Impact of lipophilic vs hydrophilic statins on the clinical outcome and biomarkers of remodelling in heart failure patients: A prospective comparative randomized study.

AIMS: There are insufficient direct comparative studies addressing the impact of the type of statin on their respective efficacy in heart failure (HF). The aim of the current study was to compare the effects of lipophilic (atorvastatin) vs hydrophilic (rosuvastatin) on left ventricular function, inflammatory and fibrosis biomarkers in patients with chronic HF. METHODS: This was a prospective, randomized, comparative, parallel study. A total of 85 patients with chronic HF optimized on guideline directed therapy were randomized to receive either atorvastatin 40 mg (n = 42) or rosuvastatin 20 mg (n = 43) for 6 months. Baseline and follow-up assessment included 2D echocardiography, measurement of N-terminal pro-brain natriuretic peptide, interleukin-6 and soluble suppression of tumorigenicity 2 (sST2) levels, liver enzymes and lipid profile. RESULTS: The increase in left ventricular ejection fraction was significantly higher in the atorvastatin group compared to the rosuvastatin group (6.5% [3-11] vs 4% [2-5], P = .006). The reduction in left ventricular end diastolic and end systolic volume was comparable between the 2 groups. The decrease in sST2 levels in pg/mL was significantly higher in the atorvastatin compared to the rosuvastatin group (-255 [-383 to -109.8 vs - 151 [-216 to -69], P = .003). There was a significant reduction in N-terminal pro-brain natriuretic peptide and interleukin-6 levels in both groups, yet the reduction was comparable in both groups. CONCLUSION: The study results suggest that lipophilic atorvastatin is superior to hydrophilic rosuvastatin in increasing left ventricular ejection fraction and reducing fibrosis marker sST2 in HF patients. Trial registration ID: NCT03255044, registered on 21 August 2017.

The efficacy and safety of itopride in feeding intolerance of critically ill patients receiving enteral nutrition: a randomized, double-blind study.

BACKGROUND: Enteral feeding intolerance (EFI) is a frequent problem in the Intensive care unit (ICU) and is associated with poor clinical outcomes leading to worse prognosis in terms of mortality and ICU stay. Nowadays, prokinetic drugs are the mainstay of therapy in EFI. However, available prokinetics have uncertain efficacy and safety profiles. Itopride, is a prokinetic agent which is different and unique from the available prokinetics because of its dual mode of action as well as its tolerability and safety. The current study compared the efficacy and safety of Itopride against metoclopramide for EFI in critically ill patients. Moreover, it tested the utility and applicability of ultrasonography to measure gastric residual volume (GRV) in this population. METHODS: This randomized, double-blind study included 76 EFI patients who were randomly assigned to either Itopride or metoclopramide group. The primary outcome was to measure GRV by ultrasonography. Secondary outcomes included the percentage ratio of enteral feed volume, energy and protein received by patients over 7 days of treatment, ICU length of stay, safety parameters and occurrence of infectious complications or vomiting. RESULTS: Thirty-five patients of each group completed the study. At day 7, itopride significantly decreased GRV compared with metoclopramide group (p = 0.001). Moreover, there was a significant increase in the ratios of received enteral nutrition feed volume, calories, and protein after the one-week therapy in the itopride group more than the metoclopramide group (p = 0.001), (p = 0.002), (p = 0.01), respectively and there were no differences in any secondary outcomes or adverse events between the two groups. CONCLUSION: In critically ill patients with EFI, itopride was well tolerated with superior efficacy to metoclopramide. In addition, we demonstrated that ultrasonography is a simple, non-invasive, inexpensive, and undemanding method for GRV measurements and can offer reliable assessments in the gastric emptying modality. TRIAL REGISTRATION: The trial was registered in ClinicalTrials.gov (NCT03698292). Date: October 5, 2018.

Impact of Docosahexaenoic acid supplementation on proinflammatory cytokines release and the development of Necrotizing enterocolitis in preterm Neonates: A randomized controlled study.

