Current medical research and opinion
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Review Meta Analysis Comparative Study
Abiraterone acetate/androgen deprivation therapy combination versus docetaxel/androgen deprivation therapy combination in advanced hormone-sensitive prostate cancer: a network meta-analysis on safety and efficacy.
A major, yet precisely studied, shift has occurred in the treatment of advanced hormone-sensitive prostate cancer (HSPC) by the addition of docetaxel to androgen deprivation therapy (ADT) in the first line. Recently, two landmark trials showed that abiraterone acetate (AA) can be an effective alternative along with ADT in the same setting. We implemented a network meta-analysis to compare the safety and efficacy of the two combinations. ⋯ Patients with metastatic HSPC (mHSPC) who received abiraterone acetate with ADT had better PFS and less toxicity compared to those receiving docetaxel with ADT. A trend towards superior OS and fewer treatment-related deaths was also observed, but was statistically non-significant. In view of lacking clear OS advantage, the choice between docetaxel and AA should include a discussion with the patient about the potential toxicities and impact on quality of life of each regimen.
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The development and use of abuse-deterrent (AD) opioids is part of a multifaceted strategy to reduce misuse, abuse, and diversion, while maintaining access for patients with severe pain who may benefit from their analgesic efficacy. Morphine AD, extended-release (ER), injection-molded tablets (morphine-ADER-IMT; ARYMO ER; Egalet US Inc., Wayne, PA) is approved by the FDA as an AD opioid. As part of the characterization of AD opioids, assessments of their human abuse potential (HAP) are required. Evidence from HAP studies can guide clinicians on the use of AD opioids in clinical practice. Herein, we describe HAP study design, and how specific AD features can impact the conduct of a study and interpretation of its results. ⋯ Results from HAP studies with morphine-ADER-IMT and other AD opioids suggest that key study design features include the release profile (immediate-release vs extended-release) of the positive control, study drug doses, and the way the products are manipulated. These elements can directly impact the outcomes of the pharmacokinetic and pharmacodynamic (e.g. Maximum Drug Liking, Overall Drug Liking, and Take Drug Again) results. When evaluating HAP studies, it is important to understand study design features to assist in the interpretation of the results and understand the clinical relevance of the data to help guide clinical decision-making about the use of AD opioids.
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Abuse and misuse of prescription opioids is a significant public health concern. This review examines the strategies used to confer abuse-deterrent properties on opioid abuse-deterrent formulations (ADFs), the characteristics and supporting data for each of the available ADFs, and the role of opioid ADFs as part of a comprehensive opioid risk management plan. ⋯ Although not sufficient by themselves to prevent prescription opioid abuse and misuse, opioid ADFs are an important component of a healthcare provider's comprehensive opioid risk management plan (along with utilization of prescription drug monitoring programs, clinical assessment tools, urine tests, co-prescribing of naloxone to patients at risk of an overdose, access to non-pharmacological treatments and addiction/mental health resources, among others). Adoption of opioid ADFs should be considered as part of an overall public health opioid risk management plan involving all stakeholders to balance legitimate safe and effective use of opioids against misuse and abuse.
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Randomized controlled trials (RCTs) have established the safety and efficacy of omalizumab on clinical parameters, and have also evaluated its impact on patient-reported outcomes (PROs). The purpose of this systematic literature review was to review published data based on PRO endpoints in order to determine the benefit of omalizumab as add-on therapy to inhaled corticosteroids in patients with moderate-to-severe persistent allergic asthma. ⋯ PROs are an integral part of outcome assessment in clinical trials related to asthma. The RCTs reviewed demonstrate that omalizumab treatment improves PROs in patients with moderate-to-severe persistent allergic asthma, particularly symptom control and HRQoL.
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To consider the key implications of iron deficiency for biochemical and physiological functions beyond erythropoiesis. ⋯ The widespread cellular and physiological effects of iron deficiency highlight the need for early detection and treatment of iron deficiency, both to ameliorate these non-erythropoietic effects, and to avoid progression to iron deficiency anemia.