Efficacy and safety of Nivolumab in patients with advanced esophageal, gastroesophageal, and gastric cancers: a meta-analysis of randomized controlled trials.

BACKGROUND: Immune checkpoint inhibitors (ICI) have revolutionized care in oncology with improved overall survival in several cancer populations. Nivolumab has recently been approved for use in patients with upper gastrointestinal cancers. We quantitatively summarized the efficacy and safety of Nivolumab use in patients with advanced esophageal, gastroesophageal, and gastric carcinoma compared to standard chemotherapy. METHODS: Systemic search of electronic databases was performed to analyze phase III randomized controlled trials (RCTs) comparing Nivolumab versus standard chemotherapy in patients with advanced upper gastrointestinal cancers. Primary endpoints were overall survival (OS) and progression-free survival (PFS). Data were pooled using random effects model via RevMan 5.4 software. RESULTS: Four RCTs with a total of 3369 patients and a median follow-up of 13 months were included. The patients' mean age was 61 ± 20 years, 74.6% were males, and 26% had ≥1% PD-L1 expression. Compared to the chemotherapy group, Nivolumab group had a significantly favorable OS and PFS [HR 0.81;95% CI (0.74, 0.89), p < .001], [HR 0.82;95% CI (0.69, 0.98), p = .03], respectively. Nivolumab significant effect was only in patients with ≥1% PD L1 expression [HR 0.72; 95% CI (0.58, 0.89), p < .001]. No statistical difference was detected between groups regarding serious adverse effects (AE) [OR 1.47; 95%CI (0.94,2.31), p = 0.09]. CONCLUSIONS: Compared to standard chemotherapy, the use of Nivolumab in patients with advanced esophageal, gastroesophageal, and gastric cancers is associated with improved overall and progression-free survival, with similar rates of AE and AE leading to death. The improvement in survival was significant in patients with ≥1% PD L1 expression.

Gender-based outcomes of coronary bifurcation stenting: A report from the National Readmission Database.

BACKGROUND: There is a paucity of data focusing on women's outcomes after percutaneous coronary interventions (PCI) for coronary bifurcation lesions (CBLs). METHODS: Patients who received PCI for CBLs in the context of acute coronary syndrome (ACS) during the period of 01 October 2015- 31 December 2017, were identified from the United States National Readmission Database. The primary endpoint of this study was in-hospital major adverse events (MAEs). The secondary endpoints were in-hospital mortality, vascular complications, major bleeding, post-procedural bleeding, need for blood transfusion, severe disability surrogates (non-home discharge and need for mechanical ventilation), resources utilization surrogates (length of stay and cost of hospitalization), and 30-day readmission rate. A 1:1 propensity score matching was used to compare the outcomes between women and men. RESULTS: A total of 25,050 (women = 7,480; men = 17,570) patients were included in the current analysis. After propensity score matching, women had higher in-hospital MAEs (7 vs 5.2%, p < .01), major bleeding (1.8 vs 0.8%, p < .01), post-procedural bleeding (6.1 vs 3.4%, p < .01), need for blood transfusion (6.4 vs 4.2%, p < .01), non-home discharges (10.2 vs 7.1%; p < .01), longer length of hospital stay (3 days [IQR 2-6] vs. 3 days [IQR 2-5], p < .01) and higher 30-day readmission rate compared to men (14.2 vs. 11.5%, p < .01). CONCLUSIONS: Among all-comers who received PCI for CBLs in the context of ACS, women suffered higher MAEs and 30-day readmission rates compared to their men' counterparts. The higher MAEs in the women were mainly driven by higher postprocedural bleeding rates and the need for blood transfusion.

Hypoxia inducible factor-prolyl hydroxylase inhibitors in anemic patients with non-dialysis dependent chronic kidney disease: a meta-analysis of randomized clinical trials.

