Evaluation of Apixaban safety and effectiveness in morbidly obese patients with atrial fibrillation: a retrospective cohort study.

BACKGROUND: The benefit of apixaban to reduce stroke risk in morbidly obese patients with nonvalvular atrial fibrillation (AF) is still undetermined. The International Society of Thrombosis and Hemostasis recommends avoiding the use of direct oral anticoagulants (DOAC)s in morbidly obese patients (body mass index > 40 or weight > 120 kg) because of limited clinical data. This exploratory study aims to evaluate the effectiveness and safety of using apixaban in morbidly obese (body mass index (BMI) ≥ 40) patients with AF. METHODS: An exploratory retrospective cohort study was conducted at a single-center, including adult patients with non-valvular AF using apixaban between 01/01/2016 and 31/12/2019. Patients were excluded if they were known to have liver cirrhosis Child-Pugh C, mechanical valve, serum creatinine > 1.5 mg/dL, follow up < 3 months, or using apixaban with a dose of ≤5 or > 10 mg/day. Included patients were categorized into two groups based on their BMI (BMI<40 Vs. BMI ≥ 40). The primary outcome was all thrombotic events, while the secondary outcomes were major and minor bleeding after apixaban initiation. Propensity score (PS) matching was used (1:1 ratio) based on the patient's age, gender, and HAS-BLED score. RESULTS: A total of 722 patients were eligible; 254 patients were included after propensity score matching based on the selected criteria. The prevalence of all thrombotic events was similar between the two groups in the first year of apixaban initiation (OR (95%CI): 0.58 (0.13, 2.5), p-value = 0.46). In addition, the odds of developing major and minor bleeding were not statistically significant between the two groups (OR (95%CI): 0.39 (0.07, 2.03), p-value = 0.26 and OR (95%CI): 1.27 (0.56, 2.84), p-value = 0.40), respectively). CONCLUSION: This exploratory study showed similar effectiveness and safety of apixaban use in both morbid and non-morbid obese patients with non-valvular AF. However, a larger randomized controlled trial with a longer follow-up period needs to confirm our findings.

Appropriateness of Using Vitamin K for the Correction of INR Elevation Secondary to Hepatic Disease in Critically ill Patients: An Observational Study.

BACKGROUND: Using vitamin K for correction of coagulopathy in critically ill patients is controversial with limited evidence. This study aims to evaluate the efficacy and safety of vitamin K in the correction of international normalized ratio (INR) elevation secondary to liver disease in critically ill patients. METHOD: A retrospective study of critically ill patients with coagulopathy secondary to liver disease. The primary outcome was to evaluate the association between vitamin K administration and the incidence of new bleeding events in critically ill patients with INR elevation; other outcomes were considered secondary. Patients were categorized into two groups based on vitamin K administration to correct INR elevation. The propensity score was generated based on disease severity scores and the use of pharmacological DVT prophylaxis. RESULTS: A total of 98 patients were included in the study. Forty-seven patients (48%) received vitamin K during the study period. The odds of the new bleeding event was not statistically different between groups (OR 2.4, 95% CI 0.28-21.67, P = .42). Delta of INR reduction was observed with a median of 0.63 when the first dose is given (P-value: <.0001). However the INR reduction with other subsequent doses of vitamin K was not statistically significant. CONCLUSION: The administration of vitamin K for INR correction in critically ill patients with coagulopathy secondary to liver disease was not associated with a lower odds of new bleeding events. Further studies are needed to assess the value of vitamin K administration in critically ill patients with liver diseases related coagulopathy.

Evaluation of thiamine as adjunctive therapy in COVID-19 critically ill patients: a two-center propensity score matched study.

