ABSTRACT
Background: Etrolizumab is a promising drug for treating moderate to severe ulcerative colitis. Aim: The aim of this study was to assess the efficacy and safety of etrolizumab for induction and maintenance of remission in moderate to severe ulcerative colitis. Methods: We searched the following databases: PUBMED, Web of Science, OVID, and SCOPUS from inception to January 15. Inclusion criteria were any phase 2 and 3 clinical trials that compared etrolizumab with a placebo in treating moderate to severe ulcerative colitis, excluding case reports, animal studies, phase 1 trials, and conference abstracts due to duplication. We used RevMan software (5.4) for the meta-analysis. Results: Five clinical trials were included in our meta-analysis. The total number of patients included in the study is 1248 patients, 860 patients in the etrolizumab group and 388 patients in the placebo group. In the induction phase, the pooled analyses showed a statistically significant association between etrolizumab and increased clinical remission, and endoscopic remission compared with placebo (risk ratio [RR] = 2.66, 95% confidence interval [CI] = 1.69-4.19, p < 0.0001), and (RR = 2.35, 95% CI = 1.52-3.65, p = 0.0001), respectively. In the maintenance phase, the pooled analyses showed a statistically significant association between etrolizumab and increased histologic remission and endoscopic remission (RR = 2.04, 95% CI = 1.40-2.98, p = 0.0002) and (RR = 1.92, 95% CI = 1.29-2.85, p = 0.001), respectively. No statistically significant difference was observed in adverse events between etrolizumab and placebo in the induction and maintenance phases. Conclusion: Our results show that etrolizumab is an effective and safe drug for the induction and maintenance of clinical remission in moderate to severe ulcerative colitis patients, as proved by histologic and endoscopic findings. Future randomized trials are still needed to compare etrolizumab to the other agents and further establish its value for the practice.
ABSTRACT
Purpose: To evaluate the effect of polypills on the primary prevention of cardiovascular (CV) events using data from clinical trials. Methods: We searched PubMed, Web of Science, EBSCO, and SCOPUS throughout May 2021. Two authors independently screened articles for the fulfillment of inclusion criteria. The RevMan software (version 5.4) was used to calculate the pooled risk ratios (RRs) and mean differences (MDs), along with their associated confidence intervals (95% CI). Results: Eight trials with a total of 20653 patients were included. There was a significant reduction in the total number of fatal and non-fatal CV events among the polypill group [RR (95% CI) = 0.71 (0.63, 0.80); P-value < 0.001]. This reduction was observed in both the intermediate-risk [RR (95% CI) = 0.76 (0.65, 0.89); P-value < 0.001] and high-risk [RR (95% CI) = 0.63 (0.52, 0.76); P-value < 0.001] groups of patients. Subgroup analysis was performed based on the follow-up duration of each study, and benefits were only evident in the five-year follow-up duration group [RR (95% CI) = 0.70 (0.62, 0.79); P-value < 0.001]. Benefits were absent in the one-year-or-less interval group [RR (95% CI) = 0.77 (0.47, 1.29); P-value = 0.330]. Additionally, there was a significant reduction in the 10-year predicted cardiovascular risk in the polypill group [MD (95% CI) = -3.74 (-5.96, -1.51); P-value < 0.001], as compared to controls. Conclusion: A polypill regimen decreases the incidence of fatal and non-fatal CV events in patients with intermediate- and high- cardiovascular risk, and therefore may be an effective treatment for these patients.