PURPOSE: Anemia persists as a challenge in chronic kidney disease (CKD) patients. Current therapies are the injectable erythropoietin stimulating agents (ESA). Concerns have been raised regarding ESA cardiovascular safety, therefore search for an alternative, convenient and safe therapy is underway. Hypoxia inducible factors-prolyl hydroxylase inhibitors (HIF-PHI) are oral agents with promising results. Numerous small studies reported favorable effects with lack of large, powered studies. METHODS: We conducted a meta-analysis of randomized clinical trials to assess the efficacy and safety of HIF-PHI in non-dialysis-dependent CKD patients. Primary outcome was hemoglobin (Hb) concentration post intervention. Secondary outcomes were all-cause mortality, MACE, and changes in iron metabolism (ferritin, hepcidin). We reported total and serious adverse effects. Data were pooled using a random effect model via RevMan 5.4 software. RESULTS: We identified 7 trials comprising of 8228 patients (mean age 66.5 ± 13.2 years, 42% were females, 53% used iron replacement) with a mean follow-up of 52 weeks. Compared with the standard of care (ESA), HIF-PHI were non-inferior for treatment of anemia, with comparable effect on mortality and major adverse cardiovascular events. HIF-PHI showed no major safety concerns. Main side effect of HIF-PHI was diarrhea. CONCLUSION: HIF-PHI might represent a safe, and convenient alternative to ESA in non-dialysis dependent CKD patients with anemia.

Meta-analysis comparing dexmedetomidine versus standard of care for sedation in patients with sepsis.

We aimed to evaluate the clinical benefits of dexmedetomidine (DEX) in comparison with the standard of care (SOC) sedation in critically ill, septic patients. Electronic databases (PubMed, EMBASE, Cochrane Central, Scopus, and Google Scholar) were systematically searched to identify only randomized clinical trials performed up until February 12, 2021. The primary outcomes were 28-day mortality, 90-day mortality, and intensive care unit (ICU) length of stay (LOS). We calculated risk ratios (RRs), 95% confidence intervals (CIs) for dichotomous data, and weighted mean differences (WMDs) for continuous data using a random-effects model. Seven randomized clinical trials were included, with a total of 529 patients in the DEX group and 520 patients in the SOC group. Compared with SOC, DEX was associated with a nonstatistically significant reduced 28-day mortality (RR = 0.76; 95% CI [0.51, 1.14]; P = 0.19), 90-day mortality (RR = 0.94; 95% CI [0.75, 1.18]; P = 0.60), and ICU LOS (WMD = -0.85; 95% CI [-2.60, 0.90]; P = 0.34). We conclude that among septic patients on sedation, the use of DEX in the ICU demonstrated no significant difference from SOC sedation protocols with respect to 28-day mortality, 90-day mortality, and total ICU LOS. Our findings suggest that DEX does not confer clinical benefit over SOC sedation in critically ill patients with sepsis.

POEMS Syndrome - A Diagnostic Dilemma with Challenging Presentation.

Polyneuropathy, Organomegaly, Endocrinopathy, M-protein, Skin changes (POEMS) syndrome is a rare disorder with multiple presentations and a constellation of symptoms. We present a 62 year-old female who presented to the Emergency Department for acute dyspnea. Chest Xray showed sclerotic lesions in the ribs and thoracic spine. Further imaging studies with computed tomography (CT) and positron emission tomography (PET) scans were suggestive of a benign process. Improvement was seen with supportive management. A few months later, patient developed neurological symptoms with reduced exercise tolerance. Mixed demyelinating and axonal polyneuropathy was diagnosed by electromyography. Further work up with bone marrow biopsy and immunochemistry testing revealed lambda and kappa plasma cell disorder, with elevated vascular endothelial growth factor (VEGF). Patient was diagnosed with POEMS and initiated on chemotherapy. POEMS syndrome is commonly missed due to its rarity and varied clinical presentations. VEGF plays a crucial role in the diagnosis. Management requires a multidisciplinary approach.