INTRODUCTION: Preterm neonates have under-developed immune-regulatory system; consequently, there is a risk for developing chronic inflammation. Necrotizing enterocolitis (NEC) is an acute devastating neonatal intestinal inflammatory disorder. Due to the obscure multifactorial etiology, early diagnosis and effective treatment of NEC are limited. Consequently, effective strategies in the prevention of NEC, including nutritional approaches, are critically needed. The current study was conducted to assess the potential immunomodulatory effect of Docosahexaenoic Acid (DHA) supplementation in preterm neonates at neonatal intensive care unit (NICU) and subsequently its effect on preventing or reducing NEC incidence. METHODS: This was a prospective randomized controlled study. A total of 67 neonates, with gestational age equal or less than 32 weeks at birth and weight less than or equal 1500 g, were randomly assigned to either DHA group or the control group. Modified Bell's staging criteria for NEC was used as an objective tool for diagnosis and staging of NEC. Levels of Interleukin 1 beta (IL-1ß) were measured at baseline and after 10 days. Mortality and NICU length of stay (LOS) were also monitored. RESULTS: Thirty neonates of each group completed the study. A statistically significant difference was observed between the two groups regarding diagnosis and staging of NEC (p = 0.0001). There was also a statistically significant difference between DHA group 22(73.3), 95% CI [55.9, 86.5] and the control group 8 (26.7), 95% CI [13.5, 44.1] in the percentage change in IL-1ß levels (p = 0.0001).A statistically significant association was found between IL and 1 ß change and NEC diagnosis (p = 0.001). NICU LOS was significantly lower among DHA group 21.63 ± 6.67 compared to the control group 25.07 ± 4.67 (p = 0.025). Mortality n (%) among the control group 4 (11.8) was higher than DHA group 3 (9.1), however, no significant difference was detected (p = 1.0). CONCLUSION: Findings of this study suggest that enteral DHA supplementation can reduce NEC incidence in preterm neonates through its immunoregulatory effect that modulates production of regulatory cytokines.Trial registration: Registered at clinical trials.gov (NCT03700957), 6 October 2018.

A tool for assessment of heart failure prescribing quality: A systematic review and meta-analysis.

INTRODUCTION: Heart failure (HF) guidelines aim to standardise patient care. Internationally, prescribing practice in HF may deviate from guidelines and so a standardised tool is required to assess prescribing quality. A systematic review and meta-analysis were performed to identify a quantitative tool for measuring adherence to HF guidelines and its clinical implications. METHODS: Eleven electronic databases were searched to include studies reporting a comprehensive tool for measuring adherence to prescribing guidelines in HF patients aged ≥18 years. Qualitative studies or studies measuring prescription rates alone were excluded. Study quality was assessed using the Good ReseArch for Comparative Effectiveness Checklist. RESULTS: In total, 2455 studies were identified. Sixteen eligible full-text articles were included (n = 14 354 patients, mean age 69 ± 8 y). The Guideline Adherence Index (GAI), and its modified versions, was the most frequently cited tool (n = 13). Other tools identified were the Individualised Reconciled Evidence Recommendations, the Composite Heart Failure Performance, and the Heart Failure Scale. The meta-analysis included the GAI studies of good to high quality. The average GAI-3 was 62%. Compared to low GAI, high GAI patients had lower mortality rate (7.6% vs 33.9%) and lower rehospitalisation rates (23.5% vs 24.5%); both P ≤ .05. High GAI was associated with reduced risk of mortality (hazard ratio = 0.29, 95% confidence interval, 0.06-0.51) and rehospitalisation (hazard ratio = 0.64, 95% confidence interval, 0.41-1.00). No tool was used to improve prescribing quality. CONCLUSION: The GAI is the most frequently used tool to assess guideline adherence in HF. High GAI is associated with improved HF outcomes.

Assessment of neonatal intensive care unit nurses' compliance with standard precautions of infection control and identification of enabling factors.

Background: Rigorous implementation of infection prevention and control practices by healthcare workers in different healthcare settings is of utmost importance. Neonates, particularly preterm babies in neonatal intensive care units, are a vulnerable population at high risk for developing nosocomial infections. Nurses have the greatest risk of spreading healthcare-associated infections among patients and healthcare workers. This study was conducted to assess the compliance of neonatal intensive care unit nurses with standard precautions of infection control and to identify the potential influencing factors. Results: This was a cross-sectional study, whereby the compliance of a total of 58 neonatal intensive care unit nurses with standard precautions of infection control was assessed using the Arabic version of the Compliance with Standard Precautions Scale (CSPS-A). Student's t test, ANOVA test, and post hoc test were used for analysis.A suboptimal compliance rate (66.7%) was detected, with the highest for disposal of sharp articles into sharps boxes (86.2%) and the lowest for disposal of sharps box not only when full (27.6%). Significant differences were observed when participants were grouped according to their clinical experience and qualifications, where participants with longer clinical experience displayed higher mean scores for the use of protective devices score (P = 0.024), disposal of sharps score (P = 0.003), and total CSPS score (P = 0.006). Conclusions: Clinical experience and educational qualifications are key factors that impact nurses' compliance with infection control practices. Nurses should receive up-to-date evidence-based educational and practical sessions that link theory to clinical practice and elucidate the importance of accurate implementation of proper infection prevention and control practices.

Guideline-led prescribing to ambulatory heart failure patients in a cardiology outpatient service.