BACKGROUND: Thiamine is a precursor of the essential coenzyme thiamine pyrophosphate required for glucose metabolism; it improves the immune system function and has shown to reduce the risk of several diseases. The role of thiamine in critically ill septic patient has been addressed in multiple studies; however, it's role in COVID-19 patients is still unclear. The aim of this study was to evaluate the use of thiamine as an adjunctive therapy on mortality in COVID-19 critically ill patients. METHODS: This is a two-center, non-interventional, retrospective cohort study for critically ill patients admitted to intensive care units (ICUs) with a confirmed diagnosis of COVID19. All patients aged 18 years or older admitted to ICUs between March 1, 2020, and December 31, 2020, with positive PCR COVID-19 were eligible for inclusion. We investigated thiamine use as an adjunctive therapy on the clinical outcomes in critically ill COVID-19 patients after propensity score matching. RESULTS: A total of 738 critically ill patients with COVID-19 who had been admitted to ICUs were included in the study. Among 166 patients matched using the propensity score method, 83 had received thiamine as adjunctive therapy. There was significant association between thiamine use with in-hospital mortality (OR = 0.39; 95% CI 0.19-0.78; P value = 0.008) as well as the 30-day mortality (OR = 0.37; 95% CI 0.18-0.78; P value = 0.009). Moreover, patients who received thiamine as an adjunctive therapy were less likely to have thrombosis during ICU stay [OR (95% CI) 0.19 (0.04-0.88), P value = 0.03]. CONCLUSION: Thiamine use as adjunctive therapy may have potential survival benefits in critically ill patients with COVID-19. Additionally, it was associated with a lower incidence of thrombosis. Further interventional studies are required to confirm these findings.

Pharmacy Students Perceptions of Their Distance Online Learning Experience During the COVID-19 Pandemic: A Cross-Sectional Survey Study.

INTRODUCTION: The COVID-19 pandemic imposed dramatic changes on educational practices worldwide. Many universities and schools have moved into the delivery of their courses and educational programs utilizing fully electronic online modes. This study aims to evaluate the pharmacy student distance online learning experience during the COVID-19 pandemic. METHODS: A cross-sectional survey was utilized where a 3-domain survey questionnaire focused on preparedness, attitude and barriers was distributed to students at the time of conclusion of the semester. Each domain consists of multiple questions that made up a score that reflects their preparedness, attitude as well as barriers relevant to distance online learning experience. The survey was voluntarily, and all data were collected and recorded via google forms with maintaining anonymity. RESULTS: The response rate was about 75% (n = 309). The results' analysis revealed no gender differences in any of these domains. However, there were some variable responses among different educational levels. The average preparedness score was 32.8 ± 7.2 (Max 45), the average attitude score was 66.8 ± 16.6 (Max 105), and the average barrier score was 43.6 ± 12.0 (Max 75). There was statistical significance difference in both preparedness score and attitude scores between different professional years (P-value <.05). However, there was no difference in barrier scores among all professional years. The results indicated that about 61.4% of the students agreed on that college of pharmacy was well-prepared and ready for the online education during the emerging COVID-19 pandemic with complete transition into online education. The results also indicated that 49.2% of the students showed positive attitude toward the provided online learning. The results indicated that about 34% of the students identify some barriers toward the provided online learning. Finally, there were strong association between the need for training on how to receive online courses and preparedness and barriers scores. DISCUSSION AND CONCLUSION: E-learning experience pose challenges and presents opportunities during emergency situations. The need for training for students and faculty was highly associated with the preparedness and barriers domains rather than the infrastructure or computer literacy, so the school can improve their experience by addressing these needs.

Intravitreal Ranibizumab Injection for the Treatment of Retinopathy of Prematurity.

OBJECTIVES: To evaluate the efficacy of a single injection of 0.3 mg intravitreal ranibizumab for the treatment of retinopathy of prematurity (ROP). METHODS: We conducted this retrospective case series study at King Abdul Aziz Medical City, Riyadh, Saudi Arabia. Seventy-four eyes of 37 preterm infants with ROP stage III with plus disease in zone I, posterior zone II, and aggressive posterior ROP received a single injection of 0.3 mg intravitreal ranibizumab. The favorable outcome measure was complete regression of the disease with normal vascularization of the retina of those infants. RESULTS: The gestational age of the 37 included cases was in the range of 23-28 weeks and their body weight at birth was between 510 and 1,235 g except for one case with 2,550 g under oxygen therapy <7days with severe hypoglycemia. All eyes showed a favorable response in terms of regression of plus disease from the first day after treatment, followed by regression of stage III retinopathy. All patients developed complete vascularization over variable periods of time. CONCLUSION: One injection of 0.3 mg intravitreal ranibizumab is effective in treating ROP stage III mainly in zones I and II.

Comparison of the application of treatment Panel III and American College of Cardiology/American heart Association guidelines for blood cholesterol treatment in Saudi Arabia.

