Assessment of Safety of Remdesivir in Covid −19 Patients with Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min per 1.73 m^2

2021 ◽  
pp. 088506662110705
Author(s):  
Shan Wang ◽  
Christy Huynh ◽  
Shahidul Islam ◽  
Brian Malone ◽  
Naveed Masani ◽  
...  
Keyword(s):  
Chart Review ◽  
Primary Outcome ◽  
Therapeutic Option ◽  
Kidney Injury ◽  
Retrospective Chart Review ◽  
Secondary Outcome ◽  
Oxygen Requirement ◽  
End Of Treatment ◽  
Review Study ◽  
T1 And T2

Purpose Safety of remdesivir in patients with renal impairment is unknown. Incidence of liver injury secondary to remdesivir is also unknown. The objective of this study is to assess the incidence of acute kidney injury (AKI) and to trend the liver enzymes during remdesivir treatment and change in eGFR from baseline to end of treatment as well as 48 h post completion of remdesivir therapy. Methods This is a retrospective chart review study including adult patients admitted with COVID-19 receiving remdesivir with a baseline eGFR < 30 ml/min per 1.73 m^2 from December 2020 to May 2021. The primary outcome was to assess the incidence of AKI and hepatic injury. The secondary outcome was to assess the efficacy of remdesivir defined by change in oxygen requirement. Results Seventy-one patients were included in the study. Patients experienced an improvement in eGFR from baseline (T0) to end of remdesivir treatment (T1), as well as 48 h after the end of the treatment (T2) ( + 30.3% and + 30.6% respectively, P < .0001). Creatinine reduced from baseline (T0) to T1 and T2 (-20.9% and −20.5% respectively, P < .0001). Creatinine clearance improved from baseline to T1 and T2 ( + 26.6% and + 26.2% respectively, p < .0001). Elevation of aminotransferase (AST) was observed at T1 ( + 2.5%, P  =  .727), however, AST reduction was seen at T2 (-15.8%, P  =  .021). Elevation in alanine transaminase (ALT) was observed at T1 and T2 ( + 25% and + 12%, P  =  .004 and P  =  .137 respectively). Both direct and total bilirubin remained stable and were not significantly changed from baseline. Conclusion Our study showed that remdesivir use in renally-impaired patients with eGFR < 30 ml/min is safe. Remdesivir may be considered as a therapeutic option in this population with COVID-19 infection.

System intervention in community pharmacy setting: Leading to better patient care through reducing harm associated with coprescribing benzodiazepines and opioids

2021 ◽  
Vol 17 (6) ◽  
pp. 445-453
Author(s):  
Angelina Vascimini, PharmD ◽  
Kevin Duane, PharmD ◽  
Stacey Curtis, PharmD
Keyword(s):  
Chart Review ◽  
Primary Outcome ◽  
Community Pharmacists ◽  
Retrospective Chart Review ◽  
Secondary Outcome ◽  
Post Intervention ◽  
Improvement Project ◽  
System Intervention ◽  
Secondary Outcomes ◽  
Pharmacy Setting

Objective: The opioid epidemic is frequently discussed including the staggering numbers involved with coprescribing opioids and benzodiazepines associated with death. Community pharmacists, with the help of a system intervention, have a unique opportunity to help reduce the coprescribing of benzodiazepines and opioids and reduce the associated risk of death.Design: A single center retrospective chart review was conducted after a system intervention was placed, as a quality improvement project, from November 2019 to May 2020.Setting: Independent community pharmacy.Patients/participants: Data included demographics, dosing of each medication pre- and post-intervention, and naloxone status.Main outcome(s) measures: The primary outcome evaluated was reduction in dose/discontinuation of these prescriptions. The secondary outcome evaluated was the number of naloxone prescriptions ordered per protocol and picked up.Results: The primary outcome did not show statistical difference; however, the secondary outcomes showed statistical significance.Conclusion: In conclusion, community pharmacists, with the help of evolving technologies, can reduce harm associated with the coprescribing of benzodiazepines and opioids.

