Current medical research and opinion
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Randomized Controlled Trial Multicenter Study
IncobotulinumtoxinA for upper- and lower-limb spasticity in Japanese patients.
Introduction: The safety and tolerability of incobotulinumtoxinA 400 U for upper- and lower-limb post-stroke spasticity was assessed in a small cohort of Japanese patients during the open-label lead-in tolerability periods (LITP) of two phase 3 studies (CTI-153029 and CTI-153030; Japan Pharmaceutical Information Centre). Methods: Adult patients received a single incobotulinumtoxinA injection session (total dose of 400 U) in the upper (J-PURE) or lower limb (J-PLUS). Adverse events (AEs) were assessed at 1, 4, 8 and 12 weeks post-injection during the 12 week follow-up. ⋯ Non-serious, transient AEs of special interest reported by two patients in J-PURE comprised muscular weakness and eyelid ptosis. No patient discontinued due to AEs. Conclusion: Preliminary results in this small population suggest that incobotulinumtoxinA 400 U is well tolerated for treating upper- or lower-limb post-stroke spasticity in Japanese patients.
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Objective: To assess the real-world use of home health services (HHS) among patients with major depressive disorder (MDD) with and without treatment-resistant depression (TRD). Methods: Adults (18-64 years) from a commercial claims database (07/2009 to 03/2015) were categorized into three cohorts: "TRD"(N = 6411), "non-TRD MDD"(N = 33,068), "non-MDD"(N = 149,884) stratified based on use of HHS (HHS vs. no-HHS). Healthcare resource utilization (HRU) and costs were evaluated up to two years following the first antidepressant pharmacy claim using descriptive statistics. ⋯ Patients without MDD who used HHS had annual healthcare costs of $22,340 while non-MDD patients who did not use HHS had healthcare costs of $3479 PPPY. However, among HHS users, HHS costs represented a relatively small proportion of total healthcare costs. Conclusions: The high proportion of TRD patients using HHS suggests it is a utilized healthcare delivery pathway by TRD patients.
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Objective: Varenicline, a selective partial agonist of the α4β2 nicotinic acetylcholine receptor, is a smoking cessation pharmacotherapy that more than doubles the chance of quitting smoking at 6 months compared with placebo. This article reviews salient knowledge of the discovery, pharmacological characteristics, and the efficacy and safety of varenicline in general and in specific populations of smokers and provides recommendations to support use in clinical practice. Methods: Literature searches for varenicline were conducted using PubMed, with date limitations of 2000-2018 inclusive, using search terms covering the discovery, mechanism of action, pharmacokinetics, efficacy and safety in different populations of smokers, alternative quit approaches and combination therapy. ⋯ Initial concerns regarding the association of varenicline with increased risk of neuropsychiatric and cardiovascular adverse events have been disproven after extensive clinical evaluations, and the benefit-risk profile of varenicline is considered favorable. Conclusions: Varenicline is efficacious and safe for all adult smokers with a range of clinical characteristics. Evidence suggests that approaches offering greater flexibility in timing and duration of treatment may further extend treatment efficacy and clinical reach.
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Objective: To perform evaluations of the CONTOUR PLUS LINK 2.4 blood glucose monitoring system (BGMS) assessed according to ISO 15197:2013 criteria. Methods: Clinical trial registered at ClinicalTrials.gov (NCT01824355). In a laboratory study (Study 1), capillary fingertip blood samples from 100 subjects were evaluated in duplicate, using three test strip lots. ⋯ Most subjects found the BGMS easy to use. There were three non-serious, non-device related adverse events. Conclusion: The BGMS exceeded minimum ISO 15197:2013-specified accuracy criteria in the laboratory and in the hands of lay users with diabetes.
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Observational Study
Distance to glycemic goal at the time of treatment intensification in patients with type 2 diabetes mellitus failing metformin monotherapy in the United States.
Background: A substantial proportion of patients with type 2 diabetes mellitus (T2DM) do not reach their target HbA1c level on metformin. The objective of this retrospective observational cohort study is to better characterize the distance between HbA1c target and patient's actual HbA1c level (the distance to goal), using a target HbA1c of 7.0% (53 mmol/mol), in patients with T2DM who have started metformin monotherapy. Methods: We used data from the GE Centricity Electronic Medical Record database by IQVIA in 2016 in the United States (US) to identify adults with T2DM who started metformin monotherapy (MM) and received at least 90 days of treatment. ⋯ The mean post-MM HbA1c for those who failed MM and did not receive intensified treatment was 8.0% (64 mmol/mol) (median 7.5%, 58 mmol/mol) and the mean distance to goal was 1.0% (median 0.5%). Conclusion: A proportion of US T2DM patients do not achieve glycemic control (target HbA1c < 7.0%) despite 90 days of MM. Patients who failed MM and eventually received intensified treatment did so when their HbA1c distance to goal exceeded the level at which one add-on therapy alone might be sufficient to bring them to goal.