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  • SAGE Publications  (9)
  • 1
    Online Resource
    Online Resource
    Tenofovir Disoproxil Fumarate Monotherapy is Superior to Entecavir-Adefovir Combination Therapy in Patients with Suboptimal Response to Lamivudine-Adefovir Therapy for Nucleoside-Resistant HBV: A 96-Week Prospective Multicentre Trial
    SAGE Publications ; 2018
    In:  Antiviral Therapy Vol. 23, No. 3 ( 2018-04), p. 219-227
    Details
    In: Antiviral Therapy, SAGE Publications, Vol. 23, No. 3 ( 2018-04), p. 219-227
    Abstract: A complete virological response is closely related to the long-term outcome of patients with chronic hepatitis B and prevention of emerging HBV mutations. We aimed to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) monotherapy compared to entecavir-adefovir dipivoxil (ETV-ADV) combination therapy in patients with suboptimal responses to long-term lamivudine-adefovir dipivoxil (LAM-ADV) therapy for nucleoside analogue-resistant chronic hepatitis B. Methods Patients ( n=60) were randomized to TDF monotherapy or ETV-ADV combination therapy for 96 weeks. All patients had the rt204I/V mutation and serum HBV DNA was measured ( 〉 60 IU/ml) during LAM-ADV therapy. The primary end point was a complete virological response (HBV DNA 〈 20 IU/ml) at week 96. Results The median duration of prior LAM-ADV rescue therapy was 43 (7–108) months. A complete virological response was achieved in 86.6% and 53.3% of patients in the TDF and ETV-ADV groups, respectively, at week 96 ( P=0.005). Reduction in serum HBV DNA was significantly greater in the TDF group than in ETV-ADV group (-3.2 ±1.2 versus -2.6 ±1.2; P=0.01). Hepatitis B e antigen loss (22.2% versus 16.6%; P=0.731) and biochemical responses (76.7% versus 73.3%; P=0.766) were not different between the TDF and ETV-ADV groups. No newly emerged mutations were detected. Both therapies demonstrated favourable safety profiles. Conclusions TDF therapy achieved a better complete virological response than ETV-ADV therapy in chronic hepatitis B patients with suboptimal response to long-term LAM-ADV rescue therapy. (KCT0000627).
    Type of Medium: Online Resource
    ISSN: 1359-6535 , 2040-2058
    URL: Article
    DOI: 10.3851/IMP3169
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2018
    detail.hit.zdb_id: 2118396-X
    SSG: 15,3
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  • 2
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    Dual antiplatelet Use for extended period taRgeted to AcuTe ischemic stroke with presumed atherosclerotic OrigiN (DURATION) trial: Rationale and design
    SAGE Publications ; 2023
    In:  International Journal of Stroke Vol. 18, No. 8 ( 2023-10), p. 1015-1020
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 18, No. 8 ( 2023-10), p. 1015-1020
    Abstract: The optimal duration of dual antiplatelet therapy (DAPT) with clopidogrel-aspirin for the large artery atherosclerotic (LAA) stroke subtype has been debated. Aims: To determine whether the 1-year risk of recurrent vascular events could be reduced by a longer duration of DAPT in patients with the LAA stroke subtype. Methods and study design: A total of 4806 participants will be recruited to detect a statistically significant relative risk reduction of 22% with 80% power and a two-sided alpha error of 0.05, including a 10% loss to follow-up. This is a registry-based, multicenter, prospective, randomized, open-label, blinded end point study designed to evaluate the efficacy and safety of a 12-month duration of DAPT compared with a 3-month duration of DAPT in the LAA stroke subtype. Patients will be randomized (1:1) to either DAPT for 12 months or DAPT for 3 months, followed by monotherapy (either aspirin or clopidogrel) for the remaining 9 months. Study outcomes: The primary efficacy outcome of the study is a composite of stroke (ischemic or hemorrhagic), myocardial infarction, and all-cause mortality for 1 year after the index stroke. The secondary efficacy outcomes are (1) stroke, (2) ischemic stroke or transient ischemic attack, (3) hemorrhagic stroke, and (4) all-cause mortality. The primary safety outcome is major bleeding. Discussion: This study will help stroke physicians determine the appropriate duration of dual therapy with clopidogrel-aspirin for patients with the LAA stroke subtype. Trial registration: URL: https://cris.nih.go.kr/cris . CRIS Registration Number: KCT0004407
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/17474930231168742
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2211666-7
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  • 3
    Online Resource
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    Optimal use of antithrombotic agents in ischemic stroke with atrial fibrillation and large artery atherosclerosis
    SAGE Publications ; 2023
    In:  International Journal of Stroke Vol. 18, No. 7 ( 2023-08), p. 812-820
