Current medical research and opinion
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Multicenter Study Observational Study
VITALITY: impact of adalimumab on health and disability outcomes in patients with Crohn's disease, rheumatoid arthritis, or psoriasis treated in clinical practice in New Zealand.
Objective: VITALITY, a 6-month, multicenter, prospective, observational study, assessed the effects of originator adalimumab (HUMIRA) on health and disability outcomes in patients with Crohn's disease (CD), rheumatoid arthritis (RA), or psoriasis treated in routine clinical practice in New Zealand (NZ). Methods: Biologic-naïve adults initiating adalimumab in accordance with NZ funding requirements were recruited. The primary endpoint was 6-month change from baseline in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 score in all participants completing the study (full analysis set). ⋯ No new adalimumab safety signals were observed. Conclusions: Health and disability outcomes improved significantly after 6 months of adalimumab use in NZ patients with severe CD, RA, or psoriasis. Clinicaltrials.gov: NCT02451839.
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Observational Study
Gamma-hydroxybutyrate: is it a feasible alternative to midazolam in long-term mechanically ventilated children?
Aim: Benzodiazepines like midazolam are commonly used for long-term sedation of critically ill children requiring mechanical ventilation. Tolerance to midazolam may occur in these patients resulting in a ceiling effect with insufficient or missing sedative response to increases of midazolam infusion or bolus application. The aim of this study was to evaluate the feasibility of a drug rotation protocol replacing continuous infusion of midazolam with gamma-hydroxybutyrate (GHB) to counteract midazolam tolerance. ⋯ In these children, dosing of midazolam could not be reduced following drug rotation. We could not identify factors which predict success or failure of drug rotation from midazolam to GHB. Conclusions: The data from our single-center study suggest that drug rotation from midazolam to GHB may be worth trying in children with midazolam tolerance during long-term sedation, but physicians should be aware of possible treatment failure.
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Objective: Cardiac arrhythmias can be serious and life threatening, and can impose a significant burden on healthcare systems. Recent technological advances in ambulatory electrocardiogram recorders have led to the development of unobtrusive wearable biosensors which allow physicians to study patients' continuous cardiac rhythm data collected over multiple weeks. The objective of this systematic literature review was to summarize evidence on the clinical effectiveness of the Zio 1 patch, a long-term, continuous, uninterrupted cardiac monitoring system. ⋯ Across the 22 studies, unweighted mean detection rates for atrial fibrillation (AF; n = 15), supraventricular tachycardia or supraventricular ectopy (n = 15), and ventricular tachycardia (n = 15) were 12.2%, 45.5% and 17.3%, respectively. Unweighted mean detection rates for chronic/sustained AF (n = 5) and paroxysmal AF (n = 5) were 5.6% and 23.3%, respectively. Conclusion: Findings from the review suggest that long-term, continuous, uninterrupted monitoring with Zio results in longer patient wear times and higher cardiac arrhythmia detection rates compared with outcomes reported in previous reviews of short-duration (24-48 h) cardiac rhythm recording studies.
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Objectives: (1) To assess the real-world incidence of inflammatory bowel disease (IBD) in patients with or without other chronic inflammatory diseases (CIDs), and (2) to understand whether IBD incidence differs in CID patients receiving interleukin-17a signaling antagonists (anti-IL-17a) or phosphodiesterase 4 inhibitors (PDE4i) versus patients using a biologic not indicated for IBD or biologic-naïve patients. Methods: The MarketScan Research Databases (January 2010-July 2017) were used. A CID population was created from patients with ankylosing spondylitis, psoriatic arthritis, psoriasis or rheumatoid arthritis (RA). ⋯ Similar results were observed in sensitivity analyses where patients with RA only were excluded (since anti-IL-17a and PDE4i agents are not indicated for RA). Conclusions: Anti-IL-17a treatment was associated with a nearly three-fold higher risk of IBD in CID patients. Treatment decisions for patients with CIDs should take into account the risk of developing of IBD.
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Background: Endocrine therapy (ET) remains a foundation of systemic therapy for HR+/ HER2- metastatic breast cancer (MBC), although chemotherapy (CT) is used in select patients. In this "real-world" study, we explored treatment patterns, health care resource use (HCRU), costs, adverse events (AEs) and overall survival (OS) in Medicare-enrolled, older patients with HR+/HER2- MBC. Methods: Patients with HR+/HER2- MBC (2007-2011) and aged >66 years were retrospectively analyzed using the SEER-Medicare data. ⋯ In multivariable analyses, receipt of CT and combination CT + ET (versus ET monotherapy) in 1 L, metastatic disease at initial diagnosis, larger tumor size, and presence of visceral and brain metastases at MBC diagnosis significantly predicted receipt of 2 L therapy. Conclusions: ET was the most common first-line treatment for study patients, but its use decreased gradually in the subsequent lines. The heterogeneity in the treatment selection highlights a lack of consensus for the management of HR+/HER2- MBC in routine practice.