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
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].
Access to the full text of the published version may require a subscription. A tool for assessment of heart failure prescribing quality: a systematic review and meta-analysis. Rights 2A 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,
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 β-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 β-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.
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.
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