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      Evaluation of the effects of food on levodropropizine controlled-release tablet and its pharmacokinetic profile in comparison to that of immediate-release tablet

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          Abstract

          Background

          Levodropropizine is a non-opioid antitussive agent that inhibits cough reflex by reducing the release of sensory peptide in the peripheral region. To improve patients’ compliance, a controlled-release (CR) tablet is under development. The aim of this study was to compare the pharmacokinetic (PK) profiles of the CR and immediate-release (IR) tablets of levodropropizine. In addition, the effect of food on the PK properties of levodropropizine CR tablet in healthy subjects was evaluated.

          Subjects and methods

          A randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence, crossover study was conducted on 47 healthy subjects. All subjects were randomly assigned to one of the six sequences, which involve combinations of the following three treatments: levodropropizine IR 60 mg three times in the fasted state (R), levodropropizine CR 90 mg two times in the fasted state (T), and levodropropizine CR 90 mg two times in the fed state (TF). Serial blood samples were collected up to 24 h after the first dose. Tolerability was assessed based on the vital signs, adverse events (AEs), and clinical laboratory tests.

          Results

          Levodropropizine CR showed lower maximum drug concentration ( C max) and similar total exposure compared to levodropropizine IR. The geometric mean ratios (GMRs) (90% confidence intervals [CIs]) of T to R for the C max and area under the concentration–time curve from the 0 to 24 h time points (AUC 0–24h) were 0.80 (0.75–0.85) and 0.89 (0.86–0.93), respectively. In the fed group, levodropropizine CR showed exposure similar to that in the fasted group. The GMRs (90% CIs) of TF to T for the C max and AUC 0–24h were 0.90 (0.85–0.97) and 1.10 (1.05–1.14), respectively. No serious AEs occurred with both levodropropizine CR and IR tablets.

          Conclusion

          Total systemic exposure for levodropropizine was similar in subjects receiving the CR and IR formulations in terms of the AUC. Although food delayed the absorption of levodropropizine CR, systemic exposure was not affected.

          Most cited references16

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          Dosing Frequency and Medication Adherence in Chronic Disease

          BACKGROUND: Prior research has shown a decrease in medication adherence as dosing frequency increases; however, meta-analyses have not been able to demonstrate a significant inverse relationship between dosing frequency and adherence when comparing twice-daily versus once-daily dosing. OBJECTIVES: To determine the effect of scheduled dosing frequency on medication adherence in patients with chronic diseases. METHODS: A systematic literature search of Medline and Embase from January 1986 to December 2011 and a hand search of references were performed to identify eligible studies. Randomized and observational studies were included if they utilized a prospective design, assessed adult patients with chronic diseases, evaluated scheduled oral medications taken 1 to 4 times daily, and measured medication adherence for at least 1 month using an electronic monitoring device. Manual searches of reference sections of identified studies and systematic reviews were also performed to find other potentially relevant articles. Standard definitions for medication taking, regimen, and timing adherence were used and evaluated. Studies were pooled using a multivariate linear mixed-model method to conduct meta-regression accounting for both random and fixed effects, weighted 
by the inverse of the variance of medication adherence. RESULTS: Fifty-one studies, comprising 65, 76, and 47 dosing frequency arms for the taking, regimen, and timing adherence endpoints were included. Unadjusted adherence estimates were highest when the least stringent definition, taking adherence, was used (range for dosing frequencies: 80.1%-93.0%) and lowest when the most stringent definition, timing adherence, was used (range for dosing frequencies: 18.8%-76.9%). In multivariate meta-regression analyses, the adjusted weighted mean percentage adherence rates for all regimens dosed more frequently than once per day were significantly lower compared with once-daily regimens (for 2-times, 3-times, and 4-times daily regimens, respectively: differences for taking adherence: –6.7%, –13.5%, and –19.2%; regimen adherence: –13.1%, –24.9%, and –23.1%; and timing adherence: –26.7%, –39.0%, and –54.2%). CONCLUSIONS: Patients with chronic diseases appear to be more adherent with once-daily compared with more frequently scheduled medication regimens. The use of more stringent definitions of adherence magnified these findings.
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            Relationship between oral antihyperglycemic medication adherence and hospitalization, mortality, and healthcare costs in adult ambulatory care patients with type 2 diabetes in South Korea.