BACKGROUND: One of the major risk factors for cardiovascular diseases is hyperlipidemia. The primary aim of this study was to estimate the proportion of individuals between 40-75 years old that would be eligible for statin therapy based on ACC/AHA guideline as compared to ATP-III guideline in a population of patients in Saudi Arabia. We also intended to extrapolate the results to the entire Saudi population, and estimate the cost implications of the ACC/AHA treatment guideline. METHODS: This study was a retrospective, observational study involving adult patients aged between 40-75 years old. The study was conducted at the primary health care clinics at King Abdul-Aziz Medical/Riyadh. The eligibility for statins use was assessed and compared for each patient based on both the recent 2013 ACC-AHA guideline and the 2002 ATP-III guideline. The cost implication of applying the ACC/AHA treatment guideline was estimated based on the average cost for 40 mg Atorvastatin in the Saudi Market. RESULTS: A total of 1005 patients were included in the study. Using the ATP-III guideline, there were 139 male (43.7%) and 279 female (40.6%) eligible to receive statin therapy. Based on the 2013 ACC/AHA guideline, treatment is recommended in 315 males (99.1%) and 564 females (82.1%). On the other hand, high-intensity statin was recommended in 302 male (95%) and 400 female (58.2%). Only 74 (10.5%) patients were prescribed high-intensity statin of the 702 eligible patients. Extrapolating the results to the entire Saudi population, 2.369 million additional patients would be eligible for statin therapy when applying the ACC/AHA guideline. Applying the new guideline would result in a cost increase of at least 4.318 billion SR per year. CONCLUSIONS: The eligibility for statin therapy was much higher when applying the ACC/AHA guideline as compared to ATP-III guideline. Applying the recent ACC/AHA dyslipidemia guideline increased the number of patients eligible for statin therapy to approximately two folds. This would be associated with a substantial increase in cost and possibly side effects. The concerns surrounding the ACC/AHA guideline should be addressed at the national level.

Assessment of patient-controlled analgesia versus intermittent opioid therapy to manage sickle-cell disease vaso-occlusive crisis in adult patients.

BACKGROUND: Vaso-occlusive crisis (VOC) is one of the acute complications of sickle-cell disease (SCD). Treatment mainly relies on hydration and pain control by analgesics. The specific aim of this study was to assess potential health outcomes within the first 72 h of admission between intermittent and patient-controlled analgesia (PCA) by opioids among VOC patients. METHODS: A retrospective chart review study was conducted to determine SCD patients with VOC. Using the hospital electronic system, the following data were collected: patient's age, gender, blood pressure, heart rate, respiratory rate, oxygen saturation, and pain score on admission and daily for 3 days as well as the cumulative opioid analgesic dose for 72 h which is reported as morphine equivalent. RESULTS: One hundred and seventeen patients were screened over a period of 5 years. Of those, 99 (84.6%) met the study inclusion criteria, and 18 patients (15.4%) were excluded from the study. During the first 72 h of admission, a significant reduction in pain score was observed in patients on intermittent intravenous (IV) administration compared to those in the PCA group (P < 0.0004) where the mean pain scores were 3 and 5, respectively. The total amount of morphine administered over 72 h of admission was significantly higher in PCA group (777 ± 175 mg) as compared to the intermittent IV administration group (149 ± 74 mg) (P < 0.000003). Clinically significant hypotension or respiratory depression was not observed in both groups over the 72 h of admission. CONCLUSION: During the first 72 h of admission, intermittent IV administration of morphine was more effective than PCA infusion in pain control.

Topical versus subconjunctival anti-vascular endothelial growth factor therapy (Bevacizumab, Ranibizumab and Aflibercept) for treatment of corneal neovascularization.