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 18, No. 7 ( 2023-08), p. 812-820
    Abstract: Optimal antithrombotic regimens to prevent recurrent stroke in patients with ischemic stroke due to atrial fibrillation (AF) and atherosclerotic large-vessel stenosis remain unknown. Aims: This study aimed to evaluate the effect of multiple antithrombotic therapies on outcomes at 1 year after ischemic stroke due to two or more causes. Methods: We identified 862 patients with ischemic stroke due to AF and large artery atherosclerosis from the linked data. These patients were categorized into three groups according to antithrombotic therapies at discharge: (1) antiplatelets, (2) oral anticoagulants (OAC), and (3) antiplatelets plus OAC. The study outcomes were recurrent ischemic stroke, composite outcomes for cardiovascular events, and major bleeding after 1 year. Inverse probability of treatment weighting (IPTW) was used to balance the three groups using propensity scores. Results: Among 862 patients, 169 (19.6%) were treated with antiplatelets, 405 (47.0%) were treated with OAC, and 288 (33.4%) were treated with antiplatelets and OAC. After applying IPTW, only OAC had a significant beneficial effect on the 1-year composite outcome (hazard ratio (HR): 0.37, 95% confidence interval (CI): 0.23–0.60, p  〈  0.001) and death (HR: 0.35, 95% CI: (0.19–0.63), p  〈  0.001). The combination of antiplatelet agents and OAC group had an increased risk of major bleeding complications (HR: 5.27, 95% CI: (1.31–21.16), p = 0.019). However, there was no significant difference in 1-year recurrent stroke events among the three groups. Conclusion: This study demonstrated that OAC monotherapy was associated with lower risks of composite outcome and death in patients at 1 year after ischemic stroke due to AF and atherosclerotic stenosis. In addition, the combination of an antiplatelet and OAC had a high risk of major bleeding.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/17474930231158211
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2211666-7
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  • 4
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    Impact of bronchiectasis on susceptibility to and severity of COVID-19: a nationwide cohort study
    SAGE Publications ; 2021
    In:  Therapeutic Advances in Respiratory Disease Vol. 15 ( 2021-01), p. 175346662199504-
    Details
    In: Therapeutic Advances in Respiratory Disease, SAGE Publications, Vol. 15 ( 2021-01), p. 175346662199504-
    Type of Medium: Online Resource
    ISSN: 1753-4666 , 1753-4666
    URL: Article
    DOI: 10.1177/1753466621995043
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
    detail.hit.zdb_id: 2387506-9
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  • 5
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    Outcome in Patients Treated with Intra-arterial thrombectomy: The optiMAL Blood Pressure control (OPTIMAL-BP) Trial
    SAGE Publications ; 2022
    In:  International Journal of Stroke Vol. 17, No. 8 ( 2022-10), p. 931-937
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 17, No. 8 ( 2022-10), p. 931-937
    Abstract: Very early stage blood pressure (BP) levels may affect outcome in stroke patients who have successfully undergone recanalization following intra-arterial treatment, but the optimal target of BP management remains uncertain. Aim We hypothesized that the clinical outcome after intensive BP-lowering is superior to conventional BP control after successful recanalization by intra-arterial treatment. Sample-size estimates We aim to randomize 668 patients (334 per arm), 1:1. Methods and design We initiated a multicenter, prospective, randomized, open-label trial with a blinded end-point assessment (PROBE) design. After successful recanalization (thrombolysis in cerebral infarction score ≥ 2 b), patients with elevated systolic BP level, defined as the mean of two readings ≥ 140 mmHg, will be randomly assigned to the intensive BP-lowering (systolic BP  〈  140 mm Hg) group or the conventional BP-lowering (systolic BP, 140−180 mm Hg) group. Study outcomes The primary efficacy outcomes are from dichotomized analysis of modified Rankin Scale (mRS) scores at three months (mRS scores: 0–2 vs. 3–6). The primary safety outcomes are symptomatic intracerebral hemorrhage and death within three months. Discussion The OPTIMAL-BP trial will provide evidence for the effectiveness of active BP control to achieve systolic BP  〈  140 mmHg during 24 h in patients with successful recanalization after intra-arterial treatment. Clinical trial registration ClinicalTrials.gov Identifier: NCT04205305.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/17474930211041213
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
    detail.hit.zdb_id: 2211666-7
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  • 6