Background Guidelines recommend heart failure (HF) patients be treated with multiple medications at doses proven to improve clinical outcomes. Objective To study guideline-led prescribing in an Irish outpatient HF population. Setting Cardiology Outpatient Clinic, Mercy University Hospital, Cork, Ireland. Methods Guideline-led prescribing was assessed using the Guideline Adherence Index (GAI-3), that considered the prescribing of ACE inhibitors and angiotensin receptor blockers; beta-blockers and mineralocorticoid receptor antagonists. The GAI-based target dose was calculated based on the prescription of ≥ 50% of the guideline-recommended target dose of each of the three GAI medications to HF patients with ejection fraction ≤ 40%. High-GAI was achieved by prescription of ≥ 2 GAI medicines. Potentially inappropriate prescribing was assessed using a HF-specific tool. Main outcome measure Heart failure guideline-led prescribing assessed using the GAI-3. Results A total of 127 HF patients, mean age 71.7 ± 13.1 years, were identified in the study. Seventy-one patients had ejection fraction ≤ 40%. Population mean GAI-3 was 65.8%. When contraindications to therapy are considered, the adjusted GAI-3 increased to 72.9%. The target dose GAI was 18.5%. High-GAI management was prescribed to 54 patients (76.1%). A potentially inappropriate medicine in HF was prescribed to 14 (19.7%) patients. Conclusion Most HF patients with ejection fraction ≤ 40% in this setting received optimal guideline-led prescribing however the proportion of patients achieving the target doses of these agents was suboptimal.

Efficacy and Safety of Metformin Use in Rheumatoid Arthritis: A Randomized Controlled Study.

Objective: To evaluate the efficacy and safety of metformin use in rheumatoid arthritis (RA) patients receiving conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs). Methods: A prospective, randomized, controlled, single blinded, study was carried on 66 RA patients with moderate and high disease activity state, receiving csDMARDs. Patients were simply randomized to receive either metformin 850 mg twice daily (Metformin group, n = 33), or placebo twice daily (Control group, n = 33) in addition to their stable anti-rheumatic regimen and followed up for 6 months. Serum C-reactive protein (CRP), disease activity of 28 joints based on CRP (DAS-28-CRP), and quality of life (QOL) were evaluated at baseline and then every 3 months. Moreover, serum adiponectin was assessed at baseline and after 6 months. Results: Sixty patients completed the study. Drop out was due to intolerance to metformin side effects (n = 3) and non-compliance (n = 3). Metformin significantly decreased CRP levels and DAS-28-CRP after 6 months compared to the control group (p-value <0.001). A significant improvement in QOL of metformin group was observed as early as after 3 months (p-value = 0.006) with a continued improvement observed at 6 months (p-value <0.001) compared to the control group. Despite the significantly higher serum adiponectin in the metformin group at baseline, it was significantly reduced after 6 months in the metformin group with median percent change of -63.49% compared to the significant increase in the control group with median percent change of 92.40%. Conclusion: Metformin significantly improved inflammation, disease severity, and QOL in RA patients with high safety profile. Clinical Trial Registration: Clinical-Trials.gov, identifier [NCT08363405].

Heart Failure Prescribing Quality at Discharge from a Critical Care Unit in Egypt: The Impact of Multidisciplinary Care.

Discharge prescriptions for heart failure (HF) patients may not adhere to the clinical practice guidelines. This study aimed to assess the impact of the clinical pharmacist as a member of a multidisciplinary team on the quality of prescribing to HF patients at discharge from a Critical Care Unit (CCU) in Egypt. This was a retrospective cohort study of HF patients discharged from the CCU between January 2013 and December 2017. Guideline Adherence Index (GAI-3) was used to assess guideline-directed prescribing at discharge. Multidisciplinary care was introduced to the CCU on 1 January 2016. The study included 284 HF patients, mean (±SD) age 66.7 ± 11.5 years, 53.2% male. Heart failure with reduced ejection fraction affected 100 patients (35.2%). At discharge, loop diuretics were prescribed to 85.2% of patients; mineralocorticoid receptor antagonists to 54.9%; angiotensin-converting enzyme inhibitors/angiotensin receptor blockers to 51.4%; and ß-blockers to 29.9%. Population Guideline Adherence Index (GAI-3) was 45.5%. High-GAI was prescribed to 136 patients (47.9%). Patients with High-GAI were younger; less affected by chronic kidney disease and had fewer comorbidities than those without High-GAI. Prescription of ß-blocker increased (24.1% vs. 38.6%, p < 0.001) and digoxin utilization decreased (34.7% vs. 23.7%, p < 0.049) after the introduction of the multidisciplinary care. The inclusion of a clinical pharmacist in the multidisciplinary care team may have a role in optimizing the prescribing of HF guideline-directed therapies at discharge from this setting.