Safety of Infliximab Treatment in Patients with Rheumatoid Arthritis in a Real-world Clinical Setting: Description and Evaluation of Infusion Reactions

2012 ◽  
Vol 39 (8) ◽  
pp. 1539-1545 ◽  
Author(s):  
JOHN KELSALL ◽  
PAMELA ROGERS ◽  
GRISELDA GALINDO ◽  
MARY A. De VERA
Keyword(s):  
Inflammatory Arthritis ◽  
Reaction Rate ◽  
Chart Review ◽  
Primary Outcome ◽  
Retrospective Chart Review ◽  
Infusion Reaction ◽  
Secondary Outcome ◽  
Infliximab Treatment ◽  
Infusion Reactions ◽  
Acute Reaction

Objective.To describe acute and delayed infusion reactions in a large cohort of patients with inflammatory arthritis, treated with infliximab (IFX).Methods.We conducted a retrospective chart review of patients treated with IFX at the Mary Pack Arthritis Centre between 2000 and 2008. The primary outcome was the occurrence of acute infusion reactions during infusions or 1–2 hours after each infusion, and secondary outcome was the occurrence of delayed infusion reactions 1–14 days after an infusion. Descriptive analyses were conducted to summarize study outcomes and identify trends over followup.Results.Since 2000, 376 patients were referred to the Mary Pack IFX clinic and 200 received 4399 IFX infusions over a mean 140 ± 132 weeks of followup. Of these, 135 were patients with RA who received 2977 IFX infusions over mean followup of 138 ± 132 weeks. In total 258 episodes of acute reactions were observed for an overall acute reaction rate of 5.8%. Acute infusion reactions were mostly mild (42.6%) and moderate (43.8%) and commonly affected sites were head and neck (31.5%) and cutaneous (21.1%). A total of 37 delayed infusion reaction episodes were observed (0.9% rate); reactions were also mostly mild (16.2%) and moderate (64.9%).Conclusion.These clinical data from 200 patients treated with IFX demonstrate that acute and delayed infusion reactions occur infrequently and are mostly mild to moderate in presentation.

scholarly journals Intermediate outcomes of ab externo circumferential trabeculotomy and canaloplasty in POAG patients with prior incisional glaucoma surgery

2020 ◽  
Author(s):  
Huaizhou Wang ◽  
Chen Xin ◽  
Ying Han ◽  
Yan Shi ◽  
Sarah Ziaei ◽  
...  
Keyword(s):  
Chart Review ◽  
Primary Outcome ◽  
Open Angle Glaucoma ◽  
Retrospective Chart Review ◽  
Glaucoma Surgery ◽  
Secondary Outcome ◽  
Filtering Surgery ◽  
Intermediate Outcomes ◽  
Topical Medications

Abstract Background: To compare the efficacy and safety of ab externo circumferential trabeculotomy (ECT) and canaloplasty on primary open angle glaucoma (POAG) patients with failed filtering surgery and intact schlemm’s canal (SC). Methods : We conducted a retrospective chart review of POAG patients with failed filtering surgery and intact SC, who further received ECT and canaloplasty. The primary outcome measures were intraocular pressure (IOP) and the number of topical medications at each follow-up point.The secondary outcome compared the quantified success rate at1-year follow-up between the groups. Results: Twenty-nine eyes were recruited in the ECT group and 19 eyes in canaloplasty group. The postoperative IOP and the number of topical medications decreased significantly in both groups(p<0.001). The IOP at 3-month and 6-monthwas significantly lower in the ECT group (p=0.039, p=0.001) than in the canaloplasty group. Although the IOP at 12-mon was similar between the two groups, the number of topical medications was less in the ECP group (p=0.040). Hyphema (72.4%) and ciliary body detachment (27.6%), which mainly resolve spontaneously, were two leading complications in the ECT group. The prevalence of hyphema was higher in ECT than in canaloplasty group (p<0.001). Conclusion: For POAG with failed filtering surgery and intact SC, canaloplasty may be safer, whereas ECT presented better IOP control.

scholarly journals Intermediate Outcomes of ab Externo Circumferentialtrabeculotomy and Canaloplastyin POAG Patients with Prior Incisional Glaucoma Surgery

