Clinical therapeutics
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Clinical therapeutics · Dec 2016
The US Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) Program - Current Status and Future Direction.
The US Food and Drug Administration (FDA) Amendments Act of 2007 granted the FDA new authorities to enhance drug safety by requiring application holders to submit a proposed Risk Evaluation and Mitigation Strategy (REMS). A REMS is a required risk management plan that uses tools beyond the package insert. REMS elements may include a medication guide and patient package insert for patients and a communication plan focused on health care professionals. ⋯ In 2011, FDA created the REMS Integration Initiative to develop guidance on how to apply statutory criteria to determine when a REMS is required, to improve standardization and assessment of REMS, and to improve integration of REMS into the existing healthcare system. A key component of the REMS Integration Initiative is stakeholder outreach to better understand how existing REMS programs are working and to identify opportunities for improvement. This review attempts to share our company's experience with the REMS program, and to provide updates on FDA's efforts to improve REMS communication, to standardize REMS process, to reduce REMS program burdens and to build a common REMS platform.
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Clinical therapeutics · Dec 2016
Meta Analysis Comparative StudyTofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis.
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This analysis compared the efficacy and safety of tofacitinib with biologic disease-modifying antirheumatic drugs in patients with RA and a prior inadequate response (IR) to tumor necrosis factor inhibitors (TNFi). ⋯ During a 24-week period, tofacitinib had efficacy and rates of AEs comparable with currently available bDMARDs in the treatment of patients with RA who had a prior IR to TNFi. ClinicalTrials.gov identifiers: ORAL Step, NCT00960440; ATTAIN, NCT00124982; GO-AFTER, NCT00299546; RADIATE, NCT00106522; REFLEX, NCT00462345.
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Clinical therapeutics · Nov 2016
Perceived Effectiveness, Self-efficacy, and Social Support for Oral Appliance Therapy Among Older Veterans With Obstructive Sleep Apnea.
Obstructive sleep apnea is a prevalent sleep disorder among older adults. Oral appliances are increasingly prescribed as therapy for obstructive sleep apnea. Adherence to oral appliance therapy is highly variable. Based on value-expectancy theory and other social-psychological theories, adherence to oral appliance therapy may be influenced by patients' perceived effectiveness of the therapy, self-efficacy, and availability of social support. We examined these perceptions among older adults with obstructive sleep apnea who were prescribed oral appliance therapy. ⋯ Although oral appliance therapy is increasingly prescribed for obstructive sleep apnea, only about one third of older adults prescribed it perceived it to be an effective treatment, were confident about oral appliance use, and/or believed that they would receive needed support. Future research is needed to better understand older adults' perceptions so that interventions can be designed to improve the effectiveness of oral appliances, their self-efficacy for using oral appliances, and their social support for this therapy, which may, in turn, improve oral appliance therapy adherence.
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This article summarizes the results of a recent systematic review and meta-analysis of the safety and efficacy of intensive blood pressure (BP) lowering, including an update with the SPRINT (Systolic Blood Pressure Intervention Trial) results. We discuss the consistency of results within this set of trials (eg, ACCORD [Action to Control Cardiovascular Risk in Diabetes] and SPRINT) and the results in the context of other BP-lowering trials, including the recently published HOPE3 (Heart Outcomes Prevention Evaluation-3) study. ⋯ The evidence accumulated thus far provides clear evidence of the benefits of BP lowering in the 120- to 140-mm Hg range for various high-risk patient groups. Although intensive BP lowering has side effects, these trials indicate that the benefits will predominate for those at high risk of major vascular events.
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Clinical therapeutics · Oct 2016
ReviewAmbulatory Blood Pressure Monitoring for the Effective Management of Antihypertensive Drug Treatment.
This purpose of this article is to review the current recommendations for ambulatory blood pressure measurement (ABPM) and the use of ABPM in assessing treatment. ⋯ In view of a deficiency in the literature on the role of ABPM in assess the efficacy of drug treatment, we put forward proposals to correct this deficiency and guide the prescribing physician on the most appropriate drug administration and dosage over time.