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    Trends and factors associated with influenza vaccination in subjects with asthma: analysis of the Korea National Health and Nutrition Examination Survey between 2010 and 2019
    SAGE Publications ; 2022
    In:  Therapeutic Advances in Chronic Disease Vol. 13 ( 2022-01), p. 204062232211239-
    Details
    In: Therapeutic Advances in Chronic Disease, SAGE Publications, Vol. 13 ( 2022-01), p. 204062232211239-
    Abstract: Despite the importance of influenza vaccination, its rates in subjects with asthma are suboptimal, especially in the young population. Methods: Among 72,843 adults aged ⩾18 years from the Korea National Health and Nutrition Examination Survey conducted between 2010 and 2019, 1643 with asthma were included. The yearly trends and factors associated with influenza vaccination were analyzed in subjects with asthma. In addition, stratified analyses were performed by age group ( 〈 65 versus ⩾65 years). Results: During the study period, the overall influenza vaccination rate among subjects with asthma fluctuated from 51.0% to 64.3%, with a consistently higher vaccination rate in elderly subjects than in young subjects. Among young subjects with asthma, factors positively associated with influenza vaccination were female sex [adjusted odds ratio (aOR) = 1.66, 95% confidence interval (CI) = 1.11–2.49] , current asthma being treated (aOR = 1.69, 95% CI = 1.14–2.50), history of pulmonary tuberculosis (aOR = 2.01, 95% CI = 1.04–3.87), and dyslipidemia (aOR = 1.86, 95% CI = 1.05–3.30). However, unmarried subjects showed an inverse relationship (aOR = 0.50, 95% CI = 0.34–0.75). In elderly subjects, unmarried status (aOR = 0.52, 95% CI = 0.29–0.94), being underweight (aOR = 0.29, 95% CI = 0.09–0.97), and having a low income (aOR = 0.42, 95% CI = 0.18–0.97) were factors negatively associated with influenza vaccination. Conclusion: In the last 10 years, influenza vaccination rates have still been insufficient in subjects with asthma, particularly in young subjects. Considering the factors that are influencing the vaccination rates of young subjects, public policies to increase influenza vaccination rates in subjects with asthma need to be established urgently.
    Type of Medium: Online Resource
    ISSN: 2040-6223 , 2040-6231
    URL: Article
    DOI: 10.1177/20406223221123979
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
    detail.hit.zdb_id: 2554816-5
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  • 7
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    Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study)
    SAGE Publications ; 2021
    In:  Therapeutic Advances in Medical Oncology Vol. 13 ( 2021-01), p. 175883592110619-
    Details
    In: Therapeutic Advances in Medical Oncology, SAGE Publications, Vol. 13 ( 2021-01), p. 175883592110619-
    Abstract: Standard intravenous (IV) paclitaxel is associated with hypersensitivity/toxicity. Alternative IV formulations have improved tolerability but still require frequent hospital visits and IV infusion. DHP107 is a novel oral formulation of paclitaxel that is approved in South Korea for the treatment of gastric cancer. Methods: This multicenter, phase II study using a Simon’s two-stage design investigated the efficacy and safety of DHP107 200 mg/m 2 administered orally twice daily on days 1, 8, and 15 every 4 weeks for the first-line treatment of recurrent or metastatic HER2-negative breast cancer. Results: Thirty-six patients were enrolled and 31 were assessable for efficacy. Patient median age was 57 years (range = 34–81) and 11 (31%) had triple-negative disease. A median of seven cycles (range = 1–28) of DHP107 was administered. Objective response rate was 55% (17 patients), all partial responses, according to the investigator’s decision and independent central review (ICR), and 44% (4/9 patients) in those with triple-negative disease. Disease control rate (partial response and stable disease) was 74% (23 patients) according to the investigator’s decision and ICR. In the intention-to-treat (ITT) population of all enrolled participants, the objective response rate was 50% (18/36 patients). Median progression-free survival was 8.9 months [95% confidence interval [CI]: 5.2–12.3) and median time to treatment failure was 8.0 months (95% CI: 4.2–10.0). DHP107 had an acceptable toxicity profile. All patients experienced treatment-emergent adverse events; the most common adverse events were decreased neutrophil count (81% all grades and 78% grade ⩾ 3) followed by peripheral sensory neuropathy (61% all grades and 8% grade 3). However, there was no febrile neutropenia or sepsis. Conclusion: DHP107 showed promising efficacy and acceptable tolerability in this phase II study and is currently being investigated in the OPTIMAL phase III study (NCT03315364). Trial registration: This trial was registered with ClinicalTrials.gov identifier: NCT03315364.