Acute motor axonal neuropathy following SARS-CoV-2 infection in the third trimester of pregnancy.

Neurological complications following SARS-CoV-2 infections are increasingly recognized. Despite that, sequelae from SARS-CoV-2 infection in gravid women are uncommonly reported. We present a case of acute motor axonal neuropathy, a variant of Guillain-Barre syndrome, in a 26-year-old primigravida at 34 weeks' gestation. She presented with worsening diplopia, dysphagia, and lower extremity sensory and motor deficits after testing positive for SARS-CoV-2 2 weeks earlier. Due to rapidly progressive symptoms, she required endotracheal intubation and mechanical ventilation. Initially she was diagnosed with Miller Fisher syndrome, but serology and electromyography studies were consistent with acute motor axonal neuropathy. Spontaneous preterm delivery, supportive care, and intravenous immunoglobulin therapy resulted in clinical improvement. Steady recovery was achieved by a prolonged rehabilitation program.

Terlipressin effect on hepatorenal syndrome: Updated meta-analysis of randomized controlled trials.

BACKGROUND AND AIM: Hepatorenal syndrome (HRS) is a fatal complication of liver cirrhosis with a limited pharmacological option. Terlipressin is a vasoconstrictor that is approved in many countries but not yet in the United States. This is a meta-analysis of randomized controlled trials (RCTs) to review terlipressin effect on HRS and the safety profile. METHODS: We searched electronic databases for RCTs comparing terlipressin versus placebo in addition to albumin in patients with type 1 or 2 HRS. Primary outcome was HRS reversal. Secondary outcomes were change in serum creatinine (Cr), requirement for renal replacement therapy (RRT) at 30 days of randomization, and 90-day survival. Risk ratios (RRs) and mean differences (MD) were calculated with 95% confidence intervals (CIs) using a random-effects model. RESULTS: We identified eight RCTs with a total of 974 patients, and median follow up of 100 days. Mean age was 55 ± 10 years, 61% were males. Alcoholic liver disease represented 56%. Compared with placebo, terlipressin was associated with a significantly higher likelihood of HRS reversal (RR 2.08; 95% CI [1.51, 2.86], P < 0.001), significantly lower serum Cr (MD -0.64; 95% CI (-1.02, -0.27), P < 0.001], and a trend toward less RRT requirements (RR 0.61; 95% CI [0.36, 1.02], P = 0.06). There was no difference in survival at 90 days between groups (RR 1.09; 95% CI (0.84, 1.43), P = 0.52). Major adverse effects (AEs) were gastrointestinal cramps, discomfort, and respiratory distress. CONCLUSION: In patients with liver cirrhosis complicated by HRS, terlipressin was associated with significant HRS reversal and decrease in serum Cr. No survival benefit was detected at 90 days.

Ebola hemorrhagic fever under scope, view of knowledge, attitude and practice from rural Sudan in 2015.

Ebola hemorrhagic fever (EHF) is an emerging threat to public health. The last epidemic in West Africa had a great effect on the affected communities. Timely and effective interventions were necessary in addition to community participation to control the epidemic. The knowledge, attitude and practices of vulnerable communities remain unknown, particularly in Sudan. The aim of this study was to explore the knowledge, attitude and practices of rural residents in Sudan regarding Ebola hemorrhagic fever. We conducted a cross sectional, community-based large-scale study in Al Gaziera state in rural Sudan in eight localities. In total, 1500 random adult participants were selected. The participants were assessed by a predesigned pretested questionnaire regarding their knowledge, attitude and practices regarding Ebola. Their sources of information were determined, and we assessed demographic factors as predictors of knowledge. We found poor knowledge, a fair attitude and suboptimal practices among the participants. The main sources of information were the press and media. Education was the only predictor of knowledge regarding Ebola. A lack of knowledge and suboptimal preventive practices mandates orientation and education programs to raise public awareness. Health care providers are advised to engage more in educating the community.