In order to evaluate the effect of topical and subconjunctival anti-vascular endothelial growth factor (anti-VEGF) therapy, Ranibizumab, Bevacizumab and Aflibercept as a therapy for corneal neovascularization (NV) treatment, the aim of this study was to review all data related to some of anti-VEGF as a promising therapies for corneal NV treatment. Corneal NV is a dangerous condition leading to a marked reduction in vision due to angiogenesis of abnormal vessels that block light. During the recent years, we have recognized new drug proliferation for corneal NV treatment. Recently, anti-VEGF therapies are one of the most important drugs used for corneal NV treatment. Several growth factors are involved in angiogenesis. The most important growth factor in corneal angiogenesis is VEGF. VEGF can be considered as key mediators in corneal angiogenesis. It is upregulated during corneal NV. In fact, anti-VEGF therapies have shown efficacy in attenuation of corneal NV in both animal models and clinical trials. A promising therapeutic success has been achieved using antibodies directed against VEGF. Bevacizumab has demonstrated efficacy and efficiency in the treatment of different neo-vascular ocular diseases and it has partially reduced corneal NV through different routes of administrations: topical, subconjunctival, and intraocular application. A similar efficacy to bevacizumab profiles in the treatment of neo-vascular age-related macular degeneration was induced by ranibizumab. Moreover, at worse levels of initial visual acuity of diabetic macular edema, aflibercept was more effective at improving vision. Anti-VEGF agents (Bevacizumab, Ranibizumab and Aflibercept) seem to have a higher efficiency and efficacy for corneal NV treatment. Both subconjunctival therapy and topical therapy of bevacizumab prohibit corneal NV, while early treatment with subconjunctival administration of ranibizumab may successfully reduce corneal NV. Therefore, establishment of safe doses is highly important before these drugs can be involved in the clinical setting. Further investigations and studies are highly warranted to adjust the dose and route of administration for the antibodies directed against VEGF to be the key therapeutic agents in the corneal NV treatment.

Exploring quality of life among renal and liver transplant recipients.

BACKGROUND AND OBJECTIVES: Despite the worldwide recognition of the importance of quality of life (QOL) assessment, research data on QOL for renal and liver transplant recipients are limited. The main objective of this study was to explore and compare QOL in renal and liver transplant patients. DESIGN AND SETTING: This cross-sectional study was conducted at at King Abdulaziz Medical City, Saudi Arabia. PATIENTS AND METHODS: Saudis 16 years of age or more who received liver or renal transplantation at least three months before the study participated. QOL was evaluated using the World Health Organization QOL instrument (WHOQOL-BREF). RESULTS: Renal and liver transplant patients were highly or moderately satisfied with most circumstances of life. Using data for subjects in all WHO centers, renal and liver transplant patients domain scores in this study were significantly higher in the psychological health domain, social relations and environmental domain (P < .0001). The results also show that renal and liver transplant recipients who were male, or had higher education or who were employed had higher QOL scores. CONCLUSIONS: This study found that both renal and liver transplant recipients achieved very high QOL domain scores as compared with international data. Lower QOL was significantly associated with social disadvantages, suggesting that these patients may require more focused attention and counselling following transplantation.

The outcome of pharmacist counseling at the time of hospital discharge: an observational nonrandomized study.

BACKGROUND AND OBJECTIVES: Adverse drug events (ADEs) may occur after discharge from acute care hospitalization because of limited instruction on medications at discharge. The right instructions given to patients may reduce the risk of ADEs. The objective of our study was to assess a program involving comprehensive medication counseling provided by pharmacists at the time of discharge from a tertiary hospital in Riyadh, Saudi Arabia. DESIGN AND SETTING: A prospective, nonrandomized observational study over a period of 3 months in a 1000-bed tertiary hospital. PATIENTS AND METHODS: Patients discharged from the internal medicine wards with more than three medications received comprehensive pharmacist counseling. The intervention pharmacist counseled patients about their discharge medications and provided written materials as needed. Topics discussed with the patients included the importance of following prescribed medication regimens and the indications, directions, and any potential side effects of discharge medications. The control group included similar patients who received routine discharge counseling by nurses. Two weeks after discharge, the same pharmacist called the patients and assessed the frequency of ADEs. Two independent clinicians reviewed each ADEs and judged its severity and preventability. RESULTS: Out of 200 patients included in the study (100 patients from the intervention group and 100 patients from the control group), 175 patients (87.5%) were successfully contacted two weeks after discharge (88 patients from the intervention group and 87 patients from the control group). ADEs occurred in 2 patients (2.3%) in the intervention group and in 21 patients (24%; 23 incidents in 21 patients) in the control group (P < .001). In the control group, 14 ADEs (61%) were judged as preventable, and 9 (39%) were judged as serious. CONCLUSIONS: A comprehensive medication counseling program at hospital discharge reduced the incidence of ADEs two weeks after discharge from a tertiary hospital in Riyadh, Saudi Arabia. Further studies assessing the long-term outcomes of such a program are needed.