    Type of Medium: Online Resource
    ISSN: 1758-8359 , 1758-8359
    URL: Article
    DOI: 10.1177/17588359211061989
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
    detail.hit.zdb_id: 2503443-1
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  • 8
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    Effect of Recombinant Human Bone Morphogenetic Protein-2 and Adipose Tissue-Derived Stem Cell on New Bone Formation in High-Speed Distraction Osteogenesis
    SAGE Publications ; 2016
    In:  The Cleft Palate-Craniofacial Journal Vol. 53, No. 1 ( 2016-01), p. 84-92
    Details
    In: The Cleft Palate-Craniofacial Journal, SAGE Publications, Vol. 53, No. 1 ( 2016-01), p. 84-92
    Abstract: The effects of recombinant human bone morphogenetic protein-2 (rhBMP-2) and osteogenically differentiated adipose tissue-derived stem cells (ADSC) on new bone formation in high-speed distraction osteogenesis of adult rabbit cranium were investigated. Materials and Methods A total of 41 adult rabbits were used in the study. Distraction began after a 5-day latency period at a rate of 1.5 mm twice a day until 10-mm length gain was obtained both in the control group, where a bone defect was induced, and in the experimental group, in which ADSC (group A), rhBMP-2 (group B), or both (group C) were injected in the distraction gap after distraction. At 4, 8, and 12 weeks after distraction, computed tomography analysis was done to determine the bone defect dimension and bone mineral density (BMD), while histologic examination was also done to calculate bone formation ratio. Results Bone defect dimension significantly decreased in groups B and C, compared with the control group, at 4 and 12 weeks after distraction. BMD was significantly increased in groups B and C at 4 weeks. On histologic examination, bone formation ratio was significantly increased in group C only at 12 weeks. Conclusion This study suggests that the use of rhBMP-2 in combination with or without ADSC is helpful to promote bone regeneration in high-speed distraction osteogenesi s of adult rabbit cranium.
    Type of Medium: Online Resource
    ISSN: 1055-6656 , 1545-1569
    URL: Article
    DOI: 10.1597/12-290
    RVK:
    XA 36625
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2016
    detail.hit.zdb_id: 2030056-6
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  • 9
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    Bronchiectasis and increased mortality in patients with corticosteroid-dependent severe asthma: a nationwide population study
    SAGE Publications ; 2020
    In:  Therapeutic Advances in Respiratory Disease Vol. 14 ( 2020-01), p. 175346662096303-
    Details
    In: Therapeutic Advances in Respiratory Disease, SAGE Publications, Vol. 14 ( 2020-01), p. 175346662096303-
    Abstract: Long-term corticosteroid (CS) use is associated with increased mortality in patients with asthma, and comorbid bronchiectasis is also associated with frequent asthma exacerbation and increased healthcare use. However, there is limited information on whether bronchiectasis further increases mortality in patients with CS-dependent asthma. This study examined the impact of bronchiectasis on mortality in patients with CS-dependent asthma. Methods: A retrospective cohort of patients with CS-dependent asthma ⩾18 years old was established using records from the Korean National Health Insurance Service database from 2005 to 2015. Patients with CS-dependent asthma with and without bronchiectasis were matched by age, sex, type of insurance, and Charlson comorbidity index. We evaluated the hazard ratio (HR) for all-cause mortality in patients with bronchiectasis compared with those without bronchiectasis. Results: The study cohort included 754 patients with CS-dependent asthma with bronchiectasis and 3016 patients with CS-dependent asthma without bronchiectasis. Patients with CS-dependent asthma with bronchiectasis had a higher all-cause mortality than those without bronchiectasis (8429/100,000 versus 6962/100,000 person-years, p  〈  0.001). The adjusted HR for mortality in patients with CS-dependent asthma with bronchiectasis relative to those without bronchiectasis was 1.33 (95% confidence interval, 1.18–1.50), and the association was primarily significant for respiratory diseases (subdistribution HR = 1.65, 95% confidence interval, 1.42–1.92). Conclusions: Bronchiectasis further increases all-cause mortality in patients with CS-dependent asthma, a trend that was especially associated with respiratory diseases including chronic obstructive pulmonary disease. Strategies to improve treatment outcomes in patients with CS-dependent asthma with bronchiectasis are urgently needed to improve long-term survival. The reviews of this paper are available via the supplemental material section.
    Type of Medium: Online Resource
    ISSN: 1753-4666 , 1753-4666
    URL: Article
    DOI: 10.1177/1753466620963030
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2387506-9
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