            Medication adherence has been identified as a major factor influencing health outcomes in patients with type 2 diabetes. We assessed the relationship between initial adherence to oral antihyperglycemic medications and subsequent health outcomes. This was a retrospective cohort study of 40,082 patients enrolled in Korea's national health insurance program, who were 20 years of age or older and first diagnosed with type 2 diabetes in 2004. The patients were followed up for 3 years using claims data to measure adherence to oral antihyperglycemic medications for the initial 2 years after diagnosis and to investigate hospitalization, mortality, and healthcare costs in the third year of follow-up. After adjusting for confounders, nonadherence in the first 2 years after prescription increased the risk for hospitalization in the third year compared with adherence over the same period [odds ratio (OR)=1.26, 95% confidence interval=1.08-1.47]. Nonadherence in at least one of the 2 years increased the risk for hospitalization compared with adherence in both years. In addition, nonadherence during both the first and second years was associated with statistically significantly greater risks for mortality during this period than was adherence (odds ratio=1.40, 95% confidence interval=1.01-1.95). Medication adherence decreased healthcare costs compared with nonadherence (β=-0.127; P<0.001). Because improved medication adherence can produce better health outcomes for diabetes patients and also save national healthcare resources, government-sponsored healthcare policies to improve medication adherence among newly diagnosed diabetes patients are urgently required.
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              Antitussive drugs--past, present, and future.

              Cough remains a serious unmet clinical problem, both as a symptom of a range of other conditions such as asthma, chronic obstructive pulmonary disease, gastroesophageal reflux, and as a problem in its own right in patients with chronic cough of unknown origin. This article reviews our current understanding of the pathogenesis of cough and the hypertussive state characterizing a number of diseases as well as reviewing the evidence for the different classes of antitussive drug currently in clinical use. For completeness, the review also discusses a number of major drug classes often clinically used to treat cough but that are not generally classified as antitussive drugs. We also reviewed a number of drug classes in various stages of development as antitussive drugs. Perhaps surprising for drugs used to treat such a common symptom, there is a paucity of well-controlled clinical studies documenting evidence for the use of many of the drug classes in use today, particularly those available over the counter. Nonetheless, there has been a considerable increase in our understanding of the cough reflex over the last decade that has led to a number of promising new targets for antitussive drugs being identified and thus giving some hope of new drugs being available in the not too distant future for the treatment of this often debilitating symptom.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                Drug Design, Development and Therapy
                Dove Medical Press
                1177-8881
                2018
                23 May 2018
                : 12
                : 1413-1420
                Affiliations
                [1 ]Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea
                [2 ]College of Pharmacy, Ajou University, Suwon, Republic of Korea
                [3 ]Korea United Pharm Inc., Seoul, Republic of Korea
                [4 ]Institute of Pharmaceutical Science and Technology, Ajou University, Suwon, Republic of Korea
                [5 ]Department of Pharmacology, Chungnam National University Hospital and College of Medicine, Daejeon, Republic of Korea
                Author notes
                Correspondence: Jang-Hee Hong, Department of Pharmacology, Chungnam National University Hospital and College of Medicine, 266 munhwa-ro, Jung-gu, Daejeon 35015, Republic of Korea, Tel +82 42 280 6940, Fax +82 42 280 6947, Email boniii@ 123456cnu.ac.kr
                Beom-Jin Lee, College of Pharmacy, Ajou University, Institute of Pharmaceutical Science and Technology, Ajou University, 206 Worldcup-ro, Yeongtong-gu, Suwon 16499, Republic of Korea, Tel +82 31 219 3502, Fax +82 31 212 3653, Email bjl@ 123456ajou.ac.kr
                [*]

                These authors contributed equally to this work

                Article
                dddt-12-1413
                10.2147/DDDT.S146958
                5973308
                c51e4dd8-0d19-4eca-8722-f398ccb64e4a
                © 2018 Lee et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                History
                Categories
                Original Research

                Pharmacology & Pharmaceutical medicine
                pharmacokinetics,controlled-release,immediate-release,food effect

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