Dataset Information

Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting.

ABSTRACT: Evolocumab has been shown to consistently reduce low-density lipoprotein cholesterol (LDL-C) across populations. The phase 3 studies included administration in the home-use and in-clinic settings but did not specifically evaluate the feasibility of home-use administration. Two clinical studies enrolled patients with hypercholesterolemia or mixed dyslipidemia on statin therapy and with/without ezetimibe received evolocumab in the home-use setting. Patients were randomized to self-administer evolocumab using one of two injection devices biweekly over 6 weeks (autoinjector or prefilled syringe; n = 149; ClinicalTrials.gov, NCT01849497) or monthly over 12 weeks (autoinjector or automated minidoser; n = 164; NCT01879319). The first self-administration occurred in the in-clinic setting, and two more were performed in the at-home setting. Patients were successful in self-administering evolocumab in the home-use setting in approximately 95 % of attempts and experienced LDL-C reductions from baseline to week 6 or the mean of weeks 10 and 12 of approximately 65 %. Rates of successful self-administration and LDL-C reduction were similar across dosing schedules and study devices. Adverse events were similar between randomized groups and generally mild in severity. In two clinical studies, therefore, patients were able to successfully self-administer evolocumab in both the in-clinic and at-home settings regardless of which dosing schedule or device they used.

SUBMITTER: Dent R

PROVIDER: S-EPMC4783317 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting.

Dent Ricardo R Joshi Raju R Stephen Djedjos C C Legg Jason J Elliott Mary M Geller Michelle M Meyer Dawn D Somaratne Ransi R Recknor Chris C Weiss Robert R

SpringerPlus 20160309

Evolocumab has been shown to consistently reduce low-density lipoprotein cholesterol (LDL-C) across populations. The phase 3 studies included administration in the home-use and in-clinic settings but did not specifically evaluate the feasibility of home-use administration. Two clinical studies enrolled patients with hypercholesterolemia or mixed dyslipidemia on statin therapy and with/without ezetimibe received evolocumab in the home-use setting. Patients were randomized to self-administer evolo ...[more]

PMID: 27066336

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Project description:PurposeThe purpose of this study was to assess the rate of hospital admissions, inpatient conversions, reoperations, and complications associated with tibial tubercle osteotomies (TTO), high tibial osteotomies (HTO), and distal femoral osteotomies (DFO) performed at our ambulatory surgery center compared with our inpatient hospital facility.MethodsA retrospective review of patients receiving a TTO, HTO or DFO at our institution between June 2011 and October 2019 was performed. Inclusion criteria consisted of patients undergoing the aforementioned procedures for malalignment, and a minimum of 90-days follow-up. Revision osteotomies, those undergoing an osteotomy for an acute fracture, and those with rule-out criteria for outpatient surgery (ASA > 3, and body mass index >40) were excluded. Complications, including readmission and reoperation, were compared between the two groups using either the Fisher's exact test and independent samples t-test, where applicable, and a P value of <0.05 was considered to be statistically significant.ResultsThe study included 531 patients undergoing osteotomies (222 ambulatory surgical center [ASC] and 309 hospital) with no patients lost to follow-up in the 90-day postoperative period. No patients operated on at an ASC required transfer to inpatient setting. There were no differences in complication rates, readmission, or reoperation rates among the two groups (4.1% vs 4.9%; P = .8328; 3.1% vs 4.5%, P = .5026; 3.1% vs 4.5%; P = .5026; respectively). Complications, including surgical site infection and arthrofibrosis were not significantly different in the two cohorts, (1.4% vs. 2.6%, P = .341 and 1.4% vs 1%; P = .698, respectively).ConclusionsOsteotomies about the knee performed in an ambulatory setting were safe, with no difference in readmission, reoperation, or postoperative complications compared to those performed at an inpatient hospital. Additionally, no patient required conversion from an outpatient to an inpatient setting.Level of evidenceLevel III, retrospective comparative study.

Project description:Background/Objectives: The rising prevalence of musculoskeletal (MSK) conditions has not been balanced by a sufficient increase in healthcare providers. Scalability challenges are being addressed through the use of artificial intelligence (AI) in some healthcare sectors, with this showing potential to also improve MSK care. Digital care programs (DCP) generate automatically collected data, thus making them ideal candidates for AI implementation into workflows, with the potential to unlock care scalability. In this study, we aimed to assess the impact of scaling care through AI in patient outcomes, engagement, satisfaction, and adverse events. Methods: Post hoc analysis of a prospective, pre-post cohort study assessing the impact on outcomes after a 2.3-fold increase in PT-to-patient ratio, supported by the implementation of a machine learning-based tool to assist physical therapists (PTs) in patient care management. The intervention group (IG) consisted of a DCP supported by an AI tool, while the comparison group (CG) consisted of the DCP alone. The primary outcome concerned the pain response rate (reaching a minimal clinically important change of 30%). Other outcomes included mental health, program engagement, satisfaction, and the adverse event rate. Results: Similar improvements in pain response were observed, regardless of the group (response rate: 64% vs. 63%; p = 0.399). Equivalent recoveries were also reported in mental health outcomes, specifically in anxiety (p = 0.928) and depression (p = 0.187). Higher completion rates were observed in the IG (79.9% (N = 19,252) vs. CG 70.1% (N = 8489); p < 0.001). Patient engagement remained consistent in both groups, as well as high satisfaction (IG: 8.76/10, SD 1.75 vs. CG: 8.60/10, SD 1.76; p = 0.021). Intervention-related adverse events were rare and even across groups (IG: 0.58% and CG 0.69%; p = 0.231). Conclusions: The study underscores the potential of scaling MSK care that is supported by AI without compromising patient outcomes, despite the increase in PT-to-patient ratios.

Dataset Information

Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting.

Publications

Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting.

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