2020 ◽  
Author(s):  
Huaizhou Wang ◽  
Chen Xin ◽  
Ying Han ◽  
Yan Shi ◽  
Sarah Ziaei ◽  
...  
Keyword(s):  
Chart Review ◽  
Primary Outcome ◽  
Open Angle Glaucoma ◽  
Retrospective Chart Review ◽  
Glaucoma Surgery ◽  
Secondary Outcome ◽  
Filtering Surgery ◽  
Intermediate Outcomes ◽  
Topical Medications

Abstract Background: To compare the efficacy and safety of ab externo circumferential trabeculotomy (ECT) and canaloplasty on primary open angle glaucoma (POAG) patients with failed filtering surgery and intact schlemm’s canal (SC).Methods: We conducted a retrospective chart review of POAG patients with failed filtering surgery and intact SC, who further received ECT and canaloplasty. The primary outcome measures were intraocular pressure (IOP) and the number of topical medications at each follow-up point.The secondary outcome compared the quantified success rate at1-year follow-up between the groups. Results:Twenty-nine eyes were recruited in the ECT group and 19 eyes in canaloplasty group. The postoperative IOP and the number of topical medications decreased significantly in both groups(p<0.001). The IOP at 3-month and 6-monthwas significantly lower in the ECT group (p=0.039, p=0.001) than in the canaloplasty group. Although the IOP at 12-mon was similar between the two groups, the number of topical medications was less in the ECP group (p=0.040). Hyphema (72.4%) and ciliary body detachment (27.6%), which mainly resolve spontaneously, were two leading complications in the ECT group. The prevalence of hyphema was higher in ECT than in canaloplasty group (p<0.001). Conclusion: For POAG with failed filtering surgery and intact SC, canaloplasty may be safer, whereas ECT presented better IOP control.Translational Relevance:

scholarly journals Intermediate outcomes of ab externo circumferential trabeculotomy and canaloplasty in POAG patients with prior incisional glaucoma surgery

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Huaizhou Wang ◽  
Chen Xin ◽  
Ying Han ◽  
Yan Shi ◽  
Sarah Ziaei ◽  
...  
Keyword(s):  
Chart Review ◽  
Primary Outcome ◽  
Open Angle Glaucoma ◽  
Retrospective Chart Review ◽  
Glaucoma Surgery ◽  
Secondary Outcome ◽  
Filtering Surgery ◽  
Intermediate Outcomes ◽  
Topical Medications

Abstract Background To compare the efficacy and safety of ab externo circumferential trabeculotomy (ECT) and canaloplasty on primary open angle glaucoma (POAG) patients with failed filtering surgery and intact schlemm’s canal (SC). Methods We conducted a retrospective chart review of POAG patients with failed filtering surgery and intact SC, who further received ECT and canaloplasty. The primary outcome measures were intraocular pressure (IOP) and the number of topical medications at each follow-up point. The secondary outcome compared the quantified success rate at1-year follow-up between the groups. Results Twenty-nine eyes were recruited in the ECT group and 19 eyes in canaloplasty group. The postoperative IOP and the number of topical medications decreased significantly in both groups (p < 0.001). The IOP at 3-month and 6-monthwas significantly lower in the ECT group (p = 0.039, p = 0.001) than in the canaloplasty group. Although the IOP at 12-mon was similar between the two groups, the number of topical medications was less in the ECT group (p = 0.040). Hyphema (72.4%) and ciliary body detachment (27.6%), which mainly resolve spontaneously, were two leading complications in the ECT group. The prevalence of hyphema was higher in ECT than in canaloplasty group (p < 0.001). Conclusion For POAG with failed filtering surgery and intact SC, canaloplasty may be safer, whereas ECT presented better IOP control. Translational Relevance: Suggestions for surgical choice for POAG with failed filtering surgery.

scholarly journals A Valid Warning or Clinical Lore: An Evaluation of Safety Outcomes of Remdesivir in Patients with Impaired Renal Function from a Multicenter Matched Cohort.

