, data analysis, statistics, generalization of results, and reporting of quality of the studies. Conclusion In this article, we gave a comprehensive review for RCT in otolaryngology discussing their importance, advantages, and drawbacks, types, steps, challenges, reporting their quality and their prevalence in the literature.

scholarly journals Vitamin D and new-onset atrial fibrillation: A meta-analysis of randomized controlled trials

2018 ◽  
Vol 59 (2) ◽  
pp. 72-77 ◽  
Author(s):  
Wei-ling Huang ◽  
Jun Yang ◽  
Jian Yang ◽  
Hui-bo Wang ◽  
Chao-jun Yang ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin D ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Onset Atrial Fibrillation ◽  
New Onset

scholarly journals Effects of Vitamin D Supplementation on Glucose and Insulin Homeostasis and Incident Diabetes among Nondiabetic Adults: A Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Huilin Tang ◽  
Deming Li ◽  
Yufeng Li ◽  
Xi Zhang ◽  
Yiqing Song ◽  
...  
Keyword(s):  
Vitamin D ◽  
Randomized Controlled Trials ◽  
Cell Function ◽  
Meta Analysis ◽  
Vitamin D Supplementation ◽  
Incident Diabetes ◽  
Controlled Trials ◽  
Insulin Metabolism ◽  
Randomized Controlled ◽  
Insulin Homeostasis

Aims. Emerging evidence has suggested a mechanistic link from vitamin D metabolism to glucose and insulin homeostasis. This study is aimed at specifically quantifying the direct effects of vitamin D supplementation on indexes of glucose and insulin homeostasis as well as incidence of type 2 diabetes (T2D) among nondiabetic adults. Methods. We systematically searched randomized controlled trials (RCTs) of vitamin D supplementation in nondiabetic adults in PubMed, EMBASE, and CENTRAL. Random-effects meta-analysis was conducted to pool the estimates. Results. Our meta-analysis included 47 RCTs involving 44,161 nondiabetic individuals with a median trial duration of 4 months and a median dose of 4000 IU/d. Vitamin D supplementation significantly reduced fasting glucose by 0.11 mmol/L, fasting insulin by 1.47 mIU/L, and HOMA-IR by 0.32 while increasing total 25 (OH) D levels by 40.14 nmol/L. We found no significant effects of vitamin D supplementation on insulin secretion or beta cell function indexes. Based on the data from six trials involving 39,633 participants and 2533 incident T2D cases, vitamin D supplementation was not associated with the risk of incident diabetes compared to placebo (pooled relative risk: 1.01, 95% confidence interval: 0.93 to 1.08). Conclusions. Our meta-analysis found that vitamin D supplementation might improve glucose and insulin metabolism without affecting the risk of T2D among nondiabetic adults.

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