2020 ◽  
Author(s):  
Tyler W. Ackley ◽  
Dayna Mcmanus ◽  
Jeffrey E. Topal ◽  
Brian Cicali ◽  
Sunish Shah
Keyword(s):  
Chart Review ◽  
Nearest Neighbor ◽  
Safety Data ◽  
Kidney Injury ◽  
Retrospective Chart Review ◽  
Mechanically Ventilated ◽  
End Of Treatment ◽  
Significant Difference ◽  
Safety Outcomes ◽  
Nearest Neighbor Matching

Objective: Per prescribing guidance, remdesivir is not recommended for SARS-CoV-2 in patients with renal disease given the absence of safety data in this patient population. Methods: This study was a multi-center, retrospective chart review of hospitalized patients with SARS-CoV-2 who received remdesivir. Safety outcomes were compared between patients with an estimated creatinine clearance (eCrCl) < 30 mL/min and an eCrCl ≥ 30 mL/min. The primary endpoint was acute kidney injury (AKI) at the end of treatment (EOT). Results: Of 359 patients who received remdesivir, 347 met inclusion criteria. Patients with an eCrCl < 30 mL/min were older [median, 80 years (IQR, 63.8-89) versus 62 (IQR, 54-74); P<0.001], were more likely to be on vasopressors on the day of remdesivir administration (30% versus 12.7%; P=0.003), and were more likely to be mechanically ventilated during remdesivir therapy (27.5% versus 12.4%; P=0.01) compared to those with an eCrCl ≥ 30 mL/min. Despite these confounders, there was no significant difference in the frequency of EOT AKI (5% versus 2.3%; P=0.283) or early discontinuation due to abnormal LFTs (0% versus 3.9%; P=0.374). Of the 5% of patients who developed EOT AKI on remdesivir with an eCrCl <30mL/min, no cases were attributable to remdesivir administration per the treating physician. Comparable safety outcomes were observed when 1:1 nearest neighbor matching was applied to account for baseline confounders. Conclusion: Remdesivir administration was not significantly associated with increased EOT AKI in patients with an eCrCl < 30mL/min compared to patients with an eCrCl ≥ 30mL/min.

Improving patient safety in Palestinian hospitals: a cross-sectional and retrospective chart review study

The Lancet ◽  
2018 ◽  
Vol 391 ◽  
pp. S44
Author(s):  
Shahenaz Najjar ◽  
Nashat Nafouri ◽  
Kris Vanhaecht ◽  
Martin Euwema
Keyword(s):  
Patient Safety ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Cross Sectional ◽  
Review Study

scholarly journals Tuberous sclerosis complex: Clinical spectrum and epilepsy: A retrospective chart review study

2018 ◽  
Vol 9 (1) ◽  
pp. 154-160
Author(s):  
Sulaiman Almobarak ◽  
Mohammad Almuhaizea ◽  
Musaad Abukhaled ◽  
Suad Alyamani ◽  
Omar Dabbagh ◽  
...  
Keyword(s):  
Tuberous Sclerosis ◽  
Gene Mutation ◽  
Tuberous Sclerosis Complex ◽  
Chart Review ◽  
Clinical Presentation ◽  
Retrospective Chart Review ◽  
Neurocutaneous Disorder ◽  
Development Delay ◽  
Review Study ◽  
New Onset

Abstract Tuberous sclerosis complex (TSC) is an autosomal dominant genetic neurocutaneous disorder, with heterogeneous manifestations. We aimed to review the clinical presentation of TSC and its association with epilepsy among Saudi population. This was a retrospective chart review study of 88 patients diagnosed with TSC with or without epilepsy. In 38.6% of patients, symptoms began before 1 year of age. The most frequent initial manifestations of TSC were new onset of seizures (68.2%), skin manifestations (46.6%) and development delay (23.9%). During the evolution of the disease 65.9% had epilepsy, 17% facial angiofibromas, 13.6% Shagreen patch, 18.2% heart rhabdomyomas and 12.5% retinal hamartomas. The genetic study for TSC diagnosis was done for 44 patients, 42 (95,4%) of them were genetically confirmed, for whom 13 patients had TSC1 mutation (29.5%), 29 patients were carrying TSC2 gene mutation (65.9%), Genetic test for TSC 1 and TSC 2 were negative for 2 patients (4.5%) despite positive gene mutation in their relative with TSC. The most common manifestations were central nervous system (predominantly epilepsy) and dermatological manifestations. Most of the patients develop epilepsy with multiple seizure types. TSC 2 mutation is more common than TSC 1